Congress’s protection from patent infringement for drug developers created under the Hatch-Waxman Act of 1984 (Act) has been extensively litigated over the past three+ decades, but the scope of the so-called “safe harbor...more
This past week, the Food and Drug Administration (FDA) announced the creation of the “Purple Book,” which will list all biological products, including any biosimilar and interchangeable biological products, licensed by the...more