Patent Docs

Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

Ever since the Supreme Court's decision in Dickinson v. Zurko, federal courts (including the Federal Circuit) are compelled under the Administrative Procedures Act to review factual determinations by the U.S. Patent and Trademark Office under a substantial evidence standard.  The consequences of this standard are illustrated (once again) in the Federal Circuit affirming the Office's determination in an inter partes review (IPR) proceeding invalidating the challenged claims, in Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc.

Challenger Regeneron obtained institution of the IPR for all claims on U.S. Patent No. 9,220,631 owned by Novartis.  The claims were directed to "a small volume syringe such as a syringe suitable for ophthalmic injections."  Such syringes are useful for administering therapeutic agents (such as vascular endothelial growth factor (VEGF) antagonists) to the eye for treating ocular diseases.  Suitable syringes must be sterile and in order to avoid damaging the therapeutic agent must be sealed to prevent sterilizing agents (such as hydrogen peroxide) from contaminating the drug.  Tight seals have the disadvantage of increasing the pressure (force, termed according to the opinion the "break-loose force") required to administer the drug into the delicate ocular tissues.  A solution known in the prior art, treating the syringe with silicone oil, had the drawback that it can cause medical complications should it get into the patient's eye.

The invention claimed in the '631 patent provided the following solution illustrated by claims 1 and 21:

1.  A pre-filled, terminally sterilized syringe for intravitreal injection, the syringe comprising a glass body forming a barrel, a stopper and a plunger and
    containing an ophthalmic solution which comprises a VEGF-antagonist, wherein:
        (a) the syringe has a nominal maximum fill volume of between about 0.5 ml and about 1 ml,
        (b) the syringe barrel comprises from about 1 μg to 100 μg silicone oil,
        (c) the VEGF antagonist solution comprises no more than 2 particles >50 μm in diameter per ml and wherein the syringe has a stopper break-loose force of less than about 11N.

21.  A blister pack comprising a pre-filled syringe according to claim 17, wherein the syringe has been sterili[z]ed using EtO or H₂O₂ with a Sterility Assurance Level of at least 10^–6.

According to the Federal Circuit's opinion, Novartis did not "meaningfully dispute" Regeneron's assertions that that the prior art disclosed all the limitations recited in the challenged claims, in particular PCT Publication No. WO 2011/006877 ("Siggs") that disclosed "a pre-filled terminally sterilized syringe containing a VEGF-antagonist" and PCT Publication No. WO 2009/030976 ("Boulange") that disclosed "a stopper with the claimed silicone oil and break-loose force limitations."  Rather, it was Novartis's contention that the worker of ordinary skill in the art would not have been motivated to combine these references having a reasonable expectation of success in doing so.  Novartis also asserted that objective indicia of non-obviousness supported its claims in defense of Regeneron's challenge.

The Patent Trial and Appeal Board (Board) agreed with Regeneron in an extensive (128 page!) Final Written Decision that the challenged claims were obvious, supporting this determination by prior art references that include the Sigg and Boulange references.  The Board found that Sigg provided a terminally sterilized pre-filled syringe and that Boulange taught silicone sterilization methods that would minimize the risk of contamination.  Additionally, the Board found that the skilled worker would have had a reasonable expectation of success using the choice of stopper (Stopper C) taught by Boulange, which provided a tight enough seal to permit the syringe to be sterilized while having a break-loose force within the claimed 11N limit.  Regarding Novartis's assertion of objective indicia of non-obviousness, the Board opined that "[t]he stronger evidence of obviousness cannot be overcome with the weaker evidence of long-felt need and failure of others."

The Federal Circuit affirmed, in an opinion by Judge Chen joined by Judges Prost and Reyna.  From the thirteen (!) arguments raised by Novartis, the opinion states that it considered only Novartis's principal ones.  The first of these was that the prior art teaches away from the combination of the Sigg and Boulange references.  In assessing and rejecting this argument, the Court noted that "teaching away" raised a question of fact, citing In re Fulton, 391 F.3d 1195, 1199–200 (Fed. Cir. 2004), and that the Board's factual determinations were reviewed by the Federal Circuit for substantial evidence, citing PersonalWeb Techs., LLC v. Apple, Inc., 917 F.3d 1376, 1381 (Fed. Cir. 2019).  The opinion summarized the Board's analysis as consisting of finding "a motivation to combine Sigg's sterilization process with Boulange's Stopper C because Boulange's baked-on siliconization process 'would help reduce the amount of "residual" or "free" silicone oil that can enter the protein formulation and cause negative effects'" and reviewed each in turn.  Regarding Boulange's Stopper C teachings, the panel rejected Novartis's contention that because the break-loose force of this stopper increased from 4.7N to 8.4N over three months, the skilled worker would not have chosen it in favor of stoppers with more consistent break-loose force characteristics over time.  The opinion notes that the challenged claims do not recite a limitation regarding consistent break-loose force and that the written description of the '631 patent disclosed that prior art stoppers having break-loose forces of up to 20N were "known in the prior art to be acceptable for intravitreal injections."  The Board's conclusions in this regard were also supported by the testimony of Regeneron's expert, and Novartis "did not submit any evidence showing that a skilled artisan would have been dissuaded from using a syringe that has a roughly 4N increase in break-loose force over time."  The Board's determination concerning the combination of Sigg with Stopper C as taught by Boulange was supported by substantial evidence according to the opinion.

Novartis also argued that Stopper C was "markedly inferior" to another stopper (B1) disclosed in the Boulange reference.  The panel rejected this argument on the basis that "[i]n assessing whether prior art teaches away, that 'better alternatives exist in the prior art does not mean that an inferior combination is inapt for obviousness purposes,'" the opinion citing Bayer Pharma AG v. Watson Lab'ys, Inc., 874 F.3d 1316, 1327 (Fed. Cir. 2017) (quoting In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012)).  Once again, the Board relied on Regeneron's expert, who testified that "a skilled artisan would have been motivated to use Stopper C because it was comprised of rubber and coated with silicone oil—a common stopper design in the prior art," as well as the break-loose force of Stopper C being within the claimed 11N and the 20N limits disclosed in the '631 specification.

The last argument from Novartis regarding "teaching away" was that Stopper C's "friction forces . . . were relatively high, something which does not appear to be acceptable for a medical device."  However, the data from the Boulange reference regarding such friction forces were obtained using versions of Stopper C that were not siliconized, whereas the embodiments of Stopper C relied upon by Regeneron in making its obviousness assertions in the IPR were siliconized.  It is this embodiment of Stopper C that the skilled worker would consider using, according to the Board (and this opinion), and for these embodiment the Court held that the Board's obviousness determination was supported by substantial evidence.

Novartis's second argument was that the Board erred in finding that the skilled worker would have had a reasonable expectation of success in combining the Sigg and Boulange references to achieve the claimed invention, a question also reviewed under the substantial evidence standard under, inter alia, Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1366 (Fed. Cir. 2016).  The basis for the Board's decision in this regard was that "Boulange's Stopper C was sealed tightly enough to be terminally sterilized using Sigg's vaporized hydrogen peroxide sterilization process," which Novartis argued was error because "Boulange's syringes were not sufficiently gas-tight to be able to use Sigg's sterilization process."  The Court considered Novartis's argument to be flawed as being "premised on an incorrect view of the [meaning] of the claim term 'terminally sterilized.'"  This is because the Board's meaning of the term was that it required "only minimizing the contact between the drug product and the sterilizing agent" (emphasis in opinion) and Novartis had not challenged that construction on appeal.  Thus, statements in the Sigg reference that few products had the "required tightness . . . to avoid ingress of sterilizing gasses [into the prefilled drug containing syringe]' (emphasis added) did not deprive the Board of substantial evidence regarding the skilled worker's reasonable expectation of success.  Yet again, the Board relied on Regeneron's expert testimony that "it was standard to design prefilled syringes to be gas-tight to protect the drug from degrading over its shelf life and to prevent sterilizing gas from entering the syringe," which was consistent with the Boulange reference, which disclosed that "lower break-loose forces are achievable in the invention 'without having to add lubricant and while preserving the tightness of the contact region between said two parts'" (emphasis in opinion).  In addition, the opinion notes that there was no evidence asserted that "any special tightness or specific stopper material, coating, or dimensions[] would have been required to achieve terminal sterilization."

A final Novartis argument addressed by the Court  in the opinion was the Board's determination that the Sigg reference disclosed the limitation in claim 21 of a sterility assurance level of at least 10^–6 being achieved using vaporized hydrogen peroxide.  The panel found the Board's conclusion in this regard to be supported by substantial evidence based on statements in the Sigg reference that "sterility for a health care product as achieving a sterility assurance level of 10^–6" combined with a description of vaporized hydrogen peroxide as being a "sterilization treatment."  The Board combined these teachings from the prior art with expert testimony from Regeneron to conclude that "a skilled artisan would have known a sterility assurance level of 10^–6 was based on regulatory requirements for health care products, and therefore pre-filled syringes are required to meet that sterility assurance level," which, according to the opinion, was supported by substantial evidence.  Although (for this issue) the Court implicitly acknowledged Novartis's identification of an inconsistency in some of Regeneron's evidence, the Federal Circuit held that under the substantial evidence standard "one inconsistent piece of evidence does not undermine [the Board's] finding."

In a footnote, the opinion addressed two other arguments made by Novartis.  First, the Court held that the Board's reliance on certain non-prior art was not error because its determinations were supported by substantial evidence even if that art were ignored.  Second, regarding Novartis's arguments concerning the objective indicia of non-obviousness, the opinion notes that the parties had "extensively redacted this portion of the public version of the Board's decision" but the Court had found substantial evidence supporting the Board regardless (perhaps evincing an acknowledgement from the Court that the public deserved to be told the outcome even if the parties' redactions prevented the Court from setting forth the bases for its decision in the opinion.

Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc. (Fed. Cir. 2024)
Nonprecedential disposition
Panel: Circuit Judges Prost, Reyna, and Chen

Astellas Pharma, Inc. v. Sandoz Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

One of the anticipated consequences of the Supreme Court's Loper Bright decision is that it will unleash judges to impose their statutory interpretations of administrative agencies' applications of the law within their areas of purported expertise.  Whether that outcome arises, (relatively) recent experience has shown that the "tyranny of the judiciary" can be and has been unleashed in other aspects of U.S. patent law; an example is the recent District Court decision (thankfully overturned by the Federal Circuit, albeit on procedural grounds) in Astellas Pharma, Inc. v. Sandoz Inc.

The case arose in ANDA litigation prompted by Sandoz's application for a generic equivalent of Astellas' Myrbetriq® drug (mirabegron) for treatment of overactive bladder conditions.  The opinion sets forth the mechanistic basis for the efficacy of the drug, which "is a beta-3 agonist that stimulates beta receptors in the bladder, thereby inducing bladder relaxation and improving bladder function."  However, during drug development it was discovered that it had a "food effect," i.e., the bioavailability of the drug was undesirably diminished by the presence of food in a patient's stomach (the drug was absorbed by the food and amounts below the clinically effective levels were absorbed by the patient's body).  Moreover, taking the drug on an "empty stomach" resulted in bioavailable levels that "reach[ed] potentially toxic [blood] concentrations."  Astellas developed sustained release formulations that were patented in U.S. Patent No. 10,842,780; after some litigation interplay, Astellas asserted claims 5, 20, and 25 of the '780 patent which were set forth in the opinion (italicized claims were independent or earlier claims in a dependency chain that are set forth for a clearer understanding of what was claimed):

1.  A pharmaceutical composition, comprising 10 mg to 200 mg of [mirabegron], or a pharmaceutically acceptable salt thereof, in a sustained release hydrogel-forming formulation comprising a hydrogel-forming polymer having an average molecular weight of 100,000 to 8,000,000 and an additive having a water solubility of at least 0.1 g/mL at 20±5° C.,
    wherein the hydrogel-forming polymer is at least one compound selected from the group consisting of polyethylene oxide, hydroxypropyl methylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose sodium, hydroxyethyl cellulose, and a carboxyvinyl polymer,
    wherein the additive is at least one selected from the group consisting of polyethylene glycol, polyvinylpyrrolidone, D-mannitol, D-sorbitol, xylitol, lactose, sucrose, anhydrous maltose, D-fructose, dextran, glucose, polyoxyethylene hydrogenated castor oil, polyoxyethylene polyoxypropylene glycol, polyoxyethylene sorbitan higher fatty acid ester, sodium chloride, magnesium chloride, citric acid, tartaric acid, glycine, β-alanine, lysine hydrochloride, and meglumine, and
    wherein a drug dissolution rate from the pharmaceutical composition is 39% or less after 1.5 hours, and at least 75% after 7 hours, as measured in accordance with United States Pharmacopoeia in 900 mL of a USP buffer having a pH of 6.8 at a paddle rotation speed of 200 rpm.

5.  The pharmaceutical composition according to claim 1, wherein the hydrogel-forming polymer is at least one compound selected from the group consisting of polyethylene oxide, hyd[r]oxypropyl methylcellulose, and hydroxypropyl cellulose.

20.  A method for treating overactive bladder comprising administering the tablet according to claim 18 to a subject in need thereof.

22.  A pharmaceutical composition, comprising 10 mg to 200 mg of [mirabegron], or a pharmaceutically acceptable salt thereof, in a sustained release hydrogel-forming formulation comprising a means for forming a hydrogel and a means for ensuring penetration of water into the pharmaceutical composition, wherein a drug dissolution rate from the pharmaceutical composition is 39% or less after 1.5 hours, and at least 75% after 7 hours, as measured in accordance with United States Pharmacopoeia in 900 mL of a USP buffer having a pH of 6.8 at a paddle rotation speed of 200 rpm.

23.  The pharmaceutical composition according to claim 22, comprising 10mg to 200 mg of [mirabegron].

25.  A tablet, comprising the pharmaceutical composition according to claim 23.

During pretrial proceedings, Sandoz limited its defenses to 35 U.S.C. § 112 (for each of written description, enablement, and indefiniteness).  A five-day bench trial and filing of post-trial motions by the parties followed.

The District Court issued its final decision based on none of the parties' contentions.  Instead, "sua sponte," the District Court held that the claims were ineligible for patenting under § 101 under Mayo Collaborative Servs. v. Prometheus Lab'ys, Inc., 566 U.S. 66 (2012).  Support for this decision came from arguments and assertions in Astellas' post-trial briefing, specifically (in arguing enablement) that "[the] "inventive concept of the '780 Patent was discovering the dissolution rate that would address the food effect and achieving it using previously known formulation technology," which the District Court took to mean that "Astellas concedes that the '780 patent is enabled because it claims invalid subject matter: a natural law applied via routine, conventional, and well-known methods."  (A reminder that the aphorism that "everything you say can be used against you" is not limited to criminal law or police procedurals.)  In the District Court's view, "the claimed invention 'reflects merely the discovery of the food-effect-resolving dissolution profile," the District Court deemed the asserted claims invalid as patent ineligible'" and entered judgment for Sandoz.  The District Court denied Sandoz's motion under Federal Rule of Civil Procedure 52(b) to make findings of fact and conclusions of law to preserve the issues that were presented at trial.  The District Court's basis for denying the motion was that "[t]he [c]ourt could not have better invoked [Mayo]."  This appeal followed.

The Federal Circuit vacated and remanded, in a decision by Judge Lourie joined by Judges Prost and Reyna.  The Court did not reach the merits (expressly; vide infra) but held that the District Court had abused its discretion based on the principle of party presentation, i.e., that courts "rely on the parties to frame the issues for decision and assign to courts the role of neutral arbiter of matters the parties present," citing Greenlaw v. United States, 554 U.S. 237, 243 (2008) (the District Court helped the panel reach this decision by stating in its ruling that it "sits not [as] an arbiter to resolve the disputes on the parties' favored terrain").  Support for the Court's finding can be found, according to the opinion, by copious precedent, including United States v. Sineneng-Smith, 590 U.S. 371, 375 (2020); United States v. Dowdell, 70 F.4th 134, 146 (3d Cir. 2023) (the opinion noting that "[w]e review procedural issues not unique to patent law under regional circuit law"); and Innogenetics, N.V. v. Abbott Lab'ys, 512 F.3d 1363, 1371 (Fed. Cir. 2008) (the opinion also noting that while not "ironclad" "rendering a patent invalid on a basis not advanced by any party is not . . . a circumstance [that would justify straying from the party presentation principle]").

The opinion also invokes the presumption of validity codified under 35 U.S.C. § 282, which imposes on the party asserting invalidity the burden of establishing it by clear and convincing evidence, citing Microsoft Corp. v. I4I Ltd. P'ship, 564 U.S. 91, 95 (2011), and the impropriety for a court to declare a patent "valid," citing Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1569 (Fed. Cir. 1987); Shelcore, Inc. v. Durham Indus., Inc., 745 F.2d 621, 627 (Fed. Cir. 1984); and Env't Designs, Ltd. v. Union Oil Co. of Cal., 713 F.2d 693, 699 n.9 (Fed. Cir. 1984) (and continuing the analogy herein, akin to a criminal defendant being found not guilty rather than innocent).  The court's role is only "to determine whether the patent's challenger carried the burden of establishing invalidity," citing Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1457 n.1 (Fed. Cir. 1984).  (It should not pass notice that much of this precedent stems from the time when a newly minted Federal Circuit began to flex its judicial muscles in setting forth consistent applications of the law over the district courts, which had been governed by the regional circuit courts of appeal with varying "takes" on how patent law should be applied.)

Under the Federal Circuit's view of the law "the district court appears to have misapprehended its role in adjudicating the issue of patentability" according to the opinion.  Synthesizing Astellas' arguments concerning enablement under § 112 to arrive at a concession of ineligibility under § 101 was an abuse of discretion in view of these legal principles.  The panel also rejected the District Court's rationale for its decision on an issue never raised by the parties, that "it sensed 'in the [parties'] assertion that patent litigants may, in essence, consent around the bounds of patent eligibility.'"  According to the panel, "[i]t is for the parties—not the court—to chart the course of the litigation," citing Lannom Mfg. Co. v. U.S. Int'l Trade Comm'n, 799 F.2d 1572, 1579 (Fed. Cir. 1986), being directly on point, finding in that case the rubric that "[i]t is beyond cavil that a district court does not have authority to invalidate a patent at its own initiative if validity is not challenged by a party."  Another basis for criticism of the District Court was that court's belief that patent eligibility was "a threshold inquiry that it had a duty to address—even in the silence of the parties" (although to be fair it can be understood why over a decade of Federal Circuit precedent affirming motions to dismiss on § 101 grounds could have left that impression; see examples in earlier posts too numerous to set forth here).  According to the opinion, the presumption of validity under § 282 applies to "all grounds of validity" (emphasis in opinion), citing Cellspin Soft, Inc. v. Fitbit, Inc., 927 F.3d 1306, 1319 (Fed. Cir. 2019).

For its part, Sandoz supported the District Court's decision, but was limited to citing "cases from the late 1800s and certain non-binding out-of-circuit cases," which were not persuasive (but do provide an interesting history lesson regarding the Supreme Court's and certain Circuit Courts of Appeal's varying historical antipathy to patents).  Moreover, the timing of these decisions, prior to enactment of the presumption of validity in the 1952 Patent Act provides the panel with sufficient justification to ignore whatever precedential force these decisions may retain.

Astellas was less successful in having the Federal Circuit remand this matter to a different district court judge.  In addition to the abuse of discretion against them, the District Court made several statements (presumably on the record) that tended to evince a prejudice against patents to pharmaceuticals and the companies that asserted them.  These statements included that "[t]he pharmaceutical industry, to put it mildly, has perverted th[e] intent [of the Hatch-Waxman Amendments].  With alarming regularity since, brand and generic drug manufacturers have colluded to protect weak or invalid patents and share in the startling profits"; and that "this 'case is about the pharmaceutical industry's long-standing 'innovation' of patenting extended-release formulas for soon-to-expire active-ingredient patents."  Astellas asserted that the District Court's sua sponte entry of judgment against them on § 101 grounds was by itself enough to justify removal.  The Federal Circuit did not agree, first because the panel considered mandating reassignment on remand to be "an exceptional remedy, one that we weigh seriously and order sparingly," citing United States v. Kennedy, 682 F.3d 244, 258 (3d Cir. 2012), and Lazare Kaplan Int'l, Inc. v. Photoscribe Techs., Inc., 714 F.3d 1289, 1298 (Fed. Cir. 2013).  The Court expressly relied upon the Third Circuit standard for reassignment set forth in Arrowpoint Cap. Corp. v. Arrowpoint Asset Mgmt., LLC, 793 F.3d 313, 329 (3d Cir. 2015), requiring that "a reasonable person, with knowledge of all the facts, would conclude that the judge's impartiality might reasonably be questioned."  Astellas did not meet this standard, according to the opinion.*  But the District Court judge's record (having "overseen nearly two hundred patent cases and has ruled in favor of both innovative and generic manufacturers alike") and that Astellas could not provide any instance in which the District Court judge had "acted in a way that called into question his ability to . . . resolve the outstanding issues impartially and fairly" over the "life of this nearly four-year-old litigation" was enough to dissuade the Federal Circuit from mandating removal on remand.  In view of the Court' believing it had "clarified the proper course for adjudication," the opinion closes with the statement that "we trust that, upon remand, the district court can and will take an objective, measured, and thorough look into the legal issues and evidence of record to resolve only those disputes that exist between the parties."

• In stating the Court's reasons for making this determination, the opinion provides, for the rest of us, the hopeful opinion that "we have serious doubts that, on the merits, the asserted claims—directed to nonnatural compositions of matter and associated methods of use—are ineligible for patent protection," albeit this being "an issue [the Court] decline[d] to resolve."

