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

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

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

Biomedical Device Consultants and Laboratories of Colorado, LLC v. Vivitro Labs, Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

A preliminary injunction is one of the most potent weapons in a patent plaintiff's arsenal, being capable of shutting down an accused infringer's continued infringement, prohibiting the infringing product from the stream of commerce, and forcing (or at least strongly motivating) a defendant to settlement.  Being so powerful, such injunctions are not easily obtained and are cabined by several requirements, the most potent being the need to show a likelihood of success on the merits at trial.  In Biomedical Device Consultants and Laboratories of Colorado, LLC  v. Vivitro Labs, Inc., the Federal Circuit illustrated the importance of such a showing in affirming a District Court denial based on plaintiff's failure to satisfy this prong of the eligibility test.

The case arose in litigation over U.S. Patent No. 9,237,935, directed to Biomedical Device Consultants (BDC) devices for testing heart valve durability based on accelerated fatigue rates.  Claim 1 was considered representative by the Federal Circuit in its opinion (wherein only the relevant limitation was reproduced therein):*

1.  A device for accelerated cyclic testing of a valved prosthetic device comprising . . .
    an excess volume area capable of operating at the accelerated pulsed rate, wherein the excess volume area is in fluid communication with the fluid return chamber providing a volume for storing a volume of a test system fluid when the test system fluid is under compression.

The opinion identified three limitations in dispute: (1) that the claimed device is "capable of operating at the accelerated pulsed rate," (2) that it is "in fluid communication with the fluid return chamber," and (3) that it "provid[es] a volume for storing a volume of a test system fluid when the test system fluid is under compression," supported by specific disclosure in the specification:

The compliance chambers 135 provide excess volume area for fluid to move into when the piston 114 performs a compression stroke. As the pressure of the gas in the compliance chamber 135 increases, the volume occupied by the gas decreases to provide additional volume for displacement of the liquid working fluid within the test chamber 106.

And illustrated by a detailed figure exemplifying the return chamber 136, the compliance chamber 135, test valve sample 130, and the fluid flow path of  the claimed device:

Fig. 3

The term "compliance," while being a recognized term of art was expressly defined in the specification wherein "'compliance' refers to the ability of the cavities forming the compliance chambers 135 to absorb some of the pressure placed upon the fluid in the test chamber 106 and further to control recoil toward the original volume dimensions upon removal of the compressive force"; this definition was not disputed.

The basis for the District Court's denial of a preliminary injunction to BDC for failure to establish a likelihood of success on the merits was that the Disrtrict Court considered there to be a "substantial question" regarding infringement.  This determination arose due to the "preliminary construction" of the term "excess volume area" to mean that the compliance chamber of the device was "separate and needs to be fluidly connected" to the remainder of the device (emphasis in opinion) (although there was some inconsistency regarding whether this construction was based on the plain meaning of the claim or on BDC's construction in an inter partes review of a related patent).  Based on this construction the District Court held that the accused infringing article did not comprise an excess volume area.  Moreover, Vivitro (according to the District Court) had asserted grounds for validity not rebutted by BDC (at least not sufficient to show that those assertions "lacked substantial merit").  These included assertions of an operating manual from a competitor (Dynatek) that anticipated (for claims 1, 2, 8 and 13), or in combination with a Chinese patent to Xi rendered obvious the entirety of BDC's asserted claims; these assertions were supported by an expert declaration and the disclosures of the art illustrated in the opinion:

Dynatek prior art:

FIGURE lA

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges Dyk and Stark.  The opinion expressly sets forth the requirements for a plaintiff to obtain a preliminary injunction (and for which the plaintiff bears the burden to establish):

"(1) it is 'likely to succeed on the merits,' (2) it is 'likely to suffer irreparable harm in the absence of preliminary relief,' (3) the 'balance of equities tips in [its] favor,' and (4) 'an injunction is in the public interest,'" citing BlephEx, LLC v. Myco Indus., Inc., 24 F.4th 1391, 1398 (Fed. Cir. 2022) (quoting Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008).

Although other than the first prong, these requirements were not discussed in the opinion.  Failure to rebut a substantial question of non-infringement or invalidity precludes a plaintiff from obtaining an injunction under, inter alia, Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997).  The standard on appeal is a showing by a rebuffed plaintiff that the district court had abused its discretion, a standard the panel opines BDC did not satisfy here.  The panel rendered its decision on the invalidity issue and did not consider the District Court's non-infringement grounds for denying BDC its injunction.

Regarding invalidity, the opinion notes that the burden on the defendant is not to establish these grounds by clear and convincing evidence (and further noting that to prevail at trial the defendant would need to satisfy that standard).  Rather to avoid a preliminary injunction a defendant must merely raise a question of "vulnerability" having a lower standard (albeit not expressly defined in the opinion).  A district court's refusal to grant a preliminary injunction on this basis is reviewed by the Federal Circuit deferentially for clear error Rule 52(a) of the Federal Rules Civil Procedure.

On the merits of BDC's arguments on appeal, the Federal Circuit rejected the argument that the Dynatek reference did not anticipate claims 1, 2, 8 and 13 because "(1) its capacitance tank is in fluid communication with the distribution chamber, not the return chamber, (2) its capacitance tank cannot store test fluid when 'the test system fluid is under compression' because the test system as a whole is not under compression, and (3) its capacitance tank is not physically capable of 'operating at the accelerated pulsed rate.'"  The panel distinguished BDC's arguments based on Vivitro's expert testimony to the contrary and the panel's appreciation of deficiencies in those arguments, such as questions regarding positioning of the test valve between the capacitance tank and the return chamber and BDC's failure to show how the District Court's assessment was erroneous (this interpretation being supported by the '935 specification itself).  The Court also rejected BDC's arguments regarding Dynatek's failure to disclose that its test system was under pressure, on the grounds that BDC's claims required that the test system fluid, not the test system itself be under such pressure.  Similarly, the panel rejected BDC's distinction that the Dynatek system could not "operate at the accelerated pulsed rate" wherein "the capacitance tank is designed to address only small variations in volume over longer periods of time and that the tube connecting the capacitance tank to the test system is, 'as a matter of ordinary physics,' too narrow to allow fluid to transfer back and forth at an accelerated rate" because these properties are not required by the plain language of the asserted claims.

Turning to the obviousness grounds for the District Court's decision, the Federal Circuit rejected BDC's assertions that the error was that "further briefing" was requested to support an obviousness determination based on the combination of the Dynatek and Xi references with a third reference BDC argued should have been included, because in the panel's opinion the evidence from the combination of Dynatek and Xi was sufficient.  The Court further rejected BDC's arguments that it was an abuse of discretion for the District Court to find a sufficient question of obviousness had been raised by the combination of Dynatek and Xi alone, based on the same logic applied to BDC's arguments distinguishing its device from those disclosed in Dynatek and Xi.  The Court also rejected BDC's arguments that the District Court had not established a motivation to combine the Dynatek and Xi teachings, stating that "simple substitution [of certain components] would result in a tester with fewer parts that would be easier for an end user to assemble, setup, and transport."  Nor were BDCs "teaching away" arguments persuasive because those allegations did not "'criticize, discredit, or otherwise discourage' investigation into the invention claimed," citing for this standard DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009).  Finally, regarding the "secondary considerations" of non-obviousness the opinion states that this argument was first raised in BDC's Reply brief, leaving Vivitro to argue at the oral hearing for the first time against these grounds of non-obviousness.

The opinion recognizes that neither claim construction nor validity (nor infringement) has been definitively decided yet and that the Court's decision here is expressly limited to BDC not being entitled to a preliminary injunction.  Those remaining questions await trial.

* Claim 1 in its entirety reads:

1.  A device for accelerated cyclic testing of a valved prosthetic device comprising
    a pressure source configured to drive a test system fluid cyclically within the device above a normal physiological rate, at an accelerated pulsed rate of greater than 200 beats per minute within the device; and
    a pressurizable test chamber for containing the test system fluid and further comprising
    a fluid distribution chamber positioned on a first side of the valved prosthetic device and in fluid communication with the pressure source;
    a fluid return chamber positioned on a second side of the valved prosthetic device;
    a fluid return conduit both structurally and fluidly connecting the fluid distribution chamber to the fluid return chamber; and
    an excess volume area capable of operating at the accelerated pulsed rate, wherein the excess volume area is in fluid communication with the fluid return chamber providing a volume for storing a volume of a test system fluid when the test system fluid is under compression.

Biomedical Device Consultants and Laboratories of Colorado, LLC  v. Vivitro Labs, Inc. (Fed. Cir. 2024)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Dyk, and Stark
Opinion by Circuit Judge Lourie

Cardiovalve Ltd. v. Edwards Lifesciences Corp. (Fed. Cir. 2024)

By Kevin E. Noonan --

Last week, the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings.  This post concerns the decision in Cardiovalve Ltd. v. Edwards Lifesciences Corp., which has as its most significant aspect an unnecessary untethering of obviousness with evidence regarding the skill and inventiveness of the person of ordinary skill in the art under KSR International Co. v. Teleflex Inc.

