Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more
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
The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...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
Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020) - In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the...more
This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more
Generic and branded pharma companies alike are waiting with baited breath to see if the U.S. Supreme Court will take up the issue of personal jurisdiction in Hatch-Waxman patent cases this term. After a broad ruling from 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
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
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
In the first decision by a federal appeals court interpreting the U.S. Supreme Court’s landmark ruling in FTC v. Actavis, the Third Circuit recently held in King Drug Co. of Florence v. SmithKline Beecham Corp. that so-called...more
Supreme Court Holds Good Faith Belief of Patent Invalidity Is Not a Defense to Induced Infringement - Commil USA, LLC v. Cisco Systems, Inc. (Supr. Ct. May 26, 2015): Pharmaceutical patents commonly include...more
Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more
Case Name: Shire Development, LLC v. Watson Pharms., Inc., 787 F.3d 1359 (Fed. Cir. June 3, 2015) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Hughes, J.) (Appeal from S.D. Fla., Middlebrooks, J.) - Drug...more
Case Name: Teva Pharms. USA, Inc., v. Sandoz, Inc., Fed. Cir. Nos. 2012-1567, -1568, -1569, -1570, 2015 U.S. App. LEXIS 10229 (Fed. Cir. June 18, 2015) (Circuit Judges Moore, Mayer, and Wallach presiding; Opinion by Moore,...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
A little more than one year ago, the U.S. Supreme Court decided Federal Trade Commission v. Actavis Inc. and affirmed that antitrust principles apply to reverse payment settlement agreements — those in which a brand-name drug...more
In This Issue: - INTRODUCTION - WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS? ..The Basic Framework of Hatch-Waxman Litigation ..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more
The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently. (Although anyone familiar with recent...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
One of the most controversial antitrust issues for the pharmaceutical industry during the last decade has been the treatment of patent settlements in which a patent-holding branded manufacturer made payments to its generic...more
In Federal Trade Commission v. Actavis, Inc., the Supreme Court held that reverse payment (“pay-for-delay”) settlement agreements made in the context of settling Hatch-Waxman ANDA litigation should be evaluated for antitrust...more