August 09, 2019
By Reuters Staff
(Reuters) - A U.S. judge on Friday said two patents relating to Amgen Inc's blockbuster rheumatoid arthritis drug Enbrel (etanercept) 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.
"Sandoz respectfully disagrees with the Court's ruling, which prevents us from launching an additional treatment option for patients with autoimmune and inflammatory diseases," said Carol Lynch, president of Sandoz US and head of North America.
Shares of Amgen closed up about 6% at $196.25 after the ruling, while U.S.-listed shares of Novartis closed down 0.5% at $90.82.
Enbrel generated $5.01 billion in sales for Amgen in 2018 and belongs to a class of medicine known as biologics, made from living cells and are therefore difficult to copy with precision.
The FDA in 2016 approved Novartis' Erelzi as a biosimilar, meaning it is not different from Enbrel in any clinically significant way, but is not identical as a generic drug would be.
Amgen has the exclusive rights to patents originally granted to F. Hoffmann-La Roche AG on etanercept.
The company sued Novartis' Sandoz unit in 2016, seeking a court order blocking Erelzi sales on the grounds that it would infringe the patents.
Novartis argued the patents were invalid as they describe technology that was obvious in light of earlier inventions.
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