NUVO PHARMACEUTICALS v. DR. REDDY’S LABORATORIES, decided May 15, 2019, Written Description

U.S. Patent Nos. 6,926,907 and 8,557,285 are directed to coordinated release of an acid inhibitor and non-steroidal anti-inflammatory drug in a single tablet (pages 3-4). The claims recite that the uncoated acid inhibitor is of an amount “effective” to raise the gastric pH of a patient to at least 3.5 (pages 4-6 and 14). It was argued that the specification does not show experimental data or a reason showing possession of an effective dose of uncoated inhibitor since it would not be expected to have uncoated inhibitor work (pages 9 and 12). The specification teaches the claim language, an example titled as immediate release, and a teaching of specific amounts (page 17). These parts of the specification never explain the efficacy (pages 17-18). A person of ordinary skill would not have known or understood that uncoated inhibitor is effective (pages 18-19). The specification must demonstrate more than a mere wish that something would work (page 19). There is no rationale as to why it would work (pages 19-20).   Teaching how to make and use does not necessarily satisfy written description as it does not show that the inventor possessed all aspects of the invention (page 21). There is not data showing effectiveness (page 22).

Hindsight: When claiming a result, the result must be supported. It is more common to claim results in an effort to deal with statutory subject matter and obviousness. The specification may be drafted to show results, such as giving a measurable way to indicate that the result has been achieved and an example showing achievement of the results.