• May 15 2019
  • |
  • Category: CAFC Updates

Nuvo sued three Generics manufacturers (Dr. Reddy’s Laboratories, Mylan Pharmaceuticals, and Lupin Pharmaceuticals) to prevent their ANDA products from going to market, if approved, before the expiration of U.S. Patent Nos. 6,926,907 and 8,557,285, relating to the coordinated the release of an acid inhibitor (such as proton pump inhibitors (“PPIs”) like omeprazole and esomeprazole) and an NSAID (like naproxen). The Generics appeal from the district court’s judgment upholding the asserted claims of the patents. Nuvo and Horizon Pharma (a licensee), cross-appeal from the district court’s grant of summary judgment of non-infringement. The CAFC presents an extensive analysis of the written description requirement, explaining that the written description requirement: 1) is not necessarily met as a matter of law because the claim language appears in ipsis verbis in the specification; 2) does not require experimental data demonstrating effectiveness; 3) does not require theory or explanation of how or why a claimed composition will be effective; and 4) does not require that the invention actually be reduced to practice. The CAFC notes, however that there must be some description, such as a constructive reduction to practice, establishing that the inventor was in possession of the claimed invention, including all of the elements and limitations, and that a mere wish or plan for obtaining the claimed invention is not adequate written description. In light of the fact that the common specification of the asserted patents provides nothing more than the mere claim that uncoated PPI might work, even though persons of ordinary skill in the art would not have thought it would work, the specification is fatally flawed because it does not demonstrate that the inventor possessed more than a mere wish or hope that uncoated PPI would work, and thus it does not demonstrate that he actually invented what he claimed. The CAFC therefore reverses the district court’s determination that the asserted claims of the ’907 and ’285 patents are valid, and dismisses Nuvo’s cross-appeal as moot.

View Decision