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Federal Circuit Clarifies Venue in Hatch-Waxman Case

JD Supra Law

Addressing venue in the context of a Hatch-Waxman case, the US Court of Appeals for the Federal Circuit explained that sending a paragraph IV notice letter to a company in the district is insufficient to establish venue. Celgene Corp. Mylan Pharmaceuticals Inc., 21-1154 (Fed. 5, 2021) (Prost, J.)

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More Venue and Corporate Games: This time with ANDA filing

Patently-O

Celgene Corp. ” Celgene markets a drug treatment for multiple-myeloma (pomalidomide) covered by several of its patents. Mylan created and submitted an ANDA to the FDA, requesting permission to make a generic version of the drug and arguing that the Celgene’s patents were invalid. Celgene then sued in D.N.J.

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Federal Circuit Clarifies Venue in Hatch-Waxman Actions in Celgene v. Mylan

Fish & Richardson Trademark & Copyright Thoughts

The Federal Circuit in Celgene Corp. The key takeaways from Celgene are these: A Paragraph IV Letter is not considered “part of” an ANDA submission, so venue cannot be predicated upon where the letter is received. Celgene markets pamolidomide as a multiple myeloma drug under the brand name Pomalyst®. Mylan Pharms.,

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Federal Circuit Panel Holds Hatch-Waxman Venue Under the Second Prong of § 1400(b) is Based on Actions Related to ANDA Submission

Fish & Richardson Trademark & Copyright Thoughts

7] If a branded company initiates an infringement action against a generic company within 45 days of receiving notice of ANDA submission, this triggers a 30-month stay during which FDA cannot issue a final approval for the ANDA. [8] If a branded company gets venue wrong, it risks a motion to dismiss for improper venue.