ARTICLE | Company News

Mylan, Teva autoimmune news

September 5, 2016 7:00 AM UTC

In inter partes review (IPR) proceedings, the U.S. Patent Trial and Appeal Board invalidated all claims in each of three patents covering a thrice-weekly formulation of Teva’s multiple sclerosis drug Copaxone glatiramer acetate. PTAB instituted a review of the patents last year after Mylan filed an IPR challenge. Teva has five Orange Book-listed patents protecting thrice-weekly Copaxone. The invalidated patents -- U.S. Patents Nos. 8,232,250, 8,399,413 and 8,969,302 -- expire in 2030. PTAB struck down all three patents based on the same prior art, saying that a person of ordinary skill would have been able to modify Copaxone’s dosing schedule to the thrice-weekly dosage protected by the patents. The patents are owned by Yeda Research and Development Co. Ltd. (Rehovot, Israel), the technology transfer company of Weizmann Institute of Science (Rehovot, Israel), and are licensed to Teva (see BioCentury, Sept. 7, 2015).

Teva said it plans to appeal PTAB’s decision to the U.S. Court of Appeals for the Federal Circuit (CAFC). The company said it is “prepared to defend the full suite of our intellectual property through the PTAB and U.S. courts regardless of the time required.” It said it will defend all five Orange Book-listed patents against filers of multiple ANDAs in a trial scheduled to begin this month in the U.S. District Court for the District of Delaware. ...