Astellas Pharma, Inc. v. Sandoz Inc. (Fed. Cir. 2024)
Panel: Circuit Judges Lourie, Prost, and Reyna
Opinion by Circuit Judge Lourie

Wisconsin Alumni Research Foundation v. Apple Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

In a joint appeal of two adverse decisions from the District Court, the Federal Circuit on procedural grounds rejected an appeal from the Wisconsin Alumni Research Foundation ("WARF") in Wisconsin Alumni Research Foundation v. Apple Inc.  The decision was based on the Court's conclusion that WARF was precluded from asserting infringement under the doctrine of equivalents (DOE) after having failed to establish literal infringement and having withdrawn its DOE assertions in an earlier litigation, and also precluded from asserting the same patent on DOE grounds against "next-generation" Apple products similar to ones deemed non-infringing earlier.

The case arose over U.S. Patent No. 5,781,752 directed to "[a] predictor circuit [that] permits advanced execution of instructions . . . [i]n an electronic computer with a single processing unit" (alleged to be infringed by Apple's A7 and A8 processors in one of the decisions at issue and Apple's A9 and A10 processors in the other).  The first decision (WARF I) on appeal (regarding earlier litigation about the A7 and A8 processors in which the District Court found infringement by Apple and the Federal Circuit reversed) is the District's Court's refusal to permit WARF to litigate infringement under DOE that had been withdrawn in the earlier litigation, on the grounds that WARF had affirmatively abandoned that theory of infringement (as explained in the opinion, this abandonment was made in a context where Apple was precluded from introducing evidence at trial of its own patent, No. 9,128,725, regarding similar technology) and that the District Court's construction of the term "particular" ("to be associated with a single load instruction") "foreclosed an equivalent where the prediction could be associated with a group of load instructions" (emphases in opinion) because WARF's DOE theory would "vitiate the claim limitation by rendering meaningless the term "particular."  The District Court (in WARF II) after lifting a stay until resolution of WARF I refused to permit WARF from pursuing infringement of Apple A9 and A10 processors under DOE based on its decision in WARF I, supported by Federal Circuit precedent under Nystrom v. Trex Co., 580 F.3d 1281 (Fed. Cir. 2009), that ruled that "the plaintiff in that case was barred from revisiting a doctrine of equivalents theory of infringement based on waiver of that doctrine in past litigation over materially similar, earlier generation of the same products despite later generations being produced during and after the course of the first litigation."  These appeals followed.

The Federal Circuit affirmed, in an opinion by Judge Prost joined by Judges Taranto and Chen.  As explained in the opinion, WARF argued in its appeal from WARF I that it did not waive its claim of infringement under DOE "generally" with respect to Apple's A7 and A8 processors, and that issue preclusion does not apply in WARF II.  Apple argued that the Kessler doctrine supported the District Court's decision in this regard, see Kessler v. Eldred, 206 U.S. 285 (1907) (the panel agreeing with this argument in its affirmance).

With regard to WARF I and the District Court's waiver determination, the Federal Circuit asserted the preeminence of Federal Circuit law for waiver questions regarding "enforcement of a patent right," citing Harris Corp. v. Ericsson Inc., 417 F.3d 1241, 1250‒51 (Fed. Cir. 2005).  WARF's ultimate position on this question was that the District Court's claim construction of the term "particular" was a change of circumstances that precluded application of waiver in its DOE infringement theory under Exxon Chemical Patents, Inc. v. Lubrizol Corp., 137 F.3d 1475 (Fed. Cir. 1998).  Apple for its part argued that WARF made its own "strategic choice to abandon its [doctrine-of-equivalents] theory in order to prevent Apple from introducing evidence of Apple's own patent during the trial's liability phase," relying in large part upon the Federal Circuit's earlier decision reversing the District Court's finding of literal infringement and the absence in that decision of remand or a new claim construction.

The Federal Circuit agreed with Apple.  Regarding WARF's "changed circumstances" concerning claim construction of the term "particular," the opinion asserts that "[t]he correct inquiry is whether the claim construction changed in a way that would excuse WARF's failure to raise, at the previous trial, the doctrine-of-equivalents theory that it now attempts to reassert in WARF I," concluding that it did not.  The Court held that the interpretation of the term was consistent with Apple's understanding that it should be given its plain and ordinary meaning (supported by its expert's testimony).  In addition, the opinion states that WARF was not prohibited from raising its DOE grounds for infringement at trial despite its assertion of its confidence regarding its literal infringement case.  Nor was the panel convinced that Apple's failure to pursue the narrower construction of the term at trial provided any justification for WARF not earlier pursuing its DOE case.

The Court also held that, "for reasons unrelated to claim construction," WARF had waived its DOE infringement theory.  The basis for this conclusion is that WARF's actions had satisfied the standard under United States v. Olano, 507 U.S. 725, 733 (1993), for "intentional relinquishment or abandonment of a known right" by failing to present substantive arguments before the District Court for infringement under the DOE, citing Boss Control, Inc. v. Bombardier Inc., 410 F.3d 1372, 1380 (Fed. Cir. 2005), and United States v. Hible, 700 F.3d 958, 961 (7th Cir. 2012).  The panel characterized WARF's arguments against waiver as "recharacter[izations]" which the Court found to be contrary to the record.  In the panel's view, WARF "agreed to 'drop doctrine of equivalen[ts] and make no doctrine of equivalents arguments whatsoever at trial'," emphasis in opinion, "in exchange for Apple's agreement not to present its own patent at trial."  This constituted a "relinquishment of a known right" which resulted in the District Court ordering both parties not to present evidence about that Apple patent at trial.  In addition, the Court considered it relevant that both parties retained the "ability to argue their positions on what the plain and ordinary meaning required or allowed."  Under these circumstances, the panel held that while WARF could have pursued its DOE theory at trial that it now asserts, not doing so constituted an abandonment constituting waiver.

Finally, in the WARF I appeal the panel turned to (and rejected) WARF's assertion of Exxon Chemical Patents, Inc. v. Lubrizol Corp.,137 F.3d 1475 (Fed. Cir. 1998), in support of its position.  The Court found WARF's assertion of this precedent, for the proposition that "when the doctrine of equivalents becomes a critical issue only after a new claim construction is adopted on appeal, a plaintiff's prior choice to not present that theory at trial does not constitute abandonment" was overbroad.  In the Court's view, that case involved circumstances where the Federal Circuit held on appeal that the District Court had discretion to consider an unasserted DOE infringement theory because the Federal Circuit had not "dispose[d] of" that infringement theory.  Although "[a]t a bird's eye view" the facts and circumstances in Exxon were similar to those here, the panel found sufficient distinctions to reject WARF's assertion of Exxon in this instance.  In Exxon, the District Court's claim construction "rendered [Plaintiff's] doctrine-of-equivalents theory moot," which was not the case here, and in Exxon "there was no reason for the jury to consider Exxon's doctrine-of-equivalents theory under the uncontested facts."  In this case, "in contrast, there were reasons for WARF to pursue its doctrine-of-equivalents theory—namely, the parties were actively disputing the scope of the plain and ordinary meaning of 'particular' before, during, and after trial," i.e., the question on the meaning of "particular" was not moot.  In addition, here (and not in Exxon) the Court found an affirmative abandonment of its DOE theory of infringement.  Finally, in Exxon, the Federal Circuit "did not grant a per se right to a new trial on the doctrine of equivalents" but provided the District Court with the discretion to do so.

Regarding the WARF II appeal, the Court affirmed based on issue preclusion and the Kessler doctrine.  For the former, the standard applied by the Court is that "(1) the issue sought to be precluded is the same as that involved in a prior action; (2) the issue was actually litigated; (3) the determination of the issue was essential to the final judgment; and (4) the party against whom estoppel is invoked was represented in the prior action," citing Adair v. Sherman, 230 F.3d 890, 893 (7th Cir. 2000); the elements at issue here are limited to the first and second, implicating the question (according to the opinion) of "what is the issue"?  WARF contends the issue in WARF I to be "whether Apple's A7 and A8 processors literally infringe the '752 patent" and in WARF II to be "whether Apple's A9 and A10 processors infringe the '752 patent under the [doctrine of equivalents]."  Apple's contention is the same in both cases to be merely "whether Apple's accused products infringe the '752 patent."  The task the Court appreciates is to determine whether the two pairs of processors -- A7/A8 and A9/A10 -- are "essentially the same" and whether literal and DOE infringement "are part of the same overall issue of infringement."

The opinion notes that "[a]ccused devices are essentially the same where the differences between them are merely colorable or unrelated to the limitations in the claim of the patent," citing ArcelorMittal Atlantique et Lorraine v. AK Steel Corp., 908 F.3d 1267, 1274 (Fed. Cir. 2018).  Here, the District Court held that the pairs of accused infringing processors satisfied this standard, and the Federal Circuit found no clear error in this determination.  The panel dismissed WARF's contentions that there was an issue based on failure of Apple to provide discovery regarding the A9/A10 processors and that there was a "'potential' significant [design] change" in the later-developed A9/A10 processors compared with the A7/A8 processors.  This decision was based on the Court's consideration of further proceedings below wherein both parties made assertions that the two pairs of processors were the same ("not more than colorably different" in Apple's language).  And the only additional discovery WARF wanted was "damaged-related discovery" according to the panel, not technical discovery relevant to the question of substantial sameness at issue here.

The Court next considered the second prong of the test for issue preclusion, "whether the issue is infringement or the separate theories of infringement" and whether the issue litigated in the first action is identical to the one WARF wishes to pursue in the second action under B & B Hardware, Inc. v. Hargis Industries, Inc., 575 U.S. 138, 154 (2015).  Importantly, the panel interpreted the B&B Hardware holding to be that the legal standards applied in both actions were the same, not that the "factors or tests must be identical for issues to be identical."  The Court purports to apply the same analytical approach taken by the B&B Hardware Court, looking at "the statutes, the history, and the Restatement (Second) of Judgments" (i.e., the common law) to make its determination of issue identity.  Here, the statute is the same (35 U.S.C. § 271), as was the historical context for the DOE (Winans v. Denmead, 56 U.S. 330, 344 (1853); see also Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950), which treated literal and DOE infringement "as a single issue").  Finally, the panel's assessment of the teachings of the Restatement (Second) of Judgments sets forth "several factors" for situations where "there is a lack of total identity between the particular matter presented in the second action and that presented in the first."  These include "substantial overlap in evidence or argument"; whether "new evidence or argument involve application of the same rule of law as that involved in the prior proceeding"; "[c]ould pretrial preparation and discovery relating to the matter presented in the first action reasonably be expected to have embraced the matter sought to be presented in the second?"; and "[h]ow closely related are the claims involved in the two proceedings?"  These rubrics as applied by the Court supported the District Court's determination that issue preclusion should apply to WARF's renewed assertion of infringement under the DOE.  This treatment is also consistent with precedent, according to the opinion, citing Nystrom v. Trex Co., 580 F.3d 1281 (Fed. Cir. 2009) (relied upon by the District Court), and Aspex Eyewear, Inc. v. Marchon Eyewear, Inc., 672 F.3d 1335, 1343 (Fed. Cir. 2012).  The opinion also asserts a policy basis for their decision:

For the foregoing reasons, we are convinced that literal infringement and the doctrine of equivalents are the same issue for issue-preclusion purposes.  To conclude otherwise would allow a patentee to proceed through the entirety of litigation only on a theory of literal infringement and, after losing its case, allow that same party to accuse the same entity of infringing the same patent, accusing the same or essentially the same products, as long as those products were sold after judgment of the first suit.

Finally, the opinion turns to the proper application of the Kessler doctrine in support of the District Court's decision.  The doctrine is specific for patent law, according to the Court, wherein it "fills the gap between [claim and issue] preclusion doctrines . . . allowing an adjudged non-infringer to avoid repeated harassment for continuing its business as usual post-final judgment," citing Brain Life, LLC v. Elekta Inc., 746 F.3d 1045, 1056 (Fed. Cir. 2014).  As applied the right (to sell a non-infringing article after having been absolved of infringement of the claimed invention) "attaches to its product—to a particular thing—as an article of lawful commerce," the panel citing Rubber Tire Wheel Co. v. Goodyear Tire & Rubber Co., 232 U.S. 413, 418 (1914).  Closer to the circumstances in this case (and cited by the Court in support of the District Court's judgment) is SpeedTrack Inc. v. Off. Depot, Inc., 791 F.3d 1317, 1329 (Fed. Cir. 2015), where a plaintiff only asserting literal infringement was precluded under the Kessler doctrine from asserting DOE infringement in a second lawsuit arising after having failed to prevail against the same defendant for accused literal infringement.  As stated in the opinion, "WARF II presents exactly this type of litigation harassment, applied to a second suit against the very same defendant."

These proceedings appear to exonerate Apple from infringement that an earlier jury had decided was worth $506 million (after prejudgment interest).

Wisconsin Alumni Research Foundation v. Apple Inc. (Fed. Cir. 2024)
Panel: Circuit Judges Prost, Taranto, and Chen
Opinion by Circuit Judge Prost

Special Committee's Suspension Recommendation Adopted by Federal Circuit

By Kevin E. Noonan -

As posted in July, the Special Committee of the Federal Circuit voted unanimously to maintain the suspension imposed on Judge Pauline Newman (see "Judge Newman Suspended for One Year by Federal Circuit") for another year.  On Friday, September 6th, the Judicial Council of the Court unanimously agreed to maintain the suspension.

The Order was succinct:  per curiam, the Council declared that:

Judge Newman shall not be permitted to hear or participate in any cases, at the panel or en banc level, for a period of one year beginning with the issuance of this Order, subject to consideration of renewal if Judge Newman's refusal to cooperate continues after that time and to consideration of modification or rescission if justified by an end of the refusal to cooperate.

In a footnote, the Order notes that "[t]he Council sees no need for oral argument in this matter" but permitted Judge Newman's counsel to file a brief.  In this brief, filed August 14th, counsel made seven assertions:

I. THE COMMITTEE IGNORED AND/OR IMPROPERLY DISCOUNTED JUDGE NEWMAN'S EVIDENCE OF CONTINUED FITNESS-

A. SUPREME COURT'S DECISION IN RUDISILL IS HIGHLY RELEVANT

B. JUDGE NEWMAN'S PARTICIPATION AT CONFERENCES IS HIGHLY RELEVANT

C. THE COMMITTEE IMPROPERLY (AND PREEMPTIVELY) DISCOUNTED THE OPINIONS OF JUDGE NEWMAN'S OWN DOCTORS

II. THE COMMITTEE IGNORED TROUBLING ACTIONS BY THE CHIEF JUDGE THAT FURTHER UNDERMINE CONFIDENCE IN THE FAIRNESS OF THE INVESTIGATION

III. REFUSAL TO SIT FOR AN INTERVIEW CANNOT SUBJECT JUDGE NEWMAN TO SANCTIONS

IV. COMMITTEE'S INSISTENCE THAT "COURT STAFF DESERVE TO WORK IN AN ENVIRONMENT FREE FROM ABUSE OR ANGER" IS IRRELEVANT TO WHETHER MENTAL HEALTH TESTING IS NEEDED

V. COMMITTEE'S RECOMMENDATION IS NOT A SANCTION, BUT AN ATTEMPT TO COERCE COMPLIANCE

VI. THE ONGOING LITIGATION PROVIDES SUFFICIENT REASON TO DECLINE THE COMMITTEE'S REQUESTS

VII. NO FURTHER SANCTIONS ARE WARRANTED.

A great deal of this argument has been made and rejected by the Special Committee (or the Judicial Counsel itself) before.  The brief notes that Judge Newman's suspension is the longest in U.S. judicial history and asserts that it is entirely unprecedented (emphasis in brief).  Reiterating a consistent theme in Judge Newman's earlier arguments the brief asserts that "Congress did not intend judiciary's self-policing mechanism to become an end-run around the constitutionally prescribed procedures for removing an Article III judge."  It demands that "[t]he Judicial Council should either bring this matter to a close or, if it believes that Judge Newman's behavior constitutes severe misconduct, refer Judge Newman for impeachment," consistent with the Judge's constitutional grounds for opposing the actions of the Special Committee and Judicial Council of the Court.

The rhetoric has increased in temperature in this brief, accusing the Special Committee's Report and Recommendation (adopted by the Judicial Council) as having an "anti-Judge Newman bent," that "the Committee is playing with a stacked deck" regarding their rejection of Judge Newman's doctors' opinions', terming the proceedings a "stealth impeachment" and accusing the Special Council of "obfuscation, double-speak, and outright illegality."  "[T]he 'my way or the highway' approach and the bullying tactics will not work," the brief strongly asserts.

The brief acknowledges the stark reality of Judge Newman's advanced age:  "While it is uncertain whether or not Judge Newman lives long enough to see herself vindicated, what is certain is that these proceedings will leave an indelible stain on the Federal Circuit and its misguided leadership."

On the purported merits, the brief notes that "the Committee has now recommended continuing an already-unprecedented sanction for no legitimate reason" and what is demanded, neurological and psychological testing, no matter its outcome, "would not change the fundamental fact: absent impeachment, whether or not to leave the bench is a decision reserved exclusively to Judge Newman (or Congress) and not to her colleagues."

According to the brief, Judge Newman's justification for her position of simple non-compliance with the Special Committee's demands is "the history of factual misstatements, misleading claims, legal errors, and overall hostility and antagonism" from the Special Committee (and thus her colleagues).

Regarding Rudisill, the brief asserts that the Supreme Court's reversal of the Federal Circuit and adoption of the rationales in Judge Newman's dissenting opinion stands as evidence that "Judge Newman is not only 'aware' of the issues present in cases [contrary to the Special Committee's allegations] but is able to resolve them better than many of her colleagues."  And as for allegations that the Judge has gotten slower in writing opinions, the brief asserts that "in balancing speed and minimizing the risk of error, Judge Newman values the latter over the former," citing Justice Scalia's dissent in Pauley v. BethEnergy Mines, Inc., 501 U.S. 680, 716 (1991), that "[a]ny adjudication of claims necessarily involves a tradeoff between the speed and the accuracy of adjudication."

For the first time, Judge Newman trains her rhetoric squarely at the Chief Judge, stating that "[t]o [do anything but bring these proceedings to an end and withdraw the suspension] is to allow any chief judge to make whatever accusations she may choose to make, launch an investigative process based on those accusations (whether they be true or not), hope to uncover something during that process, and then perpetually expand the investigation and the demands associated with it."  Indeed, one subsection of the brief is directed to allegations of "troubling actions" by that Judge as "further undermin[ing] confidence in the fairness of the accusation."

With regard to the Committee's dismissal of Judge Newman's own physicians' medical opinions on her competence, the brief states that "[i]n order for that concern [that Judge Newman is seriously impaired but her doctors have not recognized it] to have any validity, one would have to believe that Judge Newman's mental health exhibits Dr. Jekyll and Mr. Hyde qualities, i.e., that she is perfectly stable, courteous, even-keeled, and in control of her memory everywhere, except in and around 717 Madison Place, NW, thus preventing anyone outside the courthouse who interacts with her from perceiving her alleged "paranoia," "agitation," and "confusion" (opining that "[n]o rational person can or would believe that such a state of affairs exists").

The brief turns the tables on the Special Committee's allegations of Judge Newman's anger and unpleasant reactions to allegations against her by staff members, citing Katherine A. DeCelles et al., Anger Damns the Innocent, 32 Psych. Sci. 1214, 1214 (2021), for the principle that "anger is an invalid cue of guilt and is instead a valid cue of innocence; accused individuals . . . were angrier when they are falsely relative to accurately accused"; after all, according to the brief, "[i]t is highly likely that any other member of the Judicial Council would also be angry if accused by colleagues of incompetence."

In Judge Newman's view, the terms of the sanction establish that it is meant to coerce compliance and thus is outside the scope of the Disability Act and the Rules, which do not "give either the Special Committee or the Judicial Council coercive powers."  And these attempts at coercion would be unavailing in any case, the brief asserting that "[i]t should be abundantly clear by now—more than 18 months into these unwarranted proceedings—that Judge Newman 'will steadfastly refuse to yield to the coercion of' suspension, meaning the Committee and the Judicial Council has to move on."  In this regard, the brief asserts (for other reasons) that "[t]he Disability Act (to the extent it is constitutional), permits the Council to suspend Judge Newman only 'on a temporary basis for a time certain,' not until 'compliance' is achieved" under 28 U.S.C. § 354(a)(2)(A)(i), citing McBryde v. Comm. to Rev. Cir. Council Conduct & Disability Ords. of Jud. Conf. of U.S., 264 F.3d 52, 67 n.5 (D.C. Cir. 2001), and Hastings v. Jud. Conf. of U.S., 770 F.2d 1093, 1108 (D.C. Cir. 1985), as contrary precedent.

And again referencing the Judge's age, the brief asserts that "[i]t appears that the only reason the Committee is undaunted by the obvious collision between its chosen tack and the statutory and constitutional limits is its bet that, given Judge Newman's age, nature will take its course before her suspension runs into double digits."

As has been the tenor of all of Judge Newman's arguments, it is clear that neither Judge Newman nor her colleagues on the Federal Circuit are willing to back down or come to a reasonable compromise.  The history of these contretemps suggest that one way of avoiding them (and the risk of the "indelible stain" on the Court Judge Newman attributes to the Committee's behavior) would be for Congress to mandate that investigation of future allegations of incapacity not be made by judges sitting on the same court as the Judge being investigated.  Judge Newman asked for such transfer and her request was denied (with predictable results over the course of the last year).  Such a mandate would avoid the appearance of the Special Committee or Judicial Council being prosecutor, judge, and jury on the matter and might avoid the perhaps inevitable interplay of personalities that has arisen during the course of these proceedings.

