2023-05-18 11:10:46 ET
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 its 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.
For further details see:
Supreme Court rules against Amgen in Rapatha patent dispute with Sanofi/ Regeneron