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 22 February 2018, the French Health Authority (ANSM) published on its website its "Recommendations to applicants and holders of marketing and registration authorisations" on the names of medicines....more
Generic and branded pharma companies alike are waiting with baited breath to see if the U.S. Supreme Court will take up the issue of personal jurisdiction in Hatch-Waxman patent cases this term. After a broad ruling from the...more
Last week, a federal district court in Illinois held that GlaxoSmithKline (GSK), a branded drug manufacturer, owed a duty of care to a patient who took the generic version of its drug. Dolin v. SmithKline Beecham Corp., No....more
Since passage of the Hatch-Waxman Act in 1984, generic drug companies have used its Abbreviated New Drug Application (ANDA) process to bring cheaper versions of brand-name drugs to market after their patents expire. In the...more
When the Supreme Court decided Mensing, we imagine generic drug manufacturers felt like Stephen Sondheim’s “Everything’s Coming Up Roses” was written just for them. But, to borrow from another Broadway hit, they may now be...more