The case arose with Edwards's challenge of claims 1-3, 5, 6, and 8-11 of Cardiovalve's U.S. Patent No. 10,226,341 directed to an apparatus for implanting a prosthetic heart valve in a patient in need thereof. Claim 1 was considered representative by the panel:

1.  Apparatus for use at a native valve of a subject, the native valve including at least a first native leaflet and a second native leaflet, the apparatus comprising:
    an implant, comprising:
    an annular portion, being configured to be placed against an upstream side of the native valve, and having an inner perimeter that defines an opening, and
    at least one leaflet clip:
        (i) coupled to the annular portion,
        (ii) comprising:
            at least two clip arms, movable with respect to each other to open and close the clip; and a clip-controller interface, the clip-controller interface being coupled to at least one of the clip arms, and
        (iii) configured:
            to be coupled to a portion of the first native leaflet by the clip arms being brought together to close around the first native leaflet,
            to be coupled to a portion of the second native leaflet by the clip arms being brought together to close around the second native leaflet, and
            to hold together the portion of the first leaflet and the portion of the second leaflet; and
        a delivery apparatus, configured to deliver the implant to the native valve, and comprising at least one clip controller, the at least one clip controller being reversibly couplable to the clip-controller interface, and configured to facilitate opening and closing of the clip, and the delivery apparatus being intracorporeally decouplable from the implant.
    wherein the bold, italicized language is relevant to the issues before the Court.

The prior art cited in the IPR petition, U.S. Patent No. 7,635,329, in support of Edwards's obviousness contentions, disclosed a device for stabilizing valve leaflets illustrated in Figure 9B of this patent:

where the "device, 14, [that] includes two proximal elements, 16, and two distal elements, 18, [is] configured such that a proximal and distal element pair, when brought together, form a clip that grasps a heart valve leaflet, LF, from the top and bottom [and wherein the] fixation device also includes flaps, 104, which restrict upward motion of the leaflets to better enable the proximal and distal elements to grasp the leaflets."  Also noted in the opinion is that "[o]nce the leaflets have been grasped, the flaps . . . may be removed . . . or may be left behind to assist in holding the leaflets" (emphasis in opinion).  Before the Board, Cardiovalve conceded that all the limitations recited in its claims were disclosed in the '329 patent except that the device comprise "at least one leaflet clip" "coupled to the annular portion" of the device.  The Board found that the pairs of proximal and distal elements disclosed in the '329 patent together constitute a "leaflet clip" as disclosed and claimed in the '341 patent, that the flaps "constitute or contain" an "annular portion, and further that any direct or indirect attachment is a "coupling."  Based on these conclusions, the Board found the challenged claims of the '341 to be obvious, and this appeal followed.

The Federal Circuit affirmed in a decision by Judge Taranto joined by Judges Chen and Stoll.  Cardiovalve's sole argument on appeal was that the Board erred in concluding that it would have been obvious to attach, "either directly or indirectly, [the flaps] disclosed in the '329 patent" to its proximal and distal elements."  The opinion notes that the Board applied the seminal teaching from KSR that:

When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a [relevant artisan] has good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.

The panel held that the Board had substantial evidence for its conclusion that Edwards satisfied these requirements.  The panel's reasoning was that the disclosure in the '329 patent that the flaps could be "left behind" necessitated that they be attached to something fixed either to the device disclosed therein or to heart tissue, which provided a "finite number of predictable options."  The Board also relied on Edwards's expert witness regarding why the skilled artisan would know to attach the flaps to the device and why such an attachment would be expected to succeed, thus providing the reasonable expectation of success required by KSR (something Cardiovalve did not challenge).  And the fact that there might have been a small number of other alternatives, as argued by Cardiovalve, did not rebut the Board's determination that the one consistent with the invention claimed in the '341 patent was obvious.

The one interesting aspect of the decision, and one that has garnered comment, was the panel's rejection of Cardiovalve's argument that recitation of the "known options" in the cited passage of the KSR opinion should be limited to what was actually known in the prior art.  (Indeed, it was the genius of Giles Rich and PJ Federico to tether obviousness under Section 103 to the prior art in ways that a century of Supreme Court precedent never did, leaving a determination of invalidity under what philosophically was obvious to the "flash of genius" and other inchoate and unpredictable standards.)  The Federal Circuit's basis for negating this requirement on the prior art was that the requirement was "nowhere articulated in KSR, and adopting it would be inconsistent with the Supreme Court's rejection in KSR of a rigid demand for the steps in an obviousness analysis to be proved by prior-art documents, to the exclusion of the knowledge and skill of the relevant artisan."  And the Court refused to recognize such a requirement in its own precedent, abjuring such existing precedent cited by Cardiovalve (specifically, Uber Technologies, Inc. v. X One, Inc., 957 F.3d 1334, 1339–40 (Fed. Cir. 2020); and Bayer Schering Pharma AG v. Barr Laboratories, Inc., 575 F.3d 1341, 1350 (Fed. Cir. 2009); indeed, this reasoning smacks not a little of being equivalent to stating that just because the Court had reasoned correctly in the past did not necessitate continuing to do so).  Of course there is nothing in KSR's averments regarding the basis for making an obviousness determination based on the knowledge and skill of the prior art artisan that does away with the requirement for evidence that the alternatives relied upon to make that determination would have been understood by the worker of ordinary skill at the time the invention was made and not simply presumed to have existed (being the epitome of hindsight, which KSR also warns against).

The remainder of the panel's reasoning for its decision merely begs the question, i.e., assumes the conclusion, based on Edwards's argument that "a relevant artisan would have found it obvious to attach Goldfarb's flaps to its fixation device (and therefore indirectly to its proximal and distal elements), because the flaps, if left behind, had to be attached somewhere and this was an obvious location."  In the Court's application of the cited portion of the KSR decision the opinion states that "when a relevant artisan would have recognized a problem, a consideration of whether only a small number of solutions existed is a natural part of an evaluation of whether a patent-claimed solution would have been obvious.  The Board's undertaking such consideration here was therefore a legitimate exercise of its duty to evaluate whether Edwards was right or wrong about the position Edwards consistently maintained—that attachment to the implant would have been obvious" (the relevance of the italicized language being itself questionable).  The questionable nature of this basis for affirming the Board's decision is even more unfortunate because the opinion contains an ample basis for affirmance, whereby "the Board actually found reasons for a relevant artisan to choose the Edwards-urged solution over the alternative(s)—at the least, greater simplicity," reliance on which would have avoided disturbing dicta in what was otherwise (and fortunately) just another non-precedential opinion by the Court.

Cardiovalve Ltd. v. Edwards Lifesciences Corp. (Fed. Cir. 2024)
Nonprecedential disposition
Panel: Circuit Judges Taranto, Chen, and Stoll
Opinion by Circuit Judge Taranto

Medtronic, Inc. v. Teleflex Life Sciences Ltd. (Fed. Cir. 2024)

By Kevin E. Noonan --

Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings.  This post concerns the decision in Medtronic, Inc. v. Teleflex Life Sciences Ltd.

The case arose in two IPR proceedings involving U.S. Patent No. 8,142,413, owned by Teleflex and related to methods for using a coaxial guide catheter in interventional cardiology procedures.  Claims 1, 2, 4, 5, and 7-14 were challenged by Medtronic for being unpatentable for anticipation* or obviousness; claim 1 was considered to be representative by the Court in this appeal:

A method of providing backup support for an interventional cardiology device [ICD]
    for use in the coronary vasculature, the [ICD] being adapted to be passed through a standard guide catheter, the standard guide catheter having continuous lumen extending for a predefined length from a proximal end at a hemostatic valve
    to a distal end adapted to be placed in a branch artery, the continuous lumen of the guide catheter having a circular cross-sectional inner diameter sized such that [ICDs] are insertable into and through the lumen, the method comprising:
        [1.a] inserting the standard guide catheter into a first artery over a guidewire, the standard guide catheter having a distal end;
        [1.b] positioning the distal end of the standard guide catheter in a branch artery that branches off from the first artery;
        [1.c] inserting a flexible tip portion of a coaxial guide catheter defining a tubular structure having a circular cross-section and a length that is shorter than the predefined length of the continuous lumen of the standard guide catheter, into the continuous lumen of the standard guide catheter, and,
        [1.d] further inserting a substantially rigid portion that is proximal of, operably connected to, and more rigid along a longitudinal axis than the flexible tip portion, into the continuous lumen of the standard guide catheter, the substantially rigid portion defining a rail structure without a lumen and having a maximal cross-sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the flexible tip portion and having a length that, when combined with the length of the flexible distal tip portion, defines a total length of the device along the longitudinal axis that is longer than the length of the continuous lumen of the guide catheter;
        [1.e] advancing a distal portion of the flexible tip portion distally beyond the distal end of the standard guide catheter and into the second artery such that the distal portion extends into the second artery and such that at least a portion of the proximal portion of the substantially rigid portion extends proximally through the hemostatic valve;
    and
        [1.f] inserting the [ICD] into and through the continuous lumen of the standard guide catheter alongside of the substantially rigid portion and advancing the [ICD] through and beyond a lumen of the flexible tip portion into contact with or past a lesion in the second artery.

wherein the italicized language in step 1.f is relevant to the issues before the Court.  (The opinion reduces the steps from the complexity of the claim language to the following shorthand regarding the ordered and simplified steps:

1.a: inserting the standard guide catheter;
1.b: positioning the standard guide catheter;
1.c: inserting a coaxial guide catheter;
1.d: inserting a substantially rigid portion;
1.e: advancing the flexible tip portion;
1.f: inserting and advancing the ICD.)

