Pharma Forum Dialogues

Inter Partes Review Adds
Another Twist To Hatch-Waxman Litigation

Posted by New York Pharma Forum Inc. on Apr 22, 2014 4:17:00 PM

Inter Partes Review (IPR), introduced by the America Invents Act (AIA), opens the door to another venue and procedure to challenge the validity of a patent. IPR on pharmaceutical patents is drawing increasing attention as an additional threat for a research-based (brand) pharmaceutical company facing or already involved in Hatch-Waxman litigation—the most common type of patent litigation between brands and generics seeking to market copies of branded products. 

Overview of Hatch-Waxman
Litigation and IPR 

Hatch-Waxman litigation typically occurs between a brand company, which holds a New Drug Application (NDA) to sell a drug, and a generic, which files an Abbreviated New Drug Application (ANDA) requesting FDA approval to market a generic copy of the NDA holder’s drug.

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Topics: Hatch-Waxman Litigation, Generics, patent law, Inter Partes Review

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