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  • In the Wake of the Supreme Court’s Amgen v. Sanofi decision: What’s Next for Biotechnology Claims?

    By Kevin E. Noonan —

    Section 112 of the patent statute, which in earlier years was something of a backwater in patent law, has had a tumultuous quarter century beginning with the Federal Circuit decision in Regents of the University of California v. Eli Lilly & Co., which (in the view of many) heightened the written description requirement for biotechnology inventions.  This was particularly true more generally for inventions directed to isolated nucleic acids (those were the days!) and proteins, based on the principle that the complexity of such molecules required disclosure of more than a recitation of the expected product (in Lilly, human cDNA encoding insulin) and methods for making/obtaining it.  This decision led to a series of cases from that Court, including Enzo Biochem. v. Gen-Probe, University of Rochester v. G.D. Searle, Carnegie Mellon University v. Hoffman LaRoche, and culminating in the en banc Ariad v. Eli Lilly & Co. decision that imposed the interpretation that written description and enablement in 35 U.S.C. § 112(a) (then, first paragraph) were separate requirements.  The enablement requirement in this regime had the steadier interpretation, being a question of law grounded in the factual determinants of the In re Wands factors, so much so that the isolation, discovery, and characterization of a novel antigen was enough for an applicant to be granted a patent for antibodies specific for that antigen without actually disclosing said antibodies, under the Court’s 2004 Noelle v. Ledermann decision.  Many recognized that this decision was contrary to the Ariad decision but that apprehension was grounded in the written description rather than enablement requirement.

    That situation began to change during the tenure of Chief Judge Prost, who wrote the first Federal Circuit Amgen v. Sanofi opinion harmonizing the Court's precedent by overruling on written description grounds the Ledermann decision.  But lurking in the Court's consideration of that case was an inkling that the enablement requirement also contained a limitation, based on the principle of "no undue experimentation" from the Wands decision that bore fruit in several other cases, including Wyeth & Cordis Corp. v. Abbott Laboratories, Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc., and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. (the latter being a conventional chemical compound/genus case that, it had been presumed, encompassed molecules of sufficient predictability that did not implicate the complexity issues of biological molecules).  This trend reached its apogee (for now) in the Supreme Court's Amgen v. Sanofi decision, where the Court approved the limiting principle that the enablement requirement was satisfied if (but only if) the claims were commensurate in scope with what was disclosed in the specification.  The Federal Circuit has applied the Supreme Court's reasoning (and their own) since the Amgen decision, in Baxalta Inc. v. Genentech, Inc.

    In the wake of this decision (once one gets beyond the weeping and gnashing of teeth that accompany most Supreme Court forays into patent law) there have been a number of views asserted about how (if at all) biological molecules (and their chemical counterparts) could be protected with claims of sufficient scope not to be easily designed around.  An intriguing one has been (independently) promulgated by Bob Armitage and Tom Irving, who have suggested that "means-plus-function" (MPF) claims under  35 U.S.C. § 112(f) would provide a way to expand the scope of claims having great sequence or other complexity while avoiding the conundrum created by (or more accurately, affirmed by) the Amgen decision.  As a reminder this provision of the patent statute provides:

    An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

    Under this proposal,* exemplified with regard to Amgen's antibody claims, the stratagem would be implemented as follows:

    A pharmaceutical composition of an isolated monoclonal antibody preparation comprising a pharmaceutically acceptable excipient and an antibody means that specifically binds to [a particular antigen/epitope/pathogen/etc.].

    The specification would then provide (as did Amgen's) expressly disclosed antibodies as exemplars.

    Reservations arise regarding this approach because MPF claims are limited to the species expressly disclosed ("the corresponding structure [or] material") and equivalents thereof.  For antibodies (as in Amgen) this would have been the about two dozen expressly disclosed antibodies plus "equivalents."  But this begs the question because what is an "equivalent" will need to be experimentally determined and thus be subject to the same "undue experimentation" objections that forms the basis for both the Supreme Court's Amgen decision and the several Federal Circuit decisions in recent years limiting their scope even in conventional small molecule/chemical claims.  And while the doctrine of equivalents is a thin reed to rely upon to police, at best, "trivial" modifications (like substituting an isoleucine residue with an valine residue, or vice versa, insofar as the difference in these amino acids is one methylene (-CH3-) group) the scope of MPF claims is also more limiting in this regard.

