Submission of New Evidence After Institution of an IPR is “Perfectly Permissible”

Last week, in Genzyme v. Biomarin, the Court of Appeals for the Federal Circuit held petitioners may introduce new evidence after an institution decision in IPR proceedings as long as the opposing party received notice of the new evidence and an opportunity to respond. In its final written decision, the PTAB relied on references beyond […]

Advice from the Bench

On May 24th 2016, a panel consisting of Federal Circuit Court of Appeals Judges Kathleen O’Malley, Jimmie Reyna, and Raymond Chen, as well as Minnesota District Court Judge Joan Erickson, offered guidance for practice before the Federal Circuit.  Some of the insight and advice the judges shared is provided below. Focus on the Issues Do […]

Federal Circuit Affirms Invalidity of OxyContin® Patents[1] : The Tamper-Resistance Patent

On Monday, the Federal Circuit affirmed a decision from the Southern District of New York that four patents listed in the Orange Book for OxyContin® are invalid as anticipated and obvious in Purdue Pharma, L.P. v. Teva Pharmaceuticals USA, Inc.  This post addresses the second half of that decision, which was directed to a patent […]

Federal Circuit Holds it Cannot Review PTAB Decision to Institute IPR

The Federal Circuit held that the Administrative Patent Trial and Appeal Board’s (“PTAB”) decision to institute an Inter Partes Review Proceeding (“IPR”) is not reviewable by the Federal Circuit on appeal.  See Achates Reference Publishing, Inc. v. Apple Inc.  This decision arose from an appeal by the patentee, Achates, of the PTAB’s decision that several […]

Federal Circuit Clarifies Scope of § 271(e) Safe Harbor in Classen v. Elan

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 […]

Federal Circuit Renders Its First Decision of an IPR Appeal

In the first Federal Circuit ruling of an appeal from an inter partes review (“IPR”) decision, the Court held that the Patent Trial and Appeal Board (“the PTAB”) correctly applied the broadest reasonable interpretation standard to construct patent claims, held that it lacked jurisdiction to review the PTAB’s decision to institute an IPR, affirmed the […]