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

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Title Statement The Weakening of Pharmaceutical Method Patents: The Federal Circuit Addresses the ‘FDA Conundrum’
 
Added Entry - Uncontrolled Name Higgins, Brian Wm.; Blank Rome LLP
Lessler, Jay P.; Blank Rome LLP
 
Uncontrolled Index Term Hatch-Waxman; safe harbor; label; prescribing information; FDA; injunction; ANDA; submission; bioequivalence; sameness; Federal Circuit; Supreme Court
 
Summary, etc. 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.
 
Publication, Distribution, Etc. Journal of Intellectual Property Rights (JIPR)
2023-04-03 16:34:26
 
Electronic Location and Access application/pdf
http://op.niscair.res.in/index.php/JIPR/article/view/2985
 
Data Source Entry Journal of Intellectual Property Rights (JIPR); ##issue.vol## 19, ##issue.no## 2 (2014): Journal of Intellectual Property Rights
 
Language Note en