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Pharmaceutical Industry › Food and Drug Administration (FDA) › Foreign Corporations

Fish & Richardson

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

Fish & Richardson on

The Hatch-Waxman Act provides a cause of action for infringement based on the submission of an abbreviated new drug application (ANDA) to FDA. 35 U.S.C. § 271(e)(2). Following the Supreme Court’s ruling in TC Heartland LLC v....more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Announces That Domestic Inspections Will Resume

Skadden, Arps, Slate, Meagher & Flom LLP on

On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more

Saul Ewing LLP

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Saul Ewing LLP on

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

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