In an article published on May 25, 2023, in PharmaVoice, St. Louis-based Kisuk Lee provides commentary surrounding the impact on biologic patents in the wake of the Supreme Court ruling in Amgen v. Sanofi.

“The future of innovation is also a concern in Amgen’s other legal battle, which saw the Supreme Court strike down their arguments that Sanofi and Regeneron infringed upon patents for Repatha,” said Lee.

Amgen was trying to protect its patents for Repatha, its PCSK9-blocking cholesterol drug, from infringement from a similar drug. The company’s position was that blocking the PCSK9 gene was protected by an overarching patent. However, the court’s decision conveyed that it cannot use a broad patent to cover every antibody that binds to that gene. “This is really disappointing news for innovator companies, but it’s good news for generic companies,” explains Lee. “It’s a game changer.”

“While this allows generic companies to use any of the thousands of potential antibodies to make their own PCSK9 blockers, it could disincentivize companies that seek to find new ways to treat other conditions,” Lee added.

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