Category Archives: ANDA

District Court’s Handling of “Prejudicial” Discovery Violation Upheld after Proceeding to Trial on ANDA Infringement Claims

On February 9, 2018, in Merck Sharp & Dohme Corp v Amneal Pharm. LLC, the U.S. Court of Appeals for the Federal Circuit held that the District Court did not abuse its discretion in proceeding to trial despite a party’s violation of a discovery order where the court took adequate steps to ensure the opposing party would not be prejudiced. In 2014, Amneal submitted an Abbreviated New Drug Application (ANDA) to the FDA disclosing a generic version of Merck’s Nasonex®. Thereafter, Merck filed an infringement…

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Mere Hypothesis of Success is Not Reasonable Expectation of Success in Achieving the Claimed Invention

On December 18, 2017, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court’s final judgement enjoining Dr. Reddy’s Laboratories and Teva Pharmaceuticals (collectively DRL) from commercially manufacturing, using, offering for sale, selling, or importing the generic version of Genzyme’s bone marrow stimulant Mozobil®. The court found that combining the prior art in the manner suggested by DRL would not create a reasonable expectation of success in achieving the claimed invention. Genzyme, along with Sanofi Aventis, had developed a method for mobilizing…

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National Stage Applications Must Comply with Entirety of § 371 Prior to Commencement of National Stage, Unless Early Commencement Expressly Requested

Regardless of whether an application is filed before or after the amendments made to the Technical Corrections Act (TCA), the entirety of §371 must be complied with before national stage commencement of an international PCT application may begin. To commence the national stage early, an express request to do so must be made, regardless of whether pre- or post-TCA versions of §154(b)(1)(A)(i)(II) applies. The Technical Corrections Act, as amended, extends the patent term by one day for each day after the period specified, if the…

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