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. The remaining amicus briefs in support of Respondents are the subject of this post.
Amicus briefs in support of Respondents
Like the amicus briefs in favor of the Petitioner, the briefs for Respondents recite some themes in common. These include that permitting patenting of Amgen's claims (and those like them) would upset the "balance" between disclosure and claim scope to the public's detriment. Many of the briefs discuss the history of the discovery of PCSK9, its biological activity and binding to the live LDL receptor, and how blocking this binding was effective in lowering serum cholesterol; Amgen did not invent or discover any of these relationships or uses for PCSK9 antibodies. Several briefs mentioned 35 U.S.C. 112(f) as an alternative for functional claiming of PCSK9 antibodies, and Consolidated Electric Light Co v. McKeesport Light Co., 159 U.S. 465, 472-76 (1895), was recognized as a seminal case supporting Respondent's position.
Fresenius Kabi ISA LLC's amicus brief argues that enablement provides balance to the public, and overbroad patents disrupt the balance to the public's detriment. The amicus is concerned about gamesmanship by which patentees will withhold disclosure in favor of broad, functionally claimed patents with staggered specific disclosures. Citing Consolidated Electric Light Co v. McKeesport Light Co., 159 U.S. 465, 472-76 (1895) (the lead case for respondent), amicus argues that there must be a robust enablement standard, and Petitioner's standard will "negatively affect competition" because patentees will use "broad, nonspecific patent disclosures to block entire fields of innovation."
The brief recites "tensions" between innovators and the public, accusing biopharma companies of disclosing a "drug peptide sequence" and holding back "details that are required by competitors to expand on and further innovate—or even actually use the peptide—based on the work of the initial application invention" (e.g., "details on physicochemical or functional properties of the drug" such as "glycan profile, charge profile, variants profile, impurity profile, immunochemical properties, and functional activities"), which amicus calls "gam[ing] the system." These allegations of claim shenanigans against biopharma companies extend to including claim language directed towards "therapeutically effective amount" and "excipients, adjuvants, or diluents" that may be capable of overextending patent protection inequitably (although such terminology certainly did not arise with biotechnology patents). Functional claiming is available, if desired, under 35 U.S.C. 112(f), says this amicus, which does not have the aforementioned negative impacts on innovation because it has consistently been construed to "limit the scope of the claim to only those specific structures described in the specification," citing Traxcell Techs., LLC v. Spring Commc'ns Co., 15 F.4th 1121, 1134 (Fed. Cir. 2021).
The brief contains a litany of opportunities for patentees to "control" patent prosecution and claim scope, including continuation applications (but warns of these being abused too, stating that "[w]ithout a robust enablement standard, continuation applications can be used to continually expand the scope of exclusionary patent rights unfairly by encompassing embodiments not appreciated or even discovered at the time of filing the original application") and suggests that continuation-in-part applications provide an avenue for any such desired (and deserved) protections (which might be at least a trifle unrealistic).
Finally, the brief uniquely argues that the change to a "first inventor to file" regime under the AIA has increased the risk of loosened enablement standards, because under the "first to invent" provisions of earlier U.S. patent law broadened claims could be challenged by earlier inventors but no more.
Eli Lilly & Co., Ipsen Bioscience, Inc., and Innovent Biologics, Inc. filed an amicus brief arguing that Amgen's claims violated the "letter, logic, and purpose" of the enablement requirement because they recited purely functional results. The patent bargain was raised as a basis for such claims to be invalid and amici accused Amgen of attempting to "control all antibody therapeutics to a particular target" which would be "indisputably detrimental to the public." The brief provides various calculations for the number of antibodies falling within the claim scope, noting the conventional "millions" in the argument but reciting in a footnote 2060 (1 x 1078) based on 6 CDRs and 10 amino acids/CDR and 20 amino acids.
Amici asserted that claims are "nothing more than a hunting license" contrary to Brenner v. Manson, 383 U.S. 519, 536 (1966), and that they are also not properly considered to be genus claims because they do not disclose a structural similarity between them, just their function in blocking PCSK9 binding to LDL receptor.
And amici countered Amgen's (actually GSK's) R&D efficiency argument with the hypothetical that a troll with Amgen's claims could "dramatically undermine resource allocation efficiency" and Amgen's airplane analogy to permit claiming all airplanes using the Bernoulli principle, saying that this illustrates the "perennial preemption problem" created by functional claims.