In many ways nothing has changed; the Judicial Council has merely taken the procedural step of adopting the Special Committee's recommendation to continue Judge Newman's suspension from participating in the Federal Circuit's business for another year.  But without having to read between the lines it is abundantly clear that in many ways things have gotten worse and will continue to do so unless and until this matter is resolved.

Natera, Inc. v. NeoGenomics Laboratories, Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

In Natera Inc. v. NeoGenomics Laboratories, Inc. the Federal Circuit affirmed the District Court's grant of a preliminary injunction against NeoGenomics in patent infringement litigation involving Natera's U.S. Patent Nos. 11,519,035 and 11,530,454 directed to methods for amplifying targeted genetic material and methods for detecting variations in genetic material indicative for diseases and disorders, respectively.

Claim 1 of the '035 is representative and recites:

1.  A method for amplifying and sequencing DNA, comprising:
    tagging isolated cell free DNA with one or more universal tail adaptors to generate tagged products, wherein the isolated cell-free DNA is isolated from a blood sample collected from a subject who is not a pregnant women;
    amplifying the tagged products one or more times to generate final amplification products, wherein one of the amplification steps comprises targeted amplification of a plurality of single nucleotide polymorphism (SNP) loci in a single reaction volume, wherein one of the amplifying steps introduces a barcode and one or more sequencing tags; and
    sequencing the plurality of SNP loci on the cell free DNA by conducting massively parallel sequencing on the final amplification products, wherein the plurality of SNP loci comprises 25-2,000 loci associated with cancer.

The opinion explains that cell-free DNA (cfDNA) fragments are found in human blood and that a subset of these fragments are derived from tumor cells (termed ctDNA); detection of these latter species can provide a way to detect relapse in cancer patients as "molecular residual disease."  These fragments were detected using Natera's Signatera product, and in its infringement suit Natera accused NeoGenomics of infringing by selling its competing RaDaR product.  Both products "identify ctDNA within the bloodstream to assess the efficacy of cancer treatment and the risk of cancer recurrence" (i.e., "they are designed from a patient's genetic information based on a tissue biopsy of the patient's tumor").

The District Court granted Natera's motion for preliminary injunction because it held that Natera satisfied the four-prong test, specifically 1) there being a likelihood of success on the merits (infringement of at least one asserted claim of the '035 patent); 2) irreparable harm to Natera caused by NeoGenomics' infringement; 3) that the injunction would be in the public's interest; and 4) that the balance of the hardships were in Natera's favor.  The details of the injunction not only prohibited NeoGenomics from making, using, selling or offering to sell its competing RaDaR product, but also from "promoting, advertising, marketing, servicing, distributing, or supplying the RaDaR assay to allegedly induce infringement"; the injunction exempted patients already using RaDaR as well as "finalized or in-process research projects, studies, and clinical trials."  The District Court granted NeoGenomics' motions to permit three not-yet-initiated clinical testing contracts to proceed (despite testing of samples not having yet begun but for which third parties had designed the experiments and testing protocols using RaDaR), based on the public interest in this research and the negative effect that the injunction could have on these third parties.  The Court also permitted NeoGenomics to test patient samples it had received but not yet tested at the time of the injunction.  Finally, the District Court permitted NeoGenomics to use its RaDaR product in three "negotiation-stage" research contracts (but that had finalized protocols and approvals) because enforcing the injunction under these circumstances would cause "delay and hardship."  On the other hand, the Court did not permit another potential contract to go forward because the evidence for this contract was "only a conclusory statement that the sponsoring organization had done significant work designing the study." NeoGenomics appealed.

The Federal Circuit affirmed in an opinion by Chief Judge Moore, joined by Judges Taranto and Chen, expressly assessing three of the four prongs of the test in turn (the opinion does not address the "balance of the hardships" prong).  With regard to the likelihood of success on the merits for infringement of at least one asserted claim of the '035 patent, the opinion sets out the evidence for the likelihood that Natera would prevail on the question of infringement, and separately the likelihood that NeoGenomics would be unable to establish invalidity.  On the infringement question, NeoGenomics argued that the District Court erred by not engaging in explicit claim construction, but the Federal Circuit rejected this argument, noting that "[a] district court has no obligation to definitively construe claims at the preliminary injunction stage," citing Sofamor Danek Grp., Inc. v. DePuy-Motech, Inc., 74 F.3d 1216, 1221 (Fed. Cir. 1996) (while certainly a decision directed to the preliminary injunction standard Sofamor it is also curiously one handed down by the Court a few months before the Supreme Court rendered its decision in Markman v. Westview, which decision altered the claim construction landscape considerably).  Here, the parties did not present a claim construction dispute to the District Court and for its part NeoGenomics did not raise the issue despite having several opportunities to do so ("in its opposition brief before the district court, at the technology tutorial, or at the preliminary injunction hearing," only finally doing so in its motion to stay the injunction).  The Federal Circuit did not disagree with the District Court's construction nor that NeoGenomics' RaDaR product infringed the expressly recited steps of claim 1 of the '035 patent.  The Court also distinguished the facts in Amgen Inc. v. Sandoz Inc., 923 F.3d 1023 (Fed. Cir. 2019), asserted by NeoGenomics as being analogous and, as in that case, non-infringing, the Court finding no clear error in the district court's determination thereof.

On the invalidity question, the opinion rejected NeoGenomics' argument that the District Court applied an incorrect legal standard regarding their obviousness contentions, and that "mere vulnerability" to invalidation is enough to defeat a preliminary injunction motion, citing Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1358–59 (Fed. Cir. 2001).  While the Court recognized that an accused infringer "need not make out a case of actual invalidity" under Amazon the proper standard is to show a "substantial question" of invalidity, and "[t]he relevant inquiry is therefore whether the patentee has shown it is more likely than not to prevail over an invalidity challenge."  On the merits, NeoGenomics argued that the '035 patent claims were obvious over a poster presented by Fiona Kaper and colleagues and reproduced in the 2010 PROC. OF THE 101ST ANN. MEETING OF THE AM. ASS'N FOR CANCER RES. entitled "Parallel Preparation of Targeted Resequencing Libraries From 480 Genomic Regions Using Multiplex PCR on the Access Array System," which disclosed "a system for tagging, amplifying, and adding barcodes to DNA locations of interest" termed the "Fluidigm Access Array."  The opinion finds no error in the District Court's decision based in large part by the Court's assessment that NeoGenomics' assertions were "little more than conclusory argument with no meaningful supporting documentation" set forth in [only] "four paragraphs." Citing KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418–19 (2007), the Federal Circuit asserted that "[i]t is not sufficient to merely allege that the individual elements of the claimed invention were each known in the prior art," and that "NeoGenomics failed to articulate a reason why a skilled artisan would have been motivated to use the Fluidigm Access Array system with cfDNA for cancer detection as claimed by the '035 patent."  The Court further held that the District Court did not commit clear error in rejecting NeoGenomics' allegations of sufficient motivation to combine the Fluidigm Access Array system with cfDNA and a reasonable expectation of success thereof in the face of Natera's "significant evidence of obstacles to using cfDNA in the present setting that would have been known to a skilled artisan."  Nor was NeoGenomics persuasive in arguing that the District Court erred in assessing the obstacles raised by Natera based on being able to amplify and sequence ctDNA "with precision" because the '035 patent claims contained no such precision requirement. The Federal Circuit held that while "[u]nclaimed factors relevant to the feasibility of creating a useful claimed invention can impact the motivation to combine analysis," citing Auris Health, Inc. v. Intuitive Surgical Operations, Inc., 32 F.4th 1154, 1159 (Fed. Cir. 2022), here the District Court did not abuse its discretion in deciding against NeoGenomics on whether a skilled worker would have expected the method to be practiced with some level of "precision."

Turning to the issue of irreparable harm, the Court opined that the standard is whether Natera could show a "causal nexus" between infringement and the harm alleged, citing Luminara Worldwide, LLC v. Liown Elecs. Co., 814 F.3d 1343, 1352 (Fed. Cir. 2016).  Such evidence can include "head-to-head" competition and "lost market share" and can arise where the injury alleged is not quantifiable (the old bromide being "no adequate remedy at law").  Natera's evidence of direct competition between the parties in a "two-player" market meant to the Court that "any growth experienced by NeoGenomics would therefore result in lost sales to Natera" which was sufficient to satisfy the standard for irreparable harm.  The Federal Circuit rejected NeoGenomics' argument that the District Court had misinterpreted Presidio Components, Inc. v. American Technical Ceramics Corp., 702 F.3d 1351 (Fed. Cir. 2012), to create a per se standard for competition in the two-player market situation.  According to the opinion, the District Court assessed the circumstances, including the potential for "biopharmaceutical partnerships, business relationships, clinical opportunities, and market share" to be lost by Natera because of competition from NeoGenomics if permitted to continue to compete (recognizing that in Presidio, as here, the patentee was unwilling to grant a license to the accused infringer).  Other factors considered by the Court were the necessity for cancer patients of "continuity of care" which would inhibit patients using a different diagnostic test once NeoGenomics' test was used instead of Natera's test (resulting in loss of current sales plus loss of repeat business/future sales).  Regarding another NeoGenomics' argument the Federal Circuit rejected the aspect of both the Signatura and RaDaR tests as being tumor-informed testing, which was not a claimed limitation of the '035 patent, based upon Natera's evidence that the method claimed in the '035 patent was "critical to overcoming challenges associated with successfully amplifying and sequencing cfDNA in the claimed ctDNA context" and "would be impossible to achieve without practicing the particular methods claimed in the '035 patent."  Finally the Court rejected NeoGenomics' argument that Natera delaying in bringing suit, based on its involvement with other infringement cases and Natera having brought suit within days of NeoGenomics obtaining regulatory approval (Medicare coverage) and or months of NeoGenomics achieving commercial availability.

Regarding the public interest, the Court noted that the District Court considered evidence that Natera's Signatura and NeoGenomics' RaDaR products were approved for use with patients having the same cancer diagnoses and that Natera had commercial capacity to satisfy any increased demand caused by imposition of the injunction.  The Federal Circuit noted that the District Court had carved out sales to existing patients or those involved in "ongoing clinical trials or research projects."  The Federal Circuit also rejected NeoGenomics' claims that the public was harmed because their RaDaR product was superior to Natera's Signatura product in the face of controverting evidence from Natura.  Nor was the Court convinced by testimony of NeoGenomics' expert that their product was superior for certain specific cancers, finding that "the [expert's] letter provides no scientific basis for its broad and conclusory assertions" nor does it "point to any evidence that RaDaR is effective for more types of cancers than Signatera" (while on the contrary Natera provided evidence that its product was approved for all the cancer indications that the RaDaR product was approved for).  And while NeoGenomics provided testimony from a "key opinion leader" as well as market reports and other evidence of its RaDaR product being superior to Natera's Signatura product, none of this evidence was sufficient to convince the panel that the District Court had erred regarding the public interest prong of the preliminary injunction standard.

Finally, the opinion does not set forth its review of the District Court's consideration of the  balance of the hardships (or equities, as termed in the opinion) being in Natera's favor, merely stating that "[w]e have considered NeoGenomics' remaining arguments and find them unpersuasive."

Natera, Inc. v. NeoGenomics Laboratories, Inc. (Fed. Cir. 2024)
Panel: Chief Judge Moore and Circuit Judges Taranto and Chen
Opinion by Chief Judge Moore

United Therapeutics Corp. v. Liquidia Technologies Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

Zealous advocacy is a hallmark of adversarial proceedings, whether in district court or before the USPTO, where the opportunities for such advocacy have multiplied with the establishment by the Leahy-Smith America Invents Act of inter partes review or IPRs (and to a lesser extent post-grant review or PGRs).  But sometimes such advocacy can morph into overzealousness and an example of this form of advocacy arose in an IPR between United Therapeutics Corp. v. Liquidia Technologies Inc. decided in a recent decision by the Federal Circuit.

There was extensive (ANDA) litigation between the parties over inhaled formulations of treprostinil (UTC's Tyvaso®, Liquidia's Yutrepia™) for treating pulmonary hypertension, wherein UTC asserted claims in U.S. Patent No. 9,593,066 as well as U.S. Patent No. 10,716,793.  The District Court held that the asserted claims of the '066 patent were invalid for anticipation or were not infringed, a decision affirmed in all respects by the Federal Circuit, and that the asserted claims in the '793 patent were infringed and were not invalid; see "United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)".  In an inter partes review proceeding, the Patent Trial and Appeal Board held that the challenged claims of the '793 patent (which the District Court held were infringed) were invalid for obviousness, a decision also affirmed by the Federal Circuit; see "United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2024)".

In the matter at hand, Liquidia challenged in a separate IPR UTC's claims in U.S. Patent No. 9,604,901 for obviousness of a method of making treprostinil; claim 1 is representative:

A pharmaceutical batch consisting of treprostinil or a salt thereof and impurities resulting from (a) alkylating a benzindene triol, (b) hydrolyzing the product of step (a) to form a solution comprising treprostinil, (c) contacting the solution comprising treprostinil from step (b) with a base to form a salt of treprostinil, (d) isolating the salt of treprostinil, and (e) optionally reacting the salt of treprostinil with an acid to form treprostinil, and wherein the pharmaceutical batch contains at least 2.9 g of treprostinil or its salt.

Liquidia submitted an expert declaration in support of its IPR petition that did not contain the conventional recognition that the declaration testimony was made under oath and the penalties for perjury that would arise for false swearing.  UTC timely objected to the declaration and moved to exclude on 35 U.S.C. § 25 and 37 C.F.R. § 42.2 grounds; Liquidia attempted (unsuccessfully) to cured by submitting a substitute declaration having the necessary language but this submission was held to be untimely by the PTAB and insufficient because it contained no evidence in substantive response to UTC's objection.  However, and importantly, UTC deposed Liquidia's expert prior to filing its Patent Owner response, where the deponent affirmed his duty to provide "truthful and accurate testimony."  At oral argument, Liquidia explained that the deficiencies in the declaration were inadvertent and an accidental deletion of the language during drafting, was not intentional, and argued that UTC was not prejudiced due to its exercised ability to depose the expert before filing its Owner's statement and oral argument.  During oral argument, UTC's representative conceded that "he would be 'hard pressed to sit here and say, you know, that we suffered a specific cognizable prejudice.'"  The PTAB filed a Final Written Decision (FWD) that some but not all of the challenged claims were invalid, relying in some part on Liquidia's expert declaration.  The Board considered this evidence despite its deficiencies because UTC had not been prejudiced, in its view, because UTC had had the opportunity to depose the expert.  This appeal followed.

The Federal Circuit affirmed in a decision by Judge Stoll joined by Judges Hughes and Cunningham.  The panel affirmed the PTAB's reliance and consideration on Liquidia's expert declaration based on compliance with the Administrative Procedures Act (APA).  Specifically, the Court held that the Board's decision was not "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" under 5 U.S.C. § 706, citing In re Sullivan, 362 F.3d 1324, 1326 (Fed. Cir. 2004).  Nor was the decision an abuse of discretion (defined as a decision that is "(1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on [a] clearly erroneous fact finding; or (4) involves a record that contains no evidence on which the Board could rationally base its decision) under Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016) (quoting Bilstad v. Wakalopulos, 386 F.3d 1116, 1121 (Fed. Cir. 2004)).  While acknowledging the aptness of UTC's assertions regarding the statutory and regulatory standards for declarations and affidavits to be sworn under oath, the purpose for the rule is "to provide a guarantee of truthfulness where, as here, the testimonial evidence is in paper form," reciting Former Emps. of Barry Callebaut v. Chao, 357 F.3d 1377, 1383 (Fed. Cir. 2004), and is not burdensome ("easy to satisfy").  The opinion notes that UTC "made a strategic decision" to "rigorously" depose Liquidia's expert and established under oath that "there were no issues concerning the truthfulness of the opinions" therein.  The Court found "no harmful error" in the Board's reliance on the witness's testimony in rendering its FWD under these circumstances, and in the absence of an error "that was genuinely harmful or prejudicial" had no basis for finding the Board had abused its discretion, citing Swagway, LLC v. Int'l Trade Comm'n, 934 F.3d 1332, 1343 (Fed. Cir. 2019), for the opportunity for the Board and the Court to recognize harmless error under the APA.  On the merits the opinion notes that "UTC responded to Dr. Winkler's opinions in its Preliminary Response, Patent Owner Response, Sur-Reply, and its own expert's declaration" and thus had had "a full and fair opportunity to litigate Dr. Winkler's sworn opinions and suffered no prejudice."  "At bottom, under the facts here, substance beats form" the panel pithily summarized its opinion on UTC's arguments challenging the PTAB's decision (the panel relying on the parties' judgment in not having this decision used to "create a perverse incentive for a party to not depose a declarant who failed to include an oath or declaration with her affidavit").

The opinion also affirmed the PTAB's obviousness determination based on that determination being supported by substantial evidence provided by the cited prior art and Liquidia's expert.  The opinion also rejected UTC's argument that the PTAB's finding of obviousness was contrary to the Court's limitations of reliance on "common sense" in obviousness determinations enunciated in Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355 (Fed. Cir. 2016), because the Board had relied on "more than common sense" in the form of "reasoned analysis and evidentiary support."

United Therapeutics Corp. v. Liquidia Technologies Inc. (Fed. Cir. 2024)
Nonprecedential disposition
Panel: Circuit Judges Hughes, Stoll, and Cunningham
Opinion by Circuit Judge Stoll

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

The Federal Circuit once again had an opportunity to opine on the extent of behavior by a generic drugmaker who opts to accept a "section viii carve-out" in its FDA approval (resulting in a so-called "skinny label) on liability for inducing infringement in Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc.

The case arose over Amarin's Vascepa® (icosapent ethyl) drug product, an omega-3 fatty acid from fish oil, for treatment of severe hypertriglyceridemia (blood triglyceride levels at least 500 mg/dL; normal range is less than 150 mg/dL) (the "SH indication").  Amarin also later received approval for a second indication, reducing cardiovascular disease risk (wherein the second approval removed a Limitation of Use in this regard on the original label) (the "CV indication").  Hikma filed its ANDA against the first approved Vascepa® product; upon Amarin receiving its second FDA approval Hikma filed a section viii statement to carve-out the CV indication under 21 U.S.C. § 355(j)(2)(A)(viii) (the so-called "skinny label").  FDA approved Hikma's skinny label ANDA in 2020 not containing the CV Limitation of Use on the label.

Thereafter, in a series of press releases, Hikma asserted its product as a "generic version of Amarin's Vascepa®."  In a particular press release, Hikma claimed its two-month U.S. sales to be $1.1 billion, a figure for all uses of its product, with up to 75% of these sales being for the putatively carved-out CV (off-label) indication (albeit there being other press releases emphasizing the limitation of FDA approval to the SH indication).  And on Hikma's website, while asserting an AB rating for its product (generic approval for all indications on the label), the website also said "Hikma's generic version is indicated for fewer than all approved indications of the Reference Listed Drug."

In the ensuing litigation (this case), Amarin sued Hikma for inducement of infringement under 35 U.S.C. § 271(b) of Orange Book listed U.S. Patent Nos. 9,700,537 and 10,568,861 (for claim 1 of the '527 patent and claim 1 and 2 of the '861 patent):

'537 patent:

1.  A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient consisting of:
    identifying a patient having triglycerides (TG) of at least 150 mg/DL and HDL-C of less than 40 mg/dL in a blood sample taken from the patient as a risk factor of a cardiovascular event, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate in combination with a 3-hydroxy3-methylglutaryl coenzyme A reductase inhibitor,
    wherein said 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor is administered to the patient at least one of before, during and after administering the ethyl icosapentate; and wherein the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor is selected from the group consisting of pravastatin, lovastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin, and salts thereof, and
    wherein daily dose of the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor are 5 to 60 mg for pravastatin, 2.5 to 60 mg for simvastatin, 10 to 180 mg for fluvastatin sodium, 5 to 120 mg for atorvastatin calcium hydrate, 0.5 to 12 mg for pitavastatin calcium, 1.25 to 60 mg for rosuvastatin calcium, 5 to 160 mg for lovastatin, and 0.075 to 0.9 mg for cerivastatin sodium.

'861 patent:

1.  A method of reducing risk of cardiovascular death in a subject with established cardiovascular disease, the method comprising administering to said subject about 4 g of ethyl icosapentate per day for a period effective to reduce risk of cardiovascular death in the subject.

2.  The method of claim 1, wherein the subject has a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL and a fasting baseline LDL-C level of about 40 mg/dL to about 100 mg/dL.

In its complaint, Amarin asserted Hikma's press releases, website content, and product label as evidence of "specific intent to actively encourage physicians to directly infringe the asserted patents by prescribing its generic icosapent ethyl product for the off-label CV indication, an indication for which Hikma did not get FDA approval."

The District Court granted Hikma's motion to dismiss under Fed. R. Civ. Pro. 12(b)(6) for failure to state a claim in Amarin's complaint alleging inducement of infringement, based on its determination that the complaint failed to allege facts that Hikma had taken "affirmative steps" to induce infringement (a decision contrary to the recommendation of the magistrate judge to whom the district court judge referred the motion).  The District Court judge cited the cautionary language in Hikma's label regarding side effects as "hardly instruction or encouragement" for the alleged off-label use and that removal of the CV Limitation of Use from Hikma's label would not have been persuasive that its product had been "shown to reduce cardiovascular risk" and thus to have "encourage[d] its use for that purpose."  The distinction relied upon by the District Court was that "'merely describing an infringing [treatment] mode is not the same as recommending, encouraging, or promoting an infringing use,'" quoting, with alterations, Takeda Pharms. U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed Cir. 2015).  With regard to Hikma's press releases and other public statements, the District Court considered that while they "may be relevant to Hikma's intent to induce infringement" (emphasis in opinion), they were not evidence of "an inducing act" constituting a separate element for inducement under § 271(b). The website evidence was deemed insufficient because it did not "rise to the level of encouraging, recommending, or promoting taking Hikma's generic for the reduction of CV risk," comparing GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th 1320, 1336 (Fed. Cir. 2021) (per curiam) ("GSK"), with Grunenthal GmbH v. Alkem Lab'ys Ltd., 919 F.3d 1333, 1339 (Fed. Cir. 2019).

