Madelyn McCormick

Apr 5, 2024 | fr.com | Andria Rae Crisler |Casey Kraning |Philip Chen |Madelyn McCormick

In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA), post-grant disputes on biologic drug patents before the United States Patent and Trademark Office (USPTO), and proposed legislation and regulatory activities relating to biosimilars.

Dec 18, 2023 | jdsupra.com | Megan Chacon |Madelyn McCormick

The Hatch-Waxman Act allows a generic drugmaker to rely on a branded drugmaker’s Food and Drug Administration-approved New Drug Application if the generic drugmaker can show that the generic drug has the same active ingredient and is bioequivalent to the branded drug. Generally, a generic drug label must copy the branded drug label. But there are some exceptions. A generic drugmaker may propose a label that attempts to “carve out” a patented use. See Caraco Pharm. Lab’ys, Ltd. v.