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Patent infringement: Amgen sues Novartis to block generic osteoporosis, bone cancer drugs

Amgen said the proposed biosimilars infringe 21 patents covering Prolia and Xgeva.
United States: Amgen Inc sued Novartis AG's Sandoz in New Jersey federal court Monday, accusing Sandoz's proposed versions of its multibillion-dollar bone-strengthening drugs Prolia and Xgeva of infringing several patents.Amgen asked the court to block Sandoz's biosimilars of the drugs until its patents expire. One of the patents named in the complaint does not expire until...
United States: Amgen Inc sued Novartis AG's Sandoz in New Jersey federal court Monday, accusing Sandoz's proposed versions of its multibillion-dollar bone-strengthening drugs Prolia and Xgeva of infringing several patents.
Amgen asked the court to block Sandoz's biosimilars of the drugs until its patents expire. One of the patents named in the complaint does not expire until 2037.
Sandoz declined to comment on the lawsuit Tuesday. Novartis, which is also named in the complaint, is preparing to spin Sandoz off into a standalone company later this year.
Amgen's Prolia is used to treat osteoporosis. Xgeva, with the same active ingredient denosumab, treats bone cancer and prevents fractures in bone-cancer patients.
The U.S. Food and Drug Administration approved both drugs in 2010. Thousand Oaks, California-based Amgen sold $3.6 billion worth of Prolia and $2 billion worth of Xgeva last year, according to a company report.
Read also: Amgen wins patent appeal on psoriasis drug Otzela against Zydus Pharma (USA), Sandoz
The FDA accepted Sandoz's application for biosimilar versions of the Amgen biologic drugs — which are derived from living cells, unlike traditional small-molecule drugs — in February.
Amgen said the proposed biosimilars infringe 21 patents covering Prolia and Xgeva.
Read also: Novartis gets positive CHMP opinion for Cosentyx in adults with hidradenitis suppurativa
M.Com
Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751