The opinion explains that the claimed method relates to introducing a catheter into coronary arteries through the aorta, and the occasional difficulties arising from "tough lesions"(including stenosis and chronic arterial occlusion) therein which make such introductions difficult and problematic, which are addressed in the claims by using a combination of a guide catheter and a coaxial guide catheter.  The coaxial guide catheter comprises "a tip portion, a reinforced portion, and a substantially rigid portion," with the tip being distal (inserted further into the artery) to the rigid portion.  This arrangement is illustrated by Figs. 8 and 9:

with the following explanation from the '413 patent:

In operation, a guide catheter 56 is inserted into a major blood vessel in the body such as aortic arch 58 over guidewire 64 and the distal end 68 of guide catheter 56 is brought into proximity of ostium 60 of a smaller branch blood vessel, such as coronary artery 62, that it is desired to enter.  Coaxial guide catheter 12, with tapered inner catheter 14, is inserted through guide catheter 56 and over guidewire 64.  Guide catheter 56, guidewire 64, coaxial guide catheter 12, and tapered inner catheter 14 are manipulated to insert tapered inner catheter tip 42 into the ostium 60 of the blood vessel that branches off from the major blood vessel.  The bump tip 22 of coaxial guide catheter 12 is inserted with tapered inner catheter tip 42 well into ostium 60 of coronary artery 62 or other blood vessel until bump tip 22 of coaxial guide catheter 12 achieves a deep-seated position.  Tapered inner catheter 14 is then withdrawn from the lumen of coaxial guide catheter 12.  An interventional cardiology treatment device such as a catheter bearing a stent or a balloon (not shown) is then inserted through the lumen of coaxial guide catheter 12 which remains inside guide catheter 56.

Medtronic challenged these claims in the '413 patent over U.S. Patent No. 7,736,355 (for anticipation) and 7,604,612 (for obviousness, in combination with the '355 patent) in a first IPR and for obviousness over U.S. Patent No. 5,439,445 taken alone or in combination with U.S. Patent Application Publication No. US 2004/0010280.  In rendering its Final Written Decision that the challenged claims were non-obvious over any of these combinations of the asserted prior art, the PTAB construed claim 1 to require that the steps be performed in the recited order.  In both IPRs, the Board further held in its non-obviousness determination that the skilled worker would not have been motivated to combine either set of references.

The Federal Circuit affirmed, in an opinion by Judge Prost, joined by Judges Lourie and Chen.  Regarding the Board's claim construction, the panel affirmed the construction that "inserting the ICD can occur only after advancing the flexible tip portion")(emphasis in opinion); Medtronic advanced a broader interpretation for simultaneous insertion of the ICD and coaxial guide catheter.  The Court reviewed the Board's interpretation of the claim language and support therefor in the specification in arriving at its conclusion.  The relevant portion of the claim language was in 1.e (advancing the flexible tip portion) and 1.f (inserting and advancing the ICD), according to the opinion, which indicates that the tip is  advanced before the ICD if (as the Court affirms) in the proper "in order" recitation of the claimed method steps.  As stated in the opinion, "when the current step of a method claim refers to a previous step using the definite article 'the,' the claim language indicates that the previous step occurs sequentially before the current step," citing Wi-Lan, Inc. v. Apple Inc., 811 F.3d 455, 462 (Fed. Cir. 2016) (although qualifying this principle as not being "an ironclad rule").  This interpretation is further supported by the panel's consideration of the "physical requirements of the substantially rigid portion," in light of the arrangements of the elements (with the tip being "distal" and the rigid portion being "proximal" and that they are "operably connected").  Further recitation of the timing of the insertions also support this interpretation according to the opinion ("the logic of claim 1 suggests that the inserting and advancing the ICD step must occur after advancing the flexible tip portion").  Disclosure in the specification is also consistent with this construction, according to the Court, because it also discloses "an ordered performance of the recited steps in claim 1" as well as the advantages of doing so.

While characterizing Medtronic's construction to the contrary as being "plausible" "in a vacuum," the panel rejects it because Teleflex's construction as adopted by the Board is consistent with the context of the claim language and specification, citing Trs. of Columbia Univ. v. Symantec Corp., 811 F.3d 1359, 1363 (Fed. Cir. 2016).  Medtronic's acquiescence to the requirement for the other steps in the method of claim 1 to be performed in the recited order suggests to the panel that this order should not be interpreted any differently for steps 1.e and 1.f, analogous to the circumstances in Mformation Techs., Inc. v. Rsch. in Motion Ltd., 764 F.3d 1392, 1398 (Fed. Cir. 2014).  And cases that have found disparate step order to be a proper interpretation were cases where such an interpretation was expressly supported by the specification, such as Niazi Licensing Corp. v. St. Jude Med. S.C., Inc., 30 F.4th 1339, 1351–53 (Fed. Cir. 2022), or based on claim differentiation, see Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1345 (Fed. Cir. 2008).  Nor were Medtronic's distinctions based on additional recitations in dependent claims 6, 10, and 11 persuasive, the panel stating that the argument "has no support in our reasoning here or the logic and grammar of the claims."

Regarding the Board's finding that the skilled artisan would not have had a reason to combine the '355 and '612 patents, the panel applied the substantial evidence standard of review for what are factual questions supporting the Board's legal determination of non-obviousness.  According to the opinion, the '355 patent discloses an "intravascular foreign matter suction assembly" for removing foreign matter from a blood vessel, whereas the '612 patent discloses emboli protection devices.  The Court rejected Medtronic's assertion of error because, first the Board had expressly considered Medtronic's proposed motivations to combine and its conclusions were supported by substantial evidence; second, the Board compared Medtronic's evidence in favor of a reason to combine the references with Teleflex's contrary evidence and found the latter evidence more persuasive, based in part on expert testimony cited extensively in the Court's opinion; and third, that the Board had not contravened the Supreme Court's decision in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 418–19 (2007), the panel finding that the Board had not improperly applied the "teaching, suggestion, or motivation test" in arriving at its non-obviousness determination.

Turning to the Board's determination that the '445 patent considered alone did not support Medtronic's obviousness challenge, the opinion sets forth the teachings of this patent to be a support catheter (corresponding to the coaxial guide catheter of claim 1) that "protects the fragile balloon of a balloon catheter" (corresponding to the ICD) as that balloon catheter passes through a guide catheter.  The Board determined that the '445 patent had no disclosure of the requirement in claim 1 that the ICD was advanced after advancing the flexible tip portion.  The panel countered Medtronic's assertion of error by noting the "narrow presentation of the evidence" supporting Medtronic's contentions in this regard, including only one paragraph from the '445 patent plus certain expert testimony in support of Medtronic's position.  The Court also found that Medtronic's evidence in support of its position before the Board was wanting, citing Netflix, Inc. v. DivX, LLC, 84 F.4th 1371, 1377 (Fed. Cir. 2023), for the principle that "the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made."  Also supporting the Board's findings, in the Court's view, was that this argument relied alone on the disclosures of the '445 patent plus the understanding and "ordinary creativity" of the skilled worker, which the Board found insufficient to support an obviousness determination.

Finally, the Court turned to the Board's determination that the combination of the '445 patent and '280 application did not render obvious the challenged claims.  In this regard the panel understood the '280 application to disclose "an emboli protection system that occludes blood flow" by deploying a filter to catch dislodged emboli.  The Board rejected this combination for supporting obviousness because, inter alia, "[the] sealing device [disclosed in the '280 application] is withdrawn before inserting a treatment device like a stent or a balloon because occluding blood flow, which sealing device . . . does, is undesirable," a characterization supported by Teleflex's expert testimony that "occluding blood flow is undesirable, and therefore teaches that the guide seal is deployed only during deployment of the filter and not during the subsequent delivery of [ICDs] such as balloons and stents."  This understanding of the consequences of the combination "undermined what Medtronic['s interpretation] proposed - keeping [the] sealing device . . . in [the] guide catheter . . . during the insertion of a treatment device like [the '445]'s balloon catheter."  The panel rejected Medtronic's argument that the Board had not considered the proposed combination, finding that the Board had done so and come to a contrary conclusion supported by substantial evidence.  The panel held that the Board also properly considered the consequences of the combination of the references and concluded, "in light of the drawbacks of Medtronic's proposed combination" that the skilled worker would not have combined these references as Medtronic contended.

* The Board's decision that the asserted prior art reference did not anticipate the challenged claims was not appealed.

Medtronic, Inc. v. Teleflex Life Sciences Ltd. (Fed. Cir. 2024)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Prost, and Chen
Opinion by Circuit Judge Prost

Pfizer Inc. v. Sanofi Pasteur Inc. (Fed. Cir. 2024)

By Kevin E. Noonan --

Last week, the Federal Circuit handed down its opinion in Pfizer Inc. v. Sanofi Pasteur Inc., affirming the Patent Trial and Appeal Board's (PTAB) determination that all claims of U.S. Patent No. 9,492,559 challenged in five inter partes review (IPR) proceedings were obvious.  In light of the Office's promulgation of Guidance to the examining corps as well as PTAB judges of the "increased flexibility" in obviousness determinations mandated by the Supreme Court's decision in KSR v. Teleflex and the Federal Circuit's application of that mandate since the Court's decision, the instant decision (by both the PTAB and the Court) is informative if not necessarily illustrative.