These amici also argue that the Federal Circuit's enablement jurisprudence comports with the legal tenets under Consol. Elec. and Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 256-257 (1928), that the boundaries of what is claimed should be clear, and distinguish Minerals Separation v. Hyde, based on Amgen not providing anything to optimize the claimed antibodies but rather encompassing "a virtually limitless universe of other, non-conservative antibodies," stating that "[t]o hold such paltry disclosure sufficient to enable claims preempting an entire technological field would turn the patent quid pro quo on its head," citing Ex parte Sloane, 22 U.S.P.Q. 222 (P.O.B.A. Jan. 18, 1934); In re Angstadt, 537 F.2d 498, 500, 503 (C.C.P.A. 1976); and Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984).
This brief also argues regarding the use of 35 U.S.C. 112(f) for functional claims such as Amgen's, because that portion of the statute "creat[ed] a limited exception to this Court's prohibition against functional claiming," citing Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 28 (1997) (but even that doesn't save Amgen's claims amici say because "none of Amgen's claims at issue are a combination of structural and functional elements" because reciting "monoclonal antibody" does not import sufficient structure).
Turning to patent policy, amici challenge Amgen and amici supporting Amgen's position with regard to the Federal Circuit's test harming the U.S. biotechnology and pharma industries, asserting that U.S. Biotech and pharma will continue global leadership using current interpretations of enablement law, based on assertions that the sector is "booming" and accuses Amgen of trying to "upend the legal regime that has empowered that growth, innovation, and undeniable benefit to the public" by upending the full-scope standard (!) "under the guise of an 'innovation' imperative." The brief sets forth as an example antibodies to cell surface marker CD20, wherein "four innovators developed six different antibody therapies for three different illnesses while targeting the same protein." They warn "if Amgen's interpretation of the Patent Act were the law of the land, the first party to obtain a functional claim to all antibodies that inhibit binding to a target could prevent market entry and/or extract rents from all future innovators for twenty years."
Pfizer filed a brief supporting Respondents, again reciting the quid pro quo patent bargain and that permitting claims such as Amgen's would preempt future research. While acknowledging that genus claims can provide important patent protection Amgen's claims went too far into purely functional claiming without sufficient structure to support them. "[I]t is the undue breadth of the claims and the exclusive rights [Amgen] seek['s] to encompass, rather than a heightened standard for enablement of genus claims, which led the district court and the Federal Circuit to conclude that the claims are invalid as a matter of law." The brief also calls these claims "a naked attempt to preempt future innovation and an unwarranted extension of the patent monopoly."
Another group of biotech and pharma companies, including Genentech, AstraZeneca Pharma, Bayer AG, Gilead Sciences, and Johnson & Johnson, filed an amicus brief where they argue that the Federal Circuit upholds genus claims that are supported by disclosure having appropriate scope using a flexible standard that is consistent with Supreme Court and its own precedent, including O'Reilly v. Morse, 56 U.S. 62, 120-21 (1853); Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 257-58 (1928); Consol. Elec. Light Co. v. McKeesport Light Co., 159 U.S. 465, 476 (1895). But that is not the case here, they argue, and the Federal Circuit properly invalidated the claims on enablement grounds. Their brief particularly decries arguments that merely showing how to make and use one embodiment could be enough, asserting that "[a] patentee who chooses to claim a broad functional genus, unlimited by claim language delineating the specific structures that achieve that function, will necessarily have to disclose more than a patentee claiming certain specified structures or species within that genus" (and that one of the Wands factors is claim breadth).
The brief states that "Amgen and its amici desire a regime where patentees can jump the gun, rushing to the patent office with broad functional genus claims before they have discovered and can explain how to make and use, without excessive brute-force experimentation, vast swaths of the genus claimed, including structurally dissimilar species which may vary substantially in how they perform the claimed function. But such unsupported broad claims "discourage rather than promote invention" by allowing a patentee to "foreclose efforts to discover other and better types" within the genus. Holland Furniture, 277 U.S. at 257; accord Consolidated Elec., 159 U.S. at 476."
Curiously, most of the scholarly works cited in support of the arguments made by amici are at least 10 years old and some are significantly older.
