Source: https://www.patentdocs.org/2019/01/supreme-court-denies-certiorari-in-amgen-v-sanofi.html
Timestamp: 2019-04-18 10:41:51+00:00

Document:
The Supreme Court denied certiorari last week in Amgen Inc. v. Sanofi, in a case that asked the Court to review the Federal Circuit's jurisprudence related to the written description requirement of 35 U.S.C. § 112(a).
To recap, the Federal Circuit overturned the "newly characterized antigen test" set forth in Noelle v. Lederman and brought treatment of the written description requirement for antibody claims in line with the Court's en banc decision in Ariad v. Eli Lilly. The case arose when Amgen sued Sanofi and Regeneron for over its Praluent® (alirocumab) product that could compete with Amgen's Repatha™ (evolocumab); Amgen's asserted patents, inter alia, included U.S. Patent Nos. 8,829,165 ("'165 patent") and 8,859,741("'741 patent"), functionally claim a genus of antibodies that encompass Sanofi's Praluent® product. As background, blood plasma contains low-density lipoproteins that bind cholesterol and are associated with atherosclerotic plaque formation. Liver cells express receptors for LDL (LDL-R) wherein binding thereto reduces the amount of LDL cholesterol in blood and reduces the risk of plaque formation and cardiovascular disease. PCSK9 (proprotein convertase subtilisin kexin type 9) is a molecule that binds to and causes liver cell LDL-R to be destroyed, thus reducing the capacity and effectiveness of the liver cell's ability to reduce serum LDL-cholesterol. The antibodies at issue in this suit bind to PCSK9 and prevent PCSK9 from binding to LDL-R, causing their destruction.
An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDL[-]R, wherein the monoclonal antibody binds to at least S153.
It is important to note that, while reciting the structure of the residues on PCSK9 that are bound by the claimed antibody, the claim does not recite any structural limitations of the antibody. The only antibody characteristics recited as limitations are functional, i.e., the ability to bind to at least one of the recited PCSK9 residues and block binding of PCSK9 to LDLR.
Further, the "newly characterized antigen" test flouts basic legal principles of the written description requirement. Section 112 requires a "written description of the invention." But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The test thus contradicts the statutory "quid pro quo" of the patent system where "one describes an invention, and, if the law's other requirements are met, one obtains a patent." Indeed, we have generally eschewed judicial exceptions to the written description requirement based on the subject matter of the claims [citations omitted].
Whether the standard for determining the adequacy of the "written description of the invention" should be as the statute says—that the description must be "in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same"—or whether court-created standards should control instead.
The Federal Circuit's departure from § 112(a)'s standard—and the bargain the Patent Act provides—has become intolerable. It does not promote research and investment required for the breakthrough inventions most deserving of patent protection; instead, incentives are shifted to narrow advances for which narrow patents can be obtained under the Circuit's sub-tests. The ever-evolving application of the "possession" standard has produced jurisprudential anarchy, leaving inventors uncertain whether disclosures are sufficient.
The petition also contained a section directed to the purported importance (on policy grounds) of the question presented, putative negative effects on innovation, dissension amongst Federal Circuit judges over the recognition of a separate written description requirement, and the disparate effects on biotechnology inventions.
Sanofi's responsive brief provided several reasons why the Supreme Court should not grant cert. First, the brief argued that this case was an "exceptionally poor candidate for certiorari," at least because the issue underlying the Question Presented was not raised by the parties below or addressed by the Federal Circuit (the Supreme Court is "a court of review, not of first view," according to the brief, citing Byrd v. United States, 138 S. Ct. 1518, 1527 (2018)). This argument was supported by Amgen's positions, in this case and as amicus in, inter alia, the Federal Circuit's Ariad decision, supporting the Federal Circuit's decisions on written description. Under these circumstances, Sanofi argued that the Court should consider the issue waived by Amgen. Raising judicial economy principles, the brief also argued that even if the Court granted certiorari and decided the case, its judgment was not dispositive (because the Federal Circuit remanded for the District Court to reconsider Sanofi's enablement challenge based on post-arising evidence the District Court "improperly excluded") and that the case remained ongoing below. Turning to stare decisis, the brief argued that there was no reason for the Court to "disrupt more than fifty years of settled precedent" by reviewing the Federal Circuit's written description case law. Sanofi asserted that the Federal Circuit had come to the right conclusions in how its written description jurisprudence had developed, and again asserted to the Court that Amgen had "vastly overstate[d]" the importance of the Question Presented.
It is impossible to know, of course, why the Supreme Court decides whether or not to grant cert. Whether this decision signals a lessening of the Supreme Court's interest in deciding patent law cases, what we do know is that the Court will not yet be reviewing how the Federal Circuit applies the written description requirement to antibody claims.

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