Last week, in Virginia Innovation Sciences (“VIS”) v. Samsung, the Federal Circuit provided some indication of the circumstances under which it would defer to a district court’s evaluation of extrinsic evidence in the post-Teva world. We have previously written about the Supreme Court’s 2015 Teva v. Sandoz opinion, which overturned long-standing precedent, holding that while…
In Classen Immunotherapies, Inc. v. Elan Pharms., Inc., the Federal Circuit determined that an NDA-holder’s post-approval activities fall within the scope of the § 271(e) safe harbor. 2015 U.S. App. LEXIS 7854 (Fed. Circ. May 13, 2015). Specifically, 35 U.S.C. § 271(e)(1) exempts activities reasonably relating to developing clinical data on an approved drug and submitting that…
On April 9, 2014, in Purdue Pharmaceutical Products, L.P. v. TWi Pharmaceuticals, Inc., Civ. No. 12-5311 (D.N.J.), Judge Jose L. Linares of the United States District Court for the District of New Jersey ruled that a generic drug company who is not a first-filer has standing to assert a counterclaim for non-infringement despite the issuance…