Another collection of industries, the Small and Medium Biotechnology Companies (which includes ABL Bio (USP 11,261,259), Kiniksa, OPKO Health, and SK bioscience) say the Court should adopt an "if it ain't broke, don't fix it" principle and emphasized the reliance interest on the Federal Circuit's enablement jurisprudence, stating "[t]he longstanding enablement standard is consistent with text and precedent. The balance it strikes promotes innovation and saves lives. And departing from the status quo would unleash harmful consequences for industry participants like Amici, for patients, and for the public." The Wands factors "are drawn from, and reflect" a century and a half of Supreme Court case law on enablement, and have been applied "evenhandedly" "for decades" they assert. The brief cites a number of "incumbent and follow-on innovators," illustrated by Humira®, Remicade®, Cimzia®, and Simponi®, all of which are TNF-alpha inhibitors and Skyrizi®, Tremfya®, and Illumya®, which inhibit IL-23, for the purported benefits of permitting patent protection for both types of innovation.
The same curious reliance on scholarly works cited are at least 10 years old and some significantly older is the case here as in Pfizer's brief.
In addition to the legal academics' amicus briefs that were the subject of previous posts, a collection of IP Law Professors (including Sean Tu, Arti Rai, Oskar Litvak, Kevin Collins, and Bernard Chao) filed a brief and argued that claims should be limited to what is disclosed because that is what is invented. In their view, "[t]rial-and-error inventing" (like Amgen's here, in their view) is inherently narrow, as evidenced by Amgen's "roadmap" disclosure, and the professors draw a distinction between trial-and-error to find the invention and trial-and-error in making and using what has been invented. Countering some of the more heated rhetoric from Amgen and its amici (by asserting "[t]here is no paradox, no death of anything or otherwise a need for alarm"), the professors write that "[t]his case presents a classic example of a narrow invention that is coupled to overbroad claims," which are overbroad because a patent applicant "can claim broadly only when [they have] disclosed structural features that unify different species." The brief cites several examples of competing antibodies that (putatively) would be precluded by grant of broad genus claims as Amgen advocates and the professors make the case that narrow antibody claims are more conducive to innovation in this area.
Much of the argument is taken from S. Sean Tu and Christopher M. Holman, Antibody Patents: Use of the Written Description and Enablement Requirements at the Patent & Trademark Office, 38 Berkeley Tech. L. J. (Figure 8) (2023 forthcoming) (available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4025167).
In her brief, Professor Robin Feldman takes the extreme position that "[t]his Court's precedent holds that the correct standard here is not undue experimentation but rather any experimentation," based on Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1847), which can be read this way, and Consolidated Electric Light Co. v. McKeesport Light Co., 159 U.S. 465, 474-75 (1895). She writes that overbroad claiming "could bar scientists and competitors from those building blocks of invention" (notice conditional phrase) and that the certiorari grant was improvident because the Supreme Court could validate the undue experimentation standard.
The AIPLA (whose brief "suggest[s]" affirmance) argues that the Federal Circuit applied established law but that while enablement does not require disclosure of all embodiments Wands is the correct legsal and analytical framework. The brief cites as examples the seemingly settled principle that one non-enabled embodiment is not enough to be undue experimentation and states that Amgen's argument that the Federal Circuit had developed a new "full scope" test is a "facile strawman."
The Association for Accessible Medicines filed an amicus brief wherein they argued that the Federal Circuit's decision aligns with statutory text and with the structure and purpose of the Patent Act, and that Amgen's theory will inhibit competition in the pharma industry. As in other briefs discussed above this brief emphasizes the patent bargain, the dangers of permitting overbroad claiming, and the availability of Section 112(f) for such claims (consistent with its enactment in response to the Supreme Court's Halliburton Oil Well Cementing Co. v. Walker decision, 329 U.S. 1 (1946). The brief focuses on the interplay between Sections 112(a) and 112(b) (wherein the latter defines the invention) and that the existence of the "using" requirement in Section 112(a) mandates disclosing how to use the invention, i.e., which species are operable.
The brief cites the usual litany of prior Supreme Court cases, such as O'Reilly v. Morse, Consolidated Electric, and Holland Furniture, and distinguishes cases Amgen cites by stating that "the issue in each case was that an operator seeking to use the invention would need to fill in some gaps in the patent's instructions to achieve the invention's desired outcome. This Court held in each case that the specification contained sufficient information for a skilled artisan to fill in those gaps." Which is not the case here, they argue.
