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
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
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
When there are multiple ANDA filers for the same drug, it may not be possible for a branded pharmaceutical company to bring Hatch-Waxman Act patent infringement suits against all of them in the same court consistent with 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
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 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
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
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
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
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
An emerging issue in Hatch-Waxman litigation – and potentially under the Biologics Price Competition and Innovation Act (BPCIA) – is the impact of the Supreme Court’s decision in Daimler AG v. Bauman, 134 S. Ct.746 (2014), on...more
In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., No. 13-854, slip op. 574 U.S. __ (2015), the U.S. Supreme Court ruled that underlying factual issues resolved while formally construing a disputed patent claim term at the...more