Northern District Of California Finds Importation Of Medical Device Samples Protected Under The Section 271(e)(1) Safe Harbor
On October 16, 2020, the United States District Court for the Northern District of California issued an order granting summary judgment of noninfringement under 35 U.S.C. § 271(e)(1). Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd. , Case No. 4:19-cv-06593-HSG, Dkt. No. 98 (N.D. Cal., Oct. 16, 2020). The Court found that defendant’s importation of samples into the United States for conducting preclinical investigations and for intended demonstrations at a clinical conference were exempt from patent infringement liability, regardless of whether there was a commercial purpose underlying such conduct.