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GSK and IP Experts Warn that the Supreme Court’s Decision Jeopardizes Drug Innovation

In its attempt for the US Supreme Court to intervene in a long-running dispute with Sanofi and Regeneron Pharmaceuticals Inc. over the destiny of Amgen’s cholesterol medicine patents, Amgen Inc. received backing from GSK plc and ten patent law scholars.In February, the United States Court of Appeals for the Federal Circuit ruled that Amgen’s Repatha patents covering hundreds of different antibodies were invalid because they wouldn’t allow a skilled artisan to construct all potential versions of the invention without unnecessary research.

In its amicus brief, GSK claims that the Federal Circuit is modifying the rules on when an antibody genus can be patented. “This tidal change threatens to obliterate the incentives for corporations like GSK to invest billions of dollars and hundreds of thousands of research hours in creating breakthrough treatments,” the report added.

Genus claims are “the core aspect of patent law in the biological sciences sectors,” according to the academics, led by Stanford Law School’s Mark A. Lemley. They contend in an amicus brief that without genus claims, a rival might make modest modifications to a patented chemical and “escape responsibility while seizing the core of the invention.”

Sanofi and Regeneron were sued by Amgen for allegedly infringing on its patents for Repatha with their competitive medicine Praluent. Amgen’s patents cover a class of antibodies known as PCSK9 inhibitors, which aid patients with ultra-high bad cholesterol (LDL) who are having trouble controlling their disease with commonly prescribed statins like Pfizer Inc.’s Lipitor.The patents should never have been awarded, according to the trial court, because it would require a significant amount of time and effort for an expert to reproduce the genera of antibodies claimed.

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