The District Court of the Hague (Netherlands) rejected a patent revocation suit brought by Mylan’s Dutch unit.
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The District Court of the Hague (Netherlands) has rejected a patent revocation suit brought by Mylan B.V., a subsidiary of Mylan Laboratories Inc., against Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) multiple sclerosis treatment Copaxone. The court ruled that Teva’s European Patent is not invalid and will not expire until May 2015.
The favorable ruling follows a similar outcome in the English Court of Appeal in July 2013, which also affirmed that the claims of Teva’s patent are valid.
Teva said, “Any potential generic version of COPAXONE would require a marketing authorization from the Netherlands Medicines Evaluation Board (MEB) before it could be commercialized. Given the complexity of COPAXONE, Teva believes 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 RRMS patients.”
Published by www.globes-online.com