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Teva Pharmaceuticals Industries Ltd (NYSE:TEVA) announced today that the Court of Appeal for England and Wales has found in favor of Teva, upholding the validity of the asserted claims of UK patent 762,888 relating to Copaxone® (glatiramer acetate injection), following an appeal brought by Generics [UK] Limited, a subsidiary of Mylan Laboratories Inc.
In the litigation, Generics [UK] had applied to the court to revoke the patent and also grant a declaration of non-infringement for its purported generic version of Copaxone®. The High Court and the Court of Appeal have now both upheld the validity of the patent and denied the application for a declaration of non-infringement. The patent is not due to expire until May 2015.
Teva’s President and CEO, Dr. Jeremy Levin, welcomed the court’s decision: “This decision upholding the patent strengthens Teva’s exclusivity of Copaxone® in the UK until at least the date of the patent expiry. Thousands of patients in the UK and elsewhere depend on Copaxone® for relief in relapsing-remitting multiple sclerosis, and we are pleased that the English Court of Appeal has upheld the validity of the patent until its expiry in 2015.”
Any potential generic version of COPAXONE® would require a marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) before it could be commercialized.
Given the complexity of COPAXONE®, unpredictable differences between a proposed generic product and COPAXONE® could lead to immunogenic effects in patients. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of COPAXONE® would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in relapsing-remitting multiple sclerosis (RRMS) patients.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.