The Federal Circuit reversed in an opinion by Judge Lourie, joined by Chief Judge Moore and District Court Judge Albright (W.D. Tx), sitting by designation.  The opinion begins by emphasizing that the matter below was not an ANDA case under 35 U.S.C. § 271(e)(2)(A), wherein the alleged infringement does not involve an infringing act other than filing the ANDA (what the opinion denotes as a "hypothetical" act of infringement, based on what would arise if the ANDA applicant received FDA approval and marketed the allegedly infringing generic drug).  The panel also asserted that this is not a typical "skinny label" case under section viii wherein the plaintiff asserts the generic label isn't "skinny enough" and wherein "the label alone induces infringement," relying on H. Lundbeck A/S v. Lupin Ltd., 87 F.4th 1361, 1370 (Fed. Cir. 2023), and HZNP Meds. LLC v. Actavis Lab'ys UT, Inc., 940 F.3d 680, 699 (Fed. Cir. 2019).  The basis for Amarin's assertions, in the Federal Circuit's view, is the combination of the skinny label and Hikma's "public statements and marketing" of its approved generic product (which the opinion states makes this "nothing more than a run-of-the-mill induced infringement case," a characterization perhaps motivated by the contretemps arising in its decisions in GSK, see "GlaxoSmithKline LLC v. Teva Pharmaceuticals USA (Fed Cir. 2020)" and "GlaxoSmithKline LLC v. Teva Pharmaceuticals USA (Fed. Cir. 2022)", and Hikma's assertions of the consequences that would arise if the Federal Circuit reversed, see below).  In such a case, the standard the Court applied was "whether the totality of the allegations, taken as true, plausibly plead that Hikma induced infringement" (emphasis in opinion) that would provide "substantial evidence to support a jury verdict of induced infringement."

The panel noted that the case has come before them in a "nascent" stage, without the benefit of discovery or as an appeal of denial of a preliminary injunction motion or an appeal of a summary judgment motion or post-trial motion (citing several of the Court's earlier precedent on skinny label cases having those attributes).  As a consequence, the Court stated it is responsible here for "reviewing allegations, not findings, for plausibility, not probability" under Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556 (2007)(emphasis in opinion).

Turning to the evidence relied upon by the District Court in granting Hikma's motion, the opinion states as being "undisputed" that there has been direct infringement by doctors and other healthcare providers in prescribing Hikma's alleged infringing product for off-label use (the CV indication) and that Hikma had "the requisite intent and knowledge to induce that infringement" as found by the District Court.  This leads the Court to determining whether Hikma "actively" induced healthcare providers' direct infringement.  At least due to the analytical basis for reviewing motions to dismiss ("[a]ccepting all well-pleaded facts as true and drawing all reasonable inferences in Amarin's favor"), the opinion finds that it did.  However, the panel discarded any implication that Hikma's label (the "Indications & Usage" section) provides "implied or express instruction to prescribe the drug for the CV indication."

The panel instead turned to the parties' contentions.  First, Amarin's complaint alleged that other portions of Hikma's label (specifically, "the clinical studies section, which describes statin-treated patients with the same cardiovascular event history and lipid levels covered by the asserted patents") would teach physicians that the product could be prescribed for treating cardiovascular risk (because, inter alia, the patient populations for the SH and CV indications overlap).  Moreover Amarin contended that while FDA approved removal of the CV Limitation of Use regarding CV indications from their label it did not do so for Hikma's label.  Hikma's removal of the CV Limitation of Use regarding CV indications as well as including warnings of potential cardiovascular side effects from its drug, Amarin contended, communicated to physicians that its generic drug could be used off-label for the CV indication.

Hikma for its part argued that Amarin was asserting a requirement (and infringement liability for the absence thereof) for language discouraging infringement contrary to law, relying on Takeda Pharms. U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed Cir. 2015).  Hikma attempted to take refuge (as has arisen in other skinny label disputes) on FDA's requirement that the label for generic copies of branded approved drugs be "the same as the labeling approved for the listed drug" under 21 U.S.C. § 355(j)(2)(A)(v).  Also, Hikma argued that its silence regarding its product's effects on risk of cardiovascular complications "cannot plausibly instruct infringement."  Finally, Hikma argued that it is "implausible" and "borderline frivolous" to contend (as Amarin does) that information related to clinical studies and attendant warnings about side effects would encourage a physician to prescribe their drug.

The Federal Circuit conceded that Hikma's label does not "recommend[], encourag[e], or promot[e] an infringing use" as a matter of law as found by the District Court.  But (agreeing with the magistrate judge) the Court (and Amarin) did not rely on the label alone.  Rather, it is the combination (emphasis in opinion) of the label and Hikma's "public statements and marketing materials" that render the District Court's grant of Hikma's motion to dismiss to be in error.  Specifically, the Court considered that while the "AB rating" description on Hikma's website may be broad enough to encompass both infringing and non-infringing uses (and thus not support a finding of inducement liability) their press releases consistently characterized their drug as being a "generic equivalent to Vascepa®" and cite the SH indication limitation as being only a part of their approved indication.  These implications were supported by reports on sales figures resulting in large (75%) part from off-label use for CV indications.  "Those allegations, taken together with those relating to Hikma's label, at least plausibly state a claim for induced infringement," the Court held.

Importantly, these allegations by Amarin regarding Hikma's inducement liability are, according to the opinion, "question[s] of fact—not law" and therefore are "not proper for resolution on a motion to dismiss."  The panel asserted they "[we]re unpersuaded" by Hikma's arguments that, because these facts are not in dispute the District Court was correct in deciding to grant Hikma's motion to dismiss on legal grounds.  And the opinion distinguishes earlier cases where inducement was decided as a matter of law on the procedural posture of one such case, wherein HZNP was decided ("critically") on summary judgment and was solely based on the contents of the label; the parties access to discovery placing this case (motion to dismiss) on a different footing, insofar as Amarin was entitled to having all factual considerations and inferences in its favor (finding Amarin's contentions on how Hikma's statements and representations could "plausibly" suggest to a physician that its drug was effective the CV indications).  The panel also refused to interpret Hikma's representations regarding its AB rating for the drug as being sufficient to insulate it from inducing infringement liability.

The opinion also rejects Hikma's assertions that reversing the district court would be contrary to the Court's decision in GSK, distinguishing that decision on the basis of procedural differences (a motion to dismiss here with a post-trial judgment as a matter of law there) as well as substantive distinctions (there, the label itself taught an infringing use and hence "it was reasonable for the jury to find that the generic manufacturer's marketing of its product as an "AB rated generic equivalent" encouraged physicians to prescribe the drug for the infringing use instructed by the label"), which is not the case here.  Here, Amarin was entitled to have all its allegations accepted as true in the context of a motion to dismiss, including their allegations that "Hikma did much more than call its product a 'generic version' of Vascepa" in the face of evidence of Hikma's other activities.

The opinion disdainfully rejects Hikma's "inflated characterizations" regarding the dire consequences for section viii carve-outs should the Court rule (as it does) against them.  The opinion states its decision is "limited to the allegations before us" and "guided by the standard of review appropriate for this stage of proceedings," while pledging fealty to the "careful balance struck by the Hatch-Waxman Act regarding section viii carve-outs."  The Court cautioned generic drugmakers that "clarity and consistency in a generic manufacturer's communications regarding a drug marketed under a skinny label may be essential in avoiding liability for induced infringement," which was not found here.

This case is remanded to the District Court where, absent settlement (unlikely in view of Hikma's $1 billion + annual sales) the Federal Circuit will likely have the opportunity to rule on the substantive questions regarding skinny label inducement raised by these circumstances.

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2024)
Panel: Chief Judge Moore, Circuit Judge Lourie, and District Judge Albright (sitting by designation)
Opinion by Circuit Judge Lourie

Judge Newman Suspension Renewed

By Kevin E. Noonan --

Not surprisingly, the Special Committee of the Federal Circuit after an Oral Hearing on July 10th voted unanimously to maintain the suspension (see "Judge Newman Suspended for One Year by Federal Circuit") handed down against Judge Pauline Newman on July 23, 2023 until such time that the Judge complies with the Order that she "undergo specified full neuropsychological testing and a neurological examination with independent experts selected by the Committee and to turn over medical records to the neurologist and . . . that Judge Newman sit for an interview."  In response, Judge Newman has submitted evidence from her personal physicians and brought suit in the D.C. District Court (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit"), which suit was dismissed and is on appeal before the District of Columbia Circuit Court (see "Judge Newman's Suit Comes to an End").

The Court has made public the Special Committee's 97 page Report and Recommendation setting forth its evidentiary and legal rationales for the decision to maintain the suspension.  One notable aspect is the numerous citations and references that "[t]he Committee had amassed extensive ("voluminous") evidence [elsewhere in the Report specified as "393 pages of supporting evidence"] raising concerns that Judge Newman may suffer from cognitive impairments material to her job.  According to the Special Committee '[o]ver the past year, Judge Newman's conduct has not changed" although whether that is said in reference to the Judge's refusal to comply or further incidents of distressing behavior is not clear (tellingly, the Report states that "Judge Newman continues to refuse to cooperate with the Committee's orders and continues to thwart the Committee's ability to fulfill its responsibilities under the Judicial Conduct and Disability Act (Act)", suggesting the basis for the Special Committee's conclusion is the former).  The Report asserts that "Judge Newman has not presented any information to undermine the voluminous record the Committee compiled last year raising serious concerns about Judge Newman's cognitive state," and dismisses the "handful of occasions over the past year in which [Judge Newman] delivered some public remarks or sat for an interview."  The Special Committee asserts it has "strong concerns established by the extensive record compiled by the Committee showing troubling signs of cognitive decline" which include "angry and abusive behavior towards staff, with many witnesses describing increasingly erratic behavior in 2023."  And the Special Committee rejects Judge Newman's contention that the Judge's continuing litigation against these sanctions provides a basis for the Judicial Council to "refrain from addressing her continuing misconduct with an additional sanction."  One justification for the continuing sanction enunciated by the Special Committee is that staying sanctions "would seriously impair the public interest [by] impair[ing] the expeditious functioning of the self-policing mechanism in the Act that Congress intended to allow the judiciary to swiftly address issues of disability" [and] "in light of the extensive record developed in this case, permitting Judge Newman to resume hearing cases would raise a serious risk that litigants may be having their disputes decided by a judge who is not fit for executing the duties of her office."

The Report also addresses (and dismisses) three types of "new" information submitted in support of Judge Newman's response to the Committee's Order to Show Cause why the sanctions should be lifted.

The first is the Supreme Court's reliance upon Judge Newman's position (in dissent of an en banc decision by the Federal Circuit) in Rudisill v. McDonough, 601 U.S. 294 (2024).  The Report dismisses this argument, contrasting one example with the "voluminous evidence"** adduced by the Special Committee.

The Report also finds unpersuasive examples of Judge Newman's public activities and participation in four conferences or interviews over the past year, saying these do not "eliminate the concerns about her cognitive state already found sufficient to support the medical examination orders."  The Report goes on further to say:

The question under the [Judicial Conduct and Disability Act] process at issue concerns disability for fulfilling the particular duties of her office, which require abilities involving short-term memory, clarity about and concentration in working with numerous concrete facts, and stamina in doing so with multiple cases—abilities that go well beyond the ability to be or seem coherent in the settings Judge Newman now highlights.

Turning to Judge Newman's assertions that "no one, including her regular treating physicians and other medical professionals, save for members of this Committee, has suggested that Judge Newman's behavior or medical data would indicate need for any neuropsychological or psychiatric examinations," the Report responds that "[to] the extent Judge Newman claims that no one except the Committee found that the evidence of record created a reasonable basis for the Committee to order medical examinations and production of medical records, that is incorrect.  All eleven of Judge Newman's colleagues at the Federal Circuit unanimously found such a reasonable basis, . . . and all seven members of the JC&D Committee affirmed."  The Report also asserts that Judge Newman has provided no evidence regarding her physicians' assessment and judgment, nor that these physicians subjected the Judge to "the full battery of neuropsychological testing that the Committee has been seeking for over a year."  "The evaluations of Judge Newman by physicians of her choosing did not carry sufficient probative value to undermine the basis for the Special Committee's concerns" according to the Report.

The Report goes on to say that:

Far from providing evidence to allay the ample concerns supporting the medical examination orders, Judge Newman's response—by what is absent from it—has reinforced the concerns about cognitive impairment.  Nothing in the response faces up to her conduct, and why it raises various concerns, including regarding cognitive impairment, or presents meaningful evidence of changed circumstances.  Indeed, Judge Newman appears, even now, to be unable to grasp that her behavior toward staff has been inappropriate and has had a serious impact on court staff.

(It is somewhat ironic that the Special Committee seems to refuse to accept evidence from Judge Newman's physicians but places great weight on "sworn testimony from staff members in multiple units within the Court including the Clerk's Office, IT, HR, General Counsel's office, and Judge Newman's own chambers"; and that "[t]his testimony detailed interactions with Judge Newman that indicated 'significant mental deterioration' manifested in highly inappropriate and unprofessional behavior by the judge," which regardless of their probity seems to put greater weight on lay opinion rather than professional opinions bound by medical ethics (and it cannot fairly be said that the sources making up the "voluminous evidence" are entirely neutral -- it is worth considering how solicitous anyone would be who felt personally aggrieved in such a situation.)

The Report further asserts in justification of continuing sanctions the existence of "overwhelming evidence of Judge Newman's troubling interactions with staff" that "continues to provide a reasonable basis for concern over Judge Newman's ability to discharge the duties of her office."  While seeking (apparently) to minimize the burdens of the required testing ("Those medical examinations are quite limited in the burden they place on Judge Newman.  The required neurological evaluation should last 30–45 minutes and will not involve invasive procedures, such as blood work or imaging studies.  The required neuropsychological testing involves a clinical interview, administration of questionnaires related to personality and mental health symptoms, and cognitive testing.  No aspect of the process is physically invasive, and the entire examination is likely to take up to six hours") they are also qualitative in nature and thus will depend entirely on medical opinions by (necessarily) strangers.

The Report also dismisses Judge Newman's call that her suspension be lifted and the Special Committee's decision on sanctions be stayed during the course of her appeal, because "if [Judge Newman's] mental status is in question then permitting her to sit on panels while the appellate case progresses is not possible," further stating:

As the Judicial Council concluded, failing to act where there is voluminous evidence raising a reasonable concern that she may suffer from a mental disability "would breach our obligations under the Act, display disregard for the rights of litigants bringing their cases before this Court, ignore the rights of court staff to be free from increasingly dysfunctional behavior in the workplace, and undermine public confidence in the judiciary."

In brief summaries, the Report asserts that "[t]he Judicial Council found Judge Newman to have committed misconduct by non-cooperation with its investigation," that "Judge Newman's refusal to cooperate was a serious matter because it prevented the Committee from being able to fulfill its assigned task under the Act—namely, making an informed assessment (and recommendation for the Judicial Council) about whether Judge Newman suffers from a disability," and that because Judge Newman's conduct has not changed the appropriate sanction the Special Committee recommends for "[t]hwarting the Committee's ability to complete the process established by Congress for determining whether a life-tenured judge suffers from a disability" is "a further one-year sanction during which Judge Newman will not be permitted to hear cases at the panel or en banc level.

"This sanction is not for past misconduct.  Instead, it addresses Judge Newman's continuing misconduct through her continuing refusal to cooperate with the Committee's orders," the Report states.

The Report is accompanied by copies of some e-mail correspondence relating to squabbles concerning whether Judge Newman was (or was not) invited to professional and social functions at the Court, as well as the transcript of the Oral Hearing.  Judge Newman's counsel, Gregory Dolan, after fielding questions from the bench reached the Constitutional basis that Judge Newman has raised in the Judge's complaint before the District Court (abridged somewhat here for clarity), Dr. Dolan arguing:

"Our separation of powers are not meant to allow fellow judges to self-impeach even for terrible misconduct" and the recourse is to recommend to the Judicial Conference that Judge Newman be impeached, counsel making the point that even should the medical exams verify that Judge Newman is not competent the Judicial Council cannot remove her.

"[T]he interesting part about it is taking the test or not taking the test doesn't change the outcome.  Judge Newman is and will remain an active judge of this Court until she retires, dies, or is impeached."

"[T]he Committee has repeatedly declined to state that it will be even bound by the test results, a simple step that it might help us to determine things.  But the Committee has never said, not once, that if the doctors give her the green light, [Judge Newman] will be restored to the bench."

"But the point is that no one except members of this Committee -- not people who see Judge Newman socially, not people who have seen Judge Newman professionally, not people who have been on various panels with Judge Newman, not the Supreme Court that affirmed her opinion -- thought that Judge Newman is in need of a mental competency exam.  It's only this Committee and the physician who has never seen or evaluated or talked to Judge Newman.  So you have medical evidence on one hand and complaints by disgruntled staff on the other hand.  Respectfully, I think medical evidence warrants more weight."

"All of that having been said, there are still opportunities to resolve this, as we have suggested on multiple occasions.  And if the Committee is truly interested in figuring out is Judge Newman able or unable to perform this function, rather than just keeping it to itself, there is an opportunity to get a neutral decisionmaker involved and actually resolve it.  So there are off-ramps here, but Judge Newman will not submit to a 'my way or highway' approach.  And I understand it may be frustrating to the Committee, but Judge Newman is an Article III judge nominated, confirmed, and appointed by the President.  She gets to hold her office on good behavior, and she intends to do so."

It is clear that neither Judge Newman nor the Special Committee is willing to take advantage of these opportunities to resolve this matter amicably.  Nothing has changed, except that Judge Newman is one year older.  The waiting game continues.

**What is that "voluminous evidence"?

According to the Report the "voluminous evidence" amounts to:

Affidavits prepared after more than 20 interviews with Court staff reflect consistent reports of deeply troubling interactions with Judge Newman that suggest significant mental deterioration including memory loss, confusion, lack of comprehension, paranoia, anger, hostility, and severe agitation.  Critically, these reports are not isolated incidents of occasional forgetfulness based on a few interactions with only one or two staffers.  To the contrary, they come from interactions with staff members across a broad range of departments from the Clerk's Office to Information Technology (IT), to Human Resources (HR), to the General Counsel Office, to Judge Newman's own chambers staff.  And contrary to Judge Newman's assertions, the reports indicate that the behaviors suggesting that Judge Newman may have a disability emerged over two years and increased in frequency and severity.  Judge Newman has never specifically disputed any of the staff accounts, many of which are independently substantiated by Judge Newman's own emails attached as exhibits.

Beteiro, LLC v. DraftKings, Inc. (Fed. Cir. 2024)

Federal Circuit Calls "No Bet" on Beteiro's Asserted Patents

By Andrew Velzen --

Recently, the Court of Appeals for the Federal Circuit (CAFC) issued an opinion in Beteiro, LLC v. DraftKings Inc.[1]  This case is yet another case where the Federal Circuit upheld invalidity under § 101.  Here, the patents in question were directed to monitoring gaming / gambling activities at various physical locations, primarily with the idea that a user can be located in one location, but place wagers at a computer in a different location.

In my view, the opinion illustrates what is, at best, a strained § 101 analysis.  The court simply could not get past what it viewed as a substantial imbalance of non-technical content to technical content in the specification.  Notwithstanding, though, there are certainly ways in which Beteiro could have better structured their claims and specification to withstand § 101 scrutiny.  Herein, I'll briefly discuss both of these points.

Case Summary

As a preliminary point, I think it's prudent to at least briefly summarize the procedural posture of the case and the Federal Circuit's decision.  The appeal to the CAFC arose based on multiple lawsuits filed by Beteiro against various gaming entities (DraftKings, PointsBet, BetMGM, Betfair, etc.) in the District of New Jersey.  In those lawsuits, Beteiro asserted patent infringement of four different patents.  Worth noting, despite claiming priority back to applications from 2002, 2003, and 2008, each of the asserted patents was filed in 2016 or later (i.e., each of the asserted patents was prepared and filed after the U.S. Supreme Court's decision in Alice Corp. v. CLS Bank International).  Notwithstanding, each of the defendants (now appellees) filed a motion to dismiss alleging that the asserted patents were invalid under § 101.  The District Court agreed and Beteiro appealed to the CAFC thereafter.

Claim 2 of U.S. Patent No. 10,255,755 was deemed by the parties, the District Court, and the CAFC as representative of all the asserted claims for purposes of § 101 analysis.  This claim recites:

2.  A computer-implemented method, comprising:
    detecting, with or using a computer which is specially programmed for processing information for providing for a placement of a bet on or regarding a gaming activity, a gambling activity, or a sporting event, a posting of information regarding the gaming activity, the gambling activity, or the sporting event;
    generating, with or using the computer, a notification message regarding the gaming activity, the gambling activity, or the sporting event;
    initiating, with or using the computer, a communication link with a first communication device and transmitting the notification message to the first communication device as an electronic transmission, or transmitting, from the computer, the notification message as an electronic mail message, wherein the electronic mail message is received by or received at a first communication device, wherein the first communication device is associated with an individual;
    receiving, with the computer, a bet message transmitted from the first communication device or from a second communication device, wherein the second communication device is associated with the individual, and further wherein the first communication device or the second communication device comprises a global positioning device, wherein the global positioning device determines a position or location of the first communication device or the second communication device, and further wherein the bet message contains information regarding a bet to be placed on or regarding the gaming activity, the gambling activity, or the sporting event, and information regarding the position or location of the first communication device or the second communication device; and
    determining, with or using the computer, whether the bet is allowed or disallowed using the information regarding the position or location of the first communication device or the second communication device and, if the bet is allowed, processing information for placing the bet for or on behalf of the individual, or, if the bet is disallowed, processing information for disallowing the bet [emphases added].

