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Monday, March 27, 2023

Supreme Court mulls Amgen bid to revive cholesterol drug patents

 Amgen Inc sought to convince the U.S. Supreme Court on Monday to revive patents on its cholesterol-lowering drug Repatha, while rival Sanofi SA urged the justices not to stifle competition for therapies to address a common health risk.

The justices heard arguments in Amgen's appeal of a lower court's ruling that invalidated two of its patents on Repatha, a drug that can reduce risk of heart attack and stroke in people with heart disease, after a legal fight with French drugmaker Sanofi and its partner Regeneron Pharmaceuticals Inc.

Questions asked by the justices indicated they were seeking to clarify the technical issues involved, pressing lawyers for both companies about what legal test to use to determine the validity of patents involving laboratory-made antibodies - protective immune system proteins.

The case carries considerable financial stakes. Thousand Oaks, California-based Amgen sold nearly $1.3 billion worth of Repatha worldwide in 2022. Meanwhile, Sanofi and Regeneron last year sold $530 million worth worldwide of their rival drug Praluent, which works by a similar mechanism as Repatha.

Amgen has sought to patent a group of antibodies that help reduce so-called "bad" cholesterol, though its patents disclosed only a subset of antibodies it claimed. At issue is whether a valid patent can cover all the members of an identified group, or if it is limited to only those members of the group specified by the patent owner.

Amgen's lawyer, Jeffrey Lamken, and Sanofi's attorney, Paul Clement, both said a ruling against the company they represent would hurt innovation. Lamken argued that companies would not invest in research if they cannot receive patents for what they invent.

Clement urged the court not to squeeze out competition from the market for cholesterol-lowering drugs.

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