U.S. Supreme Court Affirmed Patent Enablement Requirement In Amgen

• Published date: 06 June 2023
• Law Firm: Baker Botts
• Author: Mr Steve Lendaris

On May 18, 2023, the U.S. Supreme Court issued its opinion in Amgen et al. v. Sanofi.¹ The Court unanimously affirmed the Federal Court's holding that Amgen's relevant patent claims were invalid as the patent failed "to enable any person skilled in the art . . . to make and use the [invention]" as required by 35 U.S.C. §112(a). Specifically, the Court reasoned that Amgen's patent failed to enable the full scope of the claimed antibodies, a scope determined to be "much broader than those 26 antibodies [identified in the specifications]," even allowing for a reasonable degree of experimentation.

Amgen's patents at issue claim a class of monoclonal antibodies that can lower low-density lipoprotein ("LDL") cholesterol levels.² The claimed genus of antibodies bind to a particular region or "sweet spot" on a particular protein, PCSK9, involved in regulating the levels of LDL receptors.³ Because PCSK9 can degrade LDL receptors responsible for extracting LDL cholesterol from blood-stream, it can contribute to high cholesterol levels. By binding to PCSK9 and blocking it from contributing to high cholesterol levels, members of Amgen's claimed genus of antibodies were shown to be therapeutically effective at maintaining healthy cholesterol levels. While the Amgen's patents describe 26 exemplary antibodies, the claimed genus would encompass millions of antibodies—including those unknown at the time.

After obtaining the '165 Patent and the '741 Patent, Amgen sued Sanofi for patent infringement. The case was tried to a jury twice at the U.S. District Court for the District of Delaware.⁴ During the first jury trial, the jury found that Amgen's relevant patent claims satisfied both the written description and enablement requirements under 35 U.S.C. §112(a). On appeal, the Federal Circuit reversed the jury verdict and remanded for a new trial finding that the District Court erred by excluding post-priority date evidence of the written description and enablement.⁵ The second jury also sided with Amgen finding that the enablement requirement was met.⁶ Sanofi, however, moved for JMOL and, in alternative, for a new trial. The District Court granted Sanofi's motion for JMOL for lack of enablement and denied the motion for lack of written description.⁷ On appeal, the Federal Circuit affirmed the District Court's finding a lack of enablement finding that the claimed genera—even with functional limitations—were broader than what is supported by the disclosed examples. In reaching its decision, the Federal Circuit found that...