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

ANDA Litigation, Antitrust, Settlement, Supreme Court

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

Exclusivity, FDA

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

Claim Construction, Prior Art

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

Indefiniteness

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

Uncategorized

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…

“Consisting Essentially Of” Preamble Indefinite Because the “Basic and Novel Properties” of the Invention Were Not Reasonably Clear

Uncategorized

A U.S. federal district court judged the transitional phrase “consisting essentially of” to be indefinite in view of the Supreme Court’s ruling in Nautilus. Horizon Pharma Ireland Ltd. et al. v. Actavis Laboratories UT Inc., Case no. 1:14-cv-07992, in the U.S.D.C., District of New Jersey. Background.    As we wrote about here, in its 2014 Nautilus…

Federal Circuit Dislikes “Common Sense”

Obviousness, PTAB

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…

Delaware Recognizes Declaratory Judgment Action Concerning Biosimilar Applicant’s Failure to Give Notice of Commercial Marketing

Declaratory Judgment

The District of Delaware recently held that branded biologic companies may pursue a private cause of action to address a biosimilar applicant’s anticipated violation of the commercial marketing notice requirement under 42 U.S.C. § 262(1)(8)(A). In Amgen Inc. et al. v. Hospira, Inc., Civ. Action No. 15-839 (D. Del.), the Plaintiffs filed a patent infringement…