The Weakening of Pharmaceutical Method Patents: The Federal Circuit Addresses the ‘FDA Conundrum’

Higgins, Brian Wm.; Lessler, Jay P.


The U.S. Food and Drug Administration (FDA) has strict requirements for generic drugs. These requirements may prevent a generic manufacturer from altering a drug product to unequivocally avoid patent infringement, and may also require a generic manufacturer to use a patented method for quality control purposes. We call these situations the “FDA conundrum.” While Congress and the FDA desire to have generic drugs enter the market as soon as possible, the requirements it imposes raise issues of patent infringement that often take years to resolve. The Federal Circuit addressed these issues in the last year, in three separate cases: Momenta v. Amphastar, AstraZeneca v. Apotex, and Bayer Schering Pharma AG v. Lupin.


Hatch-Waxman; safe harbor; label; prescribing information; FDA; injunction; ANDA; submission; bioequivalence; sameness; Federal Circuit; Supreme Court

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