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 […]

District of Delaware Applies IPR Estoppel Provisions to Bar Party from Pursuing New Prior Art Combinations

Although not a Hatch-Waxman case, the District of Delaware’s recent ruling in Parallel Networks Licensing, LLC. v. IBM, could have a significant impact on ANDA-filers strategic approach to IPRs.  In this case, the patentee (“Parallel”) filed a complaint in 2013 asserting that IBM infringed three patents.  The litigation proceeded in federal district court; however, in […]

Federal Circuit Reverses Examiner’s Anticipation Rejection Based on Examiner’s Belief that Prior Art Structure Inherently Performed Claimed Function

The Federal Circuit recently reversed and remanded an Examiner’s rejection of a claim that involved an element requiring both structural and functional limitations.  See In re Chudik, No. 2016-1487 (Fed. Cir. Jan. 9, 2017).  Specifically, the Federal Circuit reversed the Examiner’s rejection because the record failed to establish that a single prior art reference contained […]

PTAB Analyzes Section 112 Support in Declining to Institute IPR on Galderma’s Rosacea Patent

The PTAB recently rejected Dr. Reddy’s Laboratories’ IPR petitions for Galderma’s patent covering its Oracea® (doxycycline) product for the treatment of rosacea.  Galderma’s patent, U.S. Patent No. 8,603,506 (“’506 patent”) is directed to the treatment of rosacea using low dosages of the tetracycline antibiotic doxycycline. Dr. Reddy’s filed three petitions for IPR against the ’506 […]

District Court Grants Stay of Litigation Pending IPR and Refuses to Similarly Extend 30 Month Stay

On December 11, 2015, the Southern District of Indiana issued an order granting the request of several defendants to stay litigation pending resolution of inter partes review (“IPR”) of two of the patents-in-suit. Eli Lilly & Co. et al. v. Accord Healthcare Inc. et al., Civ. No. 14-cv-00389-SEB-TAB (S.D. Ind. Dec. 11, 2015).  Magistrate Judge […]