Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more
On October 11, 2024, Edwards filed a petition for a writ of certiorari with the U.S. Supreme Court. The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe harbor, an infringing act is “solely...more
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
What Congress has guaranteed, the courts have taken away - The Supreme Court is about to receive a Petition for Certiorari in a case that impacts how long a patent protects new inventions, we expect. Specifically, the case...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
United Therapeutics Corporation v. Liquidia Technologies, Inc., Appeal Nos. 2022-2217, 2023-1021 (Fed. Cir. July 24, 2023) In the Federal Circuit’s only precedential patent case this week, the Court considered questions...more
Today, the Supreme Court again disregarded the views of the Federal government regarding whether to grant certiorari, here in Teva Pharmaceuticals USA v. GlaxoSmithKline LLC, and in some ways the only positive outcome is that...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
After the Supreme Court invited the Solicitor General to file a brief expressing the views of the United States regarding Teva Pharms USA, Inc. v. GlaxoSmithKline LLC, et al., the Solicitor General filed its brief amicus...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
In 2020, the US Supreme Court and Court of Appeals for the Federal Circuit continued to refine key aspects of intellectual property law on issues that will have an impact on litigation, patent prosecution and business...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 month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware....more
This month we highlight the possibility that the Supreme Court will consider the standard for adequacy of written description and a Federal Circuit exposition on the relationship between “blocking patents” and objective...more
This month, we highlight significant developments in June 2018, including a Supreme Court decision regarding the PTAB, a federal court affirmation in Impax Laboratories Inc. v. Lannett Holdings Inc., and new legislation...more
This month, we highlight several significant cases including Celgene Corp. v. Hetero Labs Ltd. and Regeneron Pharmaceuticals, Inc. v. Merus N.V. as well as new legislation proposed in both houses of Congress with respect to...more
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more
On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more
The US Supreme Court this week held that the broad venue provision of 28 U.S.C. § 1391(c) does not apply to patent law—at least, when the defendant is a domestic entity. This decision arises after years of judicial...more
The Supreme Court held a 70-minute oral argument in Sandoz v. Amgen this morning. Before beginning the argument, the Chief Justice announced that the Court would give each side five extra minutes–a highly unusual step...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
The Supreme Court recently declined to hear several patent cases, thus leaving the decisions by the Federal Circuit intact. Issues that were not taken up by the Supreme Court include (1) whether performing patented methods...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