Amicus Briefing in Amgen v. Sanofi: The Rest of the Story – Part II | McDonnell Boehnen Hulbert & Berghoff LLP
The Supreme Court’s consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court’s granting certiorari in Amgen v. Sanofi. This has not surprisingly generated a great deal of interest and amicus briefing. While some of these briefs, for both Petitioners (see “Patent Law Academics File Amicus Brief in Amgen v. Sanofi”; “AbbVie Files Amicus Brief in Amgen v. Sanofi”; “GlaxoSmithKline Files Amicus Brief in Amgen v. Sanofi”) and Respondents (see “Esteemed Scientists File Amicus Brief in Amgen v. Sanofi on Respondents’ Behalf”; “Another Group of Law Professors File Amicus Brief in Amgen v. Sanofi”; “U.S. Government Files Amicus Brief in Amgen v. Sanofi”) have been the subject of earlier posts prior to oral argument last month, in the interest of completeness and because there were interesting positions taken and arguments raised in the remaining briefs, a more succinct but not cursory review of these briefs is warranted. Amicus briefs in support of neither Party are the subject of this post.
Amicus briefs in support of neither party
The amicus brief filed by the Intellectual Property Owners (IPO) argued that the enablement requirement “strikes a balance” on claim breadth with regard to the quid pro quo, from the perspective of the person of ordinary skill in the relevant art, and that it is important that the inquiry be based on the language of the statute. But even with these policy goals in mind, “an applicant is not required to describe in the specification every conceivable possible and future embodiment of his invention” they argue, citing Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003), and In re Angstadt, 537 F.2d 498, 503 (C.C.P.A. 1976).
Undue experimentation is the proper standard which is a fact-intensive inquiry that is helped but not limited to the Wands factors. However the inquiry is made, it must be applied in a predictable and fair manner that is consistent with the statutory language and longstanding precedent and should not “disrupt the settled expectations of the inventing community.” See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002), these amici argue. Also emphasized in their brief is the statutory presumption of validity that can only be overcome by clear and convincing evidence. When enablement does arise as an invalidity defense in federal district court, the burden always rests on the patent challenger to prove lack of enablement by clear and convincing evidence, under Microsoft Corp. v. i4i Limited P’ship, 564 U.S. 91, 100-03 (2011). On appellate review, courts ” give due deference to the fact-finder’s credibility determinations in weighing competing expert evidence,” citing Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 611 (1950). All this to say is that the IPO’s brief hews the course of its neutrality regarding either party in the dispute by sticking to these eternal verities of enablement law.
The Regenexbio, IGM Biosciences, and Adapative Phage Therapeutics brief was filed by a self-described group of “small to mid-sized biotech companies currently pursuing innovation across multiple platforms,” wherein Regenexbio is developing gene therapy approaches for treating “retinal, metabolic, and neurodegenerative diseases”; IGM Biosciences is developing IgM-based immunotherapies against “cancer, infectious diseases, and autoimmune and inflammatory diseases”; and Adapative Phage Therapeutics is developing bacteriophage banks that “provide evergreen, broad spectrum, and polymicrobial coverage.”
Their expressly asserted reason for filing their amicus brief is a concern that the Federal Circuit’s application of the enablement standard “threatens innovation in the life sciences” by “shift[ing] the burden from the challenger to the patentee to prove enablement of its issued patents” and “makes the burden of proving enablement nearly insurmountable for innovative start-ups, small-to-medium-sized companies, universities, and other innovators with limited resources.” This test will make innovators “waste precious resources by forcing them to reduce to practice not just instructive and illustrative examples but an undefined number of individual species that embody every ‘corner’ of the claims” they argue, which will be prejudicial to smaller companies. Accordingly, amici address the Court seeking “reasonable disclosure standards” for enablement.
Their arguments rely on the presumption of validity:
Amici rely on the statutory presumption of validity that adheres to every patent claim after the Patent Office examines and issues the patent. The presumption ensures that the innovative value captured by the claims will not be wiped away on a dubious or speculative case. It does so by placing the burden of proof on the patent challenger. And by requiring the challenger to meet that burden with clear-and-convincing evidence.
The reach-the-full-scope standard undermines that presumption. The Federal Circuit acknowledges this when it “raises the bar” or sets “high hurdles” for particular claims. These phrases lay the burden of proof on the patentee as soon as the court reads the claims. Further, they show that the court is adjusting the standard of proof to be higher for the patentee (or, more properly, lower for the patent challenger) than the standard codified in the statute.
Amici also argue that the Federal Circuit’s full scope test is inconsistent with constructive reduction to practice.
