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?
Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing the working knowledge of core essentials of FDA law and regulation, including the new amendments...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
As a special product, the quality of drugs is a matter of health and safety for millions of consumers. Therefore, China has implemented strict regulations on drugs, including their names. There are three different names for...more
Under the Federal Law “On drugs circulation” (Law), information on state registration of drugs in Russia shall be publicly available. Pursuant to Art. 37(1) of the Law, MoH-s obligation is to disclose information regarding...more
CATEGORY: Trademarks - CASE: Sony vs. PAG - DETAILS: Resolution of the Constitutional Court No. 8-P dated 13 February 2018 - SUMMARY: Unlike the counterfeit, the original (grey) product cannot be destroyed under the...more
Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names. This...more
An interesting debate recently occurred in the New England Journal of Medicine between a physician and the U.S. Food and Drug Administration (FDA) regarding whether the letters X and Z are used too frequently in...more
In This Bulletin: - Just Moot It: Supreme Court in Already v. Nike Clarifies When a Covenant Not to Sue Can Kill a Declaratory Judgment Case - Murky Waters: Post-Approval Regulatory Activities and the §...more
In This Issue: Supreme Court - Supreme Court Finds That “First Sale” Doctrine Applies to Works Patents - Joint Actors as It Relates to Method Claim Infringement; Federal Circuit Ruling Clears Way...more