By Kevin E. Noonan — In 1984, Senator Orrin Hatch (R-UT) and Rep. Henry Waxman (D-CA) shepherded a grand legislative compromise through Congress that balanced the rights and solved inefficient regulatory consequences for both branded and generic drug makers. Forever known as the Hatch-Waxman Act (formally, the Drug Price Competition and Patent Term Restoration Act), certain of the provisions created a safe harbor for generic drugs to be tested for purposes related to regulatory approval without incurring infringement liability (codified at 35 U.S.C. § 271(e)(1)) as well as a pathway for generic drug makers to challenge patents listed by branded…
View the original article here: Biogen Int’l v. Banner Life Sciences LLC (Fed. Cir. 2020)
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