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?
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more
The Federal Trade Commission (FTC) spent the better part of a decade attacking the practice of innovator drug companies settling ANDA litigation by providing payments to generic applicants challenging the validity of Orange...more
In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies. ...more
It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more
In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...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
Recently, the Third Circuit issued the first federal appellate decision interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc.[1], potentially greatly expanding the scope of settling parties in reverse...more