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 Confines Exception to Closed-Ended Interpretation of “Consisting of” Transition

On Friday, the Federal Circuit weighed in on the exception to the closed nature of the “consisting of” transition in patent claims, holding that the exception is more limited than perhaps previously thought.  In Shire Development, LLC v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court’s infringement finding, holding that a claimed Markush […]

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 […]

Private Plaintiff Must Prove Antitrust Injury to Recover for Antitrust Violations Based on Reverse Payment Settlements of ANDA Litigation

Three years ago, the Supreme Court held in Federal Trade Comm’n v. Actavis, Inc. that pay-for-delay settlement agreements may constitute antitrust violations under the rule of reason if their anticompetitive effects are unreasonable when viewed in light of the agreements’ size, scale in relation to future litigation costs, independence from other services that might justify […]

FDA Rejects Vanda Pharmaceuticals Efforts to Force ANDA-Filers to Include Labeling Statements Related to its Three-Year Exclusivity

Last week, the FDA rejected Vanda Pharmaceutical’s Citizen Petition requesting that FDA withhold approval of ANDAs for its schizophrenia drug, Fanapt®, for three years.  (Letter from Janet Woodcock, M.D., Director Center for Drug Evaluation and Research, to Richard L. Gulino, Senior Vice President, General Counsel and Secretary, Vanda Pharmaceuticals Inc., dated Nov. 28, 2016.)  Specifically, […]

PTAB Rejects Evidence Presented for First Time in Reply Papers and Upholds Patent

Altaire Pharmaceuticals Inc. filed a Petition for a post-grant review of claims 1 to 13 of U.S. Patent No. 8,859,623 (“the 623 patent”) owned by Paragon Bioteck, Inc.  The primary issue was whether Petitioner’s product—which qualified as 102(a) prior art—met the limitations of the ’623 patent claims and therefore rendered the claims obvious.  The Board […]

Federal Circuit Reverses Indefiniteness Ruling Based on Point of Novelty Analysis

In Cox Communications, Inc. v. Sprint Communication Co., the Federal Circuit reversed a district court ruling holding six of Sprint’s patents invalid as indefinite. The definiteness dispute centered on the term “processing system,” which performed the function of transforming and routing telephone signals through a data network. Cox argued that “processing system” is a structural […]

Court Requires the FDA to Reassess Decisions Rendered Under its Old Interpretation of Five-Year NCE Exclusivity

U.S. District Judge Rudolph Contreras found that the FDA’s prior interpretation of the Federal Food, Drug, and Cosmetics Act’s (“FDCA”) five-year exclusivity provision was arbitrary and capricious. Ferring Pharm., Inc. v. Burwell, No. 15-0802 (D.D.C. Sep. 9, 2016).  This provision—known as NCE exclusivity—provides a five-year period of marketing exclusivity for drugs in which “no active […]