Patent Docs

Baxalta Inc. v. Genentech, Inc. (Fed. Cir. 2023)

By Kevin E. Noonan --

There has been, since the turn of the century, a steady, seemingly inexorable trend towards limiting patent rights and focusing the application of U.S. patent law towards an emphasis on preventing innovators from obtaining patent rights broader than the minimum to which they may be entitled.  This focus puts putative interests the public may have in reducing present patent rights in favor of future ones, where granting such rights to present inventors (limited as they are in time) is more important that providing sufficient patent protection to permit exploitation and commercialization of the innovations disclosed in their patents.  Examples of this trend can be seen in the loss patent term adjustment awarded by statute due to Patent Office delay on the principle that the public has the right to freely used a patented invention including obvious variations thereof upon earliest patent expiry, the principle being found in Federal Circuit decisions from AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust and Gilead Sciences, Inc. v. Natco Pharma Ltd. and culminating in the Federal Circuit's recent In re Cellect decision.  In this climate concerns quickly arose regarding how the recent Supreme Court decision in Amgen v. Sanofi would be interpreted by the Federal Circuit.  The Court did not disappoint, in its decision handed down in Baxalta Inc. v. Genentech, Inc.

The case arose in litigation over U.S. Patent No. 7,033,590 (having an earliest priority date of September 14, 2000, the significance of which will become readily apparent).  The claims of this patent were directed to monoclonal antibodies that could provide an alternative treatment for Hemophilia A, being immunologically specific for human blood clotting factor IX and its activated form Factor IXa that would activate Factor X in the coagulation pathway in the absense of Factor VIII lacking in these hemophiliacs.  The coagulation pathway is set forth here for clarification:

In the opinion, claim 1 of the '590 patent was set forth as being representative:

1.  An isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.

By eliminating the need for Factor VIII these antibodies overcame the limitation of treatment by recombinant human Factor VIII (one of the triumphs of the application of recombinant DNA technology and transformation of cells to make useful amounts of the protein), wherein patients developed antibodies against the Factor that disabled its ability to support coagulation and treat patients' disease.

As discussed in the opinion, the specification of the '590 patent disclosed use of hybridoma technology to produce such antibodies, which technology was considered sufficiently robust and predictable that it was the basis for the Federal Circuit's opinion in Noelle v. Lederman (wherein the mere isolation of a novel antigen or epitope thereof was considered sufficient to enable claims directed to antibodies to that antigen or epitope with no demonstration of actual production of any such antibodies).  Indeed, until recently the vulnerability of such claims was considered to be a failure to satisfy the written description requirement in light of the Federal Circuit's en banc decision in Ariad v. Eli Lilly & Co.

Here, however, the matter was before the District Court on remand from an earlier Federal Circuit decision, wherein Baxalta sued Genentech over the latter's Hemlibra® (emicizumb-kxwh) product and the Court reversed based on the District Court's incorrect claim construction (ironically, by Judge Dyk who was sitting by designation in the District of Delaware).  Judge Dyk, again sitting by designation granted Genentech summary judgment that the asserted claims of the '590 patent were invalid for lack of enablement in view of the Supreme Court's intervening Amgen v. Sanofi decision.

The Federal Circuit affirmed, in an opinion by Chief Judge Moore joined by Judges Clevenger and Chen.  The Court's basis for its decision, recited more than once, is that "[t]he facts of this case are materially indistinguishable from those in Amgen" (which was not strictly speaking true; the Amgen claims recited producing antibodies based on their function of PCSK9 binding that prevented PCSK9 binding to LDL receptors, which is that elicited the blood cholesterol-reducing effect rather than, as here, antibodies directed to the target itself, a distinction without a difference to the Court).  Sufficiently significant for the Court to recite in the opinion were the facts that the hybridoma methods disclosed in the specification expressly disclosed eleven antibodies by amino acid sequence having the claimed binding properties, and that such functional antibodies amounted to only 1.6% of the "thousands" of screened antibodies resulting from the Kohler and Milstein hybridoma protocol employed by the inventors.  The panel interpreted the Supreme Court's Amgen decision to require enablement of "the full scope of the invention as defined by its claims," allowing for "a reasonable amount of experimentation."  As in Amgen, the Federal Circuit appreciated the asserted claims of the '590 patent to likewise encompass millions of potential candidate monoclonal antibodies, the screening of which itself amounted to undue experimentation.  The Court considered the circumstances here to be "materially indistinguishable" from those in Amgen, including reliance on an experimental "roadmap" (here) that required the skilled artisan to "(1) immunize mice with human Factor IX/IXa; (2) form hybridomas from the antibody-secreting spleen cells of those mice; (3) test those antibodies to determine whether they bind to Factor IX/IXa; and (4) test those antibodies that bind to Factor IX/IXa to determine whether any increase procoagulant activity."

Moreover the panel discerned that the specification provides no disclosure regarding "a quality common to every functional embodiment" that would permit the skilled worker to predict which of these potential millions of antibodies would have the claimed function.  This deficiency included no disclosure of a comparison of the eleven disclosed antibodies that would provide such a structural key to identifying functional species.  Rather, the person of ordinary skill in the art would (as in Amgen) need to produce a surfeit of antibodies and then screen them for the desired activity.  This amounted, in the panel's view, to no more than the type of "trial and error" disclosure found wanting for satisfying the enablement requirement in Amgen.

More than ten years ago Judge Lourie set forth rubrics that could satisfy that other aspect of Section 112, the written description requirement, in the Federal Circuit's en banc Ariad opinion:

[A] description of a claimed genus disclosing either (1) "a representative number of species falling within the scope of the genus," . . . or (2) "structural features common to the members of the genus," either of which must enable "one of skill in the art [to] 'visualize or recognize' the members of the genus" [emphasis in opinion].

The current emphasis on undue experimentation resonates with these requirements, which formed the reasoned basis for the Federal Circuit's decision in this case:

Moreover, it is undisputed the '590 patent contains no disclosures—such as "a quality common to every functional embodiment," Amgen, 598 U.S. at 614—that would allow a skilled artisan to predict which antibodies will perform the claimed functions.  The patent does not disclose any common structural (or other) feature delineating which antibodies will bind to Factor IX/IXa and increase procoagulant activity from those that will not.  Nor does the patent describe why the eleven disclosed antibodies perform the claimed functions, or why the other screened antibodies do not.  The only guidance the patent provides is "to create a wide range of candidate antibodies and then screen each to see which happen to bind" to Factor IX/IXa and increase procoagulant activity.  Id.  Amgen makes clear that such an instruction, without more, is not enough to enable the broad functional genus claims at issue here.  Id. at 614–15 ("[T]he . . . problem we see [is that] Amgen offers persons skilled in the art little more than advice to engage in 'trial and error.'").

For anyone looking for a rationale that supports a broader disclosure of biological molecules than a recitation limited to the expressly disclosed species, it seems Judge Lourie's suggestions would be a good place to start.

Baxalta Inc. v. Genentech, Inc. (Fed. Cir. 2023)
Panel: Chief Judge Moore and Circuit Judges Clevenger and Chen
Opinion by Chief Judge Moore

Judge Newman Suspended for One Year by Federal Circuit

By Kevin E. Noonan --

In a decision that will surprise no one who has followed the situation in the past six months (see "Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman"), the Judicial Council of the Federal Circuit has ordered Judge Pauline Newman to be suspended from the court for one year.

Despite beginning the Order with reference to prior ecomiums from at least two of her judicial brethren, the 72-page Order repeats the allegations made previously against Judge Newman, supplemented with 16 (sometimes) heavily redacted Exhibits and notations that some other supporting exhibits have been redacted in their entirety for confidentiality purposes.  Nevertheless, these arguments and supporting exhibits are apparently provided to justify the grounds for the decision, which remain Judge Newman's purported refusal to cooperate with the Special Committee's investigation into her competency (despite the Judge having provided medical and psychological results from her own doctors rather than the Committee's hand-picked ones).

While Judge Newman has shown remarkable stamina and "stating power," at 96 this suspension could be an effective ban from her ever again serving on the bench.  This suspension remains subject of course to her on-going lawsuit in the D.C. District Court asserting that the Council's suspension is unconstitutional and a violation of her due process rights (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit").

A sad day for the Federal Circuit and the U.S. patent system.

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

In re Cellect (Fed. Cir. 2023)

By Kevin E. Noonan --

The Federal Circuit decided a question left open during a recent spate of opinions involving the judicially created doctrine of obviousness-type double patenting (ODP):  the effect patent term adjustment (PTA) can (or should) have on creating circumstances where ODP will operate to find a patent invalid in the absence of a timely filed terminal disclaimer, in its opinion handed down yesterday in In re Cellect.

The issue arose in a series of ex parte reexaminations over five patents owned by Cellect, U.S. Patent Nos. 6,424,369; 6,452,626; 6,982,742; and 7,002,621, that involve "solid state image sensors which are configured to be of a minimum size and used within communication devices specifically including video telephones" according to the '621 patent (only four of these patents were invalidated, the fifth, U.S. Patent No. 6,862,036 not having any PTA that raised the issue).  The chronological situation is set forth in an exhibit from Cellect's Federal Circuit appeal brief and reproduced in modified form in the opinion:

The opinion also set forth the chain of invalidation under obviousness-type double patenting, stating that:

[T]he '621 patent claims were found to be unpatentable over the '626 patent claims, which were found to be unpatentable over the '369 patent claims.  The '742 patent claims were also found to be unpatentable over the '369 patent claims.  The '369 patent claims were themselves found to be unpatentable over the '036 patent claims.  Thus, although the ODP invalidating reference patents form a network across the four ex parte reexamination proceedings, all invalidated claims can be traced back to the single family member patent that did not receive a grant of PTA:  the '036 patent.

There was no dispute that the claims in these applications were patentably indistinct.  The Board issued four Decisions on Appeal affirming the reexamination division's invalidation of the '369, '626, '621, and '742 patents, all on the grounds that the provisions of 35 U.S.C. § 154(b)(2)(B):

No patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer . . .

mandated that a terminal disclaimer be filed under circumstances where obviousness-type double patenting arose due to extension of patent term as PTA, i.e., that ODP must be determined after application of PTA.  (It will be recalled that the Federal Circuit reached a different conclusion with regard to patent term extension (PTE) under 35 U.S.C. § 156 in Novartis AG v. Ezra Ventures LLC, the Court expressly refusing to permit "a judge-made doctrine to cut off a statutorily-authorized time extension.") Because all of these patents had expired (but Cellect retained the right to sue for prior infringement under 35 U.S.C. § 286), the Board's decision invalidated these patents with no available remedy left for Cellect.  In its consolidated decision, the Board emphasized the potential inequities to the public due to the possibility of harassment by different parties owning patents to obvious variants of one another (in the absence of a terminal disclaimer preventing this potentiality) as representing an unjust extension of patent term to the public's detriment; see In re Fallaux, 564 F.3d 1313 (Fed. Cir. 2009)).  Finally, the Board rejected arguments that the Federal Circuit's jurisprudence did not rely on whether or not there was gamesmanship or the potential thereof under Gilead Sciences, Inc. v. Natco Pharma Ltd, but that under In re Longi, the public was entitled to the assumption that it is free to practice what is claimed in the patent and obvious modifications and variants thereof once the patent has expired.  759 F.2d 887 (Fed. Cir. 1985).

The Federal Circuit affirmed the Board's judgment in these re-examinations in an opinion by Judge Lourie joined by Judges Dyk and Reyna.*  Although patentee asserted five arguments in its briefing, the Court discussed only three of these arguments (albeit in some instances apparently condensing the five arguments to three).