The above-emphasized portions are where the CAFC focused the bulk of its analysis under § 101.  After said analysis, the CAFC ultimately affirmed the determination of invalidity.

Court's § 101 Analysis

As is rote at this point, in order to analyze whether a claimed invention is directed to patent-eligible subject matter, the Federal Circuit applied the Alice/Mayo test (i.e., Step 1 -- Is the claim directed to a process, machine, manufacture, or composition of matter; Step 2A -- Is the claim directed to a judicial exception to eligibility, such as an abstract idea; and Step 2B -- Does the claim amount to significantly more than the judicial exception to eligibility).[2]  It bears noting that the patent examiner who examined these patent applications explicitly evaluated eligibility for the claims under § 101 and found them patent-eligible based on their recitation of a particular machine or processor.

Step 2A

Under Step 2A of the Alice/Mayo test, the CAFC agreed with the District Court that the claims were directed to the abstract idea of "exchanging information concerning a bet and allowing or disallowing the bet based on where the user is located."  In doing so, the CAFC indicated that the claims include many alleged "well-settled indicators of abstractness."  Setting aside the fact that that phrase borders on word salad, these so-called "indicators" included: (1) the claims broadly reciting generic steps of detecting information, generating and transmitting a notification based on the information, receiving a message, determining, and processing information; (2) the claims being drafted using largely result-focused functional language, while containing no specificity about how the purported invention achieves the results; (3) the claims being analogous to claims held abstract in other CAFC cases; and (4) the claims being analogous to longstanding "real-world" activities.

Regarding item (1) above -- Like many claims, if you abstract away all the substance and merely recite some gerunds, claims can quickly devolve into sounding rather patent-ineligible.  Regarding item (2) above -- Whether something is described overly functionally is rather subjective.  Beteiro's claims recite "a computer," "a first communication device," "a second communication device," and "a global positioning device" and also describe communications among those devices.  Obviously, more detail can always be provided in a claim, but not without the cost of narrowing the claim.  Beteiro did not want to limit their claims to any particular type of communication protocol or type of communication devices, nor did Beteiro want to provide any additional unnecessary details about the "computer" or "communication devices."  Further, clearly Beteiro did not need to incorporate such narrowing details (at least in the patent examiner's opinion) in order to demonstrate that the claims were new and non-obvious.  Hence, the CAFC demanding that additional technical details be added to the claims for § 101 purposes when Beteiro already recited multiple devices performing different acts seems dubious.

The CAFC's claim in item (3) is questionable, at best.  The Federal Circuit referenced Affinity Labs of Tex., LLC v. DIRECTV, LLC and Intell. Ventures I LLC v. Capital One Bank (USA) as allegedly containing analogous claims to Beteiro's.  The claims at issue in those cases, however, do not refer to any sort of "global positioning device" and are certainly much less tailored to communication protocols between devices.[3]  For example, the claim considered in Affinity Labs was:

1.  A broadcast system, comprising:
    a network based resource maintaining information associated with a network available representation of a regional broadcasting channel that can be selected by a user of a wireless cellular telephone device; and
    a non-transitory storage medium including an application configured for execution by the wireless cellular telephone device that when executed, enables the wireless cellular telephone device:
        to present a graphical user interface comprising at least a partial listing of available media sources on a display associated with the wireless cellular telephone device, wherein the listing includes a selectable item that enables user selection of the regional broadcasting channel;
        to transmit a request for the regional broadcasting channel from the wireless cellular telephone device; and
        to receive a streaming media signal in the wireless cellular telephone device corresponding to the regional broadcasting channel, wherein the wireless cellular telephone device is outside of a broadcast region of the regional broadcasting channel, wherein the wireless cellular telephone device is configured to receive the application via an over the air download.

Likewise, the claim considered in Intell. Ventures recites:

1.  A system for providing web pages accessed from a web site in a manner which presents the web pages tailored to an individual user, comprising:
    an interactive interface configured to provide dynamic web site navigation data to the user, the interactive interface comprising:
    a display depicting portions of the web site visited by the user as a function of the web site navigation data; and
    a display depicting portions of the web site visited by the user as a function of the user's personal characteristics.

These claims are only analogous to Beteiro's claims at a relatively high level of abstraction.  For example, neither relate to gambling / gaming in any sense.  Further, the primary purpose of both claims above is to determine what is displayed to a user, whereas the primary purpose of Beteiro's claims is to determine whether to allow or disallow a bet.

Regarding claim (4) -- Analogizing claim language to "real-world" activities, while sometimes done in § 101 cases, has always struck me as a bit ironic.  Namely, if claims are more akin to physical "real-world" activities, those claims are somehow less patent-eligible.  The "real-world" is the exact opposite of "abstract."  Thus, this flavor of analysis is essentially equivalent to saying "the claimed invention is not abstract, therefore it is an abstract idea and patent-ineligible."  It simply strains credulity.

To illustrate the "real-world" nature of Beteiro's claims, the CAFC points to an analogy posited by the District Court of a teller at a casino that straddles state lines.  This analogy is absurd.  As an initial point, I'm not aware of any real casinos that actually fit this description (i.e., where you can place bets in two different states within the same casion).  In fact, I'd assume casinos intentionally avoid this issue so they don't have to simultaneously deal with multiple sets of state laws.  Hence, this issue rarely, if ever, comes up in the context of placing physical bets at a teller.  Oppositely, with modern technology, the issue of confirming location comes up in >90% of all sports bets placed.[4]  Further, even if the scenario proposed by the District Court / CAFC did come up in reality, there would be no "global positioning device" or "communication device(s)" needed or used because the bettor and the teller would be in the same physical location.  Hence, any attempted patent claim to this fabricated "real-world" scenario would look totally different than Beteiro's claims.

On behalf of eligibility, Beteiro argued that their claims involved technological improvements and, therefore, are not directed to abstract ideas.  According to the CAFC, though, because the claims do not provide an improvement to the way computers operate nor do they solve a technical problem, the claims remain abstract ideas.

Step 2B

Under Step 2B of the Alice/Mayo test, Beteiro argued that the inclusion of a global positioning system (GPS) device in their claims was unconventional, which should provide for a path to patentability.  The CAFC attempted to refute this point by referring to the relatively limited discussion of GPS in the specification.  In particular, the lengthy specifications of the asserted patents only includes a single sentence concerning a mobile phone with an equipped GPS device.  Given this, the CAFC concluded that the inclusion of the GPS device on a mobile phone must have been conventional at the time.  This is, at the very least, a dramatic departure from the CAFC's Berkheimer decision.[5]  Regardless, in the CAFC's view, because the inclusion of a GPS on a mobile phone was routine, conventional, and well-understood, the inclusion of the GPS cannot convert a claim that is otherwise patent-ineligible into patent-eligible.

This also raises an interesting procedural point.  Because this appeal arises from a motion to dismiss, any factual disputes need to be resolved in Beteiro's favor.  Further, Beteiro contended in its complaint that the use of GPS for gaming was unconventional in 2002 (their earliest priority date), and provided evidence to support this.  In 2002, for example, the iPhone had yet to be created.  Even so, the CAFC disregarded this contention based solely on what was (and was not) in the specification.  In doing so, the court cited to the recent AI Visualize case:[6]

Conclusory allegations, or those "wholly divorced" from the claims or the specification, cannot defeat a motion to dismiss. And a patentee that emphasizes a claim's use of certain technology, for example, a general-purpose computer, fails at step two when the intrinsic record establishes that the technology is conventional or well-known in the art.

While the Beteiro patents may not have described how one incorporates GPS devices into mobile phones, in detail, I think the court's reliance on the above precedent borders on dubious.  Beteiro's claims did specifically recite a "communication device" that "comprises a global positioning device, wherein the global positioning device determines a position or location of the first communication device or the second communication device."  Hence, Beteiro's allegations were not "'wholly divorced' from the claims."  Still, the court drew a distinction between Beteiro's complaint and the complaint in Cellspin Soft, Inc. v. Fitbit, Inc. where the contentions were purportedly much more rooted in the patent-in-suit.[7]

Lastly, it is perhaps worth mentioning that the CAFC rightly wholly disregarded the patent examiner's previous consideration of § 101 issues under well-established law.  Regardless, though, the patent examiner apparently applied pre-Alice caselaw and relied on the existence of one or more physical components in deciding that the claims were patent-eligible.  This was clearly an overbroad view by the patent examiner.

Suggested Improvements to Bolster Claims Under § 101

The above clearly highlights, yet again, just how sticky § 101 is for patentees, even when physical devices (e.g., mobile devices and/or GPS sensors) are involved.  Perhaps, though, there are some ways that Beteiro could have reframed their specification or claims that would have provided a stronger bulwark for a § 101 analysis.  In that vein, let's highlight a few of them.

One step that Beteiro could have taken, and which is explicitly contemplated by the CAFC opinion, would be to bolster the description of the GPS device in the specification.  Had the specification dedicated more space to technical details about the inclusion of the GPS device in a mobile device, the court clearly thinks that would help patentability (e.g., by demonstrating how the GPS device is a technical improvement) or, at the very least, would have provided fodder to get over a motion to dismiss under § 101 (i.e., because the additional technical details could raise a genuine question of material fact over whether inclusion of a GPS in a mobile device was truly well-understood, routine, and conventional).

There are likely other technical details besides how a GPS device is integrated into a mobile device that could have been included in the specification to show that the use of a GPS device in the claimed way was unconventional.  For example, additional details on the ways in which the mobile device communicates the measured GPS data to the gaming facility computer (e.g., message communication protocols, formats in which the GPS data is communicated, where the GPS data is stored, how the GPS data is accessed / used by the gaming facility computer, etc.) could have been included.  Such additional details would not only serve to demonstrate the level to which the inventors had considered the importance of communicating the GPS data, but would also show why the inclusion of GPS data is central to the claimed invention serving its intended purpose.  Any of these technical details about the GPS could have been explicitly recited in the claims, as well, if Beteiro wanted to further strengthen their § 101 position.

Additionally, as is sage advice these days in almost any patent application that might need to pass muster under § 101, the specification could have laid out a technical problem to be solved and how the claims provide a technical solution.  The claims and specification clearly address what is, in the eyes of the CAFC, non-technical problems (e.g., gambling jurisdiction and legal compliance).  This is simply not helpful based on current § 101 jurisprudence.  Instead, if the specification had couched the discussion in terms of the gaming facility computer being unable to reliably determine the location of the mobile device based on conventional messaging between the two, and then later provided the GPS device as a means of enabling a reliable determination of location in the invention, the court may have been more inclined to find that the claims amounted to "significantly more" (based on the claims providing an arguably technical solution to a technical problem).  While this borders on quibbling about semantic differences, unfortunately, that is the present state of the law under § 101.

In addition to the changes to the specification described above, there are certainly some modifications that could have been made to the claims (many without requiring modification to the specification at all).  One that I would suggest, and this is purely psychological, is to remove references to "gaming activity," "gambling activity," "sporting event," etc. from the claims.  While these terms shouldn't impact a court's view or an examiner's view eligibility under § 101, they implicitly connote non-technical concepts to some readers.  Thus, anecdotally, their inclusion makes patent-eligibility a bit more of an uphill battle.  Hence, broadening the claims to only refer to things like "requests" and "confirmations" rather than "bets" could only help (at least in terms of § 101).

Conclusion

Ensuring compliance with jurisdictional regulations is of paramount importance to the gambling industry.  Further, Beteiro's claimed invention was, at least in the eyes of the patent examiner, a novel and non-obvious way of doing so using a GPS device. While it may seem pedestrian to use a GPS device for such purposes by modern standards, in 2002, it was likely anything but. Still, the morass that is post-Alice § 101 has claimed yet another victim.  If you're hoping to see more clarity in § 101 law soon, I wouldn't bet on it (pun intended).

Beteiro, LLC v. DraftKings, Inc. (Fed. Cir. 2024)
Panel: Circuit Judges Dyk, Prost, and Stark
Opinion by Circuit Judge Stark

[1] https://cafc.uscourts.gov/opinions-orders/22-2275.OPINION.6-21-2024_2337276.pdf

[2] Note that the CAFC opinion basically glosses over Step 1 of the Alice/Mayo test.  Hence, what I am calling "Step 2A" is referred to as "Step 1" by the Federal Circuit and what I am calling “Step 2B” is referred to as "Step 2" by the Court. The nomenclature does not matter so much, but I prefer to go with the more traditional naming that contemplates the full eligibility analysis.

[3] Affinity Labs of Tex., LLC v. DIRECTV, LLC, 838 F.3d 1253 (Fed. Cir. 2016); Intell. Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363 (Fed. Cir. 2015)

[4] https://www.gamingtoday.com/revenue/ (On July 14, 2024 – "In most markets, more than 90% of sports betting is online.  For markets where mobile wagering is heavily favored, like New York and New Jersey, more than 90% of betting happens online")

[5] Berkheimer v. HP Inc., 890 F.3d 1369 (Fed. Cir. 2018) ("Whether something is well-understood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination.  Whether a particular technology is well-understood, routine, and conventional goes beyond what was simply known in the prior art.  The mere fact that something is disclosed in a piece of prior art, for example, does not mean it was well-understood, routine, and conventional.")

[6] AI Visualize, Inc. v. Nuance Commc’ns, Inc., 97 F.4th 1371 (Fed. Cir. 2024)

[7] Cellspin Soft, Inc. v. Fitbit, Inc., 927 F.3d 1306 (Fed. Cir. 2019)

Judge Newman's Suit Comes to an End

By Kevin E. Noonan --

Today, D.C. District Court Judge Christopher R. Cooper put an end to Judge Pauline Newman's lawsuit against her colleagues, granting the Federal Circuit Judicial Council's motion to dismiss Judge Newman's suit on due process and 4th Amendment grounds (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit").

To recap, Judge Newman filed a complaint in May 2023, asserting 12 claims:

• Claim I asserted "improper removal [and] violation of separation of powers" based on Article III (life tenure of federal judges) and Article I (giving the House of Representatives the sole authority to remove a judge through impeachment after trial by the Senate).

• Claim II asserted that the Judicial Complaint is ultra vires for "improper removal [and] violation of separation of powers."

• Claim III alleged Fifth Amendment violations of due process because the members of the Special Committee are also purported witnesses to the alleged judicial misconduct.

• Claim IV asserts a First Amendment violation for unlawful prior restraint for the gag order.

• Claim V asserted that the gag order is also ultra vires as being an unlawful prior restraint on speech.

• Claim VI asserted a Fifth Amendment violation for unconstitutional vagueness of the provisions of the Disability Act.

• Claim VII asserted that the activities are ultra vires for unconstitutional examination because "[n]either the Act nor the U.S. Constitution authorizes compelling an Article III judge to undergo a medical or psychiatric examination or to surrender to any investigative authority her private medical records in furtherance of an investigation into whether the judge suffers from a mental or physical disability that renders her unable to discharge all the duties of office."

• Claim VIII also asserted a Fifth Amendment violation for unconstitutional vagueness regarding the Act's investigative authority.

• Claim IX alleged a Fourth Amendment violation for an unconstitutional search regarding the "compelled medical or psychiatric examination of an Article III judge without a warrant based on probable cause and issued by a neutral judicial official or a demonstration of constitutional reasonableness."

• Claim X alleged a Fourth Amendment violation for an unconstitutional search and seizure of a "compelled surrender of private medical records."

• Claim XI alleged a Fourth Amendment violation for "lack[ing] either a warrant issued on probable cause by a neutral judicial official or a constitutionally reasonable basis for requiring Plaintiff to submit to an involuntary medical or psychiatric examination."

• Claim XII alleged a Fourth Amendment violation for "lack[ing] either a warrant issued on probable cause by a neutral judicial official or a constitutionally reasonable basis for requiring Plaintiff to surrender her private medical records none of which bear on her fitness to continue serving as an Article III judge."

The District Court previously dismissed Counts II, III, IV, VI, X and XI for lack of subject matter jurisdiction and Count I and parts of Count VII under Fed. R. Civ. P. 12(b)(6).  Thus, only Counts V, VII (in part), VIII, and IX remained before the Court, which was the subject of Judge Newman's motion in opposition (see "Judge Newman's Suit Continues") and the Judicial Council's reply (see "Special Committee of the Judicial Council of the Federal Circuit Replies").

Judge Newman's legal arguments were that, first, as an Article III judge she is "constitutional officer of this Republic, and not merely a federal employee" who "does not have a supervisor and does not need to meet any performance metrics to keep her job."  "Congress alone has the power to remove her," her brief in opposition asserted.

Second, the operative statute, the Disability Act, lacks a definition of what constitutes a disability nor what factors are to be considered.  Rather than relying on medical professionals, her brief asserted, the determination is left "in the hands of lay people like Chief Judge Moore and her colleagues, all without providing them with any tools to determine when a disability exists."

Third, there is no provision in the statute for judicial review of any Orders or actions taken pursuant to the statute, permitting violations of the Fourth Amendment, including "invasive searches of private medical information" and allowing "self-executing" administrative orders to be promulgated by the Judicial Council, "a wholly administrative body."  The result is a regime where the Council can "employ and manipulate entirely standardless criteria in order to start and to continue investigations into and to impose unconstitutional sanctions on Article III judges."  In this regard, the brief reminds the District Court that the putative grounds and factual justifications for the Council's Orders have "evolved" in the year since the proceedings began.

The Judicial Council replied, arguing with regard to Counts VIII and IX that the orders it issued under the statute, 28 U.S.C. § 353(c), are per se reasonable and do not implicate the Fourth Amendment.  Regarding Judge Newman's Count V challenge of the disability provisions of the statute for vagueness, the Judicial Council argued that Judge Newman failed the requirement of a facial challenge to show that "the law in question is impermissibly vague in all of its applications," citing Crooks v. Mabus, 845 F.3d 412, 417 (D.C. Cir. 2017), and, on the merits, argued that the Act is not constitutionally vague because the Act permits a judicial council to "take action where a 'judge is unable to discharge all the duties of office by reason of mental or physical disability" under 28 U.S.C. § 351(a).  And with regard to Count VII, the Judicial Council argued that that Judge Newman has not asserted any reason "to doubt the sufficiency of [the standard that] "an investigation [is] as extensive as [a Judicial Council] considers necessary" (other than the implication that this is no standard at all, being entirely discretionary to the whims of the Court's Judicial Council), and that the constitutional clarity of the statute is "settled law."

The District Court's opinion granting the Judicial Council's motion to dismiss addresses the four remaining Counts in two groups: Counts VII and IX on unconstitutionality grounds and Counts V and VII for vagueness.  For Count VIII and Count IX comprised facial challenges on 4th Amendment grounds against the Judicial Conduct & Disability ("JC&D") Act, 28 U.S.C. §§ 353(a), (c) empowering the Chief Judge to form a committee to investigate the allegations against Judge Newman.  Judge Newman alleged that § 353(c) "violates the Fourth Amendment to the extent it authorizes a compelled medical or psychiatric examination of an Article III judge" (Count VIII) or "a compelled surrender of medical records belonging to an Article III judge" (Count IX) "without a warrant based on probable cause."  The opinion recites the burden for prevailing on such a facial challenge to be that the statute is "unconstitutional in all of its applications," citing Wash. State Grange v. Wash. State Republican Party, 552 U.S. 442, 449 (2008).  The Court found the statute not to be facially invalid because a special committee under the statute could engage in investigations that "do[] not run afoul of the Fourth Amendment," citing Florida v. Bostick, 501 U.S. 429, 434 (1991); United States v. Miller, 425 U.S. 435, 443 (1976); and United States v. Simons, 206 F.3d 392, 395–96, 398 (4th Cir. 2000) (notably, all of which had to do with court employees, a status which Judge Newman argued does not properly describe an Article III judge ("it should be noted that Judge Newman is not an employee, but an independent constitutional officer and that neither Chief Judge Moore, nor the Special Committee, nor the Judicial Council are her 'supervisors'" as was the case in many of the decisions cited by Defendants in their Motion").  The opinion rejects the distinction Judge Newman drew that a Chief Judge could always interrogate a court employee, on the grounds that a special committee could not do so (but apparently ignoring the fact that this special committee had as a member the Chief Judge herself).  The Court also ignored Judge Newman's distinctions with the circumstances of City of Los Angeles, Calif. v. Patel, 576 U.S. 409, 415, 418 (2015), and further applies more general standards for facial challenges (e.g., regarding drones and the FAA; see Brennan v. Dickson, 45 F.4th 48 (D.C. Cir. 2022), that seem somewhat far afield from the case before the Court).

