The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more
6/3/2025
/ Antitrust Violations ,
Enforcement Actions ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Orange Book ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sherman Act ,
Teva Pharmaceuticals ,
Warning Letters
Today, the Federal Circuit will hear oral argument in Contour IP Holding LLC v. GoPro, Inc., Case Nos. 2022-1654, -1691, once again stepping into complex questions of patentable subject matter pursuant to 35 U.S.C. § 101...more
On October 31, 2023, FDA approved Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen’s Stelara (ustekinumab). Stelara has been selected by the Center for Medicare & Medicaid Services...more
As discussed last month, the FTC sent letters to 10 pharmaceutical companies, asserting that their listing of over 100 patents in FDA’s Orange Book for a variety of products was improper. Shortly thereafter, the FTC began...more
FTC recently placed improper Orange Book patent listings squarely in its crosshairs. In its September 2023 policy statement, FTC announced that it would “scrutinize improper Orange Book listings” and “use its full legal...more
Yesterday, the Supreme Court denied certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, locking in the Federal Circuit’s second panel decision (hereafter “GSK v. Teva”), which held that Teva’s attempted...more
5/16/2023
/ Denial of Certiorari ,
Equitable Estoppel ,
Food and Drug Administration (FDA) ,
GlaxoSmithKline ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
SCOTUS ,
Teva Pharmaceuticals ,
Teva Pharms USA Inc v GlaxoSmithKline LLC