The U.S. Supreme Court will entertain Amgen‘s (Nasdaq: AMGN) pursuit to revive patents for the monoclonal antibody cholesterol drug Repatha (evolocumab), which Regeneron (Nasdaq:REGN) and Sanofi (Nasdaq:SNY) had invalidated with legal challenges.
In 2014, Amgen initiated litigation against Sanofi and Regeneron, arguing that the two companies had infringed its PCSK9 patent related to evolocumab when they sought approval for the cholesterol drug Praluent (alirocumab). FDA approved the two drugs weeks apart in 2015.
The patents covering evolocumab include 8,563,698, 8,829,165 and 8,859,741.
Amgen had sought an injunction to block Sanofi and Regeneron from marketing alirocumab.
In September, the U.S. Solicitor General (SG) accepted the Supreme Court’s invitation to file an amicus brief recommending that the Court deny Amgen’s petition.
According to an Amgen spokesperson, the Amgen Inc. vs. Sanofi case could prove to be essential for “the entire biotechnology and pharmaceutical industry to make the significant investments required to discover and develop new innovative therapeutics.”
The Supreme Court’s decision could have far-reaching implications for patenting antibodies.
The Amgen patents in the case relate to an antibody genus that is defined by function rather than structure — namely, the ability of antibodies to bind to portions of the PCSK9 antigen.
In 2021, evolocumab generated $1.1 billion in revenue. That same year, alirocumab generated $370 between Sanofi and Regeneron.
Amgen submitted a Biologics License Application to FDA for evolocumab on August 28, 2014.
Amgen has won a pair of patent cases in recent years. In 2021, the U.S. District Court for the District of New Jersey upheld patents related to the psoriasis drug Otezla (apremilast) in a lawsuit against Sandoz and Zydus Pharmaceuticals. Two years earlier, the U.S. District Court for the District of New Jersey ruled in Amgen’s favor in a case involving two patents related to Enbrel (etanercept).