The first argument which was dispositive for the Court in its affirmance was Cellect's position that PTA under 35 U.S.C. § 154 and PTE under 35 U.S.C. § 156 should be treated equivalently as Congressional mandates that should not be abridged by judicially created doctrines like obviousness-type double patenting.  The Court's opinion to the contrary was based on three principles.  The first was that it is inequitable to the public that a second, later-expiring patent should be obtained ("an unjustified timewise extension of patent term") on an obvious variant of a patented invention, based on AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1373 (Fed. Cir. 2014).  The panel's opinion found support in the statute (as had the Board), wherein application of PTA was limited under circumstances where there was or should have been a terminal disclaimer filed (35 U.S.C. § 154(b)(2)(B)): "Disclaimed term.— No patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer" (emphasis in brief).  There is no such limitation in 35 U.S.C. § 156 and even though both statutes recite that an extension of the term shall be granted this distinction between the two types of extension was enough to convince the Court that the Board had come to the correct conclusion.

This conclusion was based in part by the Court's precedent, particularly AbbVie, and by the panel's agreement with the distinction in statutory construction between 35 U.S.C. § 154 and § 156 as advocated by the Solicitor representing the USPTO.  The overriding policy consideration is the Court's focus on the need to "ensure that the applicant does not receive an unjust timewise extension of patent term" (as it has for over a decade; see "In re Janssen Biotech, Inc.; G.D. Searle LLC v. Lupin Pharmaceuticals, Inc."; "AbbVie Inc."; "Gilead Sciences, Inc. v. Natco Pharma Ltd."; "Eli Lilly & Co. v. Teva Parenteral Medicines, Inc."; and "Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co.").  The fact that the limitations of terminal disclaimers is in the PTA statute but not the PTE statute indicates to the Court that Congress intended the effect of ODP to differ between these two approaches to statutory term restoration.  They "are dealt with in different statutes and deal with differing circumstances" and while "the expiration date used for an ODP analysis where a patent has received PTE is the expiration date before the PTE has been added" pursuant to Novartis AG v. Ezra Ventures LLC (Fed. Cir. 2018), and Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317 (Fed. Cir. 2007), the "expiration date used for an ODP analysis where a patent has received PTA is the expiration date after the PTA has been added" as the holding in this case.  Cellect's argument that both PTA and PTE should be treated equally because they "provide statutorily authorized time extensions" is "an unjustified attempt to force disparate statutes into one" according to the opinion.

The panel perceived differences in the statutes ("each has its own independent framework established through an independent statutory schema") that justify the distinctions raised in this opinion despite the similarities that "both PTA and PTE are statutorily authorized extensions, and each serves to recover lost term," because they have "quite distinct purposes."  Importantly, the panel construes the statute in this manner because for them "[t]here is nothing in the PTA statute to suggest that application of ODP to the PTA-extended patent term would be contrary to the congressional design."  On the contrary, the Court understands Cellect's position to "effectively extend the overall patent term awarded to a single invention contrary to Congress's purpose" (which is to limit an extended term for a patentably distinct invention).  In the panel's view, the overriding consideration is "to ensure that the applicant is not receiving an unjust extension of time."

Finally, in this regard, the Court understands that if terminal disclaimers are the solution to the problem of unjust extensions of time precluded by ODP, permitting PTA to apply where a terminal disclaimer has not been filed (to avoid application of 35 U.S.C. § 154(b)(2)(B)) would "frustrate the clear intent of Congress [by permitting] applicants to benefit from their failure, or an examiner's failure, to comply with established practice concerning ODP" (i.e., using terminal disclaimers to avoid invalidation).

The opinion refuses to find the equities asserted in Cellect's second argument arising from the particular circumstances in this case to be a basis to come to a different conclusion than the Board had.  The Federal Circuit recognizes the preeminent policy purpose for applying ODP to the PTA circumstances in this case like every other.  If, as the Board asserted and the Federal Circuit agreed, Cellect's patents received an "unjust timewise extension" of their patent term, the absence of gamesmanship does not remedy these circumstances nor excuse Cellect from the consequences arising therefrom ("it does not matter how the unjustified extensions are obtained").  Moreover, the Federal Circuit agreed with the Board that a risk continued to exist regarding the other consideration in ODP, the possibility of separate ownership of patents that are not patentably distinct (no matter Cellect's promises that it would not alienate them, nor how remote or theoretical these risks might be).

Finally, the Federal Circuit rejected Cellect's third argument that the re-examinations were improvidently granted because there was no substantial new question of patentability raised in them, based on the same examiner being responsible for permitting these patents to grant and not issuing a rejection in any of them based on ODP.  The panel found that institution of these re-examinations was supported by substantial evidence because, inter alia, there was nothing in the prosecution history of any of these patents that "affirmatively indicates that the examiner considered whether or not an ODP rejection should be made."  The Court also rejected the alternative proposed by Cellect of only considering the adjustment term, and not the entire patent term, for invalidation as an attempt to have the PTO or the Court grant a "retroactive" terminal disclaimer, giving Cellect "the opportunity to benefit from terminal disclaimers that it never filed."

While we have come a long way from the conventional use of terminal disclaimers to protect the public from shenanigans of intentional delay by doling our patentably indistinct variations on an invention to extend protection beyond the statutory 17-year term prior to revision of the patent stature in response to U.S. accession of the GATT/TRIPS agreement, the philosophy applied by the Court in this decision is consistent with that judicial attempt to prevent "unjust" extensions of patent rights.  Of course, there are stratagems existing and to be developed to adapt to the regime established by the Federal Circuit's decision, which only reinforces the value of the clever draftsman in protecting important technologies under creative applications of the law as the Federal Circuit construed it in this case.

* In June, the Court affirmed the Board's judgment under Rule 36 in Reexamination No. 90/014,452 and Cellect, LLC v. Samsung Electronics Co. in inter partes review proceedings IPR2020- 00475, IPR2020-00476, IPR2020-00477, and IPR2020-00512.

In re Cellect (Fed. Cir. 2023)
Panel: Circuit Judges Lourie, Dyk, and Reyna
Opinion by Circuit Judge Lourie

Rembrandt Diagnostics LP v. Alere, Inc. (Fed. Cir. 2023)

By Kevin E. Noonan --

The Federal Circuit reviewed the latest decision from the Patent Trial and Appeal Board (PTAB) in an inter partes review that claims 3-6 and 10 of U.S. Patent No. 6,548,019 are obvious, in Rembrandt Diagnostics LP v. Alere, Inc.; prior proceedings were reported at Alere, Inc. v. Rembrandt Diagnostics, LP, 791 F. App'x 173 (Fed. Cir. 2019), and Rembrandt Diagnostics, LP v. Alere, Inc., 809 F. App'x 903 (Fed. Cir. 2020).

The claims are directed to assay devices for testing biological fluids, as illustrated in Figures 3 and 6 and explained in the opinion as follows:

The test assay device receives a fluid sample "introduced directly to the sample loading zone" (30) of one or more assay test strips (22) . . . the assay test strips (22) may each be encapsulated within separate "flow control channel[s]" (34) in one embodiment.  . . .  Figure 6 illustrates that to assemble the full testing assay device, the test strip assembly (22, 28, 34) from Figure 3 may be combined with a holder (40) and placed inside a fluid sample container (i.e., a cup) (2) that has a cap (45) to fit over the opening (3) of the container.  . . .  Figure 6 also shows that the sample loading zones (30) of the assay test strips are oriented toward the base (1) of the fully assembled container.  As the assay sample fluid in the container contacts the sample loading zone (30), it migrates upward through the assay test strip.  Id. at 6:55–67.  In another embodiment, multiple test strips may be held within a single "continuous in width" flow control channel.

Exemplary Claim 3 at issue in this appeal reads as follows (wherein the language of independent claim 1 is distinguished by being in italics):

3.  A device [according to claim 1] for collecting and assaying a sample of biological fluid, the device comprising:
    (a) a flow control channel defined by at least one liquid pervious side joined to liquid impervious sides, wherein the internal dimensions of the flow control channel are sufficient to permit placement therein of an assay test strip;
    (b) an assay test strip within the flow control channel, wherein the assay test strip has a sample loading zone therein, and wherein further the assay test strip is disposed within the flow control channel so the sample fluid contacts the sample loading zone at a liquid pervious side of the flow control channel; and,
    (c) a sample fluid container having a base, an open mouth, and walls connecting the base to the mouth;
wherein the flow control channel is disposed inside the sample fluid container with the liquid pervious side oriented the base of the sample fluid container so that the assay sample fluid, when added to the container, is delivered to the sample loading zone of the assay test strip by entry through a liquid pervious side of the flow control channel without migration through an intermediate structure, and     wherein entry of fluid into the flow control channel creates an ambient pressure within the flow control channel equivalent to the ambient pressure outside of the flow control channel, thereby eliminating a pressure gradient along which excess sample fluid could flow into the flow control channel.
    wherein one of the liquid impervious sides of the flow control channel is formed as a portion of a liquid impervious backing; and wherein the device farther comprises a holder fittable inside the fluid sample container, the holder having at least one slot formed therein to receive the backing.

The prior art cited by the Petitioner comprised two combinations of prior art patents:  the first, U.S. Patent No. 5,656,502 (the '502 patent) in view of U.S. Patent No. 5,985,675 (the '675 patent) or U.S. Patent No. 5,602,040 (the '040 patent) and the second, U.S. Patent No. 6,379,620 (the '620 patent) in view of the '502 patent or U.S. Patent No. 5,500,375 (the '375 patent).  As explained in the opinion, the '502 patent discloses a device that holds only one test strip, wherein one end of the strip holder is open permitting liquid to enter the device and come into contact with the test strip.  The '675 patent discloses the additional feature that such devices can contain more than one test strip that can be used for a number of different assays, and the '040 patent discloses that the device can "incorporate two or more discrete bodies of porous solid phase material, e.g., separate strips or sheets, each carrying mobile and immobilised reagents."

In the second combination, the '620 patent discloses test strips oriented upwards towards the container mouth (which is in the opposite direction to the claimed invention), and the '375 patent discloses one or a plurality of test strips that are contained in a sealed holder laminate that does not require extraneous wicks for augmenting sample migration, wherein multiple tests can be performed at the same time.

The procedural history of the case began when Rembrandt asserted the '019 patent against Alere in district court proceedings for infringement (this action remains stayed while the IPR proceedings are concluded).  In response, Alere filed an IPR petition, wherein in that IPR the Board did not institute against all '019 patent claims and Rembrandt disclaimed claims 1, 9, and 11-15 of the '019 patent.  As a consequence the Board instituted only as to claims 2-5.  The Board found claim 2 to be invalid for anticipation by the '675 patent but that the challenger failed to establish invalidity for the other claims.  In the appeal from that Board decision the Federal Circuit affirmed the Board's claim construction but remanded for consideration of all challenged claims under SAS Institute Inc. v. Iancu.

On remand, Rembrandt argued that Alere raised new theories in reply to patentee's patent owner statement, and that through its expert witness had proposed three new theories of invalidity.  As noted in the opinion, these objections were not raised against obviousness rejections based on either of the three combinations of references cited by the panel here.  The Board rejected Rembrandt's objections and found in its Final Written Decision that claims 2-6 and 10 were unpatentable, once again finding claim 2 to be anticipated by the '675 patent and the remaining claims to be obvious.  The Board's reasoning for the obviousness of claims 3-6 credited Alere's expert testimony (Rembrandt did not rebut with an expert witness of its own) that, based on the second combination of references asserted by Alere the skilled worker would have modified the disclosure of the '620 patent "to remove the wicking material and re-orient the flow control channels towards the bottom of the container."  This would have the advantage, Alere persuasively argued, of "reduc[ing] cost, complexity, and oversaturation of the test strip" based on the unrebutted testimony of its expert.  And as for claim 10, the Board credited the first combination of references for teaching modification of the single test strip embodiment disclosed in the '675 patent in view of the other references because the skilled worker would have recognized the advantages of multiple strips, an argument again supported by unrebutted testimony from Alere's expert witness.

