The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product (active pharmaceutical...more
The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method...more
On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit, in Jazz Pharmaceuticals, Inc., v. Avadel CNS Pharmaceuticals, LLC, Case No. 23-1186, affirmed a decision from the District Court of Delaware directing...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
On May 17, 2018, the Food and Drug Administration (FDA) posted a new list targeting pharmaceutical companies that, in the FDA’s view, have used “certain ‘gaming’ tactics to delay generic competition.” The list is intended to...more
Last week Markus Meier, the Acting Director of the Bureau of Competition at the Federal Trade Commission, gave testimony to the House Judiciary Committee concerning “Antitrust Concerns and the FDA Approval Process.” ...more
On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, held a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company...more
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more
Antitrust practitioners, enforcers and industry professionals came together in Washington, D.C. for the 64th installment of the ABA Section of Antitrust Law's annual Spring Meeting. The Spring Meeting provides a look at the...more
Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more