Amgen Inc. v. Sanofi, et al.
PROST, LOURIE, HUGHES
February 11, 2021 (updated June 21, 2021)
Update (June 21, 2021): Amgen’s petition for rehearing en banc was 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.” Regarding Amgen’s arguments regarding the rewards for innovation, the opinion explains 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). Summary of Feb. 11, 2021 FC panel decision: 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.