The Federal Circuit affirmed, in an opinion by Judge Reyna joined by Chief Judge Moore and Judge Dyk.  On appeal, Rembrandt argued that the Board abused its discretion in considering Alere's purportedly new theories and erred in its obviousness determinations because they were not supported by substantial evidence.  The Federal Circuit rejected Rembrandt's abuse of discretion argument because, first, it was forfeited when it objected on this basis on one obviousness ground (not at issue here) but did not assert this objection against the Board's obviousness determinations based on either of the two combinations of references at issue before the Court.  The panel rejected what the opinion term Rembrandt's "generic" objection in its brief (merely arguing the existence of their objection without expressly objecting to either of these reference combinations as it had to a third).  Part of the panel's decision was based on lack of notice and unfairness to both parties for the Board to read Rembrandt's objection this broadly.  An additional ground for rejecting Rembrandt's abuse of discretion objection is the Court's recognition of the procedural and strategic context of IPR proceedings, where the Court has not permitted the Board "to consider a new theory of unpatentability raised by petitioner in reply or a new theory of patentability raised by patent owner in surreply," citing for example Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016), and Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1329–31 (Fed. Cir. 2019), while in other instances the Court held such consideration was within the proper scope of the Board's sound discretion, citing Ericsson Inc. v. Intell. Ventures I LLC, 901 F.3d 1374, 1379 (Fed. Cir. 2018); Chamberlain Grp., Inc. v. One World Techs., Inc., 944 F.3d 919, 925 (Fed. Cir. 2019); and Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1081–82 (Fed. Cir. 2015).  In each of these cases whether the Board exercised its discretion properly or not was fact-specific and depended on whether considering such theories was fair to the parties.  Important to the Court's determination of the Board's exercise of its discretion properly included, for example, whether a party "merely expand[ed] on a previously argued rationale as to why the prior art disclosures are insubstantially distinct from the challenged claims" (Ericsson) or whether a party was "elaborating on their arguments on issues previously raised" (Chamberland).  More generally the panel acknowledged that these situation arose because "the very nature of the reply and sur-reply briefs are to respond (whether to refute, rebut, explain, discredit, and so on) to prior raised arguments within the confines of 37 C.F.R. § 42.23(b)" and thus can be proper.  The Federal Circuit accordingly has held that “there is no blanket prohibition against the introduction of new evidence during an IPR," citing Anacor Pharms., Inc. v. Iancu, 889 F.3d 1372, 1380–82 (Fed. Cir. 2018), provided there is adequate notice to the other party, Genzyme Therapeutic Prods. Ltd. P'ship v. Biomarin Pharm. Inc., 825 F.3d 1360, 1366 (Fed. Cir. 2016).

Here, the Court found Rembrandt's arguments not to support an abuse of discretion by the Board, citing two examples.  With regard to claim 10, the objection related to Alere's argument that modifying the '675 patent as suggested by the other cited references would be beneficial as to "cost and time savings."  The panel recognized that in their petition Alere argued that modifying the device disclosed in the '675 patent would increase the "efficiency" of that device by permitting "multiple tests to be conducted simultaneously."  Rembrandt countered in its Patent Owner's statement that the secondary references did not provide motivation for the combination, and Alere replied with the "cost and time savings" argument.  The Federal Circuit considered this argument to have a "nexus" in Rembrandt's arguments in its Patent Owner's statement and was "a fair extension of [Alere's] previously raised efficiency argument" and thus was not an abuse of discretion for the Board to consider it.  With regard to similar objections based on similar arguments Alere made in its Reply on the obviousness of claims 3-6, the Court held that Alere's arguments were responsive to Rembrandt's assertions in its Patent Owner statement; in addition in this case Alere was responding to the Board's original institution decision that the petition did "not explain sufficiently why modifying [the '620 patent] to remove the wicking material would have been understood to be beneficial."  Finally, the Court rejected Rembrandt's objection on the grounds that Alere cited previously unidentified disclosure in certain of the cited references.  The Court distinguished precedent where such arguments were prohibited (such as Apple and Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015)); the panel considered Alere's arguments to be "a legitimate reply" to Rembrandt's arguments because it was based on the same references and the same legal argument.  Because ("in short") "Alere's responsive reply arguments do not constitute new theories," the Court held it was not an abuse of discretion for the Board to consider them.

The panel also rejected Rembrandt's other argument, that the Board's factual findings did not support its obviousness determinations.  These arguments, the opinion states, "center on the interpretation of disclosures from the prior art and the presence of motivation to combine."  What Rembrandt is lacking, the opinion notes, is any "counter testimony from a qualified declarant to refute Dr. Bohannon's conclusions regarding how [a skilled artisan] would have interpreted the identified disclosures."  The Court notes that the Board was presented with "two alternative theories" and it was not the Court's "task 'to determine which theory [they] find more compelling,'" citing Shoes by Firebug LLC v. Stride Rite Childs. Grp., LLC, 962 F.3d 1362, 1371 (Fed. Cir. 2020).  Thus, in the Court's opinion, the Board's obviousness determination were supported by substantial evidence.

Rembrandt Diagnostics LP v. Alere, Inc. (Fed. Cir. 2023)
Panel: Chief Judge Moore and Circuit Judges Dyk and Reyna
Opinion by Circuit Judge Reyna

In re Theripion (Fed. Cir. 2023)

By Kevin E. Noonan --

The Patent Trial and Appeal Board (PTAB) has benefited, particularly after enactment of the Leahy-Smith America Invents Act, from the deference to its factual findings mandated by the Supreme Court's interpretation in Dickenson v. Zurko of the application (deferential for factual determinations) of the standard-of-review provisions in the Administrative Procedures Act.  This deference does not extend to the Board's decisions based on legal standards nor can the PTAB escape from Federal Circuit review of its reasoning (or failure to provide its reasoning), requirements illustrated in the Court's decision in In re Theripion.

The case arose as an appeal from a decision from the PTAB in ex parte prosecution of U.S. Application No. 15/909,314, a U.S. national phase application from International Publication No. WO 2017/044424.  The Board affirmed the Examiner's determination that claims 1-13, 16, 22-24, and 27 of the '314 application were obvious.  Claim 1 is representative of the claims reviewed by the Court:

1.  A fusion polypeptide comprising, from an amino-terminal position to a carboxyl-terminal position, ApoA1-L1-D, wherein:
    ApoA1 is a first polypeptide segment comprising an amino acid sequence having at least 95% identity with amino acid residues 19-267 or 25-267 of SEQ ID NO:2, wherein said first polypeptide segment has cholesterol efflux activity;
    L1 is a first polypeptide linker consisting of from 10 to 40 amino acid residues; and
    D is an immunoglobulin Fc region,
    wherein the fusion polypeptide has increased cholesterol efflux activity as compared to the ApoA1-L1-D fusion polypeptide in which L1 is a two amino acid linker or is absent.

As explained in the opinion, there is a correlation between low blood levels of high-density lipoprotein (HDL) and the risk of stroke and heart attack, which are related to atherosclerosis.  Therapeutic intervention accordingly have been directed towards increasing HDL levels.  Apolipoprotein A-1 ("ApoA1") is "the principal protein component of HDL."  Thus, one stratagem for increasing HDL levels is to introduce ApoA1 into an individual having low HDL levels.  A drawback to this approach is that ApoA1 only remains intact in a human for a short time (it has a short "half-life").  The invention claimed in the '314 application is directed to modifying the protein to increase its half-life by linking it through a polypeptide linker to a portion of an antibody molecule (comprising the immunoglobulin Fc region).  (As explained in the opinion, antibody molecules have a relatively long half-life in vivo in contrast to ApoA1.)  The opinion sets out the understanding in the art that fusion proteins comprising immunoglobulin Fc regions were known to have improved half-lives, the art disclosing an ApoA1-Fc fusion (but in contrast to the claimed invention not having a polypeptide linker between these two components of the fusion protein).  This distinction is relevant, because the prior art fusion protein was deficient in one of ApoA1-HDL's important functions, increasing the process whereby the body removes free cholesterol from the bloodstream (termed reverse cholesterol transport, RCT).  Theripion's claims were directed to ApoA1-Fc fusion proteins joined by a polypeptide linker comprising 10-40 amino acids that had such beneficial RCT properties.

The Examiner rejected the '314 application's claims for obviousness based on the combination of 4 references:  Knudson et al., 2011, U.S. Patent Publication No. 2011/0178029; Ledbetter et al., 2015, U.S. Patent No. 8,937,157; Bacus et al., 2009, U.S. Patent Publication No. 2009/0318346; and Lagerstedt et al., 2015, U.S. Patent Publication No. 2015/0353626.  (The Examiner applied other references to certain of the claims but these were not considered by the panel on appeal.)  The Board affirmed these rejections and this appeal followed.

The Federal Circuit vacated and remanded, in an opinion by Judge Stark, joined by Judges Hughes and Cunningham.  Importantly for the panel's decision, the Board is required to "make the necessary findings and have an adequate evidentiary basis for its findings" to enable the Court to review them, under In re Nuvasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016).  In addition, the Board must "articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made" concerning obviousness, Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983), although the amount of such explanation will vary case-by-case "depending on the complexity of the matter and the issues raised in the record," Pers. Web Techs., LLC v. Apple, Inc., 848 F.3d 987, 992 (Fed. Cir. 2017).

The basis for Theripion's appeal (with which the panel agreed) is that the Board erred in its analysis of whether the claimed invention showed unexpected results (one of the objective indicia of non-obviousness) and whether the skilled worker would have had a motivation to combine the cited art with a reasonable expectation of success in achieving the claimed invention.  But the Court's agreement was limited by "the extent that we find the Board failed to adequately explain how it determined the '314 application's claims are obvious in light of the totality of the record before it" according to the opinion.  One example of the dearth in the Board's explanation involved whether including the linker would produce the improved RCT activity of the claimed fusion proteins, Theripion's contention that the Board found unpersuasive.  The opinion states that the panel was unable to discern the Board's reasoning of why this result would have been expected on the record before it, which was limited to the declarative statement that "[t]hus, one of ordinary skill in the art would similarly expect that use of a peptide linker, such as Gly4Ser4, would increase the biological activity (i.e., cholesterol efflux activity) of a Fc fusion protein with ApoA1."  In contrast, Theripion had submitted a declaration from one of the named inventors (and the lead author of one of the cited references) that "common practice in the art of Fc fusion protein engineering [was] to not include a peptide linker, or to include only a short, one or two amino acid linker, between the N-terminus of an Fc region and the C-terminus of a fusion partner."  In addition, Theripion provided prior art examples of linker-comprising fusion proteins that did not necessarily increase (and in at least one instance, decreased) protein function.  Finally, Example 1 of the '314 application showed a side-by-side comparison between ApoA1-Fc fusion proteins comprising a 26 amino acid sequence linker and one having none or a 2-amino acid linker, wherein increased RCT activity was seen only in the embodiment having the long linker.  While the Court did not hold that this evidence was insufficient or that the Board erred in finding it unpersuasive, the opinion states that "we cannot discern from [the Board's] opinion the reasons for such a conclusion [of nonpersuasiveness].  Nor can we determine whether the Board adequately considered the totality of Theripion's evidence."

Illumination of the Board's reasoning was also not present in its explanation of why the Examiner was persuaded by the combination of Bacus and Ledbetter, particularly regarding the disclosure in Bacus of fusion proteins comprising linkers that involved "an entirely different type of protein."  Similarly, the panel found no reasoning on the record of why Ledbetter's disclosure that longer linkers were associated with increased DNase activity (another entirely different protein) using "yet another type of linker" was persuasive.  According to the opinion, "[t]he Board did not provide any rationale for why a skilled artisan would have expected Ledbetter's data relating to DNase fusion protein activity to be predictive of ApoA1 activity in the fusion proteins claimed in the '314 application.  After all, ApoA1 is an entirely different kind of protein than Bacus' ErbB or Ledbetter's DNase."  Finally, the Board apparently entirely ignored (at least on the record) prior art evidence that including a linker could reduce protein activity, particularly because the protein in these studies (DNase) was the same as in the Ledbetter reference relied upon by the Examiner to support the obviousness rejection.  And while recognizing that neither the Board nor the Examiner were obliged to "explicitly discuss every issue or every piece of evidence" and that failure to do so "does not alone establish that [the Board] did not consider [any such evidence]," Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1328 (Fed. Cir. 2017), the Board "must examine the relevant data and articulate a satisfactory explanation for its action[,] including a rational connection between the facts found and the choice made" under Motor Vehicle Mfrs. Ass'n. Reaching the heart of the matter, the opinion concludes this portion of its assessment of the Board's performance in this case by stating that "we are concerned that the Board may have improperly used the claims of the '314 application 'as a template for its own reconstruction,'" citing Sensonics, Inc. v. Aerosonic Corp., 81 F.3d 1566, 1570 (Fed. Cir. 1996).

