I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more
Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more
Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more
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
The Federal Trade Commission (“FTC”) sued AbbVie and Besins Healthcare, co-owners of a patent that covered brand AndroGel, in 2017. The FTC claimed that the manufacturers had brought “sham” patent infringement litigation in...more
A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse...more
The Federal Trade Commission (FTC) spent the better part of a decade attacking the practice of innovator drug companies settling ANDA litigation by providing payments to generic applicants challenging the validity of Orange...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
On October 7, 2019, California became the first state to enact legislation—Assembly Bill 824 ("AB 824")—rendering certain pharmaceutical patent litigation settlement agreements presumptively anticompetitive. This alert...more
On October 26, the Boston Patent Law Association will host a panel featuring Judge William Young to discuss the legal landscape following the Supreme Court’s 2014 opinion in Actavis v. FTC...more
On August 28, 2017, in King Drug Company of Florence, Inc., et al. v. Cephalon, Inc., et al., the Eastern District of Pennsylvania denied class certification for direct purchasers asserting Hatch-Waxman reverse-payment...more
The Third Circuit recently affirmed the grant of summary judgment to GlaxoSmithKline (“GSK”) in the nearly 10-year-old Wellbutrin XL Antitrust Litigation, which challenged the lawfulness of settlement agreements resolving...more
On November 21, 2016, the U.S. Court of Appeals for the First Circuit upheld a 2014 jury verdict for AstraZeneca (AZ) and Ranbaxy regarding a 2012 payment of $700 million from AstraZeneca for Ranbaxy to abandon its challenge...more
It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more
Patent settlement agreements were traditionally deemed outside the purview of antitrust scrutiny unless the patent holder’s conduct fell outside the legitimate scope of the patent’s exclusionary power. This all changed when...more
On March 30 the US Federal Trade Commission filed suit in federal court alleging that settlements of patent litigation in the pharmaceutical industry in which a pioneer firm agrees not to market an "authorized generic"...more
The Federal Trade Commission (FTC) filed an antitrust complaint this week against Endo Pharmaceuticals and several generic companies, alleging that these companies entered into anticompetitive “reverse payment” settlements of...more
The FTC has recently weighed in again on the evolving interpretation of the Supreme Court’s 2013 opinion in FTC v. Actavis, 133 S. Ct. 2223 (2013). The agency submitted an amicus brief to the Third Circuit in the appeal of...more
Recently, the First Circuit became the second federal appellate court interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc. to hold that non-cash "reverse payments" between pioneer and generic...more
Direct and indirect purchasers of Nexium recently appealed District of Massachusetts Judge William Young’s denial of a request for a new trial in In re: Nexium to the First Circuit. As we previously reported, In re: Nexium...more
In January, the Federal Trade Commission issued a report on the terms of settlement agreements between branded and generic drug companies in ANDA litigation under the Hatch-Waxman Act, according to the provisions of the...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
Recently, the Third Circuit issued the first federal appellate decision interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc.[1], potentially greatly expanding the scope of settling parties in reverse...more
On June 17, 2015, the U.S. District Court for the Eastern District of Pennsylvania approved a consent order (the “Consent Order”) between the Federal Trade Commission and defendants Cephalon, Inc. and its parent, Teva...more