Copaxone Supreme Court Case Could Cut Relitigation Of Patent Claims
Supreme Court to hear oral arguments in case that could restrict the ability of the Federal Circuit to overturn certain rulings on patent claim terms; Google, Intel and other tech companies back Sandoz.
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Sandoz, which has first to file on the generic, may have the most to lose after federal judge finds that Mylan and Sandoz ANDAs for generic Copaxone infringe all the claims in Teva’s patents, the latest of which expires in September 2015. FDA now has more time to review the ANDAs without pressure.
FDA guidances have provided ‘major step forward’ for use of social media data, Roche researcher notes. Agency staffer offers checklist for collecting patient experience data in this realm.
Agency staff note hurdles in obtaining evidence outlined in FDA’s patient-focused drug development guidance to support regulatory decision-making.