Amgen Inc. v. Sanofi
Case Overview
The Supreme Court addressed the legal standard governing the validity of broad genus patent claims in the life sciences sector, specifically how much disclosure a patent applicant must provide to 'enable' a patent claim covering a vast number of antibody variants, resolving decades of circuit-court disagreement that had created uncertainty for pharmaceutical and biotechnology patent portfolios.
BrynoDC Coverage 5 videos
The Facts
Amgen Inc. held patents claiming a class of antibodies that block PCSK9, a protein that raises LDL cholesterol levels, covering all antibodies that bind to specific amino acid residues on PCSK9 and block it from binding to LDL receptors. Sanofi challenged the patents as invalid for lack of 'enablement', arguing the specification did not adequately teach those skilled in the art how to make and use the full scope of antibodies claimed without undue experimentation, because millions of potential antibody variants were claimed but only a few hundred exemplified in the patent.
The Application
Amgen's patents claimed all antibodies capable of binding to specific PCSK9 residues and blocking LDL-receptor interaction encompassing millions of potential variants but the specification disclosed only a few hundred specific examples and no general principle for identifying others within that vast functional class. Under the enablement standard, a skilled artisan reading Amgen's patent would need to conduct substantial trial-and-error experimentation to discover and validate the vast majority of antibody variants claimed, far exceeding what the specification taught. The breadth of Amgen's functional claim far outpaced the actual disclosure: claiming an entire genus without enabling a person skilled in the art to make and use the full scope of that genus violated the requirement that enablement be coextensive with the scope of claims. Accordingly, the Court found that while Amgen had enabled the specific examples disclosed, it had not enabled the broader functional genus it claimed, rendering those claims invalid under section 112.
The Conclusion
Decided May 18, 2023. The Court held unanimously that Amgen's broad genus patents were invalid for lack of enablement. The majority held that patent claims covering a broad functional genus must enable the full scope of that genus, claiming a vast array of antibodies while disclosing only a handful of examples required 'undue experimentation.' The ruling constrained broad functional claiming in the life sciences and strengthened challenges to foundational biotech patents.
No circuit court data for this case.
Flag an issue
This tracker is maintained by BrynoDC and is free because readers fund it. Support