    A possibly more fruitful course (which has the benefit of also providing an argument for satisfying the written description requirement) would be the alternative ways of providing a sufficient disclosure first enunciated by Judge Lourie in California v. Eli Lilly & Co. and later in Ariad (v. Eli Lilly & Co.):

    • Rely on species and subgenus claims as much as possible, while avoiding broad genus claims, to provide a "representative number" of species

    • Focus on structure/function relationships and properties of antibodies (CDRs, for example) not antigens

    (or a combination of these).  There has been a convergence in the relationship between claim scope and the amount of disclosure supporting claims required for satisfaction of the written description and enablement requirements that can be addressed using Judge Lourie's rubrics.

    Another approach would be to align the CDR sequences in expressly disclosed antibodies and provide a sequence alignment that could be used to identify a consensus sequence having three types of alignment.  Specifically, there would be 1) invariant amino acids at some positions (which would indicate that these are important for antigenic specificity or structural stability or both); 2) positions having amino acids of related chemical properties (basic, acidic, aliphatic, etc.) that provide more structural variability/scope; and 3) positions having little consistency, except most likely not having proline or glycine which are known to disrupt protein secondary or tertiary structure.  The number of variants for such consensus sequence CDRs, while large, would then have a more limited and scientifically rational basis resulting from evolution and would not involve the "trial and error" characteristics that raised judicial disparagement at both the Federal Circuit and Supreme Court.

    There is no magic wand that can ensure that a claim will not be found wanting by a court in satisfying the disclosure requirements of Section 112.  And of course, sound patent claiming strategies (having claims of varying scope, including genus, subgenus, and species, for example) are useful in reducing the likelihood that a competitor will be able to practice an invention with impunity by clever designing around schemes.  The Amgen claims (as well as the claims in Baxalta) were prosecuted under interpretations of the enablement requirement that have now been abrogated by the courts.  While it is likely that patents having similar claims will be subject to invalidation if asserted the benefit of decisions like Amgen is that the standard, having been established by the Supreme Court is less likely to change in future, as not relying on the Federal Circuit's recent uncertain precedential value.

  • Patent Luminaries Try to Set Congress Straight on Drug Price Controls

    By Kevin E. Noonan —

    Washington - Capitol #2Over the past few years the drumbeat regarding the cost of healthcare in general and drugs in particular has steadily mounted (see "Faux-Populist Patent Fantasies from The New York Times").  Patents are often (and quite wrongly) blamed for the purported high costs, despite the crucial role patents play in spurring innovation; indeed, some advocates have been accused of skewing their statistics to make their arguments appear plausible (see "Unreliable Data Have Infected the Policy Debates Over Drug Patents"; "Tillis Wants More Info on I-MAK and Other Data Driving Anti-Patent Narratives Around Drug Pricing"; and "I-MAK Defends Integrity of Its Patent Data in Response to Tillis Letter").  But a recent tactic is for many, including members of Congress, to argue that the Bayh-Dole Act, and in particular the so-called “march-in rights” provisions (Bayh-Dole Act, Pub. L. No. 96–517 (1980), Section 203) entitle the Federal government to set drug prices, at least for those drugs developed using Federal grant money for their discovery or development (and despite valiant efforts by Joe Allen and the Bayh-Dole Coalition to explain how their reading of the Act is in error; see www.bayhdolecoalition.org).  Alternatively, the provisions outlining the jurisdiction of the Court of Federal Claims in cases involving patents and copyrights (28 U.S.C. § 1498) have been similarly invoked as giving the Federal government the right to set drug prices because the drugs in question are patent-protected.

    Today, a letter was sent by 25 scholars, former judges, and former government officials to the Senate Health, Education, Labor and Pensions Committee, the Chair and Ranking Member of the House Ways and Means Committee, and to Secretary of Health and Human Services Xavier Becerra "correcting false claims that the federal government can use the Bayh-Dole Act or § 1498 to impose price controls on prescription drugs."  That letter is set forth below and deserves serious consideration by the Biden Administration, Congress, and the rest of us to prevent unwise attempts to misapply the Bayh-Dole Act, as set forth eloquently and specifically in the letter.

