Amgen wins patent battle against Novartis for blockbuster arthritis drug Enbrel
Enbrel generated $5.01 billion in sales for Amgen in 2018 and belongs to a class of medications known as biologics, made from living cells and are therefore difficult to copy with precision.
U.S: A U.S. judge on Friday said two patents relating to Amgen Inc's blockbuster rheumatoid arthritis drug Enbrel were valid, denying a challenge by Novartis AG, which is seeking to launch a copycat version.
U.S. District Judge Claire Cecchi in Newark, New Jersey rejected arguments by Novartis' Sandoz unit that the patents covering Enbrel's active ingredient until 2029 should not have been granted because their concepts were already contained in previous patents.
Novartis said it would appeal the ruling to United States Court of Appeals for the Federal Circuit.
Enbrel generated $5.01 billion in sales for Amgen in 2018 and belongs to a class of medications known as biologics, made from living cells and are therefore difficult to copy with precision.
The FDA in 2016 approved Novartis' Erelzi as a so-called biosimilar, meaning it is not different from Enbrel in any clinically significant way but is not identified as a generic drug would be.
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Amgen has the exclusive rights to patents originally granted to F. Hoffmann-La Roche AG on etanercept, the protein in Enbrel.
The company sued Novartis' Sandoz unit in 2016, seeking a court order blocking Erelzi sales on the grounds that it would infringe the patents.
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