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
Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...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