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

    By Kevin E. Noonan —

    Federal Circuit SealThere 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 of 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:

    Image
    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 what 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 —

    Judge NewmanIn 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.

  • FTC Announces Efforts to Police Pharmaceutical Companies’ Patent Behavior

    By Kevin E. Noonan —

    Federal Trade Commission (FTC) SealA decade ago the Federal Trade Commission engaged in a crusade against reverse settlement payment agreements in ANDA litigation (which they termed, Madison Avenue-like, "pay for delay" settlements), arguing that such agreements were per se antitrust violations, despite almost universal rejection of their position by most Courts of Appeal prior to the Supreme Court's decision in Actavis v FTC.  While failing to convince the Court to give its imprimatur to a complete ban, the Commission did persuade the Justices that because such agreements could raise antitrust concerns they should be reviewed under the rule of reason (a more fulsome account of these cases can be found in earlier Patent Docs posts and in Antitrust Issues in Intellectual Property Law, The Intellectual Property Law Association of Chicago Antitrust Committee, Lyerla, B., ed., American Bar Association Publishing Co., 2016).

    The FTC's latest foray into policing pharmaceutical companies and their patent behavior was set forth in a policy statement promulgated earlier this month, entitled "Statement Concerning Brand Drug Manufacturers' Improper Listing of Patents in the Orange Book," in a classic example of begging the question and one viewed through the Commission's prism of purported patent malfeasance by branded drug companies.

    As it did with the reverse settlement issue, the Commission's attitude seems to be that something might be happening and then to proceed as if it is.  This is evident from the first sentence, where the statement asserts that "[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug Administration's ("FDA") Approved Drug Products with Therapeutic Equivalence Evaluations, known as the 'Orange Book'" (emphasis added).  The statement then extols the benefits of generic competition (which is fine as far as it goes, but of course there needs to be something to copy in the first place for generic copiers to have anything to copy that can be sold at lower prices due to the benefits of their copying).  There is a generic allegation in the midst of this rhetoric — the statement asserts that "certain manufacturers have submitted patents for listing in the Orange Book that claim neither the reference listed drug nor a method of using it" (and if so of course the Commission is empowered to and intends to pursue such manufacturers who are indeed "abus[ing] the regulatory processes set up by Congress to promote generic drug competition" under the power to investigate unfair trade practices under 15 U.S.C. §§ 45(a), (n)).

    The justification for the Commission's concerns stems apparently from the results of a 2002 study (FED. TRADE COMM'N., GENERIC DRUG ENTRY PRIOR TO PATENT EXPIRATION: AN FTC STUDY 39-52 (2022), that purportedly involved improper listing, further citing an enforcement action in that year against Biovail (In re Biovail Corp., FTC Dkt. No. C-4060 (Oct. 2, 2002)).  Also cited are a total of four instances where the Commission filed amicus briefs in cases where there may have been improper listing, such as patents for a system to implement a REMS.  The consequence of such a listing, the statement asserts, is to invoke the 30-month stay in approval attendant upon the NDA holder (or her licensee) filing suit against an ANDA applicant, because "even small delays in generic competition can generate substantial additional profits for brand companies at the expense of patients."  Patients would be harmed because they would be "deprived of the ability to choose between competing products and may be forced to pay inflated prices."  Of course the 30-month stay while statutory is not mandatory; should the infringement action be dismissed (for example, on motion that the patent asserted were improperly listed in the Orange Book), the FDA would be able to expeditiously approve the ANDA and the generic company enter the marketplace (with its own 180-day exclusivity if a first filer; under these circumstances the extent to which patients would pay deflated prices would be itself delayed).

