U.S. Supreme Court justices on Monday weighed a bid by Amgen Inc to revive patents on its cholesterol-lowering drug Repatha in a legal effort that rival Sanofi SA called a 'blatant attempt' to squeeze competitors out of the market.
Questions asked by the justices during arguments in the case indicated they were seeking to better understand 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.
Justice Ketanji Brown Jackson wondered how the company has "satisfied enablement" by claiming a large group but focusing its patents on a smaller group. In 2014, Amgen sued Sanofi and Regeneron for patent infringement over their rival drug Praluent, which works by a similar mechanism as Repatha. Both drugs use laboratory-made antibodies to block a protein called PCSK9 that inhibits the removal of bad cholesterol from the blood, but they achieve this result through different chemical combinations.
The Washington-based U.S. Court of Appeals for the Federal Circuit, which hears all patent appeals nationwide, invalidated Amgen's patents that covered PCSK9-blocking drugs as a group. The Federal Circuit in 2021 ruled that Amgen's patents granted by the government lacked the kind of detailed guidelines needed to replicate the full scope of its claims without "undue experimentation.
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