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 § […]

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. […]

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 […]

Federal Circuit Dislikes “Common Sense”

The Federal Circuit recently reversed a PTAB decision in which the Board relied on common sense to invalidate a patent on obviousness grounds.  Arendi S.A.R.L. v. Apple Inc., No. 2015-2073 (Fed. Cir. Aug. 10, 2016). Background.  Apple, Google, and Motorola filed an IPR petition challenging Arendi’s U.S. Patent No. 7,917,843 (“the ’843 patent”).  The ’843 […]

Submission of New Evidence After Institution of an IPR is “Perfectly Permissible”

Last week, in Genzyme v. Biomarin, the Court of Appeals for the Federal Circuit held petitioners may introduce new evidence after an institution decision in IPR proceedings as long as the opposing party received notice of the new evidence and an opportunity to respond. In its final written decision, the PTAB relied on references beyond […]

Beware: PTAB Mercilessly Enforces Deadlines

The Patent Trial and Appeal Board (PTAB) recently denied motions by Teva to amend the filing dates of two petitions to institute IPRs related to patents covering Suboxone, a drug used to help patients suffering from opioid addiction.  Teva’s deadline for filing these petitions was December 3, 2016, but due to technical difficulties in filing, […]

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 […]

Federal Circuit Again Defers to PTO, Granting PTAB Broad Discretion Where Statute Offers Little

Last week we posted about the Federal Circuit’s decision in In re Cuozzo Speed Techs., LLC, deferring to the PTAB’s application of the “broadest reasonable interpretation” standard in IPR proceedings.  The Federal Circuit recently gave deference to the PTAB in another context in Redline Detection LLC v. Star Envirotech Inc., granting the PTAB discretion in […]