The Federal Circuit recently held that a healthcare provider did not have standing to bring a declaratory judgment action where its only interest was as a purchaser of potential generic versions of the patented drug. AIDS Healthcare Foundation v. Gilead Sciences, Inc., No. 2016-2475 (Fed. Cir. May 11, 2018). The court held that absent direct […]
U.S. Senator Orrin Hatch, co-author of the Hatch-Waxman Act, recently proposed an amendment to the Act that would prevent generic drug companies from using any AIA post-grant procedure (IPR or PGR) on an Orange Book patent identified in their PIV certifications. The proposed amendment would require that the patent certification required under 21 USC § […]
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 […]
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 […]
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, […]
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 […]
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. […]
Last week Judge Casper of the District of Massachusetts joined the District of Delaware in holding that IPR estoppel under 35 U.S.C. § 315(e)(2) does not apply to grounds that a petitioner failed to raise in its petition. Koninklijke Philips N.V. et al. v. Wang Alliance Corp. This decision adds to a growing district court […]
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) […]
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 […]