Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Yondelis® (trabectedin) - Case Name: Janssen Prods., L.P. v. EVER Valinject GmbH, Civ. No. 24-7319, 2025 WL 639380 (N.D. Ill. Feb. 27, 2025) (Harjani, J.) Drug Product and Patent(s)-in-Suit: Yondelis® (trabectedin); U.S....more
In this edition of The Precedent, we outline the decision in Regeneron Pharms., Inc. v. Mylan Pharms. Inc. In Regeneron Pharms., Inc. v. Mylan Pharms. Inc., the Federal Circuit affirmed the district court’s grant of a...more
On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with...more
On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district courts over what constitutes...more
Last week was argument week at the Federal Circuit, which as usual meant the Court issued several Rule 36 affirmances and short non-precedential decisions. But tucked in between those was at least one case—a Hatch-Waxman...more
Somewhat remarkably, there is no settled Federal Circuit precedent regarding where a patentee can bring suit against a generic competitor in Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2). While recognizing that this...more
The Federal Circuit Thursday issued a decision that narrows the venue options available to patent owners bringing suit against generic drug manufacturers under the Hatch-Waxman Act. In a unanimous decision, the court held...more
A Tale of Two ANDAs: Jurisdiction and Venue in a Non-Traditional Sense - Judge Gilstrap’s recent opinion in Apicore US LLC v. Beloteca, Inc., No. 2:19-CV-00077-JRG, 2019 WL 1746079 (E.D. Tex. Apr. 18, 2019), highlights...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
On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of...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
Case Name: Helsinn Healthcare S.A. v. Hospira, Inc., Civil No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. Apr. 5, 2016) (Cooper, J.) - Drug Product and Patents-in-Suit: Aloxi® (palonosetron); U.S. Patents Nos....more
Clare v. Chrysler Group LLC (No. 2015-1999, 3/31/16) (Prost, Moore, Wallach) - Moore, J. Affirming summary judgment of non-infringement of patents related to storage compartment for pickup trucks. The Court rejected...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
The disputed technology is a generic rivastigmine patch. Defendant is a New Jersey corporation with a principal place of business in Vermont. Only specific jurisdiction is at issue since it is not “at home” in Delaware. ...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
The United States District Court for the Southern District of Indiana joined the District of Delaware and the Eastern District of Texas in finding specific jurisdiction based on receipt of a Paragraph IV Notice Letter. See...more