2021 Update: Interplay Between FDA Law and Patent Law: Avoiding Indigestion After Belcher v. Hospira
On September 1, 2021, the Federal Circuit issued its decision in Belcher Pharmaceuticals, LLC v. Hospira, Inc., affirming a finding of unenforceability of a patent for inequitable conduct, inferring intent based in part on inconsistent representations that were made by the patentee to the U.S. Food & Drug Administration versus the U.S. Patent & Trademark Office. This latest case is just one of many examples of the interplay between the FDA regulatory and USPTO patenting spheres. Tune into this webinar to hear more about Belcher and other cases involving FDA/USPTO interplay, involving a range of considerations including patentability, duty of candor, infringement exemption under 271(e)(1), and patent term extension for regulatory approval delay.
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