By Bryan K. Wheelock, Principal
In Nuvo Pharmaceuticals v. Dr. Reddy’s Laboratories Inc., [2017-2473, 2017-2481, 2017-2484, 2017-2486, 2017-2489, 2017-2491, 2017-2492, 2017-2493] (May 15, 2019), the Federal Circuit reversed the district court’s judgment that the asserted claims of U.S. Patent Nos. 6,926,907 and 8,557,285 were non-obvious and adequately enabled and described.
Nuvo’s expert identified portions of the specification the he said supported the claims, but the Federal Circuit disagreed, noting that it has expressly rejected the “argument that the written description requirement is necessarily met as a matter of law because the claim language appears in ipsis verbis in the specification. The appearance of words in a specification or a claim, even an original claim, does not necessarily satisfy §112 because it may not fulfill both functions of putting others on notice of the scope of the claimed invention and demonstrate possession of that invention.
The Federal Circuit noted that experimental data demonstrating effectiveness is not required. Patent applications claiming new methods of treatment are usually supported by test results, but it is clear that testing need not be conducted by the inventor. The Federal Circuit also noted that a theory or explanation of how or why a claimed composition will be effective is also not required. Nor does the invention actually have to be reduced to practice. Nevertheless, the Federal Circuit found that the record evidence demonstrates that a person of ordinary skill in the art would not have known or understood the claimed invention.
The Federal Circuit said that in light of the fact that the specification provides nothing more than the mere claim that the invention might work, even though persons of ordinary skill in the art would not have thought it would work, the specification is fatally flawed. It does not demonstrate that the inventor possessed more than a mere wish or hope that the invention would work, and thus it does not demonstrate that he actually invented what he claimed.
The Federal Circuit said that teaching how to make and use an invention does not necessarily satisfy the written description requirement. The enablement requirement, which requires the specification to teach those skilled in the art how to make and use the claimed invention without undue experimentation, is separate and distinct from the written description requirement, which focuses on whether the specification notifies the public about the boundaries and scope of the claimed invention and shows that the inventor possessed all the aspects of the claimed invention.
The Federal Circuit concluded that the patent did not meet the written description requirement, and did not reach the question of enablement or the patent owner’s appeal of summary judgment of non-infringement.