The US Patent Trial and Appeal Board (PTAB) has invalidated all claims of the ‘250, ‘413 for Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) double-dose 40 mg Copaxone (glatiramer acetate injection) multiple sclerosis treatment. Teva plans to appeal to the US Court of Appeals for the Federal Circuit.
Teva president and CEO Erez Vigodman said, “We remain confident in the strength of our intellectual property surrounding Copaxone 40mg. We are prepared to defend the full suite of our intellectual property through the PTAB and the US courts regardless of the time required. We believe patients, physicians and payers will continue to value the efficacy, safety and tolerability of Copaxone and that it will remain a proprietary, global market-leading product for the reduction of relapses in RRMS patients.”
On August 15 2016, the PTAB declined a request for a post-grant review (PGR) on an additional Copaxone 40mg patent. Teva will defend four patents (‘250, ‘413, ‘302 and ‘776), all listed in the Orange Book with expiry dates into 2030, against a number of Abbreviated New Drug Application (ANDA) filers in U.S. District Court for the District of Delaware trial scheduled to begin in September 2016. The four patents remain valid and enforceable as does a fifth patent (‘874) recently issued and listed in the Orange Book.
Despite generic competition and the availability of oral treatment for multiple sclerosis, sales of Copaxone in the second quarter of 2016 rose 8% to $1.14 billion from $1.05 billion in the corresponding quarter. In part, this rise was due to Teva's success in switching patients to the more convenient double-dose treatment.
Published by Globes [online], Israel business news - www.globes-online.com - on August 25, 2016
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