    Having established at least to its own satisfaction the basis for the Commission's attention to this issue, the statement then announced the FTC's intention to "enforce the law against those companies and individuals who continue to improperly list patents in the Orange Book" using "its full legal authority to protect patient and payors . . . from business practices that tend to negatively affect competitive conditions."  This threatened exercise of the Commission's legal authority finds its basis in "the FTC's historical use of Section 5" based on improperly listing a patent in the Orange Book being an unfair method of competition.  The statement goes on to speculate that improperly listing a patent in the Orange Book "may . . . constitute illegal monopolization," perhaps evincing a recognition that agency overreach was not greeted warmly by the Supreme Court in Actavis with regard to the FTC's position that reverse settlement agreements were a per se antitrust violation.  Treading cautiously, the statement further warns that "improperly listing patents in the Orange Book may also be worthy of enforcement scrutiny from government and private enforcers under a monopolization theory" and calls out the possibility (or likelihood) that it "may also scrutinize a firm's history of improperly listing patents during merger review" (emphasis added).  Finally, the statement suggests that "individuals" (presumably corporate officers) who "submit or cause the submission" of patents improperly to the Orange Book may be held liable individually, and that a finding of a false certification under 21 C.F.R. § 314.53(c)(2)(ii)(R) could be sent to the Department of Justice for investigation of criminal liability.  Should all else fail, the Commission also states that it "may" dispute individual Orange Book listings through the FDA process set forth in 21 C.F.R. § 314.53(f)(1) that permits "any interested person" to request patent information in the Orange Book be corrected.

    Mostly in footnotes, the statement identifies no more than 10 cases in support of the statement (and one of those, Fed. Trade Comm'n v. Shkreli, 581 F. Supp. 3d 579, 637 (S.D.N.Y. 2022), involved the infamous "Pharma Bro" whose shenanigans can hardly be held up as a standard under which ethical branded drug companies conduct their businesses).  In view of the powers the Commission can wield, the assertions, allegations, and promises of future activities set forth in the statement cannot be ignored, but it also cannot help but raise the question of whether this tempest should not have remained in the teapot from whence it sprung, at least without further evidence that improper listing occurs frequently enough to significantly impact drug prices paid by the patients and payors the FTC is attempting to serve and protect from (in the Commission's view, apparently) predatory branded drug companies.

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

    By Kevin E. Noonan —

    Federal Circuit SealThere 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

  • ACI Passport to Proficiency on Essentials of Hatch-Waxman and BPCIA

    ACIThe American Conference Institute (ACI) will be presenting its 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA as part of its VIRTUAL proficiency series on October 10-26, 2023.  The course provides a primer on IP basics and regulatory fundamentals relating to small molecules and biologics for practitioners representing brand name, generic, and biopharma drugs.

    The three week virtual course is set out in three topic areas.  Week 1 (sessions on October 10th and 12th) will set forth the regulatory foundation of pharmaceutical patent protection and regulatory approval.  These sessions will discuss the interplay of the FDA and PTO; pre-commercialization concerns; the links between the drug approval process at FDA and patenting before the USPTO; and discuss the intricacies of the Orange Book.

    Week 2 (October 17th and 19th) explore the Hatch-Waxman and BPCIA regulatory frameworks, including the Hatch-Waxman landscape; Paragraph IV dispute and litigation; biosimilars, the BPCIA and aBLA; participation in the "patent dance" set out in the BPCIA statutory regime; and the Purple Book, the biologics/biosimilar counterpart of the Orange Book, as well as the distinctions between the two.

    Week 3 (October 24th and 26th) will focus on bioequivalence, exclusivity, extensions, and exceptions.  These sessions will discuss bioequivalcency, interchangeability, and the distinctions between the two; the 180-day exclusivity provided to first generic filers under Hatch-Waxman; non-patent/regulatory exclusivities; exploring the safe harbor for research under 35 U.S.C. § 271(e)(1); and obtaining patent term extensions.

