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?
In Regeneron Pharms., Inc. v. Mylan Pharms. Inc., the Federal Circuit recently held that biosimilar pharmaceutical companies that filed abbreviated Biologics License Applications (aBLAs) and planned to make a single sale to a...more
Bayer's ‘053 patent on its drug Xarelto® expires in November 2024, and Bayer granted Mylan a covenant not to sue. Bayer has a second patent that is subject to a pediatric exclusivity that expires later - February 2025 - and...more
Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more
The Federal Circuit recently held a generic drug developer lacked Article III standing to appeal an adverse patentability determination by the Patent Trial and Appeal Board (PTAB) because it failed to prove that it suffered...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
Here are our picks for the top five most significant legal developments of 2018 that may impact the biosimilar industry: 1. New Law Requiring FTC/DOJ Review Of Biosimilar Patent Litigation Settlements - With the...more
In recent years, courts have reached divergent conclusions about the circumstances in which a damages class containing uninjured persons can be certified. Although there is some room to debate what constitutes injury, it is...more
In his October 17th post, Josh Dunlap describes in detail the First Circuit’s landmark ruling in In re Asacol Antitrust Litigation concerning classes that include uninjured members. ...more
In Tyson Foods, the Supreme Court declined to resolve the issue of whether a class may be certified if it contains members who were not injured and have no legal right to damages. ...more
Case Name: Apotex Inc. v. Alcon Research, Ltd., No. 16-3145-WTL-MJD, 2017 U.S. Dist. LEXIS 27016 (S.D. Ind. Feb. 27, 2017) (Lawrence, J.). Drug Product and Patent(s)-in-Suit: Pataday® (olopatadine); U.S. Patents Nos....more