Amgen Inc. v. Sanofi, et al.
Docket No. 2020-1074 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1074.OPINION.2-11-2021_1731739.pdf)
PROST, LOURIE, HUGHES
November 7, 2022 Update (original decision on February 11, 2021)
Fourth Update (May 18, 2023): SCOTUS concludes Amgen’s specification does not support “’the entire genus’ of antibodies that (1) ‘bind to specific amino acid residues on PCSK9,” and (2) ‘block PCSK9 from binding to [LDL receptors]’” as it only “identified the amino acid sequences of 26 antibodies that perform these two functions.” Decisions cited in support of its conclusions include Bonito Boats, Inc. v. Thunder Craft Boats, Inc. (“[t]he patent “bargain” describes the exchange that takes place when an inventor receives a limited term of “protection from competitive exploitation” in exchange for bringing “new designs and technologies into the public domain through disclosure” for the benefit of all”), O’Reilly v. Morse (“claim covered all means of achieving telegraphic communication, yet Morse’s specification did not describe how to make or use them all”), The Incandescent Lamp Patent (“rather than confining their claim to carbonized paper, “made a broad claim for every fibrous and textile material”), and Holland Furniture Co. v. Perkins Glue Co. (“specification described the key input—the ‘starch ingredient’—in terms of its ‘use or function’ rather than its ‘physical characteristics or chemical properties’). The Court stated that these decisions “reinforce the simple statutory command: If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.” Amgen’s claims, the Court concluded, “bear more than a passing resemblance to the broadest claims in Morse, Incandescent Lamp, and Holland Furniture” as “Amgen seeks to monopolize an entire class of things defined by their function—every antibody that both binds to particular areas of the sweet spot of PCSK9 and blocks PCSK9 from binding to LDL receptors—the record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid sequences, but a vast number of additional antibodies that it has not.” The Court explained that “the Federal Circuit’s treatment in this case is entirely consistent with Congress’s directive and this Court’s precedents.”
Third Update (November 7, 2022): SCOTUS granted certiorari regarding the second question raised in Amgen’s request regarding it functional anti-PCSK9 antibody-related claims and the District Court (DC) (Amgen Inc., et al. v. Sanofi, et al., Civ. No. 14-1317- SLR (D. Del.), judgment entered on January 3, 2017; Amgen Inc., et al. v. Sanofi, et al., Civ. No. 14-1317- RGA (D. Del.), judgment entered on October 3, 2019) and Federal Circuit (FC) (Amgen Inc., et al. v. Sanofi, et al., No. 2017-1480 (Fed. Cir.), judgment entered on October 5, 2017; Amgen Inc., et al. v. Sanofi, et al., No. 2020-1074 (Fed. Cir.), judgment entered on February 11, 2021) findings that those claims were invalid for lack of enablement. SCOTUS will consider Question 2: “Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort’”. The DC’s finding of a lack of enablement of Amgen’s anti-PCSK9 antibody claims 19 (“binds to at least two of the following residues…listed in SEQ ID NO:3) and 29 (“binds to at least two of the following residues…listed in SEQ ID NO:3 and blocks the binding of PCSK9 to LDLR by at least 80%”) of US 8,829,165 and claim 7 (“wherein the epitope is a functional epitope”) of US 8,859,741 was affirmed by the FC in February 2021, and Amgen’s request for rehearing en banc was denied in June 2021. Amgen’s petition for certiorari to SCOTUS on Nov. 18, 2021 asked for review of two questions: 1) “Whether enablement is aa question of fact to be determined by the jury,’ Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or ‘a question of law that [the court] review[s] without deference’…as the Federal Circuit holds”; and, 2) “Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort’”. Amicus curiae supporting Amgen’s position were filed on Dec. 22, 2021 by the Assoc. Univ. Tech. Managers (e.g., “the decision below cannot be reconciled with the language of the Patent Act and this Court’s precedent”), GSK (e.g., “Genus claims are critical to protect innovations of companies like GSK, as well as smaller entities and academic institutions, and to encourage investment and collaboration”), and Intellectual Property Professors (e.g., “The central feature of patent law in the life sciences industries is the genus claim.”) Sanofi filed a brief in opposition on March 14, 2022. In April, SCOTUS invited the Solicitor General (SG) of the United States to file a brief expressing its view, which was filed on Sept. 21, 2022. Regarding Amgen’s first question, the SG argued that “[t]he lower courts’ finding of no enablement followed naturally from their conclusions as to the Wands factors, including that ‘no reasonable factfinder could conclude that there was adequate guidance beyond the narrow scope of the working examples’ or ‘that anything but ‘substantial time and effort’ would be required to reach the full scope of claimed embodiments”, and “Petitioners do not contend that they could prevail on enablement despite the individual Wands factors having been resolved against them.” As to Amgen’s second question, the SG argued that SCOTUS’ previous “decisions confirm that the full scope of the claims must be considered in assessing enablement” (citing n Consolidated Electric Light Co. v. McKeesport Light Co., 159 U.S. 465 (1895); Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928)), Amgen’s “case-specific argument[s]” do “not warrant this Court’s review”, “disclosing how to produce some antibodies that perform a specified function is not equivalent to disclosing how to produce all such antibodies—and it is the latter that petitioners claim as their invention”, Amgen’s concern that “that the court of appeals’ standard is “‘impossible’ to satisfy any time a genus claim covers a ‘nontrivial’ number of embodiments’…is overstated” (citing McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091, 1099 (2020); Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co., 276 F. Supp. 3d 629, 662-663 (E.D. Tex. 2017), aff’d, 739 Fed. Appx. 643 (Fed. Cir. 2018), cert. denied, 140 S. Ct. 449 (2019); and Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380, 1386 (Fed. Cir. 2013) (“[e]ven ‘a considerable amount of experimentation is permissible”)), and the Federal Circuit does not “apply ‘a different,’ more stringent ‘enablement test for genus claims’ than for other types of claims” as its position here “simply reflect the fact that a disclosure must be ‘commensurate with the scope of the claims’” (citing National Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999)). The SG therefore requested denial of Amgen’s require for a writ of certiorari. As for the written description issues highlighted previously in our discussion of the Juno and Biogen cases, this case has been and will continue to be of great interest to those in the biotechnology and pharmaceutical industries.
