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?
On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and...more
Expiring patents can be a catalyst for M&A in the life sciences industry as pharmaceutical and biotechnology companies seek to maintain revenue streams and competitive advantages. In this edition of Beyond the Deal, our...more
Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more
Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more
After years of contemplation and delays, Europe’s Unified Patent Court will be operational in about one year. U.S.-based Life Sciences patent applicants should start preparing now to ensure that their applications withstand...more
In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
China has recently unveiled its own version of a patent linkage system that has been highly watched by stakeholders and industry observers. This new system will also create a new form of pharmaceutical patent litigation in...more
On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more
Earlier this month, Eric Sagonowsky reviewed the top ten drugs in the U.S. (in terms of sales) losing patent exclusivity in an article published by Fierce Pharma....more
The world-wide market share of biologic drugs is advancing at a staggering pace, with some estimates ranging from $ 300 billion to $452 billion in revenue within the next five years.The treatment costs for patients...more
Article 76 of the Amendment establishes the longanticipated patent linkage scheme in China. It aims to allow early resolution of patent disputes between innovators and generic companies during the drug review and approval...more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more
The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug...more
When the America Invents Act of 2011 ushered in a number of new administrative procedures for challenging issued patents, the biotechnology and pharmaceutical industries at first seemed largely unconcerned. Originally...more
Increasing competition within Europe’s pharmaceutical space makes knowing the market and understanding available patent protections more critical than ever for both well established and new market players. Andreas von Falck...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more
Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more
Recent antitrust challenges to pharmaceutical companies' efforts to transition patients from drugs nearing the end of their patent life to next-generation drugs have increased the risk of pursuing such "product hopping"...more
On 20 November 2013, the Japanese Diet passed the Act regarding Ensuring of Safety of Regenerative Medicine (the "Regenerative Medicine Law") and the revisions to the Pharmaceutical Affairs Law (new PAL) as it applies to...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alpex Pharma S A et al. v. Zydus Pharmaceuticals USA Inc. et al. 1:13-cv-01143; filed June 26, 2013 in the District...more