Theripion also contended that the Board erred its assessment of unexpected results by considering the Bacus and Ledbetter references (which as noted above were directed to different fusion proteins) rather than the reference by Knudson regarding ApoA1-Fc fusion proteins; this reference Theripion argued was the closest prior art which on that basis should have been considered, citing Kao Corp. v. Unilever U.S., Inc., 441 F.3d 963, 970 (Fed. Cir. 2006), and Adapt Pharma Ops. Ltd. v. Teva Pharms. USA, Inc., 25 F.4th 1354, 1372-73 (Fed. Cir. 2022).  Once again the panel states that while it appears the Board believed the Bacus and Ledbetter references were the closest prior art "the Board never expressly says so" and on these grounds the panel instructs the Board on remand to "determine which prior art is the closest prior art and explain why that is, and then consider and explain whether Theripion's results are unexpected relative to that closest prior art."

Further, regarding the question of unexpected results, the Board failed to address (and thus the Court "had no analysis to review") whether there was a problem known in the prior art regarding low RCT activity in ApoA1-Fc fusion proteins having polypeptide linkers shorter than the 10-40 amino acids recited in Theripion's claims.  The Court recognized that "the '314 application solv[ing] a problem that was not recognized in the prior art, if true, could support a finding of nonobviousness, as it would support Theripion's contention that its results were unexpected," citing In re Gruskin, 234 F.2d 493, 498 (C.C.P.A. 1956).

Turning to the question of the existence of a motivation to combine by the person of ordinary skill in the art, the panel noted that the Board asserted the combination of the Knudson, Bacus, Ledbetter, and Lagerstedt references, and Theripion argued that the "art fails to teach or suggest any functional relationship between linker length and protein function in the context of an ApoA1-Fc fusion."  Further, Teripion provided declaration evidence that the N-terminus of the Fc portion of the fusion protein "has generally been viewed in the art as a natural linker region that does not require further extension when constructing an Fc fusion protein."  This was evidence, Theripion contended before the Examiner, the Board, and the Federal Circuit that showed the skilled artisan would have had no motivation to combine the cited references.  As it did throughout the opinion, the panel found that the Board provided no basis for its conclusion to the contrary; indeed the opinion states that the Board "made findings regarding what each prior art reference taught in isolation and failed to articulate any reason why a skilled artisan would have modified Knudsen's system with Ledbetter's linker - other than the unexplained assertion that 'incorporation of such a linker increases biological activity of the fusion partner,' for which there is little, if any, support in the record."  This explanation is insufficient, the opinion asserts, because the Board "must articulate a reason why" a person of skill would be motivated to combine references," citing Nuvasive (emphasis in opinion) which in this case the Board did not.

The Federal Circuit concludes the opinion with an explanation why it vacated and remanded rather than reversed, as Theripion had advocated they do.  The opinion states that "[g]iven that we are presently unsure of the bases on which the Board reached its subsidiary factual findings supporting its ultimate legal conclusion of obviousness, we are not in a position to determine whether there is substantial evidence to support the Board's determination," citing Alacritech, Inc. v. Intel Corp., 966 F.3d 1367, 1370-73 (Fed. Cir. 2020).

In re Theripion (Fed. Cir. 2023)
Panel: Circuit Judges Hughes, Cunningham, and Stark
Opinion by Circuoit Judge Stark

Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman

By Kevin E. Noonan --

A Special Committee of Federal Circuit judges (consisting of Chief Judge Kimberly Moore, former Chief Judge Sharon Prost, and Judge Richard Taranto) that has been investigating for several months allegations against Judge Pauline Newman related to her competency to remain on the bench, released an Order on July 31st suspending the Judge from participating in the Court's business for a year.  The suspension, if imposed by the Judicial Council, is subject to review should Judge Newman agree to submit to neurological and psychiatric tests previously mandated by the Special Committee.  To date the Judge has refused, although she has provided evidence from her own medical specialists as to her competency.

The basis for a hearing held on July 13th (a redacted transcript of which is included as an Exhibit to the Order) and the Special Committee's Order is whether Judge Newman's refusal to comply was itself judicial misconduct, which the Committee found it was.  In its Order, the Committee sets forth the legal, procedural, and factual justifications for its actions and its decision in the Order.  These include a legal justification for the Committee's authority to conduct the investigation and issue its Orders, and the evidence supporting its basis for requiring the mandated medical and psychiatric examination and records that Judge Newman has failed, in their view, to provide.  Judge Newman has had no good cause for that conduct, according to the Order.  Accordingly, her refusal constitutes judicial misconduct.

The Order recognizes Judge Newman's distinguished career, but says that "[t]he question presented to this Committee, however, is not whether Judge Newman has had an extraordinary career or whether she has made important contributions to the law" but rather to address "the unenviable task of investigating . . . whether Judge Newman now suffers from a disability that renders her no longer capable of performing her job as a judge."  At the same time, the Order asserts that Judge Newman is responsible for "extraordinary delays in issuing opinions" (a substantive allegation about her performance) and "concerns about her mental fitness raised by numerous interactions with court staff" (allegations supported by information in Exhibits appended to the Order).

The Order goes on to lay the blame on Judge Newman, asserting that the Committee has been frustrated in the performance of their duties "under governing rules and statutes" by the Judge's "consistent refusal to cooperate."  These include the Judge's refusal to submit to "a neurological evaluation and neuropsychological testing ("medical examinations") by professionals selected by the Committee and to provide certain medical records," illustrating an unwillingness to recognized and address that "selected by the Committee" is at least part of the basis for the Judge's resistance.  (Judge Newman supplied such medical and psychiatric information from her own doctors, which did not satisfy the Committee.)  Indeed, the Order characterizes Judge Newman's behavior as unreasonable recalcitrance (complaining that the Committee had asked for this review "in some instances for the third time"; emphasis in Order).  And the consequence according to the Order is that the Committee has not been able to satisfy its statutory duty (which requires a "comprehensive written report"), the Order emphasizing that it has limited the inquiry to whether Judge Newman's resistance is itself judicial misconduct (a meta-style change in the issues that are the subject of the Order); as a consequence the Committee does not need to render a decision on the merits of their investigation.

The Order justifies the Committee's inquiry on the merits by the existence of "incon­trovertible data from the Clerk's Office establishing that Judge Newman (despite having a significantly reduced workload) is unable to complete her work in a timely fashion."  This evidence is that the Judge authored less than half the number of opinions (including dissents) than the average of the Court's judges (28 versus 61); these statistics are not consistent with a separate study by Professor Paul R. Gugliuzza (32 versus 47) albeit taken over a different timeframe; see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit").  (The Order responds by asserting that the public record is deficient, inter alia, for failing to take into consideration per curiam opinions.)  The Order further cites the length of time taken to issue an opinion (199 days versus 53 days) and the number of panels on which the Judge sat (65 versus 129), summarizing that the Judge "took four times as long to write half the opin­ions while sitting on half the number of cases as her colleagues."  Currently, the Order sets out, Judge Newman has "a backlog of seven opinions that have not issued, and they now average 230 days old."

Secondly, the Order cites "extensive evidence" from more than 20 interviews with court staff (some of which are in the appended materials).  This evidence is characterized as reports of "deeply troubling interactions" which "sadly suggest(s) significant mental deterioration including memory loss, confusion, lack of comprehension, paranoia, anger, hostility, and severe agitation."  The Committee "strongly disagrees" with Judge Newman's characterizations of the evidence as "minutiae" and "petty grievances," asserting that these events "raise concerns about serious dysfunction on Judge Newman's part" and accordingly "amply warrant" the Committee's demand for medical and psychiatric testing (by their doctors not the Judge's).  The Order follows with a litany of descriptions of these accusations; interestingly in one anecdote a member of Judge Newman's staff refused to curtail her assisting the Judge in personal or scheduling matters, and when compelled to testify under oath this staff member invoked the Fifth Amendment repeatedly.  Another assistant according to the Order was threatened with dismissal by the Judge for his role in raising issues relating to the Judge's behavior, along with allegations by the Judge that the assistant had stolen undefined information when his computer went with him to another assistant's post within the Court.  This description is replete with stories that the Judge was "angry," speaking in an "angry voice," "pacing back and forth," and "mumbling" about alleged slights.  The Order ascribes to unnamed Court staff description of their interactions with the Judge as being "aggressive, angry, combative, and intimidating"; "bizarre and unnecessarily hostile"; making "personal accusations"; "agitated, belligerent, and demonstratively angry"; and "ranting, rambling, and paranoid."  This purported behavior (as well as the Clerk of Court advising staff either not to interact with the Judge or to bring a co-worker with them), the Order states, "does not evince merely bad behavior; it raises serious concerns about Judge Newman's cognitive functioning."  All of these vignettes are asserted in the Order as giving the Committee "ample justification" in its demands for physical and psychological examination.  Coupled with the Judge's refusal to comply the Committee finds her conduct to be "prejudicial to the effective and expeditious administration of the business of the courts" citing 28 U.S.C. § 351(a) and In re Complaint of Judicial Misconduct, C.C.D. No. 17-01 (U.S. Jud. Conf. 2017).

After setting forth the deficiencies in the medical and psychological testing Judge Newman has offered instead of the Committee's selected medical practitioners, and the importance and statutory bases for the Committee's investigation, the Order states its conclusion that Judge Newman's behavior amounts to judicial misconduct and recommends a one-year ban on the Judge sitting on any new cases until she complies with the Committee's demands.  The remainder of the Order sets forth a history of the proceedings against the Judge and the evidence accumulated relating to the Committee's inquiries (the identities of witnesses and experts being redacted, although their status and position within the Court's staff are noted).  The Order also sets for the Committee's legal and evidentiary justifications for the proceedings and the Order (the evidentiary bases being disclosed in part in the appended affidavits and other Exhibits).  From this evidence, the Committee concluded that:

Judge Newman's extended delays relative to her colleagues, coupled with her considerably lower productivity during the same period, is strong cause for concern that she suffers from a disability impairing her ability to carry out the responsibilities of her office.

And that:

The results of the Committee investigation demonstrate that Judge Newman's lower productivity is indicated in three ways: (1) she does not assign herself a comparable share of opinions (even considering her higher rate of dissenting) and takes unreasonable lengths of time to complete opinions she does assign herself (as detailed above); (2) she does not participate in motions panels, an important and time-consuming task required of active judges; and, (3) Judge Newman's participation in cases has substantially slowed over the last year: May 2022-April 2023.  From May 2022 through April 2023, the average active Federal Circuit judge participated in deciding 129 cases; Judge Newman in contrast participated in deciding only 65 cases.

Finally, the Order addresses the allegations (see below) raised by Judge Newman in her suit brought in District Court and rejects them, and further rejects any allegations of bias against the Judge.

The Committee's recommendation for a one-year suspension is mitigated by the Committee's further decision that it may be lifted should Judge Newman undergo the required tests by the Committee's chosen medical and psychiatric professionals and should those results rebut the allegations of unfitness raised in part by the Committee itself.

Judge Newman for her part has filed suit in the District Court for the District of Columbia on allegations that the Special Committee's actions violate Article III of the Constitution (regarding life tenure for federal judges) and Article I (that the House of Representatives has sole authority to remove a federal judge from office); Fifth Amendment violations of due process; First Amendment violations related to a "gag order" against the Judge; and Fourth Amendment violations for unconstitutional search relating to the compulsory medical and psychiatric examinations.  That suit is ongoing, but the parties are under an Order by the District Court to submit to "informal" mediation that will be overseen by Thomas Griffith, a retired judge on the Court of Appeals for the D.C. Circuit.

Judge Newman has recently given interviews to IP Law 360, Bloomberg Industry Group  and the Bloomberg's On the Merits podcast, the Washington Post, and Clause 8 podcast to explain her beliefs on the falsity of the allegations against her and why the Special Committee has taken its actions against her.

