Teva Pharmaceutical Industries Ltd. (TEVA) sued Synthon BV for infringing seven patents in planning to sell a generic version of the multiple sclerosis drug Copaxone before Teva’s patents expire.
Teva, based in Petach Tikva, Israel, said it licensed the patents from Yeda Research & Development Co., according to the lawsuit filed yesterday in federal court in New York.
Copaxone, used to reduce the frequency of relapses in multiple sclerosis patients, generated sales of $3.9 billion in 2011. Synthon filed an application with the U.S. Food and Drug Administration seeking approval of a generic version of the drug, according to the complaint.
“Defendants plan to begin manufacturing, marketing, selling, offering to sell and/or importing Synthon’s generic glatiramer acetate product soon after FDA approval,” Teva said in the complaint. “Such conduct will constitute direct infringement.”
Closely held Synthon, based in Nijmegen, Netherlands, filed a document with the FDA stating that Teva’s patent claims are invalid or unenforceable and that Synthon’s drug wouldn’t infringe them, Teva said.
Fabienne Douven, a Synthon spokeswoman, said in an e-mail that the company would fight the suit.
‘Affordable and Accessible’
“We are committed to developing a generic alternative to Copaxone, to make this RRMS treatment, with a current high cost of around $40,000 per year for U.S. patients, more affordable and accessible,” she said, referring to relapsing-remitting multiple sclerosis.
Teva has also sued Sandoz AG and other drug companies over Copaxone.
Yeda Research, based in Rehovot, Israel, markets and licenses developments from the laboratories at the Weizman Institute of Science, according to the complaint.
To contact the reporter on this story: Don Jeffrey in New York at email@example.com