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While a Miranda warning isn’t given prior to starting substantive examination, perhaps it should be. In Azurity Pharmaceuticals, Inc. v. Alkem Laboratories, Ltd., a precedential decision issued on April 8, 2025, the Federal...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
ALLERGAN SALES, LLC v. SANDOZ, INC. Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of New Jersey. Summary: A “wherein” clause can be limiting if it is material to...more
Please see full chart for Bolar Excemption rules in foreign countries regarding Clinical Trials, New Drugs, Biosimilars and Foreign Jurisdiction issues. ...more
Bolar exemption in Europe - The Bolar exemption is governed by European Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Article 10(6) excludes from infringement of patent rights or...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
Many jurisdictions provide for the extension of the term of the patents that cover a regulated product. Patent term extension (PTE) is particularly important in the bio/pharma industry given that development of an innovative...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