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 Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more
Massachusetts state and federal courts issued a number of important product liability decisions in 2018. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more
Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission (“ITC”) might be able to enter the fray too. On April 18, 2018, the ITC issued a notice...more
Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the term of patent protection during which an innovator can recover its...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