The claims of the '559 patent are directed to "immunogenic compositions" (used in vaccines) against Streptococcus pneumoniae capsular saccharide antigens.  Of the 45 claims challenged in these IPRs three were set forth in the opinion as being representative:

1.  An immunogenic composition comprising a Streptococcus pneumoniae serotype 22F glycoconjugate, wherein the glycoconjugate has a molecular weight of between 1000 kDa and 12,500 kDa and comprises an isolated capsular polysaccharide from S. pneumoniae serotype 22F and a carrier protein, and wherein a ratio (w/w) of the polysaccharide to the carrier protein is between 0.4 and 2.

3.  The immunogenic composition of claim 1, wherein the composition further comprises a S. pneumoniae serotype 15B glycoconjugate and a S. pneumoniae serotype 33F glycoconjugate.

4.  The immunogenic composition of claim 3, wherein the composition further comprises a S. pneumoniae serotype 12F glycoconjugate, a S. pneumoniae serotype 10A glycoconjugate, a S. pneumoniae serotype 11A glycoconjugate and a S. pneumoniae serotype 8 glycoconjugate.

Claim 1 recites the claimed compositions most broadly (directed to the serotype 22F glycoconjugate having a range of specific molecular weights) and the two dependent claims recite in addition combinations of two (claim 3) or 4 (claims 4) additional serotype-specific glycoconjugates.  Challengers Merck Sharp & Dohme Corp. and Sanofi Pasteur Inc. and SK Chemicals Co., Ltd. based their obviousness challenges on a combination of prior art:  PCT Patent Application Publication No. 2007/071711 ("GSK-711") and U.S. Patent Application Publication No. 2011/0195086 ("Merck-086"), wherein the opinion notes that GSK-711 was directed to vaccines against S. pneumoniae comprising "'capsular saccharide antigens (preferably conjugated), wherein the saccharides are derived from at least ten serotypes of S. pneumoniae,' which may include an 'S. pneumoniae saccharide conjugate of 22F,'" while Merck-086 disclosed "'multivalent immunogenic composition[s] having 15 distinct polysaccharide-protein conjugates' in which an S. pneumoniae serotype, including 22F, is conjugated to a carrier protein."

In addition to these obviousness determinations, the Board denied Pfizer's contingent motions to amend (as not proposing patentable substitute claims).  This appeal also followed a denial by the Director of Pfizer's request for Director Review on remand from the Federal Circuit's earlier decision in the wake of United States v. Arthrex, Inc.

The Federal Circuit affirmed the Board's finding that claims 1-45 of the '559 patent were obvious and denial of some (as to claims 46, 47, and 50-52) but not others (claims 48 and 49) of Pfizer's proposed substitute claims, remanding with regard to these claims.  The basis for Pfizer's appeal of the Board's obviousness determination was that neither cited reference disclosed the range recited in independent claim 1 ("wherein the glycoconjugate has a molecular weight of between 1000 kDa and 12,500 kDa").  The panel rejected this argument, applying the rubric from OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375, 1382 (Fed. Cir. 2019) (quoting Regents of Univ. of Cal. v. Broad Inst., Inc., 903 F.3d 1286, 1291 (Fed. Cir. 2018)) that "[a]n obviousness determination requires finding that a person of ordinary skill in the art would have been motivated to combine or modify the teachings in the prior art and would have had a reasonable expectation of success in doing so."  In the Board's view (agreed to by the Federal Circuit), the limitation at issue was a "result-effective variable" and under the "result effective variable doctrine" the skilled artisan "would have been motivated to optimize to provide a conjugate having improved stability and good immune response," based on inter alia E.I. DuPont de Nemours & Co. v. Synvina C.V.  This doctrine depends on the "common sense" of the skilled worker, who would have been motivated not by any specific prior art teaching but generally to "discover the optimum or workable ranges by routine experimentation" (a concept at the heart of the Supreme Court's KSR decision and embodied in the recent Office Guidance, that the person of ordinary skill in the art is not "an automaton").  While typically arising in cases where a claimed numerical range overlaps with a prior art range (see, Genentech, Inc. v. Hospira, Inc.) the opinion asserts that the result-effective variable doctrine is not limited to such instances, and the Court held that the Board was correct in determining whether this variable range, while not expressly recited in the cited prior art, would be a parameter that the skilled worker would be motivated to optimize.  In addition, the opinion notes that the cited references disclosed the molecular weights of the expressly recited 22F serotype as well as 14 other S. pneumoniae serotypes in support of the Board's conclusion (thereby also inherently providing an overlapping molecular weight range for these serotypes and the benefits thereof).  Nor was there anything unknown in the prior art regarding conjugation methods or carrier protein-conjugated polysaccharide antigens according to the opinion, and Pfizer's contrary evidence that whether such conjugates were unexpected must be determined on a case-by-case basis was not persuasive to the panel.  Being dependent on the existence of substantial evidence the Court held that the Board's application of this reasoning for determining that the claims were obvious was not in error and affirmed.

Turning to dependent claims 3 and 4 the Federal Circuit rejected Pfizer's argument (considered and rejected by the Board) that the factual evidence was insufficient to support an obviousness determination because the prior art did not exemplify competence of the other recited carrier protein-conjugated polysaccharide antigens as immunogenic compositions.  Unpredictability, according to the opinion, is not the standard because "the expectation of success need only be reasonable, not absolute," citing Pfizer, Inc. v. Apotex, Inc. (emphasis in opinion).  In addition, these specific polysaccharide antigens (in forms not conjugated to proteins) were known to be immunogenic in the prior art (for example, being encompassed as part of commercially available pneumococcal vaccines such as PNEUMOVAX®).  This reasoning and expert testimony was persuasive to the Board and to the panel that "the person of ordinary skill in the art would have reasonably expected that the claimed glycoconjugates could be incorporated into a vaccine 'while maintaining the immunogenicity to all serotypes in the composition.'"

The opinion considers the Board's denial of Pfizer's motions to amend (to substitute claims for the challenged claims) under the Administrative Procedures Act standard of whether this decision was "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law," citing 5 U.S.C. § 706(2)(A).  The opinion sets forth proposed substitute claims 46, 48 and 49 in this regard:

46.  An immunogenic composition comprising:
    a Streptococcus pneumoniae serotype 22F glycoconjugate, wherein the 22F glycoconjugate has a molecular weight of between 1000 kDa and 12,500 kDa and comprises an isolated capsular polysaccharide from S. pneumoniae serotype 22F and a CRM₁₉₇ carrier protein, and wherein a ratio (w/w) of the polysaccharide to the carrier protein is between 0.4 and 2;
    glycoconjugates from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F all individually conjugated to CRM₁₉₇;
    an aluminum salt adjuvant; and
    wherein the composition exhibits more than a 2-log increase above baseline in serum IgG levels in New Zealand White Rabbits across all serotypes in the composition following administration of two equal doses of the composition in the form of an initial dose and a booster dose.

48.  The immunogenic composition of claim 1 46, wherein the composition further comprises a S. pneumoniae serotype 15B glycoconjugate and a S. pneumoniae serotype 33F glycoconjugate, wherein said serotypes 15B and 33F are all individually conjugated to CRM₁₉₇.

49.  The immunogenic composition of claim 3 48, wherein the composition further comprises a S. pneumoniae serotype 12F glycoconjugate, a S. pneumoniae serotype 10A glycoconjugate, a S. pneumoniae serotype 11A glycoconjugate and a S. pneumoniae serotype 8 glycoconjugate, wherein said serotypes 12F, 10A, 11A and 8 are all individually conjugated to CRM₁₉₇.

(Where additions underlined and deletions struck through.)

The Federal Circuit affirmed that proposed claim 46 would have been obvious in light of the cited prior art (including U.S. Patent Publication No. 2012/0237542) and "the knowledge of a person of ordinary skill in the art."  The specific teachings of the art (being found in the '542 application) included (the same) thirteen serotypes recited in the proposed claims, combined with the teachings of GSK-711 and Merck-086 regarding the 22F serotype in support of obviousness.  The panel responds to Pfizer's assertion that the combination of the art did not disclose successful production of an immunogenic composition having a 2-log increase in serum IgG by reciting the aphorism that "an expectation of success need only be reasonable, not absolute" from Pfizer, Inc. v. Apotex, Inc. (emphasis in opinion), because here, according to the opinion, the cited art "clearly demonstrated that the claimed 2-log IgG increase could be achieved across various serotypes in a multivalent compositions."  For claim 46, the panel agreed that the Board's denial of Pfizer's motion to amend was supported by substantial evidence.

Not so for claims 48 and 49, however.  The difference for these claims is the limitation that the greater than 2-log increase must be exhibited "across all serotypes within the claimed composition" (emphasis in opinion).  The panel found no explanation in the record for why the Board came to the same conclusion regarding obviousness for these claims that it had for claim 46, and "it is hornbook law" that an administrative agency "must provide a 'reasoned basis' for their actions that is sufficient to permit meaningful judicial review."  See In re Theripion.  On this basis the Federal Circuit remanded for further consideration by the Board.

Finally, the Federal Circuit affirmed the Director's decision not to review the Board's decision in the face of Pfizer's argument that the entire Director Review procedure violates the APA for not being "promulgated through notice-and-comment rulemaking" because the Office has changed its webpage "multiple times since it was created."  In earlier cases, the Court had held that this argument could be successfully made only if an appellant showed "prejudicial error," which Pfizer did not do here according to the opinion.

