Amici for Sanofi Add Their Two Cents as Amgen’s Day in High Court Approaches

Late last week, a slew of additional amicus briefs were filed with the U.S. Supreme Court in Amgen v. Sanofi, a closely-watched case that will consider the scope of the enablement inquiry under 35 U.S.C. § 112. More than 30 amici in total have now weighed in on the case.

The Court granted certiorari in November 2022 over the U.S. Solicitor General’s recommendation to deny the petition. The justices granted cert on one of the two questions presented:

“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.’”

Road to SCOTUS Recap

The appeal stems from the February 2021 decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) to uphold the District of Delaware’s grant of judgment as a matter of law (JMOL) that Amgen’s patent claims covering its Repatha cholesterol treatment were invalid for lack of enablement. The court found that Amgen’s composition claims were defined by meeting functional limitations, rather than by structure, and that the patent specifications didn’t enable the preparation of the full scope of the claims without undue experimentation.

Amgen’s patents at issue are U.S. Patents No. 8,829,165 (the “’165 patent”) and No. 8,859,741 (the “’741 patent”). They describe antibodies that work to lower low-density lipoprotein (LDL) cholesterol levels. Specifically, explained the CAFC at the time, “the ’165 and ’741 patents share a common written description and the specification discloses amino acid sequences for twenty-six antibodies, including the antibody (designated as “21B12”) with the generic name of evolocumab, marketed by Amgen as Repatha®…. The claimed antibodies are defined by their function: binding to a combinations of sites (residues) on the PCSK9 protein, in a range from one residue to all of them; and blocking the PCSK9/LDLR interaction.”

Amgen argued on appeal to the CAFC that the district court’s analysis of the “Wands factors” was improper. In In re Wands the Federal Circuit said that “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” These factors are applied once it has been shown that some experimentation is necessary to practice the patented claim in order to determine “whether the amount of that experimentation is either ‘undue’ or sufficiently routine such that an ordinarily skilled artisan would reasonably be expected to carry it out.”

The Federal Circuit ultimately held that “[w]hether a claim satisfies the enablement requirement of [Section 112] is a question of law that we review without deference” and that the district court “did not err in concluding that undue experimentation would be required to practice the full scope of these claims.” Amgen’s petition argued in part that this standard of review for enablement conflicted with Supreme Court precedent from Wood v. Underhill (1846), in which the Court opined that “the sufficiency of the description” enabling one skilled in the art to make and use the invention is “a question of fact to be determined by the jury.”

Sanofi filed its latest response brief with the Supreme Court on February 3, arguing that “Amgen misleadingly suggests that the Federal Circuit acknowledged adopting a novel test that raised the bar and erected high hurdles. In reality, the Federal Circuit simply pointed out that Amgen itself raised the bar and created its own high hurdles by asserting a monopoly over an entire genus of functionally-defined claims.”

Amici Urge Preserving the Status Quo

While most amici who weighed in last month were supporting Amgen, nearly all of the 16 amicus briefs submitted on February 9 and 10 are supporting Sanofi.

The American Intellectual Property Law Association (AIPLA) supports affirmance of the Federal Circuit’s decision, arguing that the ruling was factually-based and grounded in the statutory provisions and case law, and any changes to this area of law are for Congress, not the courts, to make. “The determination that the enablement disclosures in this case were inadequate was made with a time-tested method of analysis that has served the patent well by balancing the disclosure burdens on the inventor against the public interest in providing access to the invention,” said AIPLA.

Pfizer’s amicus brief in support of Sanofi asserts that Amgen’s patents are not directed to a “pioneering invention” and that a number of other companies in the space were conducting research on anti-PCSK9 antibodies to treat hypercholesterolemia at the same time. “Amgen’s patents are an attempt to monopolize that highly competitive therapeutic market,” wrote Pfizer. The brief added that the Federal Circuit’s decision did not create a new test for enablement but merely properly applied the Wands factors, explaining: “The issue here is not the test that was applied. It is instead the overbroad, functionally-defined patent claims that are not commensurate with the inventors’ contribution to the art.”

Eli Lilly urged the Court to affirm the Federal Circuit’s decision and to make it explicitly clear that “claims like Amgen’s—limited solely by functional results with no structural limitations whatsoever— are invalid under § 112.” The brief said that the claims at issue in the case are “directed to any and all antibodies that bind and block PCSK9” and that “the boundaries of Amgen’s claim are unbounded.”

Genentech, AstraZeneca, Bayer, Gilead and Johnson & Johnson also filed a brief supporting Sanofi, warning that weakening the Federal Circuit’s currently flexible enablement standard could have a disruptive effect on innovation. “[O]verbroad patents present barriers to the research, development, and provision of lifesaving therapies,” said the brief.

A number of public interest patient advocacy groups, including the Association for Accessible Medicines, the Public Interest Patent Law Institute and Arnold Ventures also weighed in to support Sanofi, arguing in part that a win for Amgen could stifle competition and result in fewer choices and higher prices for patients.

The case is scheduled for argument on March 27, 2023.

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Author: renaschild