Federal Circuit Establishes Rule for 'Product-by-Process' Claims

Any court opinion that contains the phrase “Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem.-4-carboxylic acid,” doesn’t exactly put us in our comfort zone. Yet, upon closer inspection, it appears that the Federal Circuit’s en banc decision Monday in Lupin Ltd. v. Abbot Laboratories is an important and long-awaited clarification of patent law that deserves attention. After decades of debate within the IP bar and the Federal Circuit, a divided en banc panel on Monday established the standard for evaluating so-called patent-by-process claims, which involve patents that are defined, at least in part, by the process used to make the product.

The case involved Abbott’s patent for the drug Omnicef, an antitbiotic that is often used to treat children’s ear infections. After the FDA approved Lupin Limited’s generic version of the drug, cefdinir, Lupin sought a declaratory judgment in the Eastern District of Virginia that it did not infringe, arguing that it used a different process to make its drug. The court ruled for Lupin, and Abbott appealed. The case was later combined with a similar dispute between Abbott, Sandoz and Teva Pharmaceuticals that originated in the Northern District of Illinois.