PTO rules in favor of Mylan over Copaxone 40 patent

Mylan NV yesterday announced that its inter-parties review (IPR) proceeding in regard to U.S. Patent No. 8,969,302, which is owned by Yeda Research & Development Co. and licensed to Teva Pharmaceuticals, was ruled in its favor of by the U.S. Patent and Trademark Office (PTO) and found unpatentable.

In the last week, three patents, including this patent, associated with Copaxone 40 mg/mL have been found unpatentable.

Copaxone is used to treat multiple sclerosis (MS) and to prevent relapse of MS.

"Through significant investment in research and development and by challenging these invalid patents, we are working to bring a more affordable generic alternative of Copaxone to market,” Heather Bresch, CEO of Mylan, said. “Challenging patents is just one of the ways that Mylan helps to ensure patient access to medicines. In the last few years alone, Mylan's patent challenges have allowed earlier access to generic competition for brand products equating to nearly $20 billion in annual product brand sales and reducing more than 60 years of patent life that otherwise could have blocked generics from entering the market."

Teva had two other patents, U.S. Patent Nos. 8,232,250 and 8,399,413, were found to be unpatentable in Mylan’s IPR challenge of them by the PTO’s Patent Trial and Appeal Board (PTAB) on Aug. 24.