Two former Chief Judges of the Court, Judge Paul Michel and Judge Randal Rader, have spoken out in the Judge's defense (see "Chief Judge Moore v. Judge Newman: An Unacceptable Breakdown of Court Governance, Collegiality and Procedural Fairness" and "The Federal Circuit Owes Judge Newman an Apology," respectively) and Dr. Ron Katznelson has published a study on possible motivations other than Judge Newman's competency that may have factored in the creation of the Special Committee and its recent actions.

It is likely that the Judicial Council will follow the Committee's recommendation and suspend Judge Newman from participating in the Court's business.  In view of her age, this is a significant sanction, imposed not on the asserted basis that Judge Newman cannot satisfy the requirements of her office but that in challenging the allegations against her she has committed judicial misconduct.  However this matter resolves, it is a sad chapter and perhaps ultimately an end to an illustrious career diminished (regardless of the encomiums to it contained in the Order) by these proceedings against her.

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

By Kevin E. Noonan --

In earlier times, the Federal Circuit, responding to efforts by the U.S. Patent and Trademark Office to reject patent applications directed to biotechnology-related inventions, held (In re Brana) that utility of such inventions did not require demonstration of therapeutic effectiveness, those determinations being the purview of the FDA.  Among other things, that apportionment of responsibilities was reaffirmed, albeit under different procedural circumstances, in the Federal Circuit's decision in United Therapeutics Corp. v. Liquidia Technologies, Inc.

The case arose in litigation between NDA holder United Therapeutics Corp. ("UTC") and Liquidia, who filed it 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™).  Relevant to the proceedings before the Federal Circuit, pulmonary hypertension (PH) presents in five subgroups, as explained in the opinion:

Group 1, pulmonary arterial hypertension ("PAH"); Group 2, pulmonary venous hypertension, i.e., pulmonary hypertension related to left-heart disease; Group 3, pulmonary hypertension associated with disorders damaging the lungs; Group 4, pulmonary hypertension caused by chronic thrombotic or embolic disease, including chronic blood clots in the lungs; and Group 5, a miscellaneous category for conditions that do not fit well into the other four subgroups.

A distinction between Group 2 and the remaining groups is that this malady arises due to cardiac issues ("postcapillary PH") while the rest of the groups are caused by pathologies in pulmonary capillaries ("precapillary PH").  Both parties' treprostinil formulations act by reducing pulmonary blood pressure by vasodilation.

UTC owns the Orange Book-listed patents at issue, U.S. Patent Nos. 9,593,066 and 10,716,793; representative claims of each patent are set forth in the opinion:

The '793 patent:

Claim 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 '066 patent:

Claim 1. A pharmaceutical composition comprising treprostinil or a pharmaceutically acceptable salt thereof, said composition prepared by a process comprising providing a starting batch of treprostinil having one or more impurities resulting from prior alkylation and hydrolysis steps, forming a salt of treprostinil by combining the starting batch and a base, isolating the treprostinil salt, and preparing a pharmaceutical composition comprising treprostinil or a pharmaceutically acceptable salt thereof from the isolated treprostinil salt, whereby a level of one or more impurities found in the starting batch of the treprostinil is lower in the pharmaceutical composition, and wherein said alkylation is alkylation of benzindene triol.

Claim 6. The pharmaceutical composition of claim 1, wherein the isolated salt is stored at ambient temperature.

Claim 8. A process of preparing a pharmaceutical product comprising treprostinil or a pharmaceutically acceptable salt thereof, comprising alkylating a triol intermediate of the formula:

hydrolyzing the resulting compound to form treprostinil, forming a salt of treprostinil stable at ambient temperature, storing the treprostinil salt at ambient temperature, and preparing a pharmaceutical product from the treprostinil salt after storage, wherein the pharmaceutical product comprises Treprostinil or a pharmaceutically acceptable salt thereof.

UTC brought suit asserting claims 1, 4, and 6-8 of the '793 patent and claims 1-3, 6, 8, and 9 of the '066 patent.  UTC alleged that Liquidia's product, which has not been approved by the FDA and hence not marketed, would directly infringe the asserted claims of the '793 patent under 35 U.S.C. § 271(a) and induce infringement under 35 U.S.C. § 271(b).  Liquidia counterclaimed that all asserted claims were invalid for failure to satisfy the written description and enablement requirements of 35 U.S.C. § 112(a).  The District Court held that the asserted claims of the '793 patent were not invalid and that UTC has established by a preponderance of the evidence that Liquidia's product would infringe these claims directly and by inducement to infringe, rejecting Liquidia's argument that it lacked specific intent for the latter species of infringement.  In this regard, the District Court found that administration instructions on Liquidia's label would "inevitably lead to the administration of a therapeutically effective single event dose" as recited in the asserted claims.  Concerning Liquidia's counterclaims of invalidity, despite the art-recognized differences between PH Group 2 and the other groups of PH (and putative differences in safety and efficacy resulting therefrom), the District Court held that these considerations did not require undue experimentation by the skilled artisan because the claims did not require a showing of safety and efficacy.  And the District Court found no failure to satisfy the written description requirement because the specification taught that "treprostinil would effectively vasodilate the pulmonary vasculature, improve hemodynamics, and treat a patient's elevated pulmonary blood pressure."  Accordingly, the District Court pursuant to the statute stayed FDA approval until expiration of the '793 patent.  (In a separate inter partes review proceeding brought by Liquidia, all claims of the '793 patent were found invalid, that decision being on appeal at the Federal Circuit.  Should the Court affirm the PTAB's Final Written Decision of invalidity presumably this stay would be lifted.)

The District Court held that the asserted claims 1-3, 6, and 9 of the '066 patent were invalid due to anticipation by a prior art reference (Moriarty, which "discloses the synthesis of analogues of benzindene prostacyclins, including treprostinil"), and claims 1-3 would be infringed by Liquidia's treprostinil product but claims 6, 8, and 9 would not infringed (because Liquidia's product did not satisfy the "ambient temperature" limitation).  Liquidia's counterclaims of invalidity for failure to satisfy the written description requirement, on the other hand, failed.  This appeal followed.

The Federal Circuit affirmed the District Court's decision in all respects, in an opinion by Judge Lourie joined by Judges Dyk and Stoll; in so doing the opinion illustrates the difficulty appellants have in overcoming factual issues under the "clear error" standard in bench trials, the Federal Circuit repeatedly stating that the panel did not discern clear error in the District Court's factual findings.  With regard to the '793 patent, the Federal Circuit rejected Liquidia's challenge to the District Court's claim construction of the term "treating pulmonary hypertension" not to require that such treatment be safe and efficacious based on the skilled artisan interpreting the claim to have these characteristics.  This argument focused on treatment of Group 2 PH patients, wherein both parties' experts recognized that treprostinil would not benefit them (implicating efficacy at least for such treatments).  While agreeing with the District Court that the phrase "treating pulmonary hypertension" included treating Group 2 PH patients (based on disclosure in the specification that did not distinguish between the PH groups in this regard), the District Court's construction of the phrase "a therapeutically effective single event dose of a formulation comprising treprostinil" (unchallenged by Liquidia), according to the Federal Circuit, did not incorporate into the claims "any additional efficacy limitations or any safety limitations."  Without such a construction, the opinion asserts, "Liquidia's argument concerning the safety and efficacy of treating Group 2 PH patients is not before us" because "[q]uestions of safety and efficacy in patent law have long fallen under the purview of the FDA," citing In re Brana, 51 F.3d 1560, 1567 (Fed. Cir. 1995); Scott v. Finney, 34 F.3d 1058, 1063 (Fed. Cir. 1994); and In re Anthony, 414 F.2d 1383, 1395 (CCPA 1969).  Accordingly, the Court refused to draw the distinctions Liquidia asked and thus the Federal Circuit affirmed the District Court's determination that Liquidia's treprostinil product would infringe the asserted claims of the '793 patent.

On similar bases, the Federal Circuit affirmed the District Court's determination that Liquidia did not establish by clear and convincing evidence than UTC's asserted claims were invalid for failing to satisfy either the written description or enablement requirements of 35 U.S.C. § 112(a).  The panel held that the District Court had properly relied on expert testimony that "a skilled artisan would understand that the claimed administration of treprostinil would vasodilate the pulmonary vasculature, improve hemodynamics, and in this way for a single dose, treat a patient's elevated pulmonary blood pressure independent of the type (i.e., group) of pulmonary hypertension patient" and thereby satisfy the recited limitations in the asserted claims of the '793 patent.  The Court sets forth these additional reasons for its decision regarding the § 112(a) requirements:

Liquidia essentially asks us to treat Group 2 PH as a claimed species within a larger genus (i.e., all five groups of pulmonary hypertension). But analogizing a subset of patients having a variant of a particular disease to traditional genus and species claims is inapt.  It would be incorrect to fractionate a disease or condition that a method of treatment claim is directed to, and to require a separate disclosure in the specification for each individual variant of the condition (here, an individual group of pulmonary hypertension patients) in order to satisfy the enablement and written description provisions of 35 U.S.C. § 112, unless these variants are specified in the claims.

Further:

Disease-specific treatment requirements are matters for the FDA and medical practitioners.  They are best suited to make these determinations because practitioners are informed by the findings of the regulatory agency to avoid treatment of patients who will not properly respond.  And every claim to a method of treatment of an ailment has refinements.  That is, for any given method of treatment claim, there may be a subset of patients who would not benefit from or should not take the claimed treatment.  That does not mean that such claims are not sufficiently enabled or supported by written description.  A subset of unresponsive patients is not analogous to unsupported species in a generic claim to chemical compounds.

On the question of inducement to infringe, the panel summarily rejected Liquidia's reliance on the PTAB's decision in a parallel IPR, that all claims of the '793 patent are invalid, because that decision is not yet final, distinguishing Commil USA, LLC v. Cisco Systems, Inc., 575 U.S. 632, 644 (2015).  (This seems a sound application of judicial economy principles, because should the Federal Circuit affirm that PTAB determination Liquidia has a remedy in asking the district court to lift the stay on FDA approval of its commercial product.)  On the merits, the panel agreed with UTC that all Liquidia's eventual label needs to provide is instructions to administer a therapeutically effective amount of treprostinil in a single event dose as required by the asserted '793 patent claims.

Turning to the '066 patent, the Federal Circuit deigned not to consider the parties' arguments regarding infringement based on the district court's determination that the asserted claims were invalid for anticipation by the Moriarty reference.  UTC argued that the District Court erred in this determination, because the evidence was insufficient that Moriarty's pharmaceutical product contained the pattern of impurities in UTC's treprostinil formulation due to alkylation and hydrolysis steps in its preparation.  The panel agreed with the District Court that the asserted claims were product-by-process claims that were evaluated for anticipation purposes as product claims, and the Moriarty reference showed the same level of impurities as found in UTC's treprostinil product.  Finally, the Federal Circuit affirmed the District Court's finding that Liquidia's product did not infringe claims 6, 8, or 9 based on evidence that the product was stored at 2°-8°C and not ambient temperature as required by these claims.

For those keeping score, Liquidia is free of liability under the asserted claims of the '066 patent either because these claims are invalid (claims 1-3) or not infringed (claims 6,8, and 9).  While Liquidia is precluded from obtaining FDA approval by the District Court's infringement determination of the asserted claims of the '793 patent, the existing stay on approval will likely be lifted if the Federal Circuit affirms the PTAB determination that these claim are invalid.

The Court' decision regarding safety and effectiveness appears somewhat paradoxical (at least with regard to efficacy) for claims reciting methods of treatment, particularly when further limited to a "single event dose."  Some of the logic devolves to claim construction and Liquidia's failure to challenge the "therapeutically effective single event dose" limitation, while maintaining a bright line between the purviews of patent and regulatory law provide another reason.  Further considerations involve the distinction the panel chose to draw between "unsupported species in a generic claim to chemical compounds" and "a subset of unresponsive patients" in a method of treatment claim.  Whether these distinctions provide an avenue for applicants of the former class of claims to expand the scope of claims to generic chemical compounds is of course uncertain but perhaps provides a basis for the "clever draftsman" to work semantic magic (or legerdemain) to such ends.

