Takeda Pharmaceutical Co. lost a court ruling that could shave years off the time before generic-drug versions of its top-selling cancer drug Velcade hits the market.
A patent on the medicine that expires in 2022 is invalid, U.S. District Judge Gregory Sleet concluded Thursday. He agreed with generic-drug makers who said the patent for a formulation of the drug is “the inherent result of an obvious process.”
The ruling means that a generic version of the medicine could enter the market when another patent expires in May 2017.
Velcade, given by injection, is used to treat patients with multiple myeloma, a cancer that attacks plasma cells. The drug generated 41.8 billion yen ($340 million) in sales for Takeda in the first quarter of the year, the company said in July. Johnson & Johnson markets the drug outside the U.S.
“This is a blow because no drug company wants to lose any patent protection on its top product,” Erik Gordon, a University of Michigan law professor who teaches about intellectual property issues, said in an e-mailed statement.
Takeda shares dropped 3.1 percent to 6,284 yen in Tokyo trading on Friday, the biggest decline since April 2014.
Takeda’s Millennium Pharmaceuticals filed suit in 2012, seeking to block Allergan Plc’s Actavis, Novartis AG’s Sandoz and Accord Healthcare Inc. from selling their proposed generic versions of the drug.
“We are currently reviewing the official ruling and evaluating next steps,” Elizabeth Pingpank, a U.S.-based spokeswoman for Osaka-based Takeda, said in an e-mailed statement.
The case is Millennium Pharmaceuticals Inc. v. Sandoz Inc., 12-1011, U.S. District Court, District of Delaware (Wilmington).