Pfizer Inc. v. Sanofi Pasteur Inc. (Fed. Cir. 2024)
Panel: Circuit Judges Lourie, Bryson, and Stark
Opinion by Circuit Judge Lourie

USPTO Publishes Updated Guidance for Making Proper Obviousness Determinations

By Michael Borella --

On February 27, 2024, the U.S. Patent and Trademark Office published its Updated Guidance for Making a Proper Determination of Obviousness ("Guidance") in the Federal Register.  The stated goal of the Guidance is:

To provide a review of the flexible approach to determining obviousness that is required by KSR Int'l Co. v. Teleflex Inc. (KSR).  The focus of this document is on post-KSR precedential cases of the United States Court of Appeals for the Federal Circuit (Federal Circuit), to provide further clarification for decision-makers on how the Supreme Court's directives should be applied.

At first blush, the Guidance appears to be merely restating the law and one might be inclined to think that it is much ado about nothing.  However, the Guidance is notable for what it does not cover and may actually lead to its intended audience (mainly examiners and PTAB judges) being more likely to find claims obvious and raising the bar on applicant rebuttals of obviousness contentions.

Put another way, the Guidance sets forth a number of legal principles that could result in examiners believing that they should issue more obviousness rejections.  But it does not acknowledge or even mention that examiners commonly and frequently misapply the law and facts when doing so.  Thus, the Guidance is -- at best -- one-sided in this regard and may result in more time and expense for applicants.

The Guidance states that it "is based on the Office's current understanding of the law and is believed to comport with the binding precedent of the Supreme Court and the Federal Circuit . . . [and] is meant to be consistent with the Office's present examination policy."  It is expected that the Guidance will be incorporated into an updated version of the Manual of Patent Examining Procedure (M.P.E.P.).

One tangential point that the Guidance notes is that the America Invents Act (AIA) changed "the time focus of the obviousness inquiry from 'at the time the invention was made' to 'before the effective filing date of the claimed invention.'"  The Guidance instructs USPTO personnel to "interpret references to 'at the time of invention' in KSR . . . as if they referred to the statutory time focus under the AIA."  Presumably, USPTO personnel should do the same with any use of the term "at the time of the invention" in other cases and in Applicants' comments for purposes of consistency, though such a directive is not made.  Nonetheless, this seems to be a minor clarification that is unlikely to lead to a substantive change in examination.

The Guidance goes on to reiterate that KSR affirmed that the factors set forth in Graham v. John Deere Co. still control the obviousness inquiry.  These factors require that "differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved."  Here, the USPTO missed an opportunity to advise examiners to explicitly state their interpretation of the differences (which sometimes is missing in obviousness rejections) and their understanding of the level of ordinary skill in the art (which is almost never mentioned in obviousness rejections).

More substantively, the main theme of the Guidance is that KSR set forth a flexible rather than robotic obviousness test.  The Guidance states that this flexibility has two aspects, "first with regard to the proper understanding of the scope of the prior art, and second with regard to appropriate reasons to modify the prior art."

On these points, the Guidance asserts that "a proper understanding of the prior art extends to all that the art reasonably suggests, and is not limited to its articulated teachings regarding how to solve the particular technological problem with which the art was primarily concerned."  This requires understanding the prior art "in a flexible manner that credits the common sense and common knowledge of a [person having ordinary skill in the art (PHOSITA)]."

According to the Guidance this means that "[a]n argument that the prior art lacks a specific teaching will not be sufficient to overcome an obviousness rejection when the allegedly missing teaching would have been understood by a PHOSITA—by way of common sense, common knowledge generally, or common knowledge in the relevant art."  The Guidance goes on to give examples from the case law that reject a rigid approach to obviousness and properly combine prior art elements without an express teaching to do so.

The problem here is that the Guidance is silent as to how an examiner is supposed to determine the understanding of a PHOSITA or even the proper level of ordinary skill in the art.  As noted above, such determinations are rarely made explicit in office actions.  And, even when they are explicit, the rationale provided by examiners is often conclusory with little or no supportive reasoning.

The Guidance goes on to note that "the flexible approach to obviousness encompasses not only how to understand the scope of prior art, but also how to provide a reasoned explanation to support a conclusion that claims would have been obvious."  Thus, there are "numerous possible sources that may, either implicitly or explicitly, provide reasons to combine or modify, the prior art to determine that a claimed invention would have been obvious."  As a notable example, a so-called "universal" type of improvement to improve system performance may exist "even absent any hint of suggestion in the references themselves."

The concern with this language is that examiners will use it to justify poorly-reasoned, hand-waving contentions involving uses, modifications, and combinations of prior art.  These concerns are somewhat addressed by the Guidance reiterating that "a proper obviousness rejection still requires the decision-maker to provide adequate analysis based on evidentiary support."  In other words, "Office personnel are required to provide a clear articulation of their reasoning, grounded in relevant facts, when making a determination that a claim would have been obvious."  Having said that, it is rare for said personnel to admit that their articulations have not been clear and the guidance provides little criteria for determining whether an obviousness rejection meets this requirement.

Along similar lines, the Guidance states that "[i]f objective indicia of nonobviousness are properly before the examiner, such as by way of incorporation into the written description as filed or submission of an evidentiary declaration after the filing date, the examiner must consider those indicia, even before the issuance of a first Office action."  While a well-drafted patent application may point out differences between the claimed invention and the prior art known to the applicant, it is not clear in examination procedures whether and to what extent such statements have been considered by examiners.  There currently is no requirement for examiners to make such considerations on the record.

Other issues addressed by the Guidance include the use of common sense by a PHOSITA and how to evaluate the weight of expert opinions.

Notably missing from the Guidance is any example of what a sufficient obviousness rejection would look like in practice.  It would have been helpful for the USPTO to provide examples of properly-reasoned as well as improperly-reasoned obviousness rejections.  As it stands, such details are not present, which may incentivize examiners to continue taking short cuts.

At the very least, the Guidance should have called out a few of the most common and problematic types of examiner errors.  These include <ctrl>-F rejections (the examiner finds the words of the claims in prior art references and does not consider that the words may have multiple meanings or are used in a different context), overreliance on broadest reasonable interpretation (the examiner ignores how a claim term is used in the claim and/or defined in the specification), low-effort rejections of dependent claims (the examiner uses the same references to reject all dependent claims even if those references do not teach the specific elements of those claims), the Where's Waldo rejection (the examiner essentially cites an entire reference -- perhaps dozens of pages long -- and merely tells the applicant that the claim element in question is "in there somewhere"), the "expert" examiner (the examiner claims, without any evidentiary support, that the claim element would be well-known to a PHOSITA because the examiner considers themself an expert in the field), and the ghost claim element (an element that is explicitly recited in a claim that the examiner completely and utterly fails to address).  These are just a few examples.

The point is that the USPTO needs to crack down on examiners taking liberty with lazy examination practices.  Along with the Guidance's discussion of the flexibility the obviousness analysis should be a further and more detailed discussion of how to apply it properly.

Another aspect missing from the Guidance is an acknowledgement that there is a line of Federal Circuit cases that put a fence around overly broad motivations to combine prior art references.  Notably, in Belden Inc. v. Berk-Tek LLC, the Court wrote that "obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention" (emphasis added).  Similar language can be found in Personal Web Techs., LLC v. Apple, Inc. and In re NuVasive, Inc. in other words, it is not enough for an examiner to contend that references X and Y could be theoretically combined in some fashion.  Instead, the prima facie burden on the examiner is to establish that a PHOSITA would have been motivated to combine references X and Y in a manner that results what is being claimed by the applicant.

In short, nobody is perfect.  Examiners are human.  Most are not attorneys.  They will make mistakes when applying the law of obviousness.  The USPTO, however, seems content to stick its head in the sand regarding some of the more common and egregious examiner errors that can be found in obviousness rejections without even looking that hard.

If nothing else, the USPTO should be looking closely at examiners who have very high or very low allowance rates in comparison to their art unit or technical center peers as ones that potentially are misapplying the law of obviousness.  The USPTO should also be looking at examiners who are frequently reversed during any stage of the appeals process (e.g., on a pre-appeal brief or PTAB decision) as also potentially misapplying this law.  These individuals should be targeted for additional training on how and how not to employ the obviousness inquiry.

United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)

By Kevin E. Noonan --

One of the most notable consequences (intended or not, for good or ill) of the Leahy-Smith America Invents Act (AIA) has been the possibility (now likelihood, if only in frequency) that the decisions of the Patent Trial and Appeal Board and district courts will be different (typically to the detriment of patent holders).  This outcome Is at least in part the result of differences in the burdens of proof between the two fora, specifically the preponderance of the evidence before the Board and the clear and convincing evidence in court.  These circumstances have raised concerns (most notably by now-suspended, Federal Circuit Judge Pauline Newman) regarding the constitutional propriety of an Article I court being able to overrule an Article III court on separation of powers grounds (see "XY, LLC v. Trans Ova Generics, L.C. (Fed. Cir. 2018)").  Another example of such an outcome arose in the Federal Circuit's affirmance of the PTAB decision that the claims of an asserted patent that had already been held not invalid in litigation were invalidated by the Board, in United Therapeutics Corp. v. Liquidia Technologies, Inc.

