Last week, the United States Court of Appeals for the Federal Circuit issued an opinion in Nuvo Pharmaceuticals (Ireland) Designated Activity Company v. Dr. Reddy’s Laboratories, Inc., Nos. 2017-2473, 2017-2481, 2017-2484, 2017-2486, 2017-2489, 2017-2491, 2017-2492, 2017-2493 (May 15, 2019). Nuvo owned patents to a drug form that coordinates release of an acid inhibitor and an NSAID pain reliever in a single tablet to prevent gastrointestinal problems. The claims called for an uncoated acid inhibitor around the outside of the tablet, despite the fact that, without a coating, the acid inhibitor is at risk of being degraded by stomach acid before it can reach the small intestine. Nuvo sued a number of generic drug manufacturers to prevent them from launching competing products. The generics alleged the patents were invalid due to obviousness, lack of enablement, and inadequate written description. After a bench trial on validity, the district court rejected the generics’ invalidity defenses and entered judgment in favor of Nuvo as to all but one product, as to which the district court had granted summary judgment of noninfringement.
The generics appealed on the issue of written description, and Nuvo cross-appealed the grant of summary judgment of non-infringement as to the contested product. On appeal, the generics argued that (1) the asserted claims recite therapeutic effectiveness, but the prior art taught away from effectiveness because it was known that uncoated acid inhibitors would be degraded by stomach acid and therefore less effective; and (2) the patents’ specifications failed to provide supporting experimental data or any other “reason, theory, or alternative explanation as to why the claimed invention is possessed by the inventor.”
The Federal Circuit agreed. The Court held the district court clearly erred when it concluded the claimed therapeutic effectiveness of the alleged invention was supported by adequate written description. Acknowledging that its precedent does not necessarily require experimental data to demonstrate a claimed effectiveness, the Court held that a specification providing nothing beyond a “mere claim” the drug product might work is “fatally flawed” where persons of ordinary skill in the art have reason to believe it will not work. The Court further explained that “the fact that an invention may be enabled does not mean it is adequately described, and vice versa,” and that the record did not contain evidence demonstrating the inherency of the claimed feature. Accordingly, the Court reversed the judgment of the district court.