United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)
Panel: Circuit Judges Lourie, Dyk, and Stoll
Opinion by Circuit Judge Lourie

SNIPR Technologies Ltd. v. Rockefeller University (Fed. Cir. 2023)

By Kevin E. Noonan --

One of the wonderful (as in, it makes one wonder) and frustrating (which needs no explanation) aspects of patent law is that just when you think a question is settled it either isn't or the conventional interpretation is called into question.  The Federal Circuit was created to minimize such instances, and while its track record in this regard has been a little spotty since the Supreme Court began reversing its decisions over a decade ago, the Court got it right in SNIPR Technologies Ltd. v. Rockefeller University.

The case arose over an interference declared between patents having an effective filing date after the date the Leahy-Smith America Invents Act (AIA) came into force (March 16, 2013) and an application that had its effective filing date prior to March 16th.  The interference involved SNIPR's related U.S. Patent Nos. 10,463,049; 10,506,812; 10,561,148; 10,524,477; and 10,582,712, which claimed priority to PCT Application No. PCT/EP2016/059803, filed May 3, 2016 (after March 16th and thus prosecuted under the first-inventor-to-file provisions of the AIA) and Rockefeller's U.S. Application No. 15/159,929, which claimed priority to PCT Application No. PCT/US2014/015252, filed on February 7, 2014, and U.S. Provisional Application 61/761,971, filed February 7, 2013 (prior to March 16th and filed and prosecuted under the first-to-invent provisions of the 1952 Patent Act).  The technology at issue were methods of selectively killing bacteria in a mixed set of bacteria by gene editing performed using clustered regularly interspaced short palindromic repeats (CRISPR) methodology.

The opinion sets forth extensively the motivation for the change from the first-to-invent to the first-inventor-to-file provisions regimes as recorded in the legislative history, including that "using a patent's filing date to determine priority among competing inventors is objective and simple, whereas an invention date determination 'is often uncertain, and, when disputed, typically requires corroborating evidence as part of an adjudication'"; that resolving inventorship questions required "a lengthy, complex and costly administrative proceeding (called an 'interference proceeding')" that "can take years to complete . . . , cost hundreds of thousands of dollars, and require extensive discovery"; and that "because it is always possible that an applicant could be involved in an interference proceeding, companies must maintain extensive recording and document retention systems in case they are later required to prove the date they invented the claimed invention."  In addition, the panel appreciated the benefits of harmonizing U.S. patent law with patent regimes abroad (which universally have "first to invent" priority standards).

The opinion also recited the "significant changes to the statutory scheme" occasioned by the change.  But Congress did not apply them retroactively (a decision responsible in part for the issue before the court in this case).  The opinion set out the three categories of patents and applications created by the AIA and their relationship to interference practice:

• Pure pre-AIA patents and applications: patents and applications that have only ever contained claims with pre-AIA effective filing dates (i.e., before March 16, 2013) are subject to the patentability requirements and Interference Provisions in the pre-AIA versions of 35 U.S.C. §§ 102, 103, 135, and 291.  AIA § 3(n)(1).

• Pure AIA patents and applications: patents and applications that have only ever contained claims with post-AIA effective filing dates (i.e., on or after March 16, 2013) are subject to the patentability requirements and derivation proceedings in the AIA versions of 35 U.S.C. §§ 102, 103, 135, and 291.  AIA § 3(n)(1).

• Mixed patents and applications: patents and applications that contain (or contained at any time) at least one claim with a pre-AIA effective filing date and at least one claim with a post-AIA effective filing date are subject to the patentability requirements in the AIA versions of 35 U.S.C. §§ 102–103 but are also subject to the pre-AIA Interference Provisions.  See AIA § 3(n)(1)–(2).

Below, the Patent Trial and Appeal Board granted priority to the Rockefeller application because SNIPR did not file a priority statement that antedated Rockefeller's earliest accorded priority date (February 7, 2014), after denying two SNIPR motions to dismiss the interference because none of their claims were filed prior to the March 16, 2013 date and thus were not subject to an interference proceeding.  This appeal followed.

The Federal Circuit reversed, in an opinion by Judge Chen joined by Judges Wallach and Hughes.  The basis for the PTAB's decision below was language in pre-AIA 35 U.S.C. § 135(a) that the Director was authorized to declare an interference between any application and "any unexpired patent"; accordingly, the PTAB decided that an interference to determine priority of invention was available to Rockefeller's application and the Director was authorized to declare the interference with the SNIPR patents.  The Federal Circuit interpreted the AIA, and specifically Section 3(n), according to the plain meaning of the statutory language, that language in context with the AIA, and the intent of Congress (to eliminate interferences, as that intent was effected by the statute).  In the panel's view, "AIA § 3(n) makes clear that only pure pre-AIA and mixed patents may be part of an interference" using that plain meaning.  The statutory language includes that the first-inventor-to-file regime, "'shall apply' to any  patents that have ever contained a claim with an effective filing date on or after March 16, 2013."  This language was significant as interpreted by the court because "[t]he word "'shall' is 'both mandatory and comprehensive' and 'generally imposes a nondiscretionary duty,'" citing SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1354 (2018).  The opinion interprets AIA § 3(n)(2) to establish "one limited exception" for "mixed patents" (that does not apply to the SNIPR patents at issue) which for the Federal Circuit is "strong evidence that Congress did not wish to further open the interference door to pure AIA patents and applications."  Under such circumstances the opinion states that "additional exceptions are not to be implied, in the absence of evidence of a contrary legislative intent," citing United States v. Smith, 499 U.S. 160, 167 (1991).  The panel found "no hint of congressional intent to expose pure AIA first-inventor-to-file patents and applications to interferences" and "[t]o the contrary, the purpose and history behind the AIA reinforce our understanding  of the text" that "Congress was dead set on eradicating interferences for new applications, criticizing them as lengthy, expensive, and requiring companies to maintain extensive documentation and systems to prove the date of their invention."

With regard to the Director's reliance on the "any expired patent" language in pre-AIA § 135 the Federal Circuit opined that their task is "to construe statutes, not provisions," citing King v. Burwell, 576 U.S. 473, 486 (2015).  In the context of the rest of the AIA and express recitations of Congressional intent, the opinion states it was "clear that the language 'any unexpired patent' cannot refer to pure AIA patents" because such a reading "would be inconsistent with the plain language of AIA § 3(n), which does not allow for pure AIA patents to be part of interferences, and the AIA amendments repealing interferences and the priority of invention requirement for pure AIA patents."  The opinion notes that such an interpretation would "defeat a central purpose of the AIA," i.e., "to transition the U.S. patent system to a first-inventor-to-file system and eliminate the specter of interferences going forward for new applications."  The panel also asserts that judicial interpretation of specific provisions in the AIA, such as AIA § 3(n) should prevail over the "general" language in pre-AIA § 135, citing Bulova Watch Co. v. United States, 365 U.S. 753, 758 (1961), and that interpreting the AIA as the Director and Rockefeller urge "would render superfluous Congress's limited exception in AIA § 3(n)(2)."

As for the remaining arguments asserted by the Director and Rockefeller (such as the possibility of patents being granted to different inventive entities for the same invention), the Federal Circuit posits that inter partes review, post-grant review, and ex parte reexamination provide alternative and adequate remedies under the AIA, and that the temporal logistics, that pure pre-AIA applications will always be prior art to pure AIA patents, make this scenario unlikely to impossible.

For completeness and as an illustration of how the USPTO can discern potential complications in how patents are applied for, examined, and adjudicated, the opinion sets forth this possible scenario:

1) the AIA patent must have been filed on or after March 16, 2013, see AIA § 3(n)(1);

2) the subject matter disclosed in the AIA patent must have been previously disclosed by the inventor of the AIA patent, see 35 U.S.C. § 102(b)(2)(B);

3) the previous disclosure must have been made less than one year before the AIA patent was filed so that the previous disclosure cannot be considered prior art, see 35 U.S.C. § 102(b)(1);

4) the pre-AIA application being considered as prior art must be a U.S. patent, published application, or published PCT application, see 35 U.S.C. § 102(a)(2);

5) the pre-AIA application being considered as prior art must have an effective filing date before March 16, 2013, see AIA § 3(n)(1);

6) the pre-AIA application must have been filed between the disclosure of the AIA invention and the filing of the AIA application or patent, see 35 U.S.C.§ 102(b)(2)(b); and

7) the pre-AIA application and the AIA patent must claim the same invention.

The panel considered this to be a "remote possibility" and an "obscure situation" that the Director admitted had not arisen.

The Federal Circuit then made short work of the case before it, holding that the SNIPR patents were not subject to an interference proceeding under its (proper) interpretation of the AIA, but that (as set forth in a footnote) "[w]hether [Rockefeller's] published application anticipates any of SNIPR's claims was never adjudicated during the interference.  Likewise, the Board never considered whether the Rockefeller Application satisfies the written description and enablement requirements for the claims Rockefeller amended to correspond to the SNIPR Patents [and] [t]hese issues remain disputed between the parties," giving Rockefeller some possibility of recourse in its challenge to SNIPR's patents.

The on-going multiple interferences over priority of invention to CRISPR technology (between four parties involved in six interferences over seven years (and counting) provides a counterpoint to the simple resolution to this case (for good or ill, depending on your patent proclivities).  But to the extent the PTAB believed that interferences should be available to determine inventorship disputes under the AIA the Federal Circuit's decision has closed the door once and for all on this possibility, even as the number of applications filed under the first-to-invent regime inexorably reduces to zero.

SNIPR Technologies Ltd. v. Rockefeller University (Fed. Cir. 2023)
Panel: Circuit Judges Chen, Wallach, and Hughes
Opinion by Circuit Judge Chen

Axonics, Inc., v. Medtronic, Inc. (Fed. Cir. 2023)

By Michael Borella --

Establishing a prima facie case of obviousness based on a multiple prior art references generally requires that the references teach or suggest all claim elements and that one of ordinary skill in the art would be motivated to combine the references to achieve the invention as claimed.  During patent prosecution, rebutting an examiner's motivation to combine is often considered to be more difficult than rebutting a contention that the references teach one or more specific claim elements.  This is especially true in the software arts, where many examiners implicitly take the position that it would be obvious to combine any two or more preexisting software features just because those features could (in theory) be combined.[1]  Thus, rather than rebutting the motivation to combine (arguments that are all too frequently ignored by examiners), prosecution of software applications focuses on the examiner's mapping of the prior art to the claim elements.

Nonetheless, over the last 15-plus years since KSR Int'l Co. v. Teleflex Inc. mandated a more flexible and fact-specific approach for the obviousness inquiry, the Federal Circuit has slowly been fleshing out the post-KSR requirements to establish a motivation to combine.  Applicants should pay attention to this line of cases (which include Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC; Belden Inc. v. Berk-Tek LLC; and Henny Penny Corp. v. Frymaster LLC, among others), as they provide grist for refuting poorly-reasoned obviousness rejections.

Medtronic asserted two patents against Axonics, and the latter pulled these patents into an inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB).  For both, the PTAB found that Axonics had failed to establish that any of the challenged claims were obvious.  The Federal Circuit reversed on appeal.  Despite this case not ending in favor of the patentee, its reasoning supports patentee endeavors by pointing out where motivations to combine do not meet the threshold needed to establish obviousness.

In particular, Axonics established that a combination of three or four references taught each limitation of the claims at issue.  Relying on arguments and expert testimony from Medtronic, the PTAB concluded that Axonics had not established that one of ordinary skill in the art would have been motivated to combine two of these references.

The Federal Circuit wrote "the Board committed a fundamental legal error in confining the motivation inquiry to whether a motivation would exist to make the proposed combination for use in the [context of one of these references]—to which the Medtronic patents are not limited."  Thus, the Court found a misalignment between the scope of the Medtronic claims and that of the references used in the motivation to combine.  This was a fatal flaw.

