Synthon sued for infringing certain patents for Copaxone

Synthon intends to defend vigorously

10-Apr-2012 - Netherlands

Synthon has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for glatiramer acetate, 20 mg/ml solution for injection in pre-filled syringes. The reference listed drug for glatiramer acetate is Copaxone, indicated for reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis (RRMS). April 3, Teva Pharmaceuticals USA and Yeda Research and Development Co. Ltd. (Teva) have filed a lawsuit in both the United States District Court for the Southern District of New York (case number 12-cv-2556) and the United States District Court for the Eastern District of North Carolina Western Division (case number 12-cv-00179) asserting that Synthon’s filing of its ANDA infringes certain patents.

The Teva lawsuit alleges infringement of United States patents 5,981,589; 6,054,430; 6,342,476; 6,362,161; 6,620,847; 6,939,539; and 7,199,098, all of which are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”) for Copaxone®. The Teva lawsuit alleges infringement of United States patents 5,981,589; 6,054,430; 6,342,476; 6,362,161; 6,620,847; 6,939,539; and 7,199,098, all of which are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”) for Copaxone® and 5,800,808 and 6,048,898 (“process patents”).

Synthon’s CEO Rudy Mareel stated: “Synthon intends to defend vigorously against Teva’s patent infringement claims. 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 U.S. patient per year, more affordable and accessible for patients in the U.S. and around the world.”

https://www.bionity.com/en/news/137375/synthon-sued-for-infringing-certain-patents-for-copaxone.html