Tag: ANDA

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Federal Circuit Further Clarifies Venue in Hatch-Waxman Cases
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ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

Federal Circuit Further Clarifies Venue in Hatch-Waxman Cases

Last year, in Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., the Federal Circuit confirmed that 28 U.S.C. § 1400(b) is the sole venue provision for domestic defendants in Hatch-Waxman actions.1 On Friday 5 November 2021, the Federal Circuit provided even greater clarity on venue rules in such cases, concluding that, for venue purposes, only submission of the ANDA qualifies as an act of infringement, not any action related to the submission.2

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ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

By: Trevor M. Gates, Theodore J. Angelis, and Peter Giunta

The Federal Circuit recently held that filing an abbreviated new drug application with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including Delaware), subjected Mylan to specific personal jurisdiction in Delaware.

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