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Alert: Inconsistent Positions at FDA and USPTO Render Patent Unenforceable

Unenforceability of a patent for a drug formulation was affirmed by the US Court of Appeals for the Federal Circuit earlier this month in Belcher Pharmaceuticals, LLC v. Hospira, Inc., Appeal No. 2020-1799 (Fed. Circ. Sept....more

Alert: Orange Book Transparency Act Creates Some New Obligations

The Orange Book Transparency Act of 2020, signed into law on January 5, amends section 505(j) of the Federal Food, Drug and Cosmetic Act, codifying and clarifying some patent listing requirements of existing FDA regulations....more

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