The words of the Court set forth its reasoning in a quotable manner:

When an obviousness challenge asserts a combination of identified prior art, the motivation-to-combine portion of the inquiry is whether a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention . . . .  The inquiry is not whether a relevant artisan would combine a first reference's feature with a second reference's feature to meet requirements of the first reference that are not requirements of the claims at issue.  A contrary view would run counter to established principles, including that the claim defines the invention whose obviousness is being assessed . . . .

Put another way, even if one can find a motivation to combine two references based on the teachings of the references themselves, this motivation is not relevant to an obviousness analysis unless the references' teachings are commensurate with the scope of the claims under consideration.  If, as in this case, the motivation for combining is based on a narrower use than what is claimed, then the motivation cannot stand.  Thus, the Court vacated and remanded the PTAB's decisions.

This means that finding just any reason to combine references is not sufficient when that reason is not reasonably related to the claims.  In practice, this rebuttal of the motivation to combine might not be available in all cases.  But, given the proclivity of examiners to throw any motivation around that is tangentially related to the claimed invention, it is worthwhile to at least consider a rebuttal when the facts line up against a conclusion of obviousness.

Again, this may be an odd case to rely on for such a rebuttal.  The Court ultimately held that the PTAB's motivation to combine inquiry was too narrowly confined to a use set forth by the cited references rather than that of the claims.  Nonetheless, the Court's language is strong and may be handy for doing away with poorly-reasoned motivations.

[1] Examiners in other technological fields take different approaches.  For instance, the motivation to combine is frequently easier to rebut in the mechanical arts because examiners understand that most claim elements are known but these elements have specific characteristics that may not be readily combinable.  There is also a slightly higher burden to establish the obviousness of claims in unpredictable arts, such as chemistry.

Axonics, Inc., v. Medtronic, Inc. (Fed. Cir. 2023)
Panel: Circuit Judges Lourie, Dyk, and Taranto
Opinion by Circuit Judge Taranto

Medytox, Inc. v. Galderma S.A. (Fed. Cir. 2023)

By Kevin E. Noonan --

It is not surprising that the Federal Circuit has taken the opportunity to apply the Supreme Court's recent precedent in Amgen v. Sanofi regarding the sufficiency of disclosure needed to satisfy the statutory enablement requirement under 35 US.C. § 112(a).  After all, the decision is a rare affirmance of Federal Circuit decision by the Supreme Court, and the legal rationale set forth is consistent with recent enablement jurisprudence developed by the Federal Circuit over recent years (see "Wyeth & Cordis Corp. v. Abbott Laboratories", "Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc.", and "Idenix Pharmaceuticals LLC v. Gilead Sciences Inc.").  But the decision, in Medytox, Inc. v. Galderma S.A., is itself significant because it adopts the analytical framework that the Patent and Trademark Office and district courts can be expected to follow going forward, for better or worse.

The case arose in a post-grant review (PGR) proceeding against U.S. Patent No. 10,143,728 before the Patent Trial and Appeal Board pursuant to 35 U.S.C. § 321 et seq. and brought by Galderma et al.  The challenged claims were directed towards "the use of an animal-protein-free botulinum toxin composition that exhibits a longer lasting effect in the patient compared to an animal protein-containing botulinum toxin composition," which encompasses a Medytox product designated MT10109L in the opinion.  Substitute claim 19 was set forth in the opinion as representative:

A method for treating glabellar lines a condition in a patient in need thereof, comprising:
    locally administering a first treatment of therapeutically effective amount of a botulinum toxin composition comprising a serotype A botulinum toxin in an amount present in about 20 units of MT10109L, a first stabilizer comprising a polysorbate, and at least one additional stabilizer, and that does not comprise an animal-derived product or recombinant human albumin;
    locally administering a second treatment of the botulinum toxin composition at a time interval after the first treatment;
    wherein said time interval is the length of effect of the serotype A botulinum toxin composition as determined by physician's live assessment at maximum frown;
    wherein said botulinum toxin composition has a greater length of effect compared to about 20 units of BOTOX®, when whereby the botulinum toxin composition exhibits a longer lasting effect in the patient when compared to treatment of the same condition with a botulinum toxin composition that contains an animal-derived product or recombinant human albumin dosed at a comparable amount and administered in the same manner for the treatment of glabellar lines and to the same locations(s) as that of the botulinum toxin composition; and
    wherein said greater length of effect is determined by physician's live assessment at maximum frown and requires a responder rate at 16 weeks after the first treatment of 50% or greater that does not comprise an animal-derived product or recombinant human albumin, wherein the condition is selected from the group consisting of glabellar lines, marionette lines, brow furrows, lateral canthal lines, and any combination thereof.

(wherein the claim is presented with limitations removed from the substitute claim indicate by strikethrough and those added by underlining).  The compositions were disclosed in earlier applications incorporated by reference; this application newly provides in support of these method claims the results of two clinical trials that compared botulinum toxin stabilized with human serum albumin and animal-protein-free botulinum toxin composition.  One of these was results of a Phase III clinical trial making the relevant comparison between BOTOX® and the claimed MT10109L product (showing not surprisingly "significant improvement" with the Medytox product), and results of a Phase II clinical trial comparing the two products (showing consistent improved results with the Medytox product).

The PTAB instituted a PGR against granted claims 1-10 of the '728 patent and Medytox filed a motion to amend by cancelling claims 1-10 and substituting claims 11-18.  Medytox also requested the Board to issue a Preliminary Guidance (as part of the PTO's Pilot Program regarding amendment practice in PGRs and other post-grant review proceedings) relating to the likelihood that the motion met statutory and regulatory requirements.  Galderma opposed the motion to amend on new matter grounds, and the PTAB issued a Preliminary Guidance that "Medytox had not shown a reasonable likelihood that it satisfied the statutory and regulatory requirements under 35 U.S.C. § 326(d) and 37 C.F.R. § 42.221(a)."  But the Guidance also contained the caveat that the Board would not be bound by this Guidance in its Final Written Decision, which would depend on the full record before the Board at the end of the proceedings.  In response, Medytox moved to cancel original claim 6 and substitute the remaining claims with new claims 19-27, which motion Galderma also opposed.

The Board issued its FWD and cancelled original claims 1-5 and 7-10.  On the merits of the remaining claims at issue, the Board construed the term "responder rate" with regard to Galderma's (a range of 50-100%) and Medytox's (a minimum threshold of 50%) constructions, ultimately deciding that the responder rate limitation had an upper limit of 100% (a construction that differed from the one in the Preliminary Guidance).  The Board also found that Medytox's substitute claims introduced new matter in the responder rate limitation and thus failed to meet the requirements for its revised motion to amend.  The Board accordingly found that the proposed substitute claims were invalid for failure to satisfy the written description requirement (a finding not addressed by the Federal Circuit on appeal, in view of its other grounds for affirming the Board).  On the Board's decision that the substitute claims were also not enabled, the Board applied the factors set forth in In re Wands and, based in part on expert testimony, found that the full scope of the claims was not enabled because the specification would not have enabled the skilled worker to achieve a responder rate higher than 62% without undue experimentation.  All claims in the '728 patent were thus cancelled or replacement with substitute claims precluded by their being invalid.  This appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Reyna joined by Judges Dyk and Stark.  The opinion first discussed claim construction, the panel holding that the Board properly construed the "responder rate" limitation to be a range (Galderma also arguing that Medytox on appeal for the first time contended that its construction relied on intrinsic evidence in the specification rather than extrinsic, expert testimony understandably, in light of the substantial evidence standard of review of Board decisions based on factual determinations such as expert testimony).  The Court did not address Galderma's underlying forfeiture argument, asserting instead that the parties did not dispute that the "responder rate" limitation had an "inherent" upper limit of 100% and that "there appears to be no substantive difference in the claim construction proposed by the parties for the responder rate limitation," the Federal Circuit affirming the Board's construction on that basis.

Turning to enablement, the Federal Circuit held that the Board had properly found the '728 specification did not satisfy the enablement requirement of § 112(a).  The panel rejected Medytox's argument that "the specification does not need to include a working example of 'every possible embodiment to enable the full scope of the claims,'" citing (somewhat anachronistically) Bayer Healthcare LLC v. Baxalta Inc., 989 F.3d 964, 982 (Fed Cir. 2021), and Medytox's reliance on expert testimony that there would require no undue experimentation because it was "routine to clinically confirm" whether a composition met the duration limitation (a "greater length of effect").  Galderma had argued that Medytox was required "to provide a clinical study for each formulation because clinical trials are not routine for 'determining whether pharmaceutical compositions fall within the scope of a patent claim.'"  The Federal Circuit agreed, cabining the extent of its agreement by asserting that "our caselaw may not require disclosure of every possible working example of responder rates" but noting that here the specification disclosed "at most three examples of responder rates above 50% at 16 weeks."  While citing earlier caselaw, including Wyeth & Cordis Corp. v. Abbott Lab'ys, 720 F.3d 1380, 1385–86 (Fed. Cir. 2013), and MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir. 2012), the panel based its decision on the Supreme Court rubric recently set forth in Amgen v. Sanofi that "[t]he more one claims, the more one must enable."  The opinion expressly states the basis for its analytical reasoning as also sounding in Amgen, that:

Though a specification need not always "describe with particularity how to make and use every single embodiment within a claimed class," it must nevertheless "enable the full scope of the invention as defined by its claims," for example by "disclosing [a] general quality" of the class that may "reliably enable a person skilled in the art to make and use all of what is claimed."

Applying these principles, the Federal Circuit affirmed the Board's non-enablement decision based on substantial evidence that that "the arguments and evidence were insufficient to demonstrate enablement to a skilled artisan because said artisan 'would not have been able to achieve' responder rates higher than the limited examples provided in the specification."

Procedurally, Medytox argued that the Board erred in changing its claim construction in the FWD from the construction in the Preliminary Guidance as a violation of the Administrative Procedures Act (APA) as being arbitrary and capricious under 5 U.S.C. § 706(2)(A).  Medytox's arguments focused on the Board's purported failure to consider intrinsic evidence and this had resulted in "inconsistent conclusions on a nearly identical record" [that] render[ed] its decision arbitrary and capricious," citing BASF Corp. v. Enthone, Inc., 749 F. App'x 978, 985 (Fed. Cir. 2018), and Robert Bosch, LLC v. Iancu, 778 F. App'x 871, 875 (Fed. Cir. 2019).  The Federal Circuit's assessment is in line with the arguments put forth by the Solicitor General on behalf of the Patent Office, that the Preliminary Guidance is preliminary and any contrary conclusions the Board may arrive at in its FWD is due to the further development of the record during the proceedings, something the Federal Circuit has held is an obligation falling on the Board, citing In re Magnum Oil Tools Int'l, Ltd., 829 F.3d 1364, 1377 (Fed. Cir. 2016).  Here, the panel held that the Board "provided a reasoned analysis for its ultimate claim construction" and consequently that the decision to change its construction of the claims with regard to the responder rate limitation was not arbitrary and capricious.

Finally, Medytox argued that the Board's decision and the way it was arrived at denied them due process and was contrary to the APA.  The Federal Circuit considered the public notice in the Federal Register that the Pilot Program would product a preliminary guidance, and that the "initial" and non-binding nature thereof was evident.  Reviewing the procedural steps below the Court held that there was no irregularities or denial of due process.  Some caution is provided by the Court on the limits of the application of these processes, however:

To be sure, the agency must inform the parties on procedures relevant to its practices, like the Pilot Program, and must respect the boundaries imposed by the APA.  There must be structural integrity to the program in ensuring that the patent owners who have requested such guidance be given an opportunity to be heard and due process.

But on the record before the panel the Court held that these requirements were met.

