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
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