Update (June 21, 2021): Petition for rehearing en banc denied. Judges Lourie, Prost and Hughes authored an opinion issued with the order. In it, the judges explained that Amgen incorrectly argued that the FC has “created a new test for enablement” as “[g]enus claims, to any type of invention, when properly supported, are alive and well” (referring to “[c]hemical patent specifications”). However, the opinion explained that “as with genus claims to chemical compounds, if” biological composition claims “encompass more subject matter than just a few species, they need to be enabled accordingly” (“Biological compositions not actually prepared need to be described constructively, if required to enable the full scope of the claims, with procedures and names of resultant compositions, as with chemical compositions…If the genus had been invented by the time of filing, it would have been fully enabled in the patent.”) In this case, the judges wrote, “the narrow and limited guidance in the specification made far corners of the claimed landscape that were particularly inaccessible or uncertain to make unenabled” and given that “Amgen in fact has separate patent protection on the PCSK9 antibody” (U.S. 8,030,457), “the failure to obtain unsupported, unenabled claims has not deprived it of patent protection on the fruits of its investment.” The opinion also states that the innovator can rely on the doctrine of equivalents to protect compounds “so close to species disclosed and claimed by a first entrant as to be an equivalent” and that the “second comer may encounter the expensive hurdle of having to meet its own regulatory requirements, if it does not qualify for ANDA or biosimilar status.” Regarding functional claims generally, the opinion states that the analysis “is circular; enablement comes only with success, which depends upon enablement”, “one cannot claim everything that works”, “single means claims claim too much” (citing In re Hyatt, FC 1983), and “[m]ultiple means claims simply compound the problem.” The opinion also refers to many earlier enablement decisions, noting that “[t]he much-cited Wands case is the signature authority on the issue” (In re Wands, FC 1988).
Brief Summary of Original FC Panel Opinion: DC lack of enablement of Amgen’s anti-PCSK9 antibody claims affirmed. Summary: Amgen appealed DC grant of JMOL for lack of enablement of claims 19 and 29 of US 8,829,165 and claim 7 of US 8,859,741 directed to antibodies against PCSK9. In a prior appeal related to this suit, the FC remanded the DC decision with respect to “its evidentiary rulings and jury instructions regarding Sanofi’s defenses that the patents lack written description and enablement” and vacated the permanent injunction (Amgen, FC 2017). Relevant to this appeal, “[t]he jury again found that Sanofi failed to prove that the asserted claims were invalid for lack of written description and enablement”, but the DC “granted Sanofi’s Motion for JMOL for lack of enablement and denied the motion for lack of written description.” The FC panel explained that it reviewed enablement decision without deference and the underlying factual findings for clear error, and the requirements of an enablement determination (e.g., undue experimentation, Wands factors (Alcon, FC 2014; In re Wands, FC 1988 (“‘go to’ precedent for guidance on enablement”, “disclosure adequately taught using hybridoma technology to produce the needed claims antibodies”)). It also explained that “[a]lthough a specification does not need to ‘describe how to make and use every possible variant of the claimed invention, when a range is claimed, there must be reasonable enablement of the scope of the range’” (McRO, FC 2020, citing AK Steel, FC 2003). Amgen argued that “no undue experimentation is required to obtain antibodies fully within the scope of the claims” by, e.g., “following a roadmap using anchor antibodies and well-known screening techniques described in the specification or by making conservative amino acid substitutions in the twenty-six examples” (e.g., “binds to at least one of the following residues” on PCSK9, “an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO:3, and…blocks the binding of PCSK9 to LDLR” (low-density lipoprotein receptor)). Sanofi argued “that there are millions of antibody candidates within the scope of the claims” the specification lacks sufficient guidance, and “antibody generation is unpredictable”. The FC panel reviewed the Wands decision as well as its Wyeth (FC 2013 (no enablement of “methods of preventing restenosis with compounds having certain functionality requirements”), Enzo (FC 2019 (claims requiring “particular structure and functionality” not enabled), and Identix (FC 2019 (no enablement due to “lack of guidance across…full scope”, “needle in a haystack”) decisions. The FC panel also wrote that “functional claim limitations…pose high hurdles in fulfilling the enablement requirement for claims with broad functional language”. And it concluded that “[t]he binding limitation is…require[s] undue experimentation” since, e.g., “the claims are far broader in functional diversity than the disclosed examples” (AbbVie, FC 2014), “this invention is in an unpredictable field of science”, and the “required experimentation ‘would take a substantial amount of time effort’”. The FC panel therefore affirmed the DC decision.