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?
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
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
The US Court of Appeals for the Federal Circuit upheld a US Court of Federal Claims ruling that Hatch-Waxman Act litigation expenses are ordinary and necessary business expenses under § 162(a) of the Internal Revenue Code,...more
On November 20, 2024, the Federal Court dismissed EMD Serono (Serono)’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 3,087,419 (419 Patent) on the Patent Register one week after it was...more
This issue of The PTAB Review begins by providing an analysis of how institution decisions consider declaration testimony submitted by a patent owner. Next, it summarizes proposed rulemaking from the United States Patent and...more
NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. Before Moore, Linn, and O’Malley. Appeal from the United States District Court for the District of Delaware. Summary: A patent application that was silent about a...more
The European Court of Justice's ruling in Paroxetine, handed down in record time just before Brexit, confirms the narrow interpretation of restrictions by object given in other recent cases. It also clarified certain issues...more
On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S....more
A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s invalidity and infringement judgments for patents directed to a topical nonsteroidal anti-inflammatory drug, finding that a patent claim reciting a...more
BUT FOR A CLERICAL ERROR TO BE ADDRESSED ON REMAND, THE FEDERAL CIRCUIT AFFIRMS FINDINGS OF INELIGIBLE SUBJECT MATTER AND NON-INFRINGEMENT. Case Name: INO Therapeutics LLC v. Praxair Distribution Inc., 2019 U.S. App. LEXIS...more
Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more
PMPRB amendments expected to come into force no earlier than Spring 2020 - On April 1, 2019, Health Canada released Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief...more
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...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
FCA overturns cefaclor damages decision on prejudgment interest issue, provides guidance on NIA defence - On November 23, 2018, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli...more
Case Name: Merck Sharp & Dohme Corp. v. Hospira, Inc. 874 F.3d 724, No. 17-1115, 2017 U.S. App. LEXIS 21201 (Fed. Cir. Oct. 26, 2017) (Circuit Judges Newman, Lourie, and Hughes presiding; Opinion by Lourie, J.; Dissent by...more
Last year, a jury awarded Brigham and Women’s Hospital (“BWH”) approximately $10 million after it found that defendant Perrigo Company’s (“Perrigo”) generic version of Pepcid® Complete® willfully infringed BWH’s patent. After...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
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
The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...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
To prevail in a product-hopping case, a plaintiff must be prepared to establish both monopoly power and anticompetitive effects. On September 28, a unanimous panel of the U.S. Court of Appeals for the Third Circuit...more