USPTO Begins Effort to Abandon Broadest Reasonable Construction Standard in Contested PTO Proceedings

Less than two months after Andrei Iancu was confirmed as the new Director of the USPTO, the Office issued a Notice of Proposed Rulemaking concerning the claim construction standards employed in contested USPTO proceedings, including IRPs, PGRs, and CBMs.  The proposed change would abandon the broadest reasonable construction standard currently used for unexpired patents in […]

Federal Circuit Skips the Mayo in Upholding Vanda’s Fanapt® Patent

A divided Federal Circuit panel upheld Vanda’s patent covering its iloperidone schizophrenia treatment (Fanapt®), holding the method of treatment claims were directed to patent-eligible subject matter.  Vanda Pharms. Inc., et al. v. West-Ward Pharms. Int’l Ltd., et al., Nos. 2016-2707, 2016-2708 (Fed. Cir. Apr. 13, 2018).  In meticulously evading the Supreme Court’s Mayo decision, Vanda […]

Different Outcomes for IPR Challenges to the Same Patents Reveal Common-Sense Strategies for Improving Institution Rates

Two recent sets of decisions at the PTAB provide guidance on how to increase the likelihood of a petition being successful at instituting an IPR. The first set of decisions relate to the erectile dysfunction (ED) drug tadalafil (CIALIS®).  In IPR2017-00323, Mylan successfully petitioned for an IPR against ICOS’s U.S. Patent No. 6,943,166, which claims, […]

P.T.A.B. Assumes Nothing Based on Tradenames

The Patent Trial and Appeal Board recently denied institution of inter partes review of two Allergan patents directed to a hyaluronic acid-based gel containing lidocaine.  Teoxane S.A. v. Allergan, PLC, IPR2017-01906, Paper 15 (P.T.A.B. March 9, 2018); Teoxane S.A. v. Allergan, PLC, IPR2017-02002, Paper 14 (P.T.A.B. March 9, 2018). The patents at issue, U.S. Patent […]

PTAB Narrowly Interprets Prior Art Disclosure Concerning Dosing to Shoot Down Anticipation Challenge

A recent PTAB order found that instituted claims were not unpatentable as anticipated under § 102(b) despite the prior art patent’s disclosure of the administration of the API and a range that subsumed the claimed range of doses.  Koios Pharmaceuticals LLC v. Medac Gesellschaft Für Klinische Spezialpräparate mbH et al., IPR2016-01370, Paper 54, (PTAB Feb. […]

Federal Circuit Reverses Course: Certain IPR Institution Decisions Now Appealable

Yesterday, the Federal Circuit ruled en banc that decisions by the Patent Trial and Appeal Board (“PTAB”) concerning the timeliness of inter partes review petitions under 35 U.S.C. § 315(b) can be appealed.  Wi-Fi One, LLC v. Broadcom Corp.  As we previously reported here, a Federal Circuit panel previously held that 35 U.S.C. § 314(d) […]

State University’s Filing of Patent Infringement Action Waives Sovereign Immunity to IPR Proceedings

The Patent Trial and Appeal Board (“PTAB”) recently held that sovereign immunity under the Eleventh Amendment is waived in the context of inter partes review (“IPR”) by a state’s filing of a patent litigation in federal court.  Ericsson Inc. v. Regents of the University of Minnesota, IPR2017-01186, Paper No. 14. The PTAB first addressed whether […]

Judge Lourie Questions Patentability of Product Claims Having Limitations Directed to Results and Not Structure

Carlson Caspers successfully defended an indefiniteness verdict at the Federal Circuit in Forest Laboratories, Inc. v. Teva Pharmaceuticals USA, Inc.  The asserted claims were directed to extended-release formulations of memantine, and were listed in the Orange Book for Forest’s Namenda XR® product.  The applicants chose to define their formulation based on pharmacokinetic principles rather than […]

Judge Stark Offers Guidance on Venue Inquiry for Hatch Waxman Litigation

Chief Judge Leonard Stark of the District of Delaware recently shed some light on the venue analysis in Hatch-Waxman litigation.  Bristol-Myers Squibb Company et al v. Mylan Pharmaceuticals Inc., No. 1-17-cv-00379 (D. Del. November 28, 2017).  Mylan moved to dismiss pursuant to Rule 12(b)(3), arguing that its corporate subsidiary and affiliate’s places of business cannot […]