However this first foray into applying the Supreme Court's latest imperative on how patent law will be interpreted, it is hard to say whether it bodes well.  Perhaps it is the inevitable consequence of a generalist Court steeped in considerations of the "totality of the circumstances" as the reviewing court for an inferior court charged by Congress with interpreting and harmonizing a specific area of the law.  Perhaps it has something to do with that Court spending more than a decade objecting to precedent from the inferior court that attempted to provide such harmony by developing a jurisprudence that could be applied reliably to diverse circumstances and technologies with a minimum of uncertainty.  But as with so much of the Court's "guidance" (to both the courts, the Patent Office, and the patenting public) this one on enablement seems more attuned to the Potter Steward method of legal analysis, wherein "you know it when you see it."  In addition to being anathema to the vision Congress and the early judges had in establishing the Federal Circuit, its difficulty in putting the rubrics (such as they may be) into practice has created disharmony in other areas of the law (see, e.g., "An Analytic Approach to Patent Eligibility") that may now be the fate of enablement law.  The one thread to be grasped in the Court's Amgen decision is the possibility of "[a] general quality" of the class that may "reliably enable a person skilled in the art to make and use all of what is claimed."  Whether this thread can be woven into a fabric through which enablement law can be applied consistently of course remains to be seen.

Medytox, Inc. v. Galderma S.A. (Fed. Cir. 2023)
Panel: Circuit Judges Dyk, Reyna, and Stark
Opinion by Circuit Judge Reyna

In re Couvaras (Fed. Cir. 2023)

By Kevin E. Noonan --

The Federal Circuit provided a reminder last week that merely identifying an unappreciated consequence of a prior art method cannot confer non-obviousness on practice of methods that did not acknowledge that consequence, in In re Couvaras.

The appeal arose from a Patent Trial and Appeal Board affirming an Examiner's rejection that the claims of U.S. Application No. 15/131,442 were obvious.  The claims were directed to a method for increasing prostacyclin release in systemic blood vessels when administered to a human having essential hypertension; the consequence was improved vasodilation.  How this beneficial outcome was achieved as claimed was by co-administration of two art-recognized antihypertensive agents:  a GABA-a agonist and an Angiotensin II Receptor Blocker ("ARB").  Claim 11 was included in the opinion as representative:

11.  A method of increasing prostacyclin release in systemic blood vessels of a human individual with essential hypertension to improve vasodilation, the method comprising the steps of:
    providing a human individual expressing GABA-a receptors in systemic blood vessels due to essential hypertension;
    providing a composition of a dosage of a GABA-a agonist and a dosage of an ARB combined into a deliverable form, the ARB being an Angiotensin II, type 1 receptor antagonist;
    delivering the composition to the human individual's circulatory system by co-administering the dosage of a GABA-a agonist and the dosage of the ARB to the human individual orally or via IV;
    synergistically promoting increased release of prostacyclin by blockading angiotensin II in the human individual through the action of the dosage of the ARB to reduce GABA-a receptor inhibition due to angiotensin II presence during a period of time, and
    activating the uninhibited GABA-a receptors through the action of the GABA-a agonist during the period of time; and
    relaxing smooth muscle of the systemic blood vessels as a result of increased prostacyclin release.

(wherein the underlined limitations illustrate the distinctions relied upon by the patent applicant).

It was not disputed (before the Board or the Federal Circuit) that the two co-administered compounds were known in the art as treatment for essential hypertension ("for many, many decades"), supported if not compelled by the Examiner's citation of 10 prior art references disclosing such use.  The Examiner rejected all pending claims based on his determination that the claimed results of the recited method ("increased prostacyclin release, activation of uninhibited GABA-a receptors, and smooth muscle relaxation") "naturally flowed from the claimed administration of the known antihypertensive agents."

The Board agreed and affirmed the rejection, unpersuaded by Applicant's argument that prostacyclin release was an unexpected result of the claimed methods.  The Board also held that the claimed distinction was an inherent result from co-administration of the two known antihypertensive agents.

The Federal Circuit (not surprisingly) affirmed, in an opinion by Judge Lourie joined by Judge Dyk and Stoll.  The opinion addresses three Appellant arguments:  first, that the Board erred in affirming that the skilled worker would have had a motivation to combine the asserted prior art (and a reasonable expectation of success in doing so); second, that the claimed method of action would have been unexpected and that the Board improperly discounted the resulting patentable weight this fact was entitled to; and third, that prostacyclin production as a consequence of co-administration should have been weighed under the objective indicia rubric of Graham v. John Deere (and considered to overcome the asserted prima facie obviousness determination by the Examiner).

Applicant's first argument failed to persuade the panel that the Board erred on the principle that "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose," citing In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).  In addition, the Board relied on a prior art reference that taught "the use of ARBs 'in combination with other classes of antihypertensive agents to lower blood pressure,' but also that various guidelines 'acknowledge the need for multiple drug therapy in many patients to adequately lower blood pressure.'"  The specificity of the motivation to combine arising from this reference satisfied the requirement, according to the opinion (and Applicant's arguments regarding whether the skilled worker would have had a reasonable expectation of success were waived in the Court's view because they had not been properly asserted or preserved below).

Regarding the second argument, that the Board had improperly "downgraded" the weight give the prostacyclin-releasing effect of co-administration because it was inherent, the panel rejected Applicant's reliance on Honeywell International Inc. v. Mexichem Amanco Holdings S.A., 865 F.3d 1348, 1355 (Fed. Cir. 2017), because in that case the Federal Circuit had held "unexpected properties may cause what may appear to be an obvious composition to be nonobvious" (emphasis in opinion) which was not the same as Applicant's assertion here that "unexpected mechanisms of action must be found to make the known use of known compounds nonobvious."  In the panel's view the mechanism of action "naturally flows" from co-administration and the "ultimate result" (decreasing blood pressure) was the same.  Citing In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012) and In re Huai-Hung Kao, 639 F.3d 1057, 1070–71 (Fed. Cir. 2011), the opinion states as settled law that "[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent."  Consequently, the panel held that the Board had properly determined that "the recitation of various mechanistic steps in the pending claims [were] insufficient to overcome the prima facie obviousness of the claimed methods."

Finally, the Federal Circuit rejected Applicant's arguments relating to the objective indicia, inter alia, because they did not show any unexpected benefits, such as "better control of hypertension, less toxicity to patients, or the ability to use surprisingly low dosages."  The panel also agreed that the evidence presented by Applicant regarding any of the other objective indicia (teaching away, failure of others, and the length of time between teaching co-administration of antihypertensive compounds in the art and the claimed invention) did not support overcoming the asserted prima facie obviousness case raised by the Examiner and affirmed by the Board.

In re Couvaras (Fed. Cir. 2023)
Panel: Circuit Judges Lourie, Dyk, and Stoll
Opinion by Circuit Judge Lourie

Federal Circuit Special Committee Responds to Judge Newman's Counsel's Request for Clarification Regarding Misconduct Hearing

By Kevin E. Noonan --

Responsive to the letter from Judge Pauline Newman's counsel sent June 15th (see "Judge Newman Matter Continues"), the Special Committee directing the Federal Circuit's inquiry regarding Judge Newman's fitness for continued service on the Court (consisting of Chief Judge Moore, former Chief Judge Prost, and Judge Taranto) issued a per curiam response.

The response sets forth the basis and scope of the June 1st Order which identified Judge Newman's refusal to comply with the Committee's demands, including to "undergo medical examinations, to provide medical records, and to sit for an interview with the Committee" set forth in prior Order, as in itself judicial misconduct under Rule 4(a)(5) ("Cognizable misconduct includes refusing, without good cause shown, to cooperate in the investigation of a complaint or enforcement of a decision rendered under these Rules.")   The response provides a recitation of the Committee's previous orders that parallels the history set forth in counsel's letter, with certain differences in characterization thereof.  For example, regarding their April 6th Order, the response characterizes the issue as "Judge Newman's disclosure of a confidential employment dispute matter and statements made in regard to that matter."  The April 20th Order, according to the response, was expanded to include potential misconduct related to "Judge Newman's alleged retaliatory, unprofessional, and abusive behavior towards her own and other court staff."  Not included in counsel's letter were Orders dated April 17th, May 3rd, and May 16th regarding the Committee's demands that Judge Newman provide medical records and undergo medical testing including "neurological and neuropsychological testing."

Counsel's letter purported to ask the Committee for "clarification" regarding the status of the grounds for misconduct asserted in these various Orders, characterizing them as 1) allegations of mental or physical disability; 2) improper behavior towards staff; and 3) failure/refusal to cooperate.  The Committee's Order makes plain that:

All the foregoing aspects of the investigation remain open and pending before the Committee.  No part of the investigation has been terminated.  In particular, the investigation into whether Judge Newman suffers from a disability that impairs her ability to perform the duties of her office remains ongoing.

But the Committee's response also makes plain that these various grounds of complaint cannot substantively go forward without Judge Newman's cooperation (or compliance) which is not forthcoming.  Accordingly the Committee has Ordered briefing by July 5th and a hearing on July 13th to address the somewhat meta (or Kafkaesque) question of whether Judge Newman's refusal to comply with these Orders is itself judicial misconduct.  This question unavoidably presents the due process and Constitutional issues raised in Judge Newman's complaint to the D.C. District Court (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit") but which (apparently) will not be addressed in the upcoming briefing and hearing.  The Committee's asserted basis for this course of action is that:

[T]he Committee's investigation into whether Judge Newman suffers from such a disability has been seriously impeded by Judge Newman's refusal to undergo neurological and neuropsychological examinations, to provide medical records, and to sit for an interview with the Committee.  Her refusal to cooperate in those respects impairs the ability of the Committee to gather sufficient information to come to a definitive conclusion and recommendation for the Judicial Council on the disability issue.

The consequences to Judge Newman are clearly laid out in the response, wherein the Committee asserts its rationale that "it would be most efficient for the Committee to focus immediate proceedings on a more discrete issue on which the Committee could likely reach a conclusion and make a final recommendation to the Judicial Council despite Judge Newman's lack of cooperation," i.e. a finding of judicial misconduct without needing to establish the purported prerequisites of mental, psychological, or physical disability that was the presumed basis for the Special Committee's actions in the first place.

The response also denies Judge Newman's counsel's request that the hearing be open to the public.  The reason for this decision is that traditionally such inquiries on judicial fitness are kept confidential under the Judicial Conduct and Disability Act of 1980 and by the Rules for Judicial-Conduct and Judicial-Disability Proceedings, according to the Committee.  This creates a "strong presumption" for the Committee that the proceedings should remain confidential.  As a practical matter, the response asserts that confidentiality "facilitates the investigative process" and its beneficial effects in this regard "ha[ve] been almost universally accepted," citing First Amendment Coalition v. Judicial Inquiry & Review Bd., 784 F.2d 467, 475 (3d Cir. 1986).  In particular, despite there having been "a great deal about the current proceedings" that have been open to the public the Committee "has taken particular care to ensure that publicly released material does not identify witnesses or confidential details of witness statements and that the public releases would not compromise the investigative process."  Opening the hearing to the public would pose "grave risk[s]" of "inadvertent" disclosure of such information in the Committee's view.  The response also contends that there is no prejudice to Judge Newman by maintaining this confidentiality because "all affidavit and deposition transcripts" have been turned over to the Judge's counsel (thus making their existence public knowledge).  Because this evidence has provided the basis for the various Orders by the Special Committee, and whether Judge Newman's non-compliance therewith constitutes judicial misconduct raises the possibility that argument on this points might result in disclosure of at least some of this evidence, which the Committee does not want to happen.  And in attempts to prevent such disclosure the Committee asserts their fears that witnesses will "censor themselves in real time" to prevent disclosure.

The response also provides the Committee's rebuttal to the case law cited by Judge Newman's counsel.  Waller v. Georgia is inapposite, the response asserts, because that was a criminal case, and thus precluded from being held in private based on a defendant's Sixth Amendment right to a public trial.  The response also contradicts Judge Newman's counsel's argument that the hearing will be based on the paper record, because inter alia "the entire record has not been made public" (although they have been provided to counsel).

Nevertheless, the Committee "will consider" releasing a transcript redacted as to witness identities and other confidential material in due course after the hearing is held.  This would permit "some public transparency" and "allow a more considered approach to redacting [confidential] material" than could be achieved at a live hearing, while at the same time it would "not hamper the efficiency of the Committee's investigation by impeding the flow of the argument itself."

Briefing will be submitted by July 5th and a hearing transcript sometime thereafter (although it is unlikely that there will be publication of the recorded hearing in view of the Committee's discussion in its response).