ANDA Advisors Blog - Carlson Caspers IP Litigation & Counseling

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

Posted at 21:12h December 28, 2016 in ANDA Litigation, Antitrust, Settlement, Supreme Court by Carlson Caspers

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

Posted at 21:20h December 8, 2016 in Exclusivity, FDA by Carlson Caspers

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

Posted at 19:59h November 28, 2016 in Claim Construction, Prior Art by Carlson Caspers

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 […]

FDA’s New ANDA Rule: Key Implications

Posted at 2:40h October 19, 2016 in ANDA Litigation by Carlson Caspers

Earlier this month, the FDA published a final rule that updates the requirements for ANDA submissions under section 505(j) of the Food, Drug, and Cosmetic Act (“FDCA”) and NDA submissions under section 505(b)(2) of the FDCA. The new rule takes effect on December 5, 2016, and the following is an overview of the most important […]

Federal Circuit Reverses Indefiniteness Ruling Based on Point of Novelty Analysis

Posted at 20:24h September 30, 2016 in Indefiniteness by Carlson Caspers

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

Posted at 14:40h September 22, 2016 in Uncategorized by Carlson Caspers

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 […]

Method Claims Can Salvage Inventions From Section 101 Attack

Posted at 14:44h September 7, 2016 in Patent Eligible, Section 101, Supreme Court by Carlson Caspers

In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court held invalid under § 101 patent claims that were directed to isolated genes that could be used to test for increased risk of breast cancer. While the Court found that discovery of the genes was important and useful, “separating [the] gene from its surrounding […]

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

Posted at 14:57h August 26, 2016 in Uncategorized by Carlson Caspers

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”

Posted at 15:15h August 23, 2016 in Obviousness, PTAB by Carlson Caspers

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

Posted at 15:08h August 12, 2016 in Declaratory Judgment by Carlson Caspers

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 […]