Intention to File an ANDA may be Sufficient to Establish Standing for a PGR Appeal

Around the same time the Federal Circuit decided that a prospective ANDA customer lacked declaratory judgment standing in AIDS Healthcare, reported on here, it held that a prospective ANDA filer has standing to appeal a PTAB decision.  In Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., No. 2017-1487 (Fed. Cir. May 2, 2018), a sharply-divided panel found […]

Federal Circuit Holds That a Customer Does Not Have Standing For a Declaratory Judgment

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 […]

Proposed Amendment to Hatch-Waxman Act May Prohibit Use of Post-Grant Procedures

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 § […]

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) […]