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The Court of Appeal has ruled that Copaxone patents in the UK are valid through May 2015.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has chalked up a victory in the UK against Mylan Inc. (NYSE: MYL), after losing a court case in the US. The Court of Appeal for England and Wales has found in favor of Teva, upholding the validity of the asserted claims of its Copaxone patent through May 2015. The court dismissed the appeal by Mylan subsidiary Generics [UK] Ltd.
Copaxone, for the treatment of multiple sclerosis, is Teva's flagship product, and is reportedly responsible for half of the company's profits. On Friday, the US Court of Appeals for the Federal Circuit ruled in favor of Mylan and Sandoz Inc. that Copaxone's patents were only valid until May 2014. That ruling will allow the launch of generic Copaxone in the US next year. Teva's share price fell 2% in New York yesterday, and fell 2.5% in morning trading on the TASE today.
“This decision upholding the patent strengthens Teva’s exclusivity of Copaxone in the UK until at least the date of the patent expiry," said Teva president and CEO Dr. Jeremy Levin. 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."
Teva intends to appeal against the US appellate court decision, arguing that any generic version of Copaxone should undergo full clinical trials in order to obtain US Food and Drug Administration (FDA) approval, because of the complexity of the formula. Such trials would take years, and delay competition to Copaxone, and would also give Teva time to switch more patients to the Copaxone 40 mg dosage, which is under development and due for launch in early 2014. This dosage requires three weekly injections, instead of the daily injections for the current treatment. The new version has patent protection through 2030. Teva expects to obtain FDA approval for Copaxone 40 mg dosage in early 2014.
Teva today reiterated its statement following the US appellate court ruling, saying, "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 patients."
Published by Globes [online], Israel business news - www.globes-online.com - on July 30, 2013
© Copyright of Globes Publisher Itonut (1983) Ltd. 2013
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