Regarding Count V and Count VII for vagueness, Judge Newman's contentions were that the JC&D Act violates the due process clause of the Fifth Amendment and were unconstitutionally vague.  As for Count V, the Court says that statutes are not impermissibly vague "merely because they 'require[] a person to conform his conduct to an imprecise but comprehensible normative standard, whose satisfaction may vary depending upon whom you ask,'" citing United States v. Bronstein, 849 F.3d 1101, 1107 (D.C. Cir. 2017).  Based upon "the text, legislative history, and implementing rules of the JC&D Act, section 351(a)" the Court held the statute not to be unconstitutionally vague.  According to the Court, the text defines the standard of conduct to be the "duties of [judicial] office" (which is not vague inter alia because "judges, the only individuals against whom § 351(a) can be enforced, are well aware of their duties" and because judges swear an oath to "faithfully and impartially discharge and perform all the duties incumbent upon" them" under 28 U.S.C. § 453).  The Court also relies upon the legislative history to the effect that the statute is directed towards "judicial transgression" (which, on its face, seems to be more directed to outcome rather than process, which is what seems to be at issue here and behind Judge Newman's complaint).  Citations to the Code of Judicial Conduct and the Canons of Judicial Ethics of the American Bar Association also seem inappropriate in this case because, after all, the basis for Judge Newman's suspension was contrary to neither of these canons but was based on the Judge's allegations that the "independent neurological testing and provide it relevant medical records" was outside the scope of the special committee's powers and an infringement on her due process and privacy rights.  And the "[e]xamples of disability" including "substance abuse, the inability to stay awake during court proceedings, or impairment of cognitive abilities that renders the judge unable to function effectively" under JC&D R. 4(c) of the Rules for Judicial-Conduct and Judicial-Disability Proceedings do not seem to apply to Judge Newman's circumstances, either, although they are cited by the Court in support of the lack of vagueness in the statute.  The Court rejects Judge Newman's rebuttals to the special committee's arguments as being subjective ("which is not unconstitutional") and interprets the distinctions Judge Newman makes between a federal employee and an Article III judge by citing definitions of "judicial independence" as "not giv[ing] 'judges "absolute freedom from" discipline or sanctions that fall short of removal or salary diminution," quoting McBryde v. Comm. to Rev. Cir. Council Conduct & Disability Ords. of Jud. Conf. of U.S., 264 F.3d 52, 65 (D.C. Cir. 2001)), citing these as "accepted limits on judicial independence."

Regarding Count VII, the Court asserts that the investigative provisions of the JC&D Act fall within the scope of prohibition in neither of two scenarios:  "[I]f it leaves judges and jurors free to decide, without any legally fixed standards, what is prohibited and what is not in each particular case, . . . or permits them to prescribe the sentences or sentencing range available," citing Beckles v. United States, 580 U.S. 256, 266 (2017), and  El-Shifa Pharm. Indus. Co. v. United States, 607 F.3d 836, 856 n.4 (D.C. Cir. 2010).  This is because, in the Court's view, "[i]t does not vest a special committee with authority to decide what judicial conduct is or is not permissible, nor does it allow a committee to choose the proper penalty for such conduct."  The Court finds the scope of the special committee's powers to be consistent with activities of federal prosecutors and agencies.  The Court further rejects what the opinion terms "tangential arguments" by Judge Newman, the first that the statute provides no standards (the opinion having set forth its opinion on these standards) and the second that the special committee can compel the Judge to disclose private documents and "directly sanction" her for not doing so (the opinion characterizing this argument as "repackaging" an argument made in an earlier round of motions that the Court rejected, and further that the special committee has no enforcement power, which is reserved to the Judicial Council which have such power).

Thus ends Judge Newman’s attempts to regain her position on the Federal Circuit (absent appeals, of course).  This unfortunate situation has harmed the stature of the Court.  Judge Newman deserved better.  Her wonderful and admirable legacy, on the other hand, remains and will be long remembered.

Special Committee of the Judicial Council of the Federal Circuit Replies

By Kevin E. Noonan --

Suspended Federal Circuit Judge Pauline Newman's lawsuit (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit") against Chief Judge Kimberly Moore, and Circuit Judges Sharon Prost and Richard Taranto (in their roles as members of the Special Committee of the Judicial Council of the Federal Circuit responsible for the Order suspending Judge Newman) soon may be reaching an important milestone:  the District Court overseeing Judge Newman's complaint will rule on Defendant Committee's motion to dismiss the remaining Counts (see "Judge Newman's Suit Continues"), now that the Committee recently filed its Reply brief to Judge Newman's opposition to its motion.

The Committee begins its argument regarding Judge Newman's constitutional challenge in Counts VII and IX by asserting that orders issued under the statute are per se reasonable and do not implicate the Fourth Amendment:  "The statutory scheme ensures that orders issued in the ordinary course of investigations will be reasonable, the touchstone of the Fourth Amendment inquiry" they contend.  Further, the Reply asserts the standard that the statute must be unconstitutional in all its applications for Judge Newman to prevail, which suggests that the Committee's position is that the statute cannot be applied in a particular instance that contravenes a judge's Fourth Amendment rights, and because there are "multiple applications of 28 U.S.C. § 353(c)'s investigation provision that are undisputedly constitutional" Judge Newman's facial challenge cannot prevail.  Statutory support for the Committee's position includes that "the special committee is authorized to 'conduct an investigation as extensive as it considers necessary'" 28 U.S.C. § 353(c) which is not limited to the issues presented by Judge Newman relating to "medical examinations and private medical records," and that the "no set of circumstances" test for unconstitutionality in United States v. Salerno, 481 U.S. 739, 745 (1987), is controlling and supported by City of Los Angeles v. Patel, 576 U.S. 409 (2015), and Wash. State Grange v. Wash. State Republican Party, 552 U.S. 442, 449 (2008).  Another statutory basis on which the Committee relies is that "in the absence of § 353's authority" the Committee "cannot even exist."  The Committee's argument implies that Judge Newman had the burden to show that any action by the Committee would be unconstitutional ("certainly all coercive investigative steps"), thus apparently interpreting both the statute to authorize and the process to require investigative steps to be coercive.  Under this interpretation, the Committee argues that the statute expressly provides its authority to take such steps, even to the extent they would otherwise violate a judge's Fourth Amendment rights.

The Committee rests its defense to Judge Newman's assertions of unconstitutionality on whether its actions are "reasonable," which it argues "depends on the context within which a search takes place," citing New Jersey v. T.L.O., 469 U.S. 325, 337 (1985), and cites authority "outside the 'crime control' context" in support (Indianapolis v. Edmond, 531 U.S. 32, 44 (2000)); see, e.g., National Treasury Employees Union v. Von Raab, 489 U.S. 656, 679 (1989)) (each of which involve employees).  This involves a "balancing test" between "the nature and quality of the intrusion on the individual's Fourth Amendment interests against the importance of the governmental interests alleged to justify the intrusion," the Committee argues, citing O'Connor v. Ortega, 480 U.S. 709, 719–20 (1987) (plurality op.) (quoting United States v. Place, 462 U.S. 696, 703 (1983)), spurred by the existence of governmental "special needs" wherein requiring the government to obtain a warrant would be "impracticable."  Regarding this requirement, the Committee argues that "finding a warrant requirement impracticable in a particular context is a possible result—not a necessary precondition—of an assertion of special needs."

The Reply also asserts that Judge Newman was entitled to "precompliance review" of the order, stating that "[a] judge subject to a special committee's investigative order under § 353(c) thus has ample 'opportunity to obtain precompliance review' of that order by challenging it before the neutral decisionmaker[s]' of the judicial council prior to the imposition of any penalty for noncompliance" under Patel.  (While perhaps true, these assertions seem to ignore the imposition of the consequence of non-compliance -- suspension -- because Judge Newman exercised her right not to merely comply and does not address Judge Newman's assertions that the Special Committee of the Federal Circuit Judicial Council was not a "neutral decisionmaker" but instead "investigator, judge, and jury—and even, if necessary, witnesses.")

The Reply also asserts that Judge Newman could have "availed herself of the opportunity for Judicial Conference review by the judges drawn from across the country" under 28 U.S.C. § 331; id. § 357(a) (permitting a "judge aggrieved by an action of the judicial council under section 354" to petition the Judicial Conference); Rule 21(b)(1) (permitting a subject judge to petition the Judicial Conference's Committee on Judicial Conduct and Disability to review judicial council actions such as censures or suspensions); see Memorandum of Decision at 40, In re: Complaint of Judicial Misconduct, C.C.D. 17-01 (Comm. on Jud. Conduct & Disability Aug. 14, 2017)" (but note a seeming contradiction in the Committee's position discussed below).  This factual disagreement is important because its existence is one of the bases for the Committee's argument that there is no Fourth Amendment violation by the Committee's actions ("These opportunities for precompliance review of a special committee's § 353(c)'s orders by neutral adjudicators render the statute consistent with the Fourth Amendment's requirements especially for § 353(c) orders that (as was true of the orders Plaintiff focuses on) are issued with individualized suspicion that the subject of the search had triggered the governmental need at issue.")  That factual disagreement encompasses Judge Newman's contentions that:

Chief Judge Moore "unilaterally" removed Judge Newman from the bench, the suspension being "extended by an unprecedented, unrecorded and unpublished vote of the Defendant Judicial Council" in a meeting that was "neither noticed nor memorialized."  Only after this suspension, the brief asserts, did the Chief Judge "instigate[]" an investigation over alleged physical infirmities (a heart attack and a fainting episode) that "Defendants themselves now acknowledge were false."  [See "Judge Newman's Suit Continues".]

by asserting that "no § 353(c) investigation can even begin absent a finding of "probable cause" that the subject judge suffered from a disability within the meaning of the Act" and "[t]he individualized suspicion accompanying the types of investigative orders under § 353(c) that Plaintiff challenges strongly reinforces the reasonableness of searches conducted per such orders."

The Reply justifies the Committee's actions here based on the:

"significance of the core interest Defendants advanced:  ensuring that judges entrusted with the power to render decisions profoundly affecting the public in both immediate and lasting ways—e.g., issuing bail decisions, depriving individuals of liberty or property, making factual findings subject only to deferential review—do not suffer from disabilities that render them "unable to discharge all the duties of office" (or that they have not "engaged in conduct prejudicial to the effective and expeditious administration of the business of the courts").  28 U.S.C. § 351(a)"

(generalizing the issue to all judges rather than specifically to Judge Newman, i.e., in how these principles impact and were applied to the Judge in this instance).

The Reply also seems to assert that there is "[an]other side of the ledger" between the distinctions Judge Newman raised between an Article III judge and a government employee ("as an Article III judge she is a 'constitutional officer of this Republic, and not merely a federal employee' who 'does not have a supervisor and does not need to meet any performance metrics to keep her job'") insofar as that status imposes a quid pro quo that a judges privacy interests are "qualified by the acceptance of a life-tenured judicial position" wherein their "lives and careers are routinely scrutinized during the confirmation process, and the same goes for their financial arrangements throughout their judicial tenure" and "investigations into misconduct or potential disability are fully authorized by the Act, and thus an established component of life tenure on the federal bench."  In this regard, the Committee casts the dispute as one in which while Judge Newman's privacy interests must be given "weight," "they do not categorically trump the legitimate and significant objectives advanced by the statute, as they would have to do for Plaintiff to prevail in her facial challenge."  In this regard, the Reply also notes that the provisions of § 353(c) are not "confined to investigations of Article III judges; it applies equally to magistrate judges and bankruptcy judges who do not enjoy life tenure or the constitutional status on which Plaintiff rests her argument."  And the Reply turns Judge Newman's argument on its head, wherein the special role of the judiciary "underscores the importance of having investigatory means like those in the Act—which were deliberately designed to respect the special independence of the Judicial Branch—to uncover and address disability or misconduct among Article III judges" because of "the absence of the usual mechanisms for terminating an employee who cannot fulfill their duties."

The Reply attempts to rebut Judge Newman's argument that she was entitled "to resort to outside judicial officers to conduct even basic investigatory steps" by the need for expediency under the circumstances of purported judicial disability.  However, this argument also seems to implicate the issue of compliance and Judge Newman's ability for challenging such "basic investigatory steps" that the Reply earlier asserted the Act provided.  While it may be the case that "[r]equiring resort to judicial officers outside the congressionally defined judicial conduct and disability mechanism would functionally constitute the type of outside as-applied challenge that Congress has plainly and constitutionally deemed inconsistent with the Act's streamlined judicial "housekeeping" mechanisms," how else would Judge Newman have been about take advantage of the means provided for the Act (according to the Reply) to challenge the committee's requirements?

Turning to Judge Newman's Count V challenge of the disability provisions of the statute for vagueness, the Reply renews its argument that Judge Newman fails the requirement of a facial challenge to show that "the law in question is impermissibly vague in all of its applications," citing Crooks v. Mabus, 845 F.3d 412, 417 (D.C. Cir. 2017).  On the merits, the Reply argues that the Act is not constitutionally vague because the Act permits a judicial council to "take action where a 'judge is unable to discharge all the duties of office by reason of mental or physical disability.'"  28 U.S.C. § 351(a).  According to the Reply, the basis for its constitutional clarity is that it ties the definition of "disability" to whether a judge is "unable [to perform] all the duties of office," where disability is a term used "since the Founding" and thus presumed to have meaning based on "historical usage in the law," citing Arnett v. Kennedy, 416 U.S. 134, 160 (1974).  This argument is bolstered by the constitutional clarity with which the misconduct provision of the Act has been acknowledged, which is a term is "arguably less precise than the relatively concrete assessment" of being unable to perform judicial duties according to the Reply.  The Committee contends that "a vagueness challenge cannot succeed where the statutory standard is 'imprecise but comprehensible,' that is, where a conclusion whether the standard has been met 'may vary depending upon whom you ask,'" citing United States v. Bronstein, 849 F.3d 1101, 1107 (D.C. Cir. 2017) (citations omitted)" and faults Judge Newman for "never grappl[ing] with the vagueness standard or explain[ing] how the statute fails to meet that standard."  According to the Reply, a law is not constitutionally vague when it "'call[s] for the application of a qualitative standard to real-world conduct'" under Bronstein nor because a statute must be drafted to be "both general enough to take into account a variety of human conduct and sufficiently specific to provide fair warning," citing Arnett.

The remainder of the Reply in this regard consists of the Judicial Council's contentions that Judge Newman has not rebutted its arguments in favor of the statute's constitutionally sufficient clarity.

Finally, turning to Count VII of Judge Newman's complaint that the investigation provision of the Act is unconstitutionally vague, the Reply brief contends that Judge Newman has not asserted any reason "to doubt the sufficiency of [the standard that] "an investigation [is] as extensive as [a Judicial Council] considers necessary" (other than the implication that this is no standard at all, being entirely discretionary to the whims of the Court's Judicial Council).  Nevertheless, the Reply asserts that the constitutional clarity is "settled law," relying on other, seemingly inapposite jurisprudence (particularly Kincaid v. District of Columbia, 854 F.3d 721, 729 (2017), discussing United States v. Batchelder, 442 U.S. 114 (1979)).  "If the broad discretion over criminal charges and sentences at issue in those cases did not raise a constitutional problem, it follows that a provision merely granting investigative discretion cannot offend the Due Process Clause," the Reply asserts.

It is fair to say that to the extent Judge Newman's brief focused on the particulars of her circumstances and the justification vel non of the Judicial Council's actions in these proceedings, the Committee's Reply focuses more generally on how the statute is constructed to address the issue of judicial misconduct or inability of a judge to satisfy judicial responsibilities.  Whether the case is dismissed or the remaining Counts are permitted to proceed will likely depend on how the District Court considers these different perspectives and their impact on Judge Newman's rights and interests, and whether they have been abridged.

Judge Newman's Suit Continues

By Kevin E. Noonan --

Over the past year suspended Federal CIrcuit Judge Pauline Newman's lawsuit (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit") against Chief Judge Kimberly Moore, and Circuit Judges Sharon Prost and Richard Taranto (in their roles as members of the Special Committee of the Judicial Council of the Federal Circuit responsible for the Order suspending Judge Newman) has continued without much fanfare.  However, in the face of Defendant's Motion for Judgment on the pleadings the status quo is likely to change no matter now the District Court rules.

The opening paragraph of Judge Newman's brief opposing Defendant's motion demonstrates her intention not to go quietly.  The brief avers that Chief Judge Moore "unilaterally" removed Judge Newman from the bench, the suspension being "extended by an unprecedented, unrecorded and unpublished vote of the Defendant Judicial Council" in a meeting that was "neither noticed nor memorialized."  Only after this suspension, the brief asserts, did the Chief Judge "instigate[]" an investigation over alleged physical infirmities (a heart attack and a fainting episode) that "Defendants themselves now acknowledge were false."  These actions constitute a "pattern of harassment" that "continues unabated to the present day" according to the brief, an allegation illustrated by refusing to permit Judge Newman to hire a judicial assistant (to which in her status as a Circuit Court judge she was entitled to do), removing the Judge from an internal e-mail distribution list, which deprived Judge Newman of information about the Court's business, and refusing her request to extend the term of one of her clerks.  The Chief Judge and the Judicial Council were able to take these steps, according to the brief, because the legal authority they are based upon, the Judicial Conduct and Disability Act ("Disability Act"), 28 U.S.C. §§ 351–364, "unconstitutionally vest unfettered discretion in Defendants, which permits them, without impeachment, for all intents and purposes, to divest an Article III judge of her office."

To recap, the legal grounds for Judge Newman's complaint were the following:

• Claim I asserts "improper removal [and] violation of separation of powers" based on Article III (life tenure of federal judges) and Article I (giving the House of Representatives the sole authority to remove a judge through impeachment after trial by the Senate). 

• Claim II asserts that the Judicial Complaint is ultra vires for "improper removal [and] violation of separation of powers."  This allegation is based on Judge Newman being removed from her duties before the special committee's investigation was concluded (which removal the Judicial Disability Act of 1980 codified at 28 U.S.C. § 354(a)(2)(A)(i) requires to be after the investigation according to the complaint).

• Claim III alleges Fifth Amendment violations of due process because the members of the Special Committee are also purported witnesses to the alleged judicial misconduct (the complaint stating that "[i]t has been established for centuries that one cannot serve as a 'judge in his own cause'").

• Claim IV asserts a First Amendment violation for unlawful prior restraint for the gag order, contrary to several Supreme Court cases prohibiting prior restraint on speech (Houston Cmty. Coll. Sys. v. Wilson, 142 S. Ct. 1253, 1259 (2022) (the First Amendment prohibits prior restraint on speech) and Alexander v. United States, 509 U.S. 544, 550 (1993)).

• Claim V asserts that the gag order is also ultra vires as being an unlawful prior restraint on speech.

• Claim VI asserts a Fifth Amendment violation for unconstitutional vagueness of the provisions of the Disability Act.

• Claim VII asserts that the activities are ultra vires for unconstitutional examination because "[n]either the Act nor the U.S. Constitution authorizes compelling an Article III judge to undergo a medical or psychiatric examination or to surrender to any investigative authority her private medical records in furtherance of an investigation into whether the judge suffers from a mental or physical disability that renders her unable to discharge all the duties of office."

• Claim VIII asserts a Fifth Amendment violation for unconstitutional vagueness regarding the Act's investigative authority, with regard to "authoriz[ing] compelled medical or psychiatric examinations of Article III judges or demands from special committees for Article III judges to surrender their private medical records."  In particular, this allegation is directed to Section 353(c) of the Act.

• Claim IX alleges a Fourth Amendment violation for an unconstitutional search regarding the "compelled medical or psychiatric examination of an Article III judge without a warrant based on probable cause and issued by a neutral judicial official or a demonstration of constitutional reasonableness."

• Claim X alleges a Fourth Amendment violation for an unconstitutional search and seizure of a "compelled surrender of private medical records."

• Claim XI alleges a Fourth Amendment violation for "lack[ing] either a warrant issued on probable cause by a neutral judicial official or a constitutionally reasonable basis for requiring Plaintiff to submit to an involuntary medical or psychiatric examination."

• Claim XII alleges a Fourth Amendment violation for "lack[ing] either a warrant issued on probable cause by a neutral judicial official or a constitutionally reasonable basis for requiring Plaintiff to surrender her private medical records none of which bear on her fitness to continue serving as an Article III judge."

Judge Newman's legal arguments are that, first, as an Article III judge she is "constitutional officer of this Republic, and not merely a federal employee" who "does not have a supervisor and does not need to meet any performance metrics to keep her job."  "Congress alone has the power to remove her," the brief asserts.

Second, the operative statute, the Disability Act, lacks a definition of what constitutes a disability nor what factors are to be considered.  Rather than relying on medical professionals, the brief asserts, the determination is left "in the hands of lay people like Chief Judge Moore and her colleagues, all without providing them with any tools to determine when a disability exists."

Third, there is no provision in the statute for judicial review of any Orders or actions taken pursuant to the statute, permitting violations of the Fourth Amendment including "invasive searches of private medical information" and allowing "self-executing" administrative orders to be promulgated by the Judicial Council, "a wholly administrative body."  The result is a regime where the Council can "employ and manipulate entirely standardless criteria in order to start and to continue investigations into and to impose unconstitutional sanctions on Article III judges."  In this regard, the brief reminds the District Court that the putative grounds and factual justifications for the Council's Orders have "evolved" in the year since the proceedings began.

The District Court previously dismissed Counts II, III, IV, VI, X and XI for lack of subject matter jurisdiction and Count I and parts of Count VII under Fed. R. Civ. P. 12(b)(6).  Thus, only Courts V, VII, VIII, and IX remain and are the subject of the Defendant's Motion for Judgment on the Pleadings and Judge Newman's motion in opposition thereto.  The arguments Judge Newman through counsel asserts for these remaining Counts are that the Disability Act is unconstitutionally vague in defining what is a disability under the Act (Count V) and "its grant of investigative authority to the Special Committee (Count VII)" and that the Act authorizing the Council to "demand medical examinations and private medical records as a condition for maintaining one's Article III judicial office[] violates the Fourth Amendment's prohibition on unreasonable searches."

The brief sets forth the standard of review for a facial challenge to a statute authorizing warrantless searches to be a showing that the searches authorized by the statute are "unreasonable," citing City of Los Angeles, Cal. v. Patel, 576 U.S. 409, 419-20 (2015).  Such a challenge can be brought when a law threatens to inhibit the exercise of constitutionally protected rights or allows for arbitrary and discriminatory enforcement the brief argues, citing Vill. of Hoffman Ests. v. Flipside, Hoffman Ests., Inc., 455 U.S. 489, 499 (1982).  Importantly, the brief further argues that Judge Newman does not need to show that the Disability Act is unconstitutional in all of its applications, but rather that it creates "a danger of arbitrary and discriminatory enforcement" or "threatens to inhibit the exercise of constitutionally protected rights," citing Hoffman Ests, 455 U.S. at 494, 498.