The case arose in litigation between NDA holder United Therapeutics Corp. ("UTC") and Liquidia, who filed its own NDA (under § 505(b)(2) of the Food, Drug, and Cosmetic Act).  Both regulatory approval applications were directed towards inhaled formulations of treprostinil for treating pulmonary hypertension (UTC's Tyvaso®, Liquidia's Yutrepia™).  UTC asserted two Orange Book-listed patents, U.S. Patent Nos. 9,593,066 and 10,716,793 in the litigation.  The District Court found that the '066 patent claims were invalid albeit infringed and are not at issue here.  For the '793 patent, the District Court found the asserted claims not to be invalid and that Liquidia's competing product would infringe (having not yet obtained FDA approval), and enjoined Liquidia from marketing its version of the drug until after expiration of the '793 patent (expected on May 14, 2027).  However the District Court noted that Liquidia had challenged the validity of the '793 patent in an ongoing IPR (No. IPR2021-00406) and that, should the PTAB hold the asserted claims of this patent to be invalid Liquidia would be able to seek having the injunction lifted (for further details, see "United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)").

All claims of the '793 patent were challenged in the IPR, with claim 1 being representative:

1.  A method of treating pulmonary hypertension comprising administering by inhalation to a human suffering from pulmonary hypertension a therapeutically effective single event dose of a formulation comprising treprostinil or a pharmaceutically acceptable salt thereof with an inhalation device, wherein the therapeutically effective single event dose comprises from 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof delivered in 1 to 3 breaths.

The opinion also sets forth relevant dependent claims 4, 6, and 7:

4.  The method of claim 1, wherein the inhalation device is a dry powder inhaler.

6.  The method of claim 4, wherein the formulation is a powder.

7.  The method of claim 6, wherein the powder comprises particles less than 5 micrometers in diameter.

Liquidia's IPR petition asserted obviousness of all '793 claims based on U.S. Patent No. 6,521,212 ("the '212 patent") in combination with two scientific abstracts to Voswinckle (termed "JESC" and "JAHA").  The '212 patent described methods for delivering benzindene prostaglandins (of which treprostinil sodium is one) by inhalation to treat pulmonary hypertension, while the Voswinckle references described studies using various amounts of treprostinil (16, 32, 48, and 64 μg/mL) (JESC) and wherein patients in the study were administered the drug in three breaths (JAHA).  UTC responded to Liquidia's obviousness allegation by challenging the status of the Voswinckle references as prior art.  The basis for this assertion was that Liquidia had not established that the Voswinckle references were printed publications under pre-AIA 35 U.S.C. § 102(b).  Liquidia relied upon the Voswinckle references having been stored in libraries but it had not (according to UTC) shown that "both [had] been available at the library and sufficiently indexed or categorized by priority date" (see In re Hall, 781 F.3d 897, 898–99 (Fed. Cir. 1986)).  In rejecting this challenge, the Board noted that each of the Voswinckle references were presented at a public conference attended by 20,000 people (including "scientists, physicians, and nurses, as well as journalists") (emphasis in opinion).  In addition, the Board recognized that the Voswinckle references were cited in other documents available to the public prior to the '793 priority date.  On these bases the Board concluded that the combination of the Voswinckle references and the '212 patent rendered obvious the invention claimed in the '793 patent.  The Board also held that the objective indicia asserted by UTC ("unexpected results, copying, and long-felt and unmet need") did not overcome their prima facie obviousness determination.

UTC petitioned for rehearing (including an appeal to the PTO's Precedential Opinion Panel) on the question of whether the Voswinckle references were prior art.  While the Panel did not deign to review the decision, it did direct the Board to reconsider because in its judgment the Board had failed to determine whether the "other publications" (identified as "research aids") that purportedly disclosed the Voswinckle references had themselves had been available to the public before the critical date.  In addition, the Panel determined that the Board had not "adequately addressed" whether the Voswinckle references "were publicly accessible by way of their presentation and/or inclusion in distributed materials, such as at a conference or library."  The Board dutifully reconsidered the evidence and maintained its decision that the references were prior art.  Admitting it had not recognized that the research aids had not been publicly available before the priority date, the Board nevertheless found that the Voswinckle references had been distributed at conferences prior to that date (including in an "abstract book" provided to attendees).  Having dispensed with any deficiencies in its reasoning on this issue, the Board held the asserted claims of the '793 patent to be invalid for obviousness and UTC appealed.

The Federal Circuit affirmed in an opinion by Judge Lourie joined by Judges Prost and Reyna.  With regard to the prior art status of the Voswinckle references, the Court first addressed whether the Board's analysis "improperly exceeded the prior art theories set forth in Liquidia's petition" under 35 U.S.C. § 312(a)(3) as interpreted by the Supreme Court in SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018).  UTC argued that the Board's reasoning regarding the prior art patency of the Voswinckle references that depended on their inclusion of the abstract books at conferences exceeded Liquidia's arguments in its petition.  The panel held that Liquidia's position in its petition was that the Voswinckle references were prior art because they had been publicly disclosed, and that the Board properly found Liquidia's later arguments in its Reply to be timely under the statute because they were asserted "in direct response" to UTC's contrary arguments first raised in its Response.  This reasoning was not an abuse of discretion, according to the panel, under inter alia Anacor Pharms., Inc. v. Iancu, 889 F.3d 1372, 1380–82 (Fed. Cir. 2018), because Liquidia's arguments in its Reply were not inconsistent with its position in its Petition (i.e., that the Voswinckle references were prior art under pre-AIA 35 U.S.C. § 102(b)).

The panel also agreed with the Board's substantive determination that the Voswinckle references were prior art.  UTC argued that the Board's reasoning regarding the references was entirely "hypothetical" and only supported by "conclusory expert testimony."  In this regard, the Court rejected UTC's assertion that "evidence of actual existence or dissemination" was required, saying this was "not the proper standard" (emphasis in brief).  Rather, the opinion asserts that "[o]ur cases have consistently held that the standard for public accessibility is whether a person of ordinary skill in the art could, after exercising reasonable diligence, access a reference," citing Samsung Elecs. Co. v. Infobridge Pte. Ltd., 929 F.3d 1363, 1374 (Fed. Cir. 2019) (emphasis in brief).  But once such public accessibility has been established "there is no requirement to show that particular members of the public actually received the information," according to the opinion citing Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018), quoting Constant v. Adv. Micro-Devices, Inc., 848 F.2d 1560, 1569 (Fed. Cir. 1988) (emphasis added).  On this basis, the panel held that the Board relied on substantial evidence that the Voswinckle references were prior art.

Turning to the ultimate question of obvious for sole independent claim 1, the Court held that the Board had relied on substantial evidence in concluding that, while no one reference explicitly taught the recited administered range of a therapeutically effective single event dose that comprises from 15 micrograms to 90 micrograms of treprostinil, the skilled worker would have understood that the JESC reference disclosed solutions within this range.  This reference taught administration of treprostinil in various concentrations (16, 32, 48, and 64 μg/mL) but did not disclose explicitly recited administered dosage volumes.  However, according to the Federal Circuit the Board properly relied on expert testimony regarding such volumes (ranging from at least 1 mL and up to 5 mL of solution), which would deliver 16–80, 32–160, 48–240, or 64–320 μg, each of which contained a value falling within the dose recited in claim 1.  The panel considered UTC's challenges to these calculations on technical grounds, finding that the Board had heard and rejected these same arguments.  Accordingly, the panel accepted the Board's conclusions to be supported by substantial evidence on the obviousness question.

Regarding the objective indicia of non-obviousness, the panel found that the Board's rejection of UTC's arguments was also supported by substantial evidence (noting that UTC's assertions regarding unexpected results were included in "only a single paragraph in UTC's opening brief, [which] borders on waiver").  On the merits the Court held that UTC provided assertions but not evidence of any such unexpected results.

Finally, the Federal Circuit upheld the Board's obviousness determination of dependent claims 4, 6, and 7.  UTC's arguments regarding these claims were that the recitation therein of dry power administration of treprostinil was a "separated invention" not disclosed in any of the asserted prior art references.  Thus, UTC argued that the Board failed to explain how the ordinarily skilled worker would have had any reasonable expectation of success in administering treprostinil as a dry powder.  The panel first held that UTC had waived this argument because it had not raised it (at least in this form) before the Board.  And on the merits, the panel held that as with independent claim 1 the Board's decision on these dependent claims was supported by substantial evidence (including the unrebutted testimony of Liquidia's experts) and thus affirmed.

United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Prost, and Reyna
Opinion by Circuit Judge Lourie

Jager Pro, Inc. v. W-W Manufacturing Co. (Fed. Cir. 2023)

By Kevin E. Noonan --

Although merely exemplifying the burden imposed on an appellant by the Federal Circuit's substantial evidence standard of review over decisions by the U.S. Patent and Trademark Office regarding the facts underlying legal decisions on obvious, an inter partes review of patents directed to capturing feral pigs provides enough of a curiosity to provoke a post, in Jager Pro, Inc. v. W-W Manufacturing Co.

