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Update on the Proposed TRIPS Waiver at the WTO: Where is it Headed, and What to Expect?

On June 8-9, 2021, the World Trade Organization’s (WTO) TRIPS Council will hold their first meeting in the wake of the U.S. Trade Representative (USTR) announcing “the Biden-Harris Administration’s support for waiving...more

D.C. Circuit Concludes that Serial Periods of Exclusivity May Be Available Under the Orphan Drug Act

On March 13, 2020, the U.S. Court of Appeals for the D.C. Circuit affirmed the D.C. District Court’s 2018 summary judgment ruling in favor of Eagle Pharmaceuticals and against the FDA, finding that (1) the Orphan Drug Act...more

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