No Standing for ANDA Partner to Appeal Unfavorable IPR Ruling

The Federal Circuit recently dismissed an appeal of an adverse IPR decision by a generic pharmaceutical company for lack of Article III standing, finding that the company—which had yet to file an ANDA—had not suffered an injury-in-fact. The underlying IPR, originally filed by Apotex, involved U.S. Patent No. 9,187,405 (directed to methods of treating multiple […]

PETITIONERS SHOULD ADDRESS OBJECTIVE INDICIA OF NONOBVIOUSNESS IN PETITIONS FILED WITH THE PTO

Recently, the PTAB denied Gilead Sciences, Inc.’s (Gilead) request to institute an inter partes review of two patents relating to HIV-prevention, U.S. Patent No. 9,044,509 (the ’509 patent) and U.S. Patent No. 9,579,333 (the ’333 patent). One key reason for the denial was because Gilead failed to adequately address unexpected results in its Petition. The […]

Success in an IPR Does Not Necessarily Ensure Success in Court

In a recent opinion, the District Court of New Jersey held that a decision in a parallel proceeding at the Patent and Trademark Appeal Board (PTAB) does not give rise to collateral estoppel in the court proceeding. The case concerns Sanofi Aventis’s (“Sanofi”) LANTUS® injectable insulin drug, indicated for the treatment of diabetes mellitus. After […]

PTAB DENIES INTER PARTES REVIEW IN VIEW OF PETITIONER’S INCONSISTENT CLAIM CONSTRUCTION POSITIONS

The PTAB recently denied a petitioner’s request for inter partes review of a competitor’s surgical device patent, stating that the petitioner failed to provide a claim construction necessary to meet its burden to show a reasonable likelihood that at least one claim is unpatentable.  OrthoPediatrics Corp. v. K2M, Inc., IPR2018-01548, Paper 9 (P.T.A.B. March 1, […]

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 […]

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 […]

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 […]