    Instructors include Li Feng/Finnegan, Henderson, Farabow, Garrett, and Dunner; Rachel L. Pernic Waldron/Rakoczy Molino Mazzoci Siwik; David B. Abramowitz/Locke Lord; Michael A. Davitz/Leason Ellis; Daniel Klein/Groombridge, Wu, Baughman & Stone; Frederick Ball/Duane Morris; Dov Grossman/Williams & Connolly; Keeto Sabharwal/Husch Blackwell; Daniel P. Margolis/Allen & Overy; Bryan Vogel/Robins Kaplan; April Weisbruch/McDermott Will & Emery; Kyle Musgrove/Parker Poe Adams & Bernstein; Gary Vernon/Hogan Lovells; Mureen Rurka/Winston & Strawn; Christina Markus/King & Spaulding; Jordan Markham/Steptoe & Johnson; Christopher Noyes/WilmerHale; Brian Burgess/Goodwin Proctor; Lara E. FitzSimmons/ Rakoczy Molino Mazzoci Siwik; David Ffazier/Latham & Watkins; Rob Vrna/Young Conaway Stargatt & Taylor; Fabian Koenigbauer/Ice Miller; and Matthew Murphy/Axinn, Veltrop & Harkrider.

    The brochure, agenda, and registration information can be found here.  The registration fee for the program, including all modules, is $1,795 if registration and payment is received by September 22, 2023 and $1,895 if registration and payment is received by October 10th.  ACI can be contacted by e-mail at customerservice@americanconference.com and by telephone at 1-888-224-2480.

    Patent Docs readers can save 10% by using promo code: D10-999-PD24.

  • ACI Paragraph IV Disputes Master Symposium

    ACIThe American Conference Institute (ACI) will be presenting its 9th Annual Paragraph IV Disputes Master Symposium on October 24-25, 2023 in Chicago, IL.  As in the past, this curated program will not only address "hot" topics but also will put the issues within the context of pre-suit considerations, case filings, final adjudication, and every step in between.

    This year's co-chairs are Laura DeMoor, IP Associate General Counsel, Baxter Healthcare Corp.; Andrea D. Tiglio, Executive Director, Assistant General Counsel, Intellectual Property, Jazz Pharmaceuticals; and Honorable Theresa Rea, Partner, Crowell and Moring.

    Sessions include the following topics:

    • Patents, Drug Pricing, and Price Controls: Understanding the Inflation Reduction Act (IRA) Will Impact The Value of Pharmaceutical IP
    • Insights on the Future of §112: Satisfying the Requirements of Enablement and Written Description under Amgen v. Sanofi
    • The Pain of Rejection: A Deep Dive into the Business and Legal Implications of the Supreme Court's Denial of Cert. in Recent Patent Eligibility and Carve-Out Cases
    • What Every U.S. Pharmaceutical Patent Litigator Needs to Know About the Unitary Patent (UP) and the Unified Patent Court (UPC)
    • Patent Reissue and Reexamination in the Hatch-Waxman Realm: Strategies for When to Pursue and Correct Patent Errors
    • Brand and Generic Insights on FDA Programs Impacting Pharmaceutical Patents: Regulatory Initiatives and Recent FDA Litigation Every PIV Practitioner Needs to Know About
    • A 360 Degree Examination of Reverse-Payment Settlements: Non-Monetary Provisions, State Legislation, Expert Testimony, and Recent Litigation
    • A Comprehensive Handbook for Pharmaceutical Patent Litigation Funding and Alternative Fee Arrangements
    • Ethics Case Studies on Cybersecurity, Information Security, and the Ethical Protection of Data

    Also included are a Chief IP Counsel Roundtable on day-to-day concerns and forward-looking strategic planning; a Magistrate Town Hall on Understanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings featuring the Hon. Christopher Burke from the District Court of Delaware; a View from the Federal Bench on District Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Settlements and Timings, featuring the Hons. Tonianne J. Bongiovanni from the District Court of NJ and Joshua Wolson of the Eastern District Court of Pennsylvania; an FTC Keynote address on Antitrust Developments concerning Brands and Generics from Rebecca Egeland; and a collection of APJs from the PTAB speaking about practices, policy, and procedures, including the Hons. Linda Horner and Grace Obermann.

    The brochure, agenda, and registration information can be found here.  The fee for the conference is $2,395 for registering and payment by October 25, 2023, with a special in-house counsel rate of $1,895.  ACI can be contacted by e-mail at customerservice@americanconference.com and by telephone at 1-888-224-2480.

