Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
The US Court of Appeals for the Federal Circuit affirmed (on its second review) a district court’s ruling upholding the validity of patent claims related to a long-acting injectable dosing regimen, finding that the...more
Purdue Pharma (Purdue) has filed a petition for a writ of certiorari challenging a recent Federal Circuit decision upholding the invalidation of several Purdue patents on grounds of obviousness....more
On July 8, the US Court of Appeals for the Federal Circuit issued a precedential opinion in Janssen Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals USA, Inc. affirming the district court’s finding that patent claims to a...more
Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal Nos. 2025-1228, -1252 (Fed. Cir. July 8, 2025) Our Case of the Week focuses on obviousness. More particularly, the decision included a lengthy...more
On March 28, 2025, the United States Court of Appeals for the Federal Circuit issued an opinion affirming the United States District Court for the District of New Jersey decision that Mylan Laboratories Ltd. (“Mylan”) induced...more
Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...more
Mirror Worlds Technologies, LLC v. Meta Platforms, Inc., Appeal Nos. 2022-1600, -1709 (Fed. Cir. Dec. 4, 2024) In this appeal from the United States District Court for the Southern District of New York, the Federal...more
On September 3rd, the Federal Circuit affirmed under Rule 36 the decision by the District Court of Nevada (Du, J.) in March that the claims asserted by Amarin Pharma against West-Ward Pharmaceuticals International Ltd., Hikma...more
In a precedential decision delivered this week, the Federal Circuit shot down arguments from Appellants BTG International Limited; Janssen Biotech, Inc.; Janssen Oncology, Inc.; and Janssen Research & Development, LLC (BTG),...more
Before Judges Reyna, Taranto, and Chen. Appeal from the U.S. District Court for the District of New Jersey. Summary: There may be no reasonable expectation of success in producing a specific polymorph of a compound when...more
On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of Health from issuing a notice of compliance to Generic Partners for its generic version of Valeant’s GLUMETZA,...more
PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted - In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more
In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board finding UCB’s patent to certain chemical derivatives of diphenylpropylamines...more
Federal Circuit Summary - Before Lourie, Chen, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: A generic pharmaceutical company had standing to appeal the Board’s decision in an IPR that claims of a...more
Federal Circuit Summary - Before Newman, Hughes, and Stoll. Appeal from the United States District Court for the District of Delaware Summary: Objective indicia of nonobviousness cannot be dismissed merely because all...more
Distribution Agreements Can Constitute Offers for Sale Under Section 102(b) - In The Medicines Company v. Hospira, Inc., Appeal Nos. 2014-1469, 2014-1504, the Federal Circuit held that a distribution agreement qualified as...more
In Sanofi v. Watson Labs., the Circuit affirms a determination of induced infringement of one patent and direct infringement of another, thus assuring Sanofi another 12 years of exclusivity as to its Multaq® atrial...more
In Bayer v. Watson, the panel throws out Bayer’s patent to its Staxyn erectile dysfunction drug as being obvious, noting that the district court focused too heavily on the commercial availability of the prior art. The panel...more
MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC - (Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) - This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA...more
On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more
Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more
With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more
Addressing infringement under the doctrine of equivalents and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling barring approval of a generic version of Finacea® gel...more
Hoffmann La-Roche Inc. v. Apotex Inc. - Addressing the validity of a dosing regimen patent in Abbreviated New Drug Application (ANDA) litigation, the U.S. Court of Appeals for the Federal Circuit affirmed a lower...more