Teva Pharma (TEVA) to Appeal PTAB's Decisions on Two COPAXONE Patents
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Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today confirmed the Patent Trial and Appeal Board (PTAB) decisions from an Inter Partes Review (IPR) to invalidate all claims of the ‘250 and ‘413 patents for 40 mg COPAXONE® (glatiramer acetate injection). Teva plans to appeal to the United States Court of Appeals for the Federal Circuit
“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 U.S. courts regardless of the time required,” said Erez Vigodman, President and CEO of Teva. “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.
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