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Patent Infringement › 35 U.S.C. § 271(e)(1) › FDA Approval

Haug Partners LLP

Federal Circuit Clarifies Safe Harbor from Injunctive Relief in Jazz v. Avadel

Haug Partners LLP on

On May 6, 2025, the U.S. Court of Appeals for the Federal Circuit refined the boundaries of injunctive relief under the Hatch-Waxman Act in its precedential opinion in Jazz Pharms., Inc. v. Avadel CNS Pharms. The decision...more

Akin Gump Strauss Hauer & Feld LLP

Section 271(e)(1) Safe Harbor Applies to Importation Regardless of Intent or Actual Use

Akin Gump Strauss Hauer & Feld LLP on

A divided panel of the Federal Circuit affirmed a district court’s grant of summary judgment of noninfringement, holding that importation of two product samples into the U.S. was reasonably related to obtaining FDA approval...more

Fenwick & West Life Sciences Group

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

Fenwick & West Life Sciences Group on

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more

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