The Intellectual Property Law Association of Chicago (IPLAC — amici asserting that they are “the country’s oldest bar association devoted exclusively to intellectual property matters”) in their brief ask the Court to vacate and remand because the case can be settled by the application of the statute and stare decisis. “Enablement is not, because it never has been and never should be—but for decisions such as the reviewed one—a matter of whether the specification has catalogued all possible embodiments of invention and taught each of them; that is not the law” they assert. The brief relies heavily on the Karshtedt et al. law review article, and one by Jason Rantanen, The Doctrinal Structure of Patent Law’s Enablement Requirement, 69 Vanderbilt L. Rev. 1679, 1680 (2019). Both stand for the proposition that the Federal Circuit has recently “varied greatly from deciding enablement in a proper manner and muddled their own jurisprudence on the issue.” Their brief also criticizes In re Wands for leaving the definition of undue experimentation “amorphous”
The brief suggests that the Court’s decision in Consol. Elec. Light Co. v. McKeesport Light Co. (Incandescent Lamp), 159 U.S. 465 (1895), sets the standard for undue experimentation (albeit it should be recognized that this takes the definition from the extreme, where >6,000 failed attempts constitute undue experimentation; while that is certainly the case it seems unlikely to be encountered routinely). The brief distinguishes the Consol. Elec. standard with the facts below, where Respondent did not identify any antibody that would/could not be obtained using Amgen’s disclosure (the “roadmap”).
And In a sad or amusing footnote (depending on your prejudices) the brief sets forth a “list of areas of patent law in which this Court has overturned the Court of Appeals [that] is long, and the frequency of the overrulings notorious”; with two exceptions these cases were all decided in this century and over 80% since 2010.
Another local intellectual property law group, the New York Intellectual Property Law Association (NY IPLA) argued in its brief that the Federal Circuit has gone beyond the requirements of the plain language of the statute, which has been the standard applied by the court since In re Hyatt, 708 F.2d 712, 714 (Fed. Cir. 1983). But as applied to biotechnology inventions amicus argues that genus claims have required “disclosure of every species in the genus,” citing Wyeth v. Abbott Laboratories, 720 F.3d 1380, 1385 (2013), Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340, 1345–48 (Fed. Cir. 2019), and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149, 1160–63, 1165 (Fed. Cir. 2019), based on the court’s perceptions regarding “the uncertainty of the science and the required functionality.” The NYIPLA contend that “the requirement for enablement of the full scope of the claimed invention is not supported by the plain language of the statute and is contrary to th[e] Court’s holding as Minerals Separation v. Hyde, 242 U.S. 261, 270-71 (1916).”
Although the brief recognizes that there is a valid concern at issue, that an inventor not be “granted patent claim coverage that exceeds what the inventor has invented,” amici predict a severe adverse impact that would arise should the Court affirm the Federal Circuit test, specifically that “could lead inventors to disclose less than what they discovered, such as a functional relationship at the heart of why the invention works. Although the amicus appreciates the potential inequities that could be occasioned by claims like Amgen’s, on balance the consequences of affirming the Federal Circuit’s “full scope” test are worse due to the inherent unpredictability of the chemical and biotechnological arts, amicus argues, citing In re Fisher, 427 F.2d 833, 839 (CCPA 1970), for the principle that “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.”) Affirming the Federal Circuit would create a situation wherein “the inventor will have no incentive (or duty) to disclose the genus, which perhaps comprises the most important part of the discovery” and “[t]he rest will be kept from the public as a trade secret,” until such time that the patentee develops another species that can be subject to its own 20-year term.
While amicus argues that the Federal Circuit’s decisions “goes beyond the literal requirements of the statute’s plain language,” the brief also gives little credence to Amgen’s arguments that the Federal Circuit had only recently imposed an unnecessarily stringent enablement standard, citing earlier precedent to the same effect, including In re Fisher, 427 F.2d 833, 839 (CCPA 1970); In re Hyatt, 708 F.2d 712, 714 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, (Fed. Cir. 1991); In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993); and Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997).
Their solution: requiring disclosure of a “reasonable number of species” test for prosecution before the USPTO that could be limited at trial by claim construction and having undue experimentation be a defense against infringement species by species, the patentee being protected by the clear and convincing evidence standard (to the extent it is respected by district courts and the Federal Circuit in deciding JMOL motions).
As for disposition, the brief advises that “[i]n the present case, respectfully the Court should remand the case for a determination of whether the Sanofi antibody was obtainable from the disclosure in the Amgen patents with some — but not undue — experimentation at the time of the filing of the Amgen application.”
