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Life Sciences › FDA Approval › 35 U.S.C. § 271(e)(1)

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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