The brief concludes by exhorting the Court to restrict "therapeutically effective amount" language and excipient claims (also argued by Fresenius Kabi ISA LLC, see above), citing biologic drugs with "secondary" characteristics not disclosed or claimed in protein composition of matter-claiming patents based on failure to disclose how to use a claimed biologic drug.
A sole generic drugmaker, Viatris Inc. filed an amicus brief making many of these same arguments, for example about the quid pro quo and the patent bargain, and asserts that deviating from the Wands precedent would destabilize U.S. patent law and innovation. Uniquely this brief also argues that changes in the enablement standard would have a "major ripple effect" into other areas of patent law including obviousness. This brief also ties enablement under 112(a) with the statutory requirements of defining an invention by claims in 112(b) as the basis for the scope of the claim be commensurate with the "full scope" of the invention as claimed. Asserting the crux of their argument the brief recites:
Accordingly, this Court has long held that the specification—"[a]ddressed as it is to those skilled in the art"—"may leave something to their skill in applying the invention" (Mowry v. Whitney, 81 U.S. 620, 644 (1872)), provided the requisite experimentation is routine rather than "painstaking" (Consol. Elec. Light Co. v. McKeesport Light Co., 159 U.S. 465, 475 (1895)) or "elaborate" (Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 256-257 (1928)).
A group of medical doctors and affiliated groups, styled in the caption as Arnold Ventures, National Centers for Health Research, and Certain Medical Doctors, filed an amicus brief whose arguments are directed to perceived negative consequences on innovation and competition in pharma, citing reports about high drug costs, many by the "certain medical doctors" themselves. They argue (as have others) that functional genus claims would permit pharma companies to use such claims to prevent other companies from developing different drugs to the same target. The brief cites four ways that adopting Amgen's position would hurt patients:
1) "multiple treatment options will be delayed in development and approval, or not available at all" (e.g., if the claimed drug fails in the clinic);
2) "patients will be forced to take medicine that may be either more risky or less efficacious—or both—than an alternative." (when first-to-market drugs are not the most efficacious);
3) "patients may not have the treatment option that works best for their specific circumstances" (when humans have differential responses to different drugs to the same target); and
4) "competition between innovators, under the right circumstances, can lower spending on brand-name drugs," stating that "[h]igh drug prices are a major cause of lack of patient access, or of long-term non-adherence to treatments, which contributes to thousands of excess hospitalizations and deaths annually."
The brief provides an informative schematic showing the timeline of PCSK9 research, which throws shade on Amgen's entitlement to a patent in view of what they contend Amgen did not invent:
and provides a series of tables showing "second to market" drugs that could have been precluded if Amgen's enablement position had been the standard:
The amicus filed by Unified Patents illustrated the concerns the enablement issue raised for patentees outside the biotech and pharma industries. This brief argues that functional claims impede innovation regardless of technology and that the "full scope" test is needed to prevent this negative outcome. In addition, the brief argues that the "full scope" test is not new but instead is supported by established precedent which Amgen's proposed test would overturn, citing Morse, Béné v. Jeantet, The Incandescent Lamp Patent, Corona Cord Tire Co. v. Dovan Chem. Corp., Holland Furniture and CCPA/Federal Circuit precedent and stating that:
The Court has identified three relevant factors: (1) whether the patent involves an area of invention where results are unpredictable; (2) whether the claim breadth vastly outstrips the disclosures in the specification; and (3) whether the patentee has demonstrated that the proven function of disclosed embodiments can be reliably extrapolated to non-disclosed embodiments within the claim scope.
For this amicus the greatest threat raised by Amgen's argument is the issuance of overbroad "high-tech" patents, devoting an entire section of the brief to this "problem" and stating that such broad functional claims would have an in terrorem effect on the public. The brief also provides a footnote asserting that a study of patent litigations estimated that 100% of NPE-asserted software patents and 50% of non-NPE asserted software patents utilized functional patent claiming. Colleen V. Chien and Aashish R. Karkhanis, Functional Claiming and Software Patents (Santa Clara Univ., Working Paper No. 06-13, 2013), https://ssrn.com/abstract=2215867).
The Court at oral argument and the parties cited amicus briefs they hoped would resonate with the Justices. It will be interesting to see if any of those briefs or the ones discussed herein have any influence on how the Court will rule.
