In the ten years since the Supreme Court ruled in Federal Trade Commission v. Actavis that reverse payment settlements—or settlements where a patent holder pays an accused patent infringer cash or other consideration to end...more
On February 3, 2020, the Federal Trade Commission ("FTC") and the Food and Drug Administration ("FDA") issued a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive...more
This past year has seen renewed challenges to reverse payment settlement agreements in the pharmaceutical industry. Since the Supreme Court’s Actavis decision in mid-2013, potentially anti-competitive agreements are...more
In 2013, the U.S. Supreme Court rendered its decision in FTC v. Actavis, finding that although so-called reverse payment settlement agreements were not per se antitrust violations in cases brought against generic drug makers...more
Applying its previous rulings in related litigation and interpreting FTC v. Actavis, 570 U.S. 756 (2013), the U.S. District Court for the Eastern District of Pennsylvania was tasked with determining whether to preclude expert...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
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
Our first post in this series was titled “What Is a Reverse Payment?” As the recent cases discussed in today’s post show, the courts are struggling with a fundamental component of that question: What, for that matter, is a...more
In this Issue: - New Developments - U.S. Supreme Court Will Decide Whether Patent Agreements That Postpone the Sale of Generic Drugs Violate Antitrust Laws - Direct Purchasers Have Standing to Bring Antitrust...more
In Federal Trade Commission v. Actavis, Inc., the Supreme Court, in a 5-3 decision written by Justice Breyer, reversed the Eleventh Circuit's dismissal of an FTC complaint under Section 5 of the Federal Trade Commission...more
Patent rights and antitrust law contain inherently antagonistic policies: While antitrust law is aimed at preventing monopolies and promoting competition, patent law explicitly rewards inventors with a time-limited right to...more
A divided Supreme Court recently held in an opinion by Justice Breyer that “reverse payment” or “pay for delay” agreements between patent holders and potential competitors are not immune from scrutiny under antitrust laws....more
On June 17, 2013, the U.S. Supreme Court handed down a decision that addressed a “reverse payment” settlement agreement between a brand-name pharmaceutical company (plaintiff patent holder) and multiple generic drug companies...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
In Federal Trade Commission v. Actavis, Inc., the Supreme Court, in a 5-3 decision written by Justice Breyer, reversed the Eleventh Circuit's dismissal of an FTC complaint under Section 5 of the Federal Trade Commission Act...more
Earlier this week in FTC v. Actavis, No. 12-416 (U.S. Jun. 17, 2013), the Supreme Court handed down its long-anticipated ruling on “reverse payment” or “pay-for-delay” agreements, holding that these agreements—while not...more
The U.S. Supreme Court yesterday ruled on the long-awaited FTC v. Actavis case concerning ANDA reverse payments, resolving a sharp circuit split. The Court held that settlement agreements that include reverse payments to end...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