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.
United Therapeutics Corp. claims the agency wrongly allowed Liquidia to submit an amendment to add a new indication to its tentatively approved NDA for a rival version of its pulmonary arterial hypertension blockbuster treprostinil.
Following request by Universities Allied for Essential Medicines, FDA creates a public dashboard of pre-notices of noncompliance on registering trials and submitting results to ClinicalTrials.gov. The agency denies request to impose civil penalties on those who fail to comply, citing its discretion.