Supreme Court rules against Amgen in Repatha patent dispute with Sanofi/ Regeneron
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Update 12:13 PM EST: Adds comments from Regeneron
The U.S. Supreme Court unanimously ruled against Amgen (NASDAQ:AMGN) on Thursday in its bid to revive patents related to the PCSK9 cholesterol drug, Repatha, marking a legal victory for partners Sanofi (NASDAQ:SNY) and Regeneron (NASDAQ:REGN).
The justices upheld the U.S. appeals court ruling that found Amgen’s (AMGN) patent claims were invalid in a case centered on an area of patent law called “enablement.
Under the enablement requirement, a patent is deemed valid if it contains sufficient details to allow a person with ordinary skills in a relevant trade to make or use an invention without undue experimentation.
“The courts below correctly concluded that Amgen failed “to enable any person skilled in the art . . . to make and use the [invention]” as defined by the relevant claims,” the Supreme Court justices wrote.
The dispute started in 2014 when Amgen (AMGN) filed a lawsuit against Sanofi (SNY) and Regeneron (REGN) before FDA approval of the companies' rival PCSK9 drug Praluent.
The U.S. Supreme Court reviewed the case after an appeals court rejected Amgen’s (AMGN) bid to reverse a ruling in which a Delaware judge sided with Sanofi (SNY) and Regeneron(REGN) in 2019.
While Pfizer (PFE), Eli Lilly (LLY), AstraZeneca (AZN), and Johnson & Johnson (JNJ) filed multiple briefs in favor of partners, AbbVie (ABBV), Bristol Myers Squibb (BMY), Biogen (BIIB), Merck (MRK) and GSK (GSK) took opposing views.
Issuing a statement, Regeneron (REGN) welcomed the ruling as the nearly decade-old patent dispute comes to an end.
The decision “protects access to this medicine and defends our industry and others against overreaching patent claims that cover an entire therapeutic category and could have a chilling effect on bringing life-saving medicines to people in need,” CEO Leonard Schleifer remarked.