Litigation » Justices Skeptical About Patent Covering “Millions and Millions of Antibodies”

Justices Skeptical About Patent Covering “Millions and Millions of Antibodies”

April 13, 2023

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During arguments in Amgen Inc. v. Sanofi in late March, U.S. Supreme Court Justices expressed concern about the breadth of Amgen’s patent which addresses monoclonal antibodies that lower LDL (bad) cholesterol. It covers every monoclonal antibody that binds to particular spots on a particular protein and blocks that protein from binding to LDL receptors. Amgen’s counsel tried to focus the scrutiny on a few hundred “meaningfully distinct” antibodies covered by the patent, but counsel for Sanofin and several Justices viewed the patent as applying much more broadly. Amgen’s counsel said that the patent covers “millions and millions of antibodies,” which became the major focus of the argument. According to Eric M. Fraser, writing on Scotus Blog, the case has implications far beyond the LDL-lowering drugs at issue. The real question is what it takes to have a valid patent that covers an entire genus. One expert witness told the Court that broad genus claims, which are common in pharmaceutical, chemical, and biotech development,  “stifle innovation.”

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