India-based Natco Pharma and US-based Mylan plans to appeal against the judgement by a district court in New York that dealt the two companies a severe blow denying them permission to make a version of generic giant Teva Pharmaceutical’s Copaxone.
The decision by the US court covers several patents for the chemical composition of Copaxone, methods of using the product and processes for manufacturing the product. The last of the patents expires in September 2015.
Both Natco and Mylan are looking at alternative options of dealing with this directive. The district court judge is expected to deliver the entire order in detail with the reasons for striking down permission to make drugs in two weeks’ time.
Heather Bresch, Chief Executive Officer, Mylan commented: “Although Mylan is disappointed with the court’s decision, and while we have not yet had the opportunity to review the court’s opinion, we fully intend to evaluate our options for an appeal once the court’s full opinion becomes available. Importantly and as previously stated, Mylan’s earnings guidance for 2012 and earnings targets for 2013 are not reliant on the launch of a generic Copaxone, and therefore our expectations for these periods are unchanged.”
EP News Bureau – Mumbai
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