The case arose over two decisions by the Patent Trial and Appeal Board (PTAB) where all challenged claims of U.S. Patent Nos. 9,814,228 and 10,098,339 were held unpatentable as obvious.  These claims were directed to apparatus and methods for capturing feral pigs.  Claim 1 of the '228 patent was set forth in the opinion as representative:

1.  A method for capturing a plurality of feral pigs, comprising:
    [a] moving at least one portion of an enclosure from an open position that permits passage of a plurality of feral pigs into the enclosure to a closed position that restricts passage of the plurality of feral pigs out of the enclosure, [b] wherein in the closed position, the enclosure cooperates with a ground surface to define an enclosure area in which the plurality of feral pigs are trapped, [c] and wherein the ground surface extends continuously from within the enclosure area to areas surrounding the enclosure,
    [d] wherein the enclosure comprises a release mechanism that effects movement of the at least one portion of the enclosure from the open position to the closed position,
    [e] wherein the release mechanism effects movement of the at least one portion of the enclosure from the open position to the closed position upon receipt of a release signal from a control mechanism that is in communication with a display device, [f] wherein the display device is in communication with a camera assembly and configured to:
        receive a wireless detection signal from the camera assembly; and
        [g] transmit a wireless control signal upon receipt of the wireless detection signal from the camera assembly, wherein the wireless control signal corresponds to an instruction to the control mechanism to generate the release signal, and
    [h] wherein, upon detection of a presence of the plurality of feral pigs within the enclosure by the camera assembly, the camera assembly transmits the wireless detection signal to the display device.

Challenger W-W Manufacturing asserted the combination of an archived webpage to Texas Boars which included teachings regarding the preamble of claim 1 and bracketed limitations 1[a]–1[e] and Korean Patent No. 10-0688143 which contained this figure which taught or at least suggested "wireless transmission of signals from a camera assembly to a display device as well as from the display device to a control mechanism":

The Board also considered Jager Pro's assertion of certain objective indicia of non-obviousness to be inadequate because the patentee did not provide any evidence of there being a nexus between the evidence adduced and the objective indicia, nor was their argument entitled to a presumption that such a nexus existed.

The Federal Circuit affirmed, in an opinion by Judge Chen joined by Judges Lourie and Reyna.  The panel rejected patentee's arguments that the Board's obviousness determinations were not supported by substantial evidence, that the Board did not articulate a basis for there to have been a motivation to combine the cited references, nor that the skilled worker would have had a reasonable expectation of success.  On the contrary, the Federal Circuit relied on there being a "simple substitution" of an animal-instigated closure (through a trip wire) and human-instigated closure (pushing a button in response to received images of the animals), which in the Board's opinion was motivated by the advantages resulting from this substitution.  Such advantages of the substitution that the skilled worker would have recognized include increased control and chance for success in trapping the animals.  These considerations were supported by substantial evidence on the record in the Board's opinion, unrebutted by patentee.

The panel also rejected Jager Pro's arguments regarding deficiencies in the asserted references because (in the Court's view) the references were argued individually rather than the asserted combination of the references.  Specifically, the opinion takes issue with the purported absence of wireless connection embodiments in the '134 patent because the panel interpreted broken lines in the Figure above to indicate such wireless embodiments.

With regard to the objective indicia and the nexus vel non with the claims, Jager Pro argued entitlement to this presumption due to the display device of their commercial product "transmit[ting] a wireless signal directly to the release mechanism, which then releases the gate" (emphasis in opinion).  The Federal Circuit agreed with the Board that this feature was not a requirement of the claims, which had the complication that the wireless signal was sent from the display to a controller which then sent another signal to a mechanism that opens the gate.  The Board had found Jager Pro's instruction manual regarding use of the apparatus to be inconclusive because it contained no explanation of how the control box was controlled according to limitation 1[e].  This Board finding was also supported by substantial evidence according to the panel opinion.

The panel held that the substantial evidence standard was satisfied by the Board for the factual questions at issue supporting its obviousness determination of the challenged claims and thus affirmed the Board determination that the challenged claims were obvious.

Jager Pro, Inc. v. W-W Manufacturing Co. (Fed. Cir. 2023)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Reyna, and Chen
Opinion by Circuit Judge Chen

Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, Inc. (Fed. Cir. 2023)

By Kevin E. Noonan --

The Federal Circuit dismissed an appeal from an unsuccessful challenger in an inter partes review (IPR) proceeding based on failure to satisfy the standing requirements for appeal in Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, Inc.

The case arose in an IPR over U.S. Patent No. 10,149,820, directed to compositions and methods for treating pterygium, "an eye condition in which a tumor-like growth extends from the nasal or temporal side of the eye to the cornea."  Surgery was the recognized treatment, and also recognized was the likelihood of tumor recurrence.  The '820 patent claims use of multikinase inhibitors including nintedanib, pazopanib, and sunitinib.

Nintedanib

Claims 4 and 5 were the only claims remaining after the IPR; claim 4 was set forth as representative:

1.  [disclaimed] A method for reducing hyperemia or symptoms thereof in pterygium in an affected eye of a subject in need of such treatment, without surgically excising a pterygium, comprising administering to the affected eye of the subject a therapeutically effective amount of a multikinase inhibitor.

3.  [disclaimed] The method of claim 1, wherein the multikinase inhibitor is administered to the affected eye in the form of topical ocular formulation or ocular implant.

4. The method of claim 3, wherein the multikinase inhibitor is nintedanib and the nintedanib is administered to the affected eye in the form of a topical ocular formulation and is administered topically to the affected eye.

Relevant to the issues on appeal, the Board held that Allgenesis had not shown the remaining (not disclaimed) claims of the '820 patent were invalid for anticipation or obviousness over its own PCT application because the earliest priority date for the '820 patent (June 5, 2015) was earlier than the priority date of the PCT application (June 22, 2015) and Cloudbreak's provisional application provided sufficient written description support for claims 4 and 5 of the '820 patent.  The Board also determined that the '820 claims were not obvious in view of the combination of two other references because of the '820 patent's disclosure of unexpected results of improved efficacy and safety.  Allgenesis appealed both grounds of the Board's determination of non-obviousness.

The Federal Circuit dismissed the appeal based on Allgenesis' failure to satisfy Article III requirements, in a decision by Chief Judge Moore joined by Judges Stoll and Cunningham.  The opinion sets forth the basis for Allgenesis' deficiency as being rooted in the requirement for standing of injury in fact under Spokeo, Inc. v. Robins, 578 U.S. 330, 338 (2016).  This requirement, while not arising for standing to file an IPR petition, Cuozzo Speed Techs., LLC v. Lee, 579 U.S. 261, 279 (2016), is required to appeal the Board's decision under Consumer Watchdog v. Wis. Alumni Rsch. Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014).  Allgenesis asserted standing based on "(1) its potential infringement liability and (2) the Board's priority determination."  Neither assertion was sufficient, according to the opinion, because Allgenesis' allegations of injury were speculative and insufficiently concrete to establish injury in fact.  With regard to potential liability for infringement, the opinion states that the evidence, a declaration from Allgenesis' Vice President of Finance, relied on a Phase II clinical trial in 2020 and vague assertions of future plans to produce a nintedanib commercial product.  The opinion found these assertions to be unconvincing, saying that they "fail[] to identify any specific, concrete plans for Allgenesis to develop a nintedanib product that might implicate claims 4 and 5 of the '820 patent."  Nor did Allgenesis provide testimony regarding plans for further development such as a Phase III trial.  Instead, according to the panel, Allgenesis provided "generic" statements that it had not abandoned plans for a commercial product.  However, according to the opinion, "[s]uch conclusory testimony is insufficient to establish that Allgenesis has any concrete plans to develop and bring to market a nintedanib treatment for pterygium."  Nor did Allgenesis assert any threat from Cloudbreak to file suit for infringement.  The panel concludes that "Allgenesis has failed to establish it has nonspeculative, concrete plans for future activity that creates a substantial risk of future infringement."

Allgenesis was no more successful in its second assertion of injury in fact, that the Board's decision on priority of invention in favor of Cloudbreak would impair its ability to obtain its own patent on using nintedanib to treat pterygium.  Once again, the Federal Circuit found Allgenesis' evidence and argument to be insufficient to support its injury in fact claim.  The opinion analogizes the circumstances with the Court's  earlier decision in Best Medical International, Inc. v. Elekta Inc., 46 F.4th 1346 (Fed. Cir. 2022) (despite significant distinctions between the factual circumstances, recognized by the Court).  What the cases had in common, in the Federal Circuit's view, was reliance on collateral estoppel as the basis for the injury and, as the Court notes, "[c]ollateral estoppel will not attach to the Board's non-appealable priority determination," citing SkyHawke Techs., LLC v. Deca Int'l Corp., 828 F.3d 1373, 1376 (Fed. Cir. 2016).  And again the Court states that "Allgenesis has, based on these quite vague allegations, failed to establish a concrete injury."  Even when eschewing estoppel arguments Allgenesis "failed to articulate with any specificity how the Board's priority determination will impact its issued patents or pending continuation applications which claim priority to its PCT application," those articulations being found in "a single paragraph containing only vague allegations in its opening brief and reply brief, respectively."

Having decided that Allgenesis failed to establish injury in fact as required for standing the Federal Circuit dismissed the appeal without reaching the merits.

Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, Inc. (Fed. Cir. 2023)
Panel: Chief Judge Moore and Circuit Judges Stoll and Cunningham
Opinion by Chief Judge Moore

Azurity Pharmaceuticals Inc. v. Alkem Laboratories Ltd. (Fed. Cir. 2023)

By Kevin E. Noonan --

There has been some comment in certain quarters regarding the recent penchant for the Federal Circuit to issue Rule 36 summary affirmances instead of full-fledged opinions as had been the Court's practice for much of its 40-year existence (see, e.g., D. D. Crouch, Wrongly Affirmed without Opinion, 52 Wake Forest Law Review 561 (2017)).  The Supreme Court has deigned not to review the practice (see, e.g., writs of certiorari in Shore v. Lee (2017) and Broadband ITV v. Hawaiian Telecom (2017)).  In its recent decision in Azurity Pharmaceuticals Inc. v. Alkem Laboratories Ltd., the Court handed down a non-precedential opinion that is unlikely to still those voices raised in criticism of cases affirmed without opinion.

