Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Nature of the Case and Issue(s) Presented: The ’948 patent claims non-sterile drinkable liquid formulations of vancomycin, an antibiotic used to treat Clostridium difficile infection. These formulations are particularly...more
The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...more
Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more
BELCHER PHARMACEUTICALS v. HOSPIRA, INC. Before Reyna, Taranto, and Stoll. Appeal from the District of Delaware. Summary: A patentee committed inequitable conduct by advancing an argument during patent prosecution...more
Patent term extension (PTE) is available under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act (The Act). The Act allows the extension of the term of a patent claiming a product...more
The enactment of the Biologics Price Competition and Innovation Act (“BPCIA”) in 2010 established for the first time ever in the US an abbreviated pathway for obtaining FDA approval of a new biological product that is deemed...more
Bolar Exemptions in the U.S. Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use exemption with respect to regulated...more
Worldwide Bolar Exemptions - Many countries have exemptions for patent infringement for a product and/or process that is not being used for direct commercialization and profit. For biopharmaceuticals, this exemption,...more