Regarding Counts VIII and IX, Judge Newman's argument relates to the constitutionality (or lack of it) of the scope and type of searches the Disabilities Act permits (at least as demanded by this Judicial Council), specifically the "investigation" provision, 28 U.S.C. § 353(c).  The brief argues that this scope in practice violates Fourth Amendment prohibitions against unlawful searches and seizures, specifically "by authorizing special committees to compel medical examinations and the production of medical records without a warrant or a demonstration of constitutional reasonableness."  The challenges are "facial, not as applied," citing City of Los Angeles v. Patel for the standard that a facial challenge is not required to show that a law is unconstitutional in all of its applications, countering the Defendant's position that the existence of some legitimate searches rebuts Judge Newman's facial challenge.  The brief cites additional language from the Supreme Court that "when assessing whether a statute meets this standard, the Court has considered only applications of the statute in which it actually authorizes . . . conduct" (emphasis in brief); 576 U.S. at 418.  Accordingly, instances where a search under the Disabilities Act is performed with acquiescence or consent are irrelevant to the legal inquiry under Patel.  Indeed, according to the brief a requirement in a facial challenge of a showing of unconstitutionality in all of a statute's applications "would preclude facial relief in every Fourth Amendment challenge to a statute authorizing warrantless searches" under Patel.

The brief also argues that the Disability Act violates the Fourth Amendment because while the Judicial Committee's orders may be based on "reasonable suspicion" of the subject judge's disability, under the Fourth Amendment searches conducted outside the judicial process without a warrant must have a showing of constitutional reasonableness that is absent here.  Moreover, the brief asserts that the "special needs" exception, which applies to certain administrative searches, does not apply to the Disability Act because obtaining a warrant is not impracticable in this case and the burden of obtaining a warrant would not frustrate the government's purpose behind the search.  ​The "special needs" exception applies, according to the brief, when "special [government] needs, beyond the normal need for law enforcement, make the warrant and probable-cause requirement impracticable," citing Vernonia Sch. Dist. 47J v. Acton, 515 U.S. 646, 653 (1995) (quoting Griffin v. Wisconsin, 483 U.S. 868, 873 (1987)) (emphasis in brief).  That is not the case here, where the acceptable standard for impracticability is not satisfied (being that obtaining a warrant must "seriously disrupt the routine conduct of business," citing O'Connor v. Ortega, 480 U.S. 709, 722 (1987), or "when 'the burden of obtaining a warrant is likely to frustrate the governmental purpose behind the search,'" citing New Jersey v. T.L.O., 469 U.S. 325, 340 (1985) (quoting Camara v. Municipal Court, 387 U.S. 523, 533 (1967)).  And even should Defendants be able to make such a showing, whether a warrant is required is subject to a "balancing test" between government interests and individual privacy interests, under Skinner v. Railway Lab. Execs.' Ass'n, 489 U.S. 602, 619 (1989)).  Judge Newman argues that the cumulative impact of this case law is that Defendants were required to show both that the special exception applies and that obtaining a warrant would have been impracticable, which they did not do, according to her brief, providing an analysis and assessment of the cases advanced by Defendants in support of their position and the inapplicability thereof ("it should be noted that Judge Newman is not an employee, but an independent constitutional officer and that neither Chief Judge Moore, nor the Special Committee, nor the Judicial Council are her 'supervisors'" as was the case in many of the decisions cited by Defendants in their Motion).

The brief takes particular apparent umbrage at assertions in Defendant's Motion to Dismiss that "special committees can require medical examinations without a warrant because 'psychological testing and psychiatric interviews are a routine feature of occupations which involve stress and sensitive interpersonal contact,'" and that in this respect, "[t]here is no reason to distinguish between [government] employees and judicial officers."  First, the brief asserts that "there is an obvious need to distinguish mere employees who constitutionally speaking are not meant to be independent or to enjoy any tenure protections and Article III judges who enjoy such protections precisely because they are meant to be independent."  Second, the brief challenges the assertion that subjecting Article III judges to such medical examinations is routine, stating that "an Article III judge has never before undergone compelled medical testing of any kind . . . [i]n the 44 years the Disability Act has been in effect (and the 235-year history of the federal judiciary), medical testing has been ordered once and has never taken place" (and in that case the Judicial Council discontinued their efforts when the judge contested the Order).  Unlike the governmental employees in the cases Defendants asserted in support of their Motion to Dismiss, Judge Newman asserts that "Article III judges are officers of the United States, appointed by the President with the advice and consent of the Senate, [that] "hold their positions for life" and "the Constitution and the Supreme Court guard these judges' independence," citing Mistretta v. United States, 488 U.S. 361, 410 (1989), for the latter proposition and for the proposition that "no Act can authorize the President (or by extension anyone else) "to remove, or in any way diminish the status of Article III judges, as judges" (emphasis in brief).  Article III judges "are removable only by the Senate, not by a supervisor who might search their offices or subject them to medical testing, and not by their circuit's judicial council" under Mistrella the brief argues.  Finally, adopting Defendants' position would deny Article III judges from judicial review "both ex ante and ex post" putting the judge in a less favorable position ("have less constitutional protection") than other governmental employees (emphasis in brief).  And being thus denied judicial review is exacerbated by Judicial Councils, as Defendants would have it, being "investigator, judge, and jury—and even, if necessary, witnesses."

Even if the special needs exception could apply, according to Judge Newman, the District Court cannot determine at the pleadings stage whether a warrantless search is reasonable.  The requirement for a balancing test under the Fourth Amendment between governmental rights and individual privacy rights is inconsistent with dismissing Judge Newman's challenge to the Judicial Council's actions without the District Court having the opportunity to consider the evidence (and Judge Newman ​the opportunity to present such evidence) (and even if the Court were to do so on the current record Judge Newman argues Defendants' motion should be denied) according to the brief.

Judge Newman further argues that the Disability Act fails to articulate any standard for "judicial disability," contrary to other Acts of Congress related to disabilities in other contexts.  The history of the Act is evidence of this standardlessnes, "[b]egin[ning] with this case," Judge Newman asserts:

Throughout both this litigation and the administrative process within the Judicial Council, Defendants have not even been able to articulate what judicial duties Judge Newman is unable to perform.  At most, they have alleged that Judge Newman is able to perform those duties slowly.  Defendants have not been able to point to a single opinion (whether majority, concurring, or dissenting) that was not well-written or otherwise fell below any conceivable standard of judicial craftsmanship.  Nor have they pointed to any behavior that Judge Newman may have exhibited on the bench or in conference that indicates (or would even cause one to suspect) an inability to perform the functions of judicial office.

Indeed, the "disability" allegations against Judge Newman throughout these proceedings read like a Chinese menu with Defendants making and withdrawing seemingly haphazard allegations.  For example, in the initial order launching administrative proceedings against Judge Newman, Chief Judge Moore alleged (based apparently on a thirdhand remark from Judge Newman's former judicial assistant) that she suffered a heart attack.  But no explanation was given as to why a heart attack—a not uncommon malady—would make one unable to perform duties of an appellate judge.  The same goes to the allegations (also erroneous and apparently since abandoned) that Judge Newman had a fainting spell and had difficulty walking significant distances.  Surely, an ability to walk without resting is not even remotely indicative of one's ability to reason through and write about legal issues.  Yet, it was these allegations that allowed Chief Judge Moore to kick-start the administrative process against Judge Newman.

(The brief includes several other statements by other members of the Judicial Council supporting Judge Newman's argument of the standardlessness of the term "judicial disability," as well as examples of other conditions having more significant impacts on a judge's ability to perform her duties, that have not provided a basis for suspending her from the bench.)  The situation is worsened, as the brief sets out, because "[a]t no point have the Defendants ever suggested that were Judge Newman to receive medical clearance the administrative proceedings against her would be terminated and she would be restored to the calendar," which "further confirms the latent subjectivity at play."

Finally, Judge Newman asserts that the Act's grant of unfettered investigatory authority fails to articulate any standards for launching or continuing an investigation or for demanding cooperation, and is therefore void for vagueness.  (Such investigations "have no boundaries," which circumstances permit "arbitrary and discriminatory enforcement.")  The role of gatekeeper imposed on the Chief Judge under the Act in determining whether a complaint is sufficient to commence proceedings such as this one is "simply ouroboric" insofar as the statute provides no definition for the Chief Judge to apply in making her determination.  The brief further asserts that Judge Newman does not object to being investigated ("[i]n this country, anyone is free to 'investigate' anyone for any reason and on any topic.  To the extent that Defendants wish to ask questions, write reports, and even urge Congress to remove Judge Newman, they are free to do so").  The issue, and the significance of the statutory vagueness, is "whether Defendants can compel Judge Newman to turn over private documents and then directly sanction her for declining to do so") (emphasis in brief).  As a consequence:

[A] Chief Judge (and then the Special Committee) can decide, without meeting any standards whatsoever, to launch the investigation, expand it, request whatever records they deem appropriate, and then impose self-executing sanctions (without any outside supervision by an Article III court) all without the benefit of a clearly defined standard of behavior for the judge being investigated to adhere to.  And as this very case shows, because the Act confers such an unlimited power on Defendants, it authorizes them to conduct an interminable investigation and to continue sanctioning a judge in Plaintiff's position whenever the Plaintiff does not completely accede to whatever demands a Special Committee or a Judicial Council might conjure up[.]

(which is true even should a Chief Judge "make entirely unsubstantiated allegations" and then "empanel a special committee which can then proceed to an investigation entirely untethered from the initial allegations," a position consistent with the Council's own arguments and assertions earlier in the course of this case according to Judge Newman).

"In short, the Act's combining of the power to investigate without any limits or well-defined causes with the power to sanction a subject judge who declines the outlandish demands that accompany the investigation renders the provision unconstitutionally vague," Judge Newman's brief concludes.

The District Court is expected to rule on Defendants' Motion to Dismiss the remaining Counts of Judge Newman's complaint in due course after the Judicial Council files its Reply brief.

Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

The Federal Circuit handed down an opinion earlier this month that invalidated several asserted claims and found infringement under 35 U.S.C. § 271(e)(2) of the claims, while refusing to modify its judgment on infringement after Defendant Norwich submitted a revised ANDA containing a Section viii "carveout" in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc.  The majority opinion raises issues in its invalidity analysis regarding the extent to which the prior art should be required to disclose the recited administered dose to satisfy the "reasonable expectation of success" prong for obviousness for pharmaceutical claims (wherein the standard adopted by the majority motivated Judge Cunningham to dissent in part).  The reasoning provided by Judges Lourie and Chen appeared to be rooted in the broader scope of creativity imparted to the skilled artisan under KSR v. Teleflex as discussed below.

The case arose in ANDA litigation over rifaximin, the active ingredient in Salix's commercial product Xifaxan^®, which the opinion informs has been used as an antibiotic for 40 years.  The use at issue was FDA-approved treatment of irritable bowel syndrome with diarrhea (IBS-D) and hepatic encephalopathy (HE), specified in each instance by treatment with 550 mg doses three times per day (TID) for a total of 1650 mg administered dose.  Salix asserted three "groups" of patents:

• U.S. Patent Nos. 8,624,573, 9,421,195, and 10,335,397 directed to HE treatment;
• U.S. Patent Nos. 8,309,569 and 10,765,667 directed to treating IBS-D using the 550 mg TID administration protocol; and
• U.S. Patent Nos. 7,612,199 and 7,902,206 directed to rifaximin polymorph b

The District Court held* that claim 2 of U.S. Patent No. 8,309,569, claim 3 of U.S. Patent No. 10,765,667, claim 4 of U.S. Patent No. 7,612,199, and claim 36 of U.S. Patent No. 7,902,206 were obvious, and that claim 8 of U.S. Patent No. 8,642,573, claim 6 of U.S. Patent No. 9,421,195, and claims 11 and 12 of U.S. Patent No. 10,335,397 were not invalid and infringed, and entered judgment that the FDA not approve Norwich's ANDA for HE indications until the final patent in this group expired in October 2029.  Norwich amended its ANDA to provide a Section viii "carveout" of indications related to HE treatment and filed a motion to modify the judgment under Fed. R. Civ. Pro. 60(b) which the District Court denied.  This appeal by both parties of the adverse decisions below followed.

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judge Chen in toto and by Judge Cunningham in part, who also dissented in part.  Regarding obviousness of claims to IBS-D treatment, the opinion sets forth claim 2 of the '569 patent as being representative:

1.  A method of providing acute treatment for diarrhea-associated Irritable Bowel Syndrome (dIBS) comprising: administering 1650 mg/day of rifaximin for 14 days to a subject in need thereof, wherein removing the subject from treatment after the 14 days results in a durability of response, wherein the durability of response comprises about 12 weeks of adequate relief of symptoms.

2.  The method of claim 1, wherein the 1650 mg is administered at 550 mg three times per day.

The District Court's decision was based on the combination of a Phase II clinical trial protocol disclosing twice-daily dosing of IBS patients with 550 mg doses (1100 mg total) or 1100 mg doses (2200 mg total) of rifaximin (the opinion noting that "the Protocol does not include any efficacy or safety data, nor does it mention a 1,650 mg/day dose or TID dosing"), taken in view of a scientific journal article to Pimentel that disclosed treating IBS with administration of 400 mg of rifaximin TID (for a total of 1,200 mg); significantly for the Federal Circuit's decision, this reference contained a speculative statement that "optimal dosage of rifaximin may, in fact, be higher than that used in our study."  These references were used by the District Court to provide a motivation to combine them with a reasonable expectation of success, and the majority agreed (Judge Cunningham adducing here disagreement on this point in her dissent).  Salix argued that the District Court erred in the reasonable expectation of success prong of this analysis, which as a question of fact required a showing of clear error on appeal.  Curiously, Salix (according to the opinion) did not dispute the District Court's finding that all limitations of claims to IBS-D treatments were "effectively disclosed" in the cited art, despite there being no express disclosure of administering 550 mg rifaximin TID (for a total of 1650 mg) (other than the speculation in the scientific reference that higher doses may be optimal).

The Federal Circuit majority restricted the application of its conclusion that this prior art disclosure supports a finding that there is a reasonable expectation of success under these circumstances by asserting that:

Although we have rejected the idea that "efficacy data [are] always required for a reasonable expectation of success," OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375, 1385 (Fed. Cir. 2019), we are hesitant to conclude as a general matter that the disclosure of a Phase II clinical trial plan, standing alone, provides an expectation of success sufficient to render obvious a dosage that was not included within the planned clinical trial.

However, the majority distinguished the situation here by the combination of the clinical trial protocol with the Pimentel reference.  For the majority, that speculative sentence, that "[r]ecent data suggest that the optimal dosage of rifaximin may, in fact, be higher than that used in our study" was sufficient to create in the skilled artisan sufficiently reasonable expectation of success to satisfy the requirement for finding obviousness (emphasis in opinion), at least in view of the clear error standard of review.  The majority's reasoning was that Pimentel expressly disclosed 400 mg rifaximin TID and that "the next higher dosage unit from the Protocol was 550 mg" combined with the unsupported suggestion that higher doses may be optimal.  This conclusion was supported in the majority's view by the Court's earlier precedent that "certainty and absolute predictability are not required to establish a reasonable expectation of success, citing Almirall, LLC v. Amneal Pharms. LLC and Acorda Therapeutics, Inc. v. Roxane Lab'ys, Inc.  The majority also cited several "references establishing the background knowledge of a person of ordinary skill in the art" consistent with their finding of no clear error in the District Court's obviousness determination (although, as explicated in the dissent these references were not considered by the District Court).  The majority appeared to have been satisfied that ex post facto verification of the skilled artisan's purported expectation of success using increased dosage amounts supports its reasonableness beforehand.  The majority similarly used this reasoning to credit the skilled artisan of apprehending that administering increased dosages would not create "an intolerable increase in negative side effects."  And the majority also asserted that there had been "[w]idespread off-label use" of rifaximin for treating IBS-D that supported this safety expectation.

Similarly the Court (Judge Cunningham not dissenting from this aspect of the judgment) affirmed the District Court's determination that claims to the β-polymorph of rifaximin would have been obvious.  Claim 4 of the '199 patent was set forth in the opinion as representative:

4.  Rifaximin in polymorphic form β, wherein the rifaximin has x-ray powder diffraction pattern peaks at about 5.4°; 9.0°; and 20.9°2θ and wherein the rifaximin has a water content of greater than 5%.

The prior art disclosed preparations of crystalline rifaximin (albeit not the β-polymorph expressly) and methods for preparing such crystalline forms including in particular solvents used to prepare them (it being recognized that in the arcane rituals of crystallization such solvent choice frequently determines the resulting crystalline product).  The panel noted that the District Court's factual determinations supporting its obviousness conclusions were supported by expert testimony that "(1) a skilled artisan would have had good reason to characterize the crystalline rifaximin obtained by following the Cannata protocols, (2) that such characterization was routine and could have been performed 'in one day,' and (3) that doing so would have led the skilled artisan to have 'detected rifaximin β.'"  The Federal Circuit also distinguished prior precedent including Grunenthal GmBH v. Alkem Laboratories Ltd., 919 F.3d 1333 (Fed. Cir. 2019), and Pharmacyclics LLC v. Alvogen, Inc.; regarding Grunenthal, the panel asserted that the prior art produced one particular polymorph and that the art disclosed no evidentiary basis to expect that a second form would be produced using prior art guidance regarding "what particular solvents, temperatures, agitation rates, etc., were likely to result" in the claimed polymorphic form, which conclusion the Federal Circuit held was not clear error.  The panel here maintained that this precedent merely showed the reliance on particular factual aspects involved in such decisions, citing Sanofi-Synthelabo v. Apotex, Inc. and Pfizer, Inc. v. Apotex, Inc.  A particular distinction persuasive to the Court was that in Grunenthal there was a question of whether the skilled artisan could produce a crystalline form of the claimed compound, which was not the case here (the parties agreeing that methods for preparing crystalline rifaximin were established in the prior art, as well as there being an appreciation in the art that "polymorph β is a commonly produced polymorph and the most stable form of rifaximin").  While abjuring a conclusion that there would always be a reasonable expectation of success in producing the β-rifaximin polymorph the panel found no clear error in the District Court's fact finding here and thus affirmed.

(Regarding Pharmacyclics its status as a non-precedential decision put squarely within the District Court's discretion its decision not to follow its conclusions, as well as stating that the Court's "later affirmance of the factual findings in Pharmacyclics did not retroactively override the district court's analysis here.")

The panel assessed Norwich's appeal of the District Court's decision that, as a consequence of its ANDA constructively infringing Salix's claims to methods for treating HE it was correct in ordering that a final approval of Norwich's ANDA could not be effective before the HE patents expired under 35 U.S.C. § 271(e)(4)(A) as a question of statutory interpretation.  In this regard, the opinion notes that the statute instructs that "the court shall order the effective date of any approval of the drug or veterinary biological product involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed."  Norwich contended that this mandate includes the requirement that the order take into consideration (and is limited to) the indication for which an ANDA applicant seeks approval.  The basis for this argument was that Norwich's original ANDA had indications for both HE and IBS-D and the District Court's infringement determination was limited to the HE indication.  While Norwich voiced its concern that this Order would "unfairly preclude[] it from receiving final approval of a new non-infringing ANDA" the opinion flatly rejects this concern ("The district court did no such thing")(arguably thus receiving the Federal Circuit's imprimatur for any such filing of such an ANDA successfully).  The statutory construction bases for this conclusion by the panel is that FDA approves drugs for specific and particular indications and thus proper construction is "directed to approval of particular infringing uses of the drug, not all uses of the drug including non-infringing uses."  This limits the scope of infringement to submission of an ANDA to the infringing use under 35 U.S.C. § 271(e)(2)(A).  But "[t]he order appropriately said nothing that would prevent approval of a new non-infringing ANDA."

Regarding the panel's affirmance of the District Court's denial of Norwich's Rule 60(b) motion, the Federal Circuit asserted that the question was whether that denial was an abuse of discretion under Third Circuit law, citing Amstar Corp. v. Envirotech Corp., 823 F.2d 1538, 1550 (Fed. Cir. 1987).  The opinion states that a district court can reconsider its infringement finding when a defendant files an amended ANDA but is not compelled to do so, citing Ferring B.V. v. Watson Lab'ys, Inc. Fla.  Here, the Federal Circuit appreciated that "[i]t is not a simple matter to determine whether an ANDA applicant has successfully carved out language from a label to turn infringement into non-infringement" and Norwich's motion would amount to "essentially" a second litigation.  Because under Third Circuit law there is no obligation to grant such a motion the panel discerned no abuse of that discretion in this case.