The case arose in ANDA litigation as an appeal of a decision by the U.S. District Court for the District of Delaware finding the asserted claims of U.S. Patent Nos. 10,786,482 and 10,918,621 to be invalid for obviousness and insufficient written description.  These patents claimed liquid formulation of enalapril, a drug for treating high blood pressure that conventionally was dispensed in tablet form.  Some patients (children and the elderly) have difficulties swallowing tablets but liquid formulations had the drawback that the drug degrades in water.  The claimed formulation overcame this limitation; claim 16 is set forth here to illustrate the claimed invention:

16.  An oral liquid formulation, comprising:
    (i) about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable salt or solvate thereof;
    (ii) a buffer comprising a mixture of citric acid and sodium citrate, wherein the buffer is present at a concentration between about 5 mM and about 20 mM in the oral liquid formulation;
    (iii) about 1 mg/ml of a preservative, wherein the preservative is a paraben or a mixture of parabens; and
    (iv) water;
    wherein the formulation maintains about 95% w/w or greater of the initial enalapril amount at the end of a storage period of at least 12 months at about 5±3° C, wherein the sweetener is sucralose.

(As set forth, the italicized portion of the claim is recited in independent claim 14 and the remainder in dependent claim 16.)

The Federal Circuit affirmed in an opinion by Judge Dyk joined by Judges Hughes and Stoll.  The following is the entirety of the discussion portion of the opinion:

"Obviousness is a mixed question of fact and law."  Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1327 (Fed. Cir. 2017).  The district court's legal conclusion of obviousness is subject to de novo review, while "subsidiary factual findings are reviewed for substantial evidence."  Id.  Substantial evidence is "such relevant evidence as a reasonable mind might accept as adequate to support a conclusion."  Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938).

We see no legal error in the district court's obviousness determination and conclude that it was supported by substantial evidence.  Because we affirm the district court's obviousness determination, we decline to reach the issue of written description.

For anyone counting at home, the total word count for the discussion portion of the opinion is 115 words (the entire opinion takes 332 words to be expressed).  For comparison, this post is 536 words in length.

Azurity Pharmaceuticals Inc. v. Alkem Laboratories Ltd. (Fed. Cir. 2023)
Nonprecedential disposition
Panel: Circuit Judges Dyk, Hughes, and Stoll
Opinion by Circuit Judge Dyk

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

By Kevin E. Noonan --

In those (in retrospect) halcyon days more than a decade ago (before Mayo, Myriad, Alice, and the subject matter eligibility quagmire arose), perhaps the most significant Supreme Court decision was KSR Int'l Co. v. Teleflex Inc. (2007), where the Court addressed the proper standard for determining obviousness for the first time since the Federal Circuit was created by Congress in 1982.  While the consequences of that decision may have been somewhat less dire than first feared (see "Implications of the Supreme Court's KSR v. Teleflex Decision for Biotechnology"; "Bayer Schering Pharma AG v. Barr Laboratories, Inc. (Fed. Cir. 2009)"), the impact of the decision continues to be felt (as does the Court's decision in Dickerson v. Zurko regarding judicial deference to the USPTO on questions of fact) as illustrated by the Federal Circuit decision earlier this year in Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc.

The case arose in an inter partes review initiated by Mylan Pharmaceuticals over Reissue Patent No. RE47,617.  The reissue patent was directed to drug delivery devices having settings permitting selection of different dose sizes; Claim 1 was considered to be representative:

1.  A drug delivery device comprising:
    a housing with a proximal end and a distal end,
    a cartridge adapted to accommodate a drug,
    a cartridge retaining member adapted to retain the cartridge, the cartridge retaining member releasably secured to the housing, and
    a spring washer arranged within the housing so as to exert a force on the cartridge and to secure the cartridge against movement with respect to the cartridge retaining member,
    wherein the spring washer has at least two fixing elements configured to axially and rotationally fix the spring washer relative to the housing.

(wherein the italicized limitations were relevant to the issues on appeal).  As explained in the opinion, the spring washer is secured to the device housing to "prevent relative axial movement between [the] spring washer and housing" wherein the spring washer "exert[s] a force on the cartridge and secure[s] the cartridge against movement."

Challenger Mylan asserted a combination of three prior art references:  (1) U.S. Patent Application No. 2007/0021718 ("Burren"); (2) U.S. Patent No. 2,882,901 ("Venezia"); and (3) U.S. Patent No. 4,144,957 (a patent directed to clutch bearings in an automobile).  Mylan argued that the '718 application disclosed the use of springs in a drug delivery device and that the combination of this reference with the '901 patent taught using spring washers in drug delivery devices.  Mylan's petition and position before the Board was that the '957 patent "addresse[d] a problem analogous to that addressed in [the '901 patent] ([axial] fixation and support of two components relative to one another)"; this argument was supported by expert testimony.  As it did on appeal, Sanofi argued that the '957 patent was non-analogous art (cars versus drug delivery devices) wherein "a person of ordinary skill in the art 'would not have considered a clutch bearing to be within the same field of endeavor'."  Mylan in response argued that the problem to be solved was the same and that the skilled worker would have considered the solution disclosed in the '957 patent to be relevant to the claimed drug delivery device.  The PTAB rendered a Final Written Decision finding all eighteen challenged claims of the '617 reissue patent to be invalid for obviousness, stating that the combination of the '718 application and the '901 patent was not sufficient to support an obviousness determination, but the addition of the '957 patent's teachings rendered the challenged claims obvious.  In doing so, the Board held that the '957 patent was analogous art to the '718 application (wherein the common problem to be solved was "axially fixing two components relative towards each other" as argued by Mylan).  This appeal followed.

The Federal Circuit reversed, in an opinion by Judge Cunningham joined by Judges Reyna and Mayer.  Sanofi's argument on appeal was based on the Mylan's purported failure to argue that the '957 patent was analogous art to the claimed invention in the '617 reissue patent, instead arguing that the '957 patent was analogous art to another prior art reference, the '901 patent.  Mylan argued that there was "no functional difference" between the problem addressed in the '718 patent and the solution/invention claimed in the '617 reissue patent.

In reversing the Board, the Federal Circuit held that Mylan had not shown that the '957 patent was analogous art to the '614 reissue claims.  According to the opinion, the test for analogous art is either that the art is from the same field of endeavor, "regardless of the problem addressed," or that when it is not within the same field of endeavor, "whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved," citing In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004); In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992); and In re Wood, 599 F.2d 1032, 1036 (CCPA 1979).  The Federal Circuit stated that it had "consistently held that a patent challenger must compare the reference to the challenged patent" (which was clearly not what the Board had done here), citing Donner Tech., LLC v. Pro Stage Gear, LLC, 979 F.3d 1353, 1358 (Fed. Cir. 2020), and Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001 (Fed. Cir. 2016).  The rationale for these principles is that the factfinder must "examine whether a reference can be considered as prior art to the challenged patent in the first place," citing Chemours Co. FC, LLC v. Daikin Indus., Ltd., 4 F.4th 1370, 1376 (Fed. Cir. 2021).  The defects in Mylan's assertions that the '957 patent was analogous art was that the Federal Circuit's jurisprudence consistently required a determination of whether art is analogous to be in comparison to the claimed invention, the Court stated.  The opinion also distinguished the factual predicates in cases cited by Mylan in support of its argument, which included Mandel Bros., Inc. v. Wallace, 335 U.S. 291, 295–96 (1948), and In re Mariani, 177 F.2d 293, 294–96 (CCPA 1949).  The deficiencies in Mylan's interpretation of precedent were that they would "allow a challenger to focus on the problems of alleged prior art references while ignoring the problems of the challenged patent," the panel stated.  Although analogous art can (or must, according to Mylan) be construed broadly because "familiar items may have obvious uses beyond their primary purposes," citing KSR and Wyers v. Master Lock Co., 616 F.3d 1231, 1238 (Fed. Cir. 2010) (italics in opinion), "that conclusion does not allow a fact finder to focus on the problems contained in other prior art references to the exclusion of the problem of the challenged patent" according to the Federal Circuit's opinion here.

Turning to the facts before the Board, the panel held that Mylan had not borne its burden to assert substantial evidence supporting its obviousness argument, because Mylan did not show that the '957 patent was analogous art to the challenged '614 reissue patent claims.  After asserting its precedent that the challenger has the burden of showing obviousness and that the Court will reverse PTAB obviousness determinations where a challenger fails to satisfy its burden (e.g., on motivation to combine, citing In re Magnum Oil Tools International, Ltd., 829 F.3d 1364 (Fed. Cir. 2016)), the panel held Mylan's failure to argue that the '957 patent was analogous art to the challenged '617 reissue patent claims was fatal to its IPR challenge (noting, no doubt to Mylan's chagrin, that it had passed up the opportunity to remedy this deficiency in its Reply to the patent owner's "opposition, patent owner preliminary response, patent owner response, or [the Board's] decision on institution).

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)
Panel: Circuit Judges Reyna, Mayer, and Cunningham
Opinion by Circuit Judge Cunningham