    Patent Docs readers can save 10% by using promo code: D10-999-PD24.

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

    By Kevin E. Noonan —

    Federal Circuit SealIn 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

  • Broad Files Reply Brief in Interference No. 106,115 Cross-Appeal

    By Kevin E. Noonan —

    Broad InstituteIn its contingent cross-appeal from the Patent Trial and Appeal Board's (PTAB) adverse decision on priority against Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") in Interference No. 106,115 (directed to CRISPR-mediated gene editing), Senior Party Broad Institute, Harvard University, and MIT (collectively, "Broad") argues that the PTAB erred in denying two Preliminary Motions in that interference.  The first, Broad's Motion No. 2 would have changed the Count to encompass double-guide RNA (dgRNA) species of the CRISPR-Cas9 complex, and the other (Motion No. 3) would have designated certain (a majority) of Broad's claims as not corresponding to the Count.  On July 24th, Broad filed its Reply brief to CVC's responsive brief against Broad's appeal.

    The basis for Broad's appeal (which the brief acknowledges the Federal Circuit will not address unless the Court overturns the Board's decision in its favor on priority) is that the Board did not give the term "guide RNA" it broadest reasonable interpretation.  This argument relies on what Broad contends was the understanding of the term at the time the invention was conceived and reduced to practice (~late 2012), which would have included both dgRNA and single-guide RNA (sgRNA) species, the latter being the species the Board declared the Count to exclusively encompass.  Broad further argues that the Board's limited construction was not consistent with the definition of guide RNA in its specification(s), and also argues, counter to CVC's contentions, that the Court has discretion to address the claim construction issue regardless of whether that interpretation would affect the Board's decisions on these Motions.  The importance of the interpretive scope given the term "guide RNA" is that if the Count was broadened to include dgRNA Broad's evidence regarding its purported earlier reduction to practice of dgRNA embodiments of eukaryotic CRISPR could be used to establish their priority claim.  Regarding Motion No. 3, a decision in Broad's favor would have left Broad with dominating claims for CRISPR performed using either guide RNA species (similar to the position CVC was in at the conclusion of the earlier interference between these parties, No. 106,048, with regard to claims to eukaryotic cells versus claims not limited to biological species).  Broad also argues the ultimate issue, that the Board erred in not granting its motions.

    On the specifics, the brief cites Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1301-02 (Fed. Cir. 2015), for the principle that "if there are different reasonable constructions of a claim term to the POSITA in light of all of the evidence, the Court must adopt the broadest of those constructions."  The brief also cites the Jinek 2012 reference (from CVC's Doudna lab; Jinek et al., 2012, "A Programmable Dual-RNA–Guided DNA Endonuclease in Adaptive Bacterial Immunity," Science 337(6096): 816-21))) that the term "guide RNA" would be understood by one of ordinary skill in the art to encompass both dgRNA and sgRNA CRISPR embodiments.  Broad argues than Jinek was the only reference prior to Broad's asserted conception that disclosed the sgRNA species, and that all other prior references disclosed the dgRNA form.  Moreover, Broad contends that Jinek disclosed this sgRNA as only an alternative to dgRNA-based CRISPR.  Further, the brief counters CVC's position in its responsive brief that Broad's specification provided an express definition that overcame the more generic meaning by arguing that "[where] a plain and ordinary meaning exists and the specifications as a whole do not clearly provide a different and narrower meaning, the plain meaning controls," citing Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1356-58 (Fed. Cir. 2004), and  Thorner v. Sony, 669 F.3d 1362 (Fed. Cir. 2012).  Broad's specification, the brief maintains, provides no support for the CVC's contention (or the Board's conclusion) that "guide RNA" should be limited to the sgRNA form.  Under these circumstances and the cited precedent the Board erred in choosing the narrower sgRNA-only construction, according to Broad.

    Broad appears to be on weaker rhetorical ground in challenging CVC's contention and the Board's conclusion that Broad's own specification equates "guide RNA" with "sgRNA," based on this sentence:

    In aspects of the invention the terms "chimeric RNA," "chimeric guide RNA," "guide RNA," "single guide RNA," and "synthetic guide RNA" are used interchangeably and refer to the polynucleotide sequence comprising the guide sequence, the tracr sequence and the tracr mate sequence [emphasis in brief].

