Thou Shall Describe A Reason For Negative Claim Limitations

In addressing a written description issue relating to the adequacy of support in the specification for including a "negative limitation" in the claims, the U.S. Court of Appeals for the Federal Circuit established a standard requiring the specification to describe a reason for the negative limitation.  Santarus, Inc., et al., v. Par Pharmaceutical, Inc., Case No. 10-1360 (Fed. Cir., Sept. 4, 2012) (per curiam) (Newman, J., concurring-in-part and dissenting-in-part).

The patent-at-issue was one of several patents asserted by Santarus against Par Pharmaceuticals after Par filed an Abbreviated New Drug Application (ANDA) for FDA approval to sell a generic counterpart to Santarus' Zegerid^® products.  The claims of the asserted patent were directed to a method for treating an acid-caused gastrointestinal disorder by administering to a subject suffering from such disorder a solid composition of omeprazole and sodium bicarbonate, wherein the composition contains no