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For nearly a decade, the Supreme Court’s FTC v. Actavis decision has guided pharmaceutical litigators and advisors exploring the antitrust risks inherent in settling pharmaceutical patent lawsuits, especially when such...more
A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
Addressing for the first time whether reverse settlement agreements involving non-cash consideration merit antitrust scrutiny, the U.S. Court of Appeals for the Third Circuit reversed the district court, applying the...more
Antitrust challenges to so-called “pay-for-delay” settlements in drug patent suits are allowed under the U.S. Supreme Court’s recent decision in Federal Trade Commission v. Actavis, Inc....more
On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation....more
Today, the U.S. Supreme Court held in Federal Trade Commission v. Actavis, Inc. that so-called “reverse payment” settlement agreements should be analyzed under a rule-of-reason analysis under which the court assesses any...more
The U.S. Supreme Court issued its much-anticipated opinion today in FTC v. Actavis, Inc., ruling that so-called “reverse payment” patent settlements between innovator and generic pharmaceutical manufacturers that are...more
Par PharmaceuticalPar/Paddock, one of the generic drug company defendants in FTC v. Actavis Inc. et al. (the "reverse payment" ANDA settlement case now before the Supreme Court) filed its reponsive brief last week. In it,...more