    Broad's argument is that dgRNA and sgRNA fall within the scope of this definition because they both encompass "the guide sequence, the tracr sequence and the tracr mate sequence."  While this may be functionally true to the extent this disclosure was related to the structure of the guide RNA, it seems unsupported that sgRNA and dgRNA were used interchangeably.  And Broad's further arguments, that the sentence lacks such characteristics as reciting a phrase like "as used herein" to negate the disclosure's provision of a definition would not appear to negate the construction CVC asserts and the Board applied, even in the context of the Broad specifications using such definitional phrases elsewhere.  Broad's further contention that the word "interchangeably" can be reasonably interpreted to mean "that the concepts are used interchangeably only in certain contexts, and do not mean the same thing for all purposes" seems similarly uncompelling compared with the Board's interpretation.  Broad also argues that using the term "aspects" does not require an interpretation to apply to all aspects; while this may be true it seems to be a heavy burden for the Court to rebut the Board's interpretation in the context of the other rationales used in the interference.  Finally, the brief parses the meaning of "the" in the phrase "the polynucleotide sequence."  The brief distinguishes the cases (Rumsfeld v. Padilla, 542 U.S. 426 (2004), Shum v. Intel Corp., 629 F.3d 1360 (Fed. Cir. 2010)) cited by CVC to support its interpretation.  On the basis of all these arguments, Broad contends that "[t]he question before the Court is whether "guide RNA" must exclusively be read as limited to the single-molecule configuration.  Taking the specifications as a whole, the answer to that question is a resounding 'no.'"

    The brief then parses through various portions of Broad's specification(s) that disclose or could be construed to disclose dgRNA species as alternatives to sgRNA species and further argues the significance of dgRNA embodiments to Broad's proofs of earlier conception.  In doing so, Broad contends that the existence of examples of dgRNA CRISPR species is what is relevant, not experimental results and whether the skilled worker would have considered the dgRNA species to be operable.  Broad further argues that the PTAB erred under the rubric that "construction like the PTAB's here that reads out embodiments, especially preferred embodiments, is 'rarefy, if ever, correct,'" citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996); MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1333 (Fed. Cir. 2007); and Oatey Co. v. IPS Corp.,514 F.3d 1271, 1276 (Fed. Cir. 2008).  Finally, the brief cites disclosure in the specifications regarding dgRNA CRISPR embodiments that reflect experiments performed in 2011-2012 that provide an earlier priority date for the proposed Count having broadened scope that would result in Broad being awarded on that basis.

    The Broad concludes this portion of the brief by asserting the Court's discretion to revisit the Board's claim construction even if it would not affect the judgment on appeal, citing Thorner.

    The brief then counters CVC's argument that the Board had "independent bases" to reach its conclusions in denying Broad's Motions No. 2 and No. 3, asserting that claim construction is a "threshold issue" as recognized by the Board.  This is so because the motion were directed, the brief asserts, to "to bring the scope of the count of the interference in line with the scope of the involved claims, under the proper claim construction."  Moreover, in the event that the Board denied Motion No. 2 (which it did) Broad sought in Motion No. 3 to remove claims that were not limited to sgRNA (i.e., wherein inter alia the claims recited "guide RNA" which, in Broad's view encompassed both species and should be removed from the interference under a Count limited to sgRNA for that reason).  Denying both motions was error on this basis according to Broad and supported the Court reversing these decisions:

    "By simultaneously retaining Count 1 (denying Motion 2), while keeping Broad's generic RNA claims in the interference (denying Motion 3), the PTAB created a disconnect: Count 1 was not commensurate in scope with the involved claims and this worked a significant unfairness to Broad.  Under the PTAB's decision, the interference was not fulfilling its 'primary purpose' of determining the priority over 'the common inventions claimed by the parties,'" [in contravention of this purpose as enunciated by] Godtfredsen v. Banner, 598 F.2d 589, 592 (C.C.P.A. 1979) (overruled on other grounds).

    The Federal Circuit is expected to hear oral arguments by year's end.