Judge Cunningham's dissent was limited to the Court's affirmance that the asserted claims in the '569 and '667 patents were invalid for obviousness.  In Judge Cunningham's opinion, Norwich has satisfied its burden to convince the Judge that she is "'left with the definite and firm conviction that a mistake has been committed' regarding these findings," citing Pfizer, Inc. v. Apotex, Inc. (quoting United States v. U.S. Gypsum Co., 333 U.S. 364, 395 (1948)).  The basis of this conviction is the disconnect the Judge apprehends regarding the disclosure of the cited art (400 mg TID, 1200 mg/day in Pimentel or 550 mg BID or 1100 mg/day) and the scope of the claims (550 mg TID, 1650 mg/day).  There was just as great a likelihood in the Judge's mind that the 1100 mg/day dose would have implied that higher doses would not lead to more successful results, inter alia because the tested 2200 mg/day dose did not.  And the citations of the later-arising references don't cure these analytical deficiencies on the merits because they teach 1200 mg/day wherein the claimed invention recited dosages "almost 40% higher."  Anecdotal reference to off-label use was also unavailing in the Judge's opinion to support the purported reasonable expectation of success because there was no disclosure of dosages therein.  Requiring a correspondence between the recited dosages and the cited prior art is consistent with other Federal Circuit precedent including In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Pat. Litig. and Ferring B.V. v. Watson Lab'ys, Inc.-Fla.  The single sentence in the Pimentel reference also drew the Judge's attention, wherein "the lack of discussion of any actual dosage that may be optimal, the use of the word 'may,' and the fact that the RFIB 2001 Protocol discloses a specific dosing regimen of 2,200 mg/day rather than 1,650 mg/day all call into question the majority's finding" in Judge Cunningham's opinion.  It had also not escaped the Judge's attention that this sentence was considered by the District Court for the motivation to combine requirement and not the reasonable expectation of success prong of the obviousness analysis.  Finally, Judge Cunningham would decline to assess the significance and content of the after-arising art in the first instance, because none of this art provided any basis for the District Court's decision and thus had made no findings of fact regarding it, citing Golden Bridge Tech., Inc. v. Nokia, Inc., 527 F.3d 1318, 1323 (Fed. Cir. 2008).  The first order of business for the district court on remand (if Judge Cunningham's views had prevailed) would be to consider the significance of this art, see, ACS Hosp. Sys., Inc. v. Montefiore Hosp., 732 F.2d 1572, 1578 (Fed. Cir. 1984).

* The totality of these claims at issue were:

U.S. Patent No. 8,309,569

2.  A method of providing acute treatment for diarrhea-associated Irritable Bowel Syndrome (dIBS) comprising: administering 1650 mg/day of rifaximin for 14 days to a subject in need thereof, wherein removing the subject from treatment after the 14 days results in a durability of response, wherein the durability of response comprises about 12 weeks of adequate relief of symptoms, wherein the 1650 mg is administered as 550 mg three times per day.

U.S. Patent No. 10,765,667

3.  A method of treating one or more symptoms of irritable bowel syndrome (IBS) in a subject 65 years of age or older, said method comprising administering, 550 mg of rifaximin TID for 14 days to the subject, thereby treating one or more symptoms of IBS in the subject 65 years of age or older, wherein the IBS is diarrhea-predominant IBS.

U.S. Patent No. 7,612,199

4.  Rifaximin in polymorphic form β, wherein the rifaximin has x-ray powder diffraction pattern peaks at about 5.4°; 9.0°; and 20.9°2θ and wherein the rifaximin has a water content of greater than 5%.

U.S. Patent No. 7,902,206

36.  A solid pharmaceutical composition comprising rifaximin in polymorphic Form β and a pharmaceutically acceptable excipient or carrier, wherein the rifaximin Form β has x-ray powder diffraction pattern peaks at about 5.4°; 9.0°; and 20.9° 2-θ, wherein the rifaximin Form β has a water content of between about 4.5% to about 40%.

U.S. Patent No. 8,642,573

8.  A method of maintaining remission of hepatic encephalopathy (HE) in a subject in need thereof comprising administering between about 1000 mg to about 1200 mg rifaximin daily to the subject for a period of 12 months or longer, thereby maintaining remission of HE, wherein remission is defined as a Conn score of 0 or 1.

U.S. Patent No. 9,421,195

6.  A method of reducing the risk of hepatic encephalopathy (HE) recurrence in an adult subject in need thereof comprising:
    orally administering between about 1000 mg to about 1200 mg of rifaximin daily to the adult subject for a period of 12 months or longer, thereby reducing the risk of hepatic encephalopathy (HE) recurrence,
    comprising orally administering about 1100 mg of rifaximin per day to the adult subject,
and
    orally administering about 550 mg of rifaximin twice daily to the adult subject.

U.S. Patent No. 10,335,397

11.  A method of reducing a subject's risk of experiencing a breakthrough overt hepatic encephalopathy (HE) episode, comprising administering to the subject between about 1000 mg to about 1200 mg of rifaximin daily for a period of about 12 months or longer, wherein the subject has a Conn score of 0 or 1, wherein the rifaximin is administered orally, wherein 1100 mg of rifaximin is administered per day, and wherein 550 mg of rifaximin is administered twice daily.

12.  A method of reducing a subject's risk of experiencing a breakthrough overt hepatic encephalopathy (HE) episode, comprising administering to the subject between about 1000 mg to about 1200 mg of rifaximin daily for a period of about 12 months or longer, wherein the subject has a Conn score of 0 or 1, further comprising administering lactulose.

In each instanced italics denotes independent claims from which the asserted claims depend.


Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc. (Fed. Cir. 2024)
Panel:  Circuit Judges Lourie, Chen, and Cunningham
Opinion by Circuit Judge Lourie; opinion dissenting-in-part by Circuit Judge Cunningham

Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

In its recent decision in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. the Federal Circuit reminds us that most verities in patent law are not eternal and are frequently subject to case-by-case interpretation, in this case the purported verity being that reciting the indefinite article ("a") in a patent claim is construed to mean "one or more."  Besides showing that "it ain't necessary so" the case is beneficial for motivating a review of when and under what circumstances "a" means "one or more" and when it means "one," but it also illustrates how this perhaps necessary flexibility in claim construction can also lead to what can appear to be outcome-oriented decisions producing more head scratching than enlightenment.

The issue arose in ANDA litigation over Janssen's Invega Sustenna drug, an "extended-release intramuscular injectable of paliperidone palmitate, which is indicated for the treatment of schizophrenia in adults," according to the opinion.  Janssen asserted several claims of U.S. Patent No. 9,439,906; dependent claim 2 was considered representative by the Court:

2.  A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder, or schizophreniform disorder comprising
    (1) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment;
    (2) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of about 100 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained re-lease formulation on the 6th to about 10th day of treatment; and
    (3) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a first maintenance dose of about 25 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation a month (±7 days) after the second loading dose,
[The dosing regimen of claim 1] wherein after administration of the first maintenance dose, subsequent maintenance doses of from about 25 mg-eq. to 150 mg-eq. are administered in the deltoid or gluteal muscle of the psychiatric patient in need of treatment at monthly (±7 days) intervals.

(where the italicized portion is the language of independent claim 1).

as was dependent claim 10:

10.  A dosing regimen for administering paliperidone palmitate to a renally impaired psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder, or schizophreniform disorder comprising
    (a) administering intramuscularly in the deltoid of a renally impaired psychiatric patient in need of treatment a first loading dose of from about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment;
    (b) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of from about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and
    (c) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a first maintenance dose of about 25 mg-eq. to about 75 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation a month (±7 days) after the second loading dose,
[The dosing regimen of claim 8] wherein the sustained release formulation is an aqueous nanoparticle suspension.

(where the italicized portion is the language of independent claim 8).

Dependent claim 13 was also asserted, which limited the patient population to schizophrenics and included the limitation that the dose range was 25 mg-eq. to about 50 mg-eq. for the "maintenance dose"; and finally dependent claims 20 and 21 directed to the particle size of the dosage, the opinion setting forth claim 19, from which claims 20 and 21 depend as reciting the "most pertinent" particle size:

19.  The dosing regimen of claims 1, 4, 8 or 11 wherein the sustained release depot formulation is an aqueous nanoparticle suspension consists essentially of
    (a) 156 mg/ml of the paliperidone palmitate having an average particle size (d50) of from about 1600 nm to about 900 nm;
    (b) 12 mg/ml of polysorbate 20;
    (c) one or more buffering agents sufficient to render the composition neutral to very slightly basic (pH 8.5);
    (d) 30 mg/ml of a suspending agent wherein the suspending agent is polyethylene glycol 4000; and
    (e) water q.s. ad 100%.

(wherein here italics identify the relevant limitations):

The opinion recites that paliperidone itself is the "major active metabolite" of an earlier (1990's) antipsychotic drug, risperidone.  Paliperidone esters such as the palmitate were known in the prior art to have the beneficial property of slow dissolution after intramuscular injection, and the opinion notes that the skilled worker could "easily determine the effective amount of paliperidone to administer."  Although the drug has been on the market for some time in tablet form patient compliance has been an issue.  There were earlier patents directed to methods for administering the drug by injection monthly (U.S. Patent Nos. 6,577,545 and 6,555,544).  In addition to treatment regimens, the '906 patent discloses optimal particle sizes for the formulation, as well as injection in the deltoid muscle for rapid initial plasma concentrations and thereafter administering to the deltoid or gluteal muscles.

Teva stipulated to infringement but challenged the validity of the asserted claims on obviousness and indefiniteness grounds.  The opinion notes that the "safety of paliperidone, its efficacy for treating schizophrenia, and its recommended dosing were all well established as of the '906 patent's priority date" and that "long acting injectables (LAIs)—administered intramuscularly—of other antipsychotics were [also] on the market" at that time.  For its obviousness challenge under these prior art circumstances Teva asserted three references:  "(1) clinical study protocol NCT00210548 ("the '548 protocol"); (2) the '544 patent; and (3) International Publication No. WO 2006/114384 ("WO'384")."  The '548 protocol described a Phase III clinical trial intending to show that three fixed doses (50, 100, or 150 milligrams equivalent) of paliperidone administered to the buttocks were more efficacious than placebo in treating schizophrenia (both party's experts agreed that this protocol was expected to be safe and effective, although there were no results reported therein).  Even though not available in the art at the '906 patent's earliest priority date, the opinion notes that the 50 mg dose was not more effective than placebo, while both the 100 and 150 mg doses had defects that precluded Janssen from using these results to support FDA approval.

The '544 patent (owned by Janssen) claimed "'[a] pharmaceutical composition [of paliperidone palmitate] suitable as a depot formulation for administration by intramuscular or subcutaneous injection, comprising,' among other things, a 'therapeutically effective amount' of paliperidone palmitate," as well as methods of using this pharmaceutical composition to treat schizophrenia.  The specification of the '544 patent discloses ("emphasizes," according to the opinion) the ability to "space out" paliperidone palmitate administration by "three weeks to a month" while maintaining a blood plasma concentration of "above 10 ng/ml and below 100 ng/ml."  "Most pertinent for our purposes on appeal," the opinion states, is disclosure of optimal particle size and "details related to applying 'mechanical means' to reduce the effective average particle size," specifically providing this table:

Finally, the PCT application (WO'384, also owned by Janssen) discloses both the Invega Sustenna formulation and particle sizes at drug concentrations of 25-150 mg-eq.

The District Court held that Teva had not established that any of the claims of the '906 patent were invalid for obviousness or indefiniteness, and this appeal followed.

The Federal Circuit affirmed the trial court's finding regarding indefiniteness of claims 19-21 but vacated and remanded its non-obviousness determination as to all claims, in an opinion by Judge Prost joined by Judges Dyk and Hughes.  The Court agreed with Teva that the District Court erred in requiring Teva to show that:

[I]t would have been obvious to use the recited dosing regimens for the general population of patients—i.e., a generalized dosing regimen.  The court found that the prior art did not demonstrate population-wide safety and efficacy and thus did not teach a generalized dosing regimen.  Teva contends that the claims were not directed to a generalized dosing regimen and therefore the district court asked for a showing of obviousness that went beyond what was claimed.

The opinion specifically asserts that the claims were directed to "a psychiatric patient in need of treatment for schizophrenia" using certain dosage amounts and administration times (emphasis in opinion).  In the Court's opinion:

Nothing in the claims requires that the regimen be used for—let alone be ideal for—the patient population generally or a certain percentage of the patient population.  On their face, the claims only recite a dosing regimen for a psychiatric patient.  Because "[w]hat matters is the objective reach of the claim," KSR[ v. Teleflex], 550 U.S. at 419, the district court erred to the extent it effectively defined its obviousness inquiry as one concerning the "generalized" suitability of the dosing regimens [emphasis in opinion].

This sentiment raises at least two questions:  first, the proper scope of claims reciting "a" member of a patient population (and how it Is to be determined) and second whether disclosure of clinical trial results can be interpreted as being insufficient to satisfy patentability standards for patient populations for such claims.  The jurisprudential history of construction of the indefinite article "a" is not completely straightforward; although treatises somewhat blithely assert that using "a" indicates the proper construction to be "one or more" (see Robert C. Faber, Landis on Mechanics of Patent Claim Drafting 531 (3d ed. 1990)), in fact the case law is more nuanced.  The Federal Circuit in  KCJ Corp. v. Kinetic Concepts, Inc. 223 F.3d 1351 (Fed. Cir. 2000), opined that "[t]his court has repeatedly emphasized that an indefinite article 'a' or 'an' in patent parlance carries the meaning of 'one or more' in open-ended claims containing the transitional phrase 'comprising,'" citing Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 977, 52 USPQ2d 1109, 1112 (Fed. Cir. 1999); AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1023, 43 USPQ2d 1545, 1548 (Fed. Cir. 1997); and North Am. Vaccine, Inc. v. American Cyanamid Co., 7 F.3d 1571, 1575-76, 28 USPQ2d 1333, 1336 (Fed. Cir. 1993).  And "[m]oreover, standing alone, a disclosure of a preferred or exemplary embodiment encompassing a singular element does not disclaim a plural embodiment."  The opinion also states that "although the specifications may well indicate that certain embodiments are preferred, particular embodiments appearing in a specification will not be read into the claims when the claim language is broader than such embodiments," citing Electro Med. Sys., S.A. v. Cooper Life Sciences, Inc., 34 F.3d 1048, 1054, 32 USPQ2d 1017, 1021 (Fed. Cir. 1994).

But some of this cited case law embodies the exceptions to this general rule (to the extent it is general); for example, Abtox, wherein "a" gas chamber was construed as limiting the claims to a single gas-containing chamber based on intrinsic evidence, including the specification (and drawings) as well as the prosecution history that were consistent with construing the claim language to be limited to a single chamber and North Am. Vaccine, Inc. where in the absence of use of "a" in the specification to mean "one or more" (by example) construing the claim to encompass more than one would create a written description deficiency, the Court stating that "[a] patent applicant cannot disclose and claim an invention narrowly and then, in the course of an infringement suit, argue effectively that the claims should be construed to cover that which is neither described nor enabled in the patent."  It is fair to say that "construction of the indefinite article does not conform to uniform treatment or 'black letter law' but rather is interpreted based on how it is used in the intrinsic evidence (claims, specification, and prosecution history)," Insituform Technologies v. Cat Contracting, 99 F.3d 1098 (Fed Cir 1996).

Here, the claim recites "a" dosing regimen for treating "a" psychiatric patient (this of course is done individually to a population of individuals not to a population per se) comprising the details of the regimen.  The Court held that the District Court used evidence adduced by Janssen of clinical trial results improperly to read a limitation regarding patient populations into the claim that recited the dosing regimen for treating "a" psychiatric patient. (In a footnote the panel states "it is unclear whether that [dosing] requirement would indicate that physicians typically (or always) dose that way or that some (or all) patients achieve a certain level of a particular unnamed result").  This principle brings to mind recent precedent on enablement, and whether claims to therapeutic treatments and regimens for administering them will be subject to similar requirements for a showing of how many psychiatric patients would be enough for these claims to be non-obvious under similar circumstances as in this case (contrary, for example, to distinctions by the Court between patentability requirements and regulatory requirements; see, In re Brana, 51 F.3d 1560 (Fed. Cir. 1995)).

The District Court's "misunderstanding" the Court apprehends based on these distinctions made it clear to the panel that they "impacted the district court's overall obviousness analysis," citing statements in the district court decision related to injection site (deltoid, thigh, or gluteal) and dosing amounts.  The opinion asserts that the District Court erred for not considering evidence that the prior art taught making these choices on an individualized rather than patient population basis, based on the Court's construction that such individualized evidence was indicated if not mandated by claim limitations to "a" psychiatric patient being treated by "a" dosage regimen.  And with regard to the District Court's assessment of there not having been a reasonable expectation of success in combining the asserted prior art the panel states that "there too [the District Court] seemed to require an expectation of success not for administering paliperidone palmitate to a patient according to the dosing regimen claimed, but rather success in achieving the goals a POSA would have across an (undefined) average population of patients, such that a POSA would expect to use the regimen as a 'generalized multi-dose regimen.'"  This error, according to the opinion was the result of "conflat[ing] the invention of the claims with Janssen's approval process when it referred to the difficulties Janssen encountered with the . . . clinical trial as an indication of unpredictability in the 'invention process.'"  "In sum," according to the opinion, " . . . the court's framing led it to ask the wrong questions about important aspects of the obviousness inquiry.  This error requires a remand as to all claims because as it currently stands, the record does not contain underlying obviousness factfindings that are cued to the 'a psychiatric patient' claims at issue here."

The opinion also faults the District Court for assessing obviousness of claims regarding administration to patients having renal impairment to those patients wherein the impairment was "mild," there being no such limitation recited in the claims.

More generally, the Court gave credence to Teva's argument that the District Court had contravened the dictates in KSR regarding "impermissibly rigid" assessment of obviousness, based on the District Court not giving the proper weight to the ability of the skilled worker to deduce what the references "fairly suggest[ed]" or employ "ordinary creativity," inter alia by purportedly applying these references to the claims in a "one-by-one" manner (a criticism countless patent prosecutors have heard from PTO examiners), calling it a "seemingly siloed and inflexible approach."  Consequently, the panel believed that the District Court did not consider "how background knowledge in the art would have impacted a POSA's understanding of, or motivation to modify, the primary references at issue, thereby inflating the significance of minor variations between the prior art and the claims."  The opinion also criticizes how the District Court relied on the '548 protocol with regard to the skilled worker's motivation to combine, insofar as the District Court "concluded that in the pharmaceutical context, if a prior art reference does not contain safety and efficacy data, there is no reason to combine it with other prior art references."  The Federal Circuit rejected this approach, stating that the lack of safety and efficacy data in a prior art reference to a clinical trial did not justify the lower court "discarding" that prior art (echoing recent Federal Circuit precedent that claims directed to pharmaceutical compositions and methods of treatment require affirmative recitation of safety and efficacy requirements; see United Therapeutics Corp. v. Liquidia Technologies, Inc., cited in the opinion).  The opinion faults the District Court for not considering what the results of the '548 protocol would have suggested to the skilled worker, or the relevance of the Phase III status of the clinical trial, or that "paliperidone was already on the market and prescribed to patients in need of treatment for schizophrenia" (which might be an important motivation for the Court's opinion).  According to the opinion, what was "more important" was that the '906 claims "do not recite any particular result or outcome, nor do they recite a need for population-wide statistically significant data" (ignoring the implicit meaning of claims to a therapeutic treatment regimen as being safe and effective, or the formalistic futility of requiring such claims (or all such claims) to affirmatively make such representations, with the opinion once again making a distinction between "a psychiatric patient" and a population of such patients).  The status of the clinical trial as having failed was not public knowledge and thus, the panel reasonably contends the skilled worker might have had a different motivation towards combining this reference with other prior art in the absence of such knowledge.  Finally, the Court found error in the District Court's analysis of modifications of unequal loading doses and injections sites, based on its erroneous consideration of the '548 protocol, as well as asserting particular error regarding claims to treatment of renally impaired psychiatric patients (such as not giving sufficient weight to prior art dosage information from orally administered paliperidone palmitate for claims to the drug administered by injection).

Turning to the District Court's nonobviousness determination for claims directed to particle size, the panel found error over the standard applied for teaching away from the '544 patent, based on lack of specific disclosure regarding this parameter ("[S]ilence does not imply teaching away," Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 964 (Fed. Cir. 2014)).

The opinion also provides a thorough discussion of the remedial requirements on remand for the District Court regarding secondary considerations (objective indicia) of non-obviousness, including unexpected results (involving comparisons to psychiatric drugs other than paliperidone palmitate and reliance on the unknown bases for clinical failure in the '548 protocol).  The opinion criticizes the District Court's lack of proper nexus evidence regarding industry praise, and disregard for the effect of blocking patents to the long-felt need and commercial success considerations, citing Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 903 F.3d 1310, 1339 (Fed. Cir. 2018).

Regarding the indefiniteness decision for claims 19-21 directed to particular particle sizes, the Court affirmed the District Court based on that decision being supported by "factual findings that Teva has not shown to be clearly erroneous."  Teva argued that various means for determining particle sizes could lead to "meaningfully different results, creating a situation where the same physical samples of paliperidone palmitate would simultaneously fall inside and outside the claim depending only on how its particle-size measurement is taken," and in particular on particle size deviations that the District Court found were "an outlier measurement taken with a defective device."  The Federal Circuit held that Teva had not established that this District Court determination was clearly erroneous, citing Takeda Pharm. Co. v. Zydus Pharms. USA, 743 F.3d 1359, 1366–67 (Fed. Cir. 2014), for the principle that "the 'mere possibility of different results' is insufficient for indefiniteness."

The panel opinion is sufficiently thorough that the District Court should have ample direction regarding how it should fashion its considerations of the facts, claims, and prior art references to satisfy the Federal Circuit's criticisms of its non-obviousness determinations.  More concerning is the extent to which a court created to harmonize U.S. patent law has apparently endeavored to decide the specific case before it without due considerations on how "black letter" law will be properly applied to the next case it reviews, with regard to claims reciting "a" limitations and the inherent limitations of safety and efficacy for therapeutic treatments and methods of use thereof otherwise not challenged on written description or enablement grounds.  The decision (and United Therapeutics before it) suggests that it would be prudent in future to include affirmative disclosure regarding these inherencies in specifications supporting claims to therapeutic treatments and administration regimens therefor.

Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2024)
Panel: Circuit Judges Dyk, Prost, and Hughes
Opinion by Circuit Judge Prost