Written Description Requires Disclosure in Support of Efficacy When Claims Expressly Require Efficacy

June 2019

 

Nuvo Pharmaceuticals v. Dr. Reddy’s Laboratories / Mylan Pharmaceuticals / Lupin Pharmaceuticals, Nos. 2017-2473, -2481, -2484, -2486, -2489, -2491, -2492, -2493 (Fed. Cir. May 15, 2019)

 

In Nuvo, the Federal Circuit held that the formulation claims of Nuvo’s patent were invalid for lacking adequate written description in a decision that explains the extent that pharmaceutical efficacy must be demonstrated to satisfy the written description requirement.  Although it may be not always be necessary to prove a pharmaceutical achieves a certain result to satisfy written description, when a result is expressly claimed it must be supported by adequate disclosure in the specification.

Nuvo Pharmaceuticals was the owner of a patent directed to a pharmaceutical tablet dosage form containing a coated NSAID and an uncoated proton pump inhibitor effective to raise the pH of the stomach above a threshold. Nuvo sells such a tablet under the tradename Vimovo.   After generic pharmaceutical makers Dr. Reddy’s Laboratories, Mylan Pharmaceuticals, and Lupin Pharmaceuticals filed Abbreviated New Drug Applications to market generic versions of Vimovo, Nuvo filed suit. The generics argued that the patent was invalid for failure to satisfy the written description requirements of pre-AIA U.S.C. 35 § 112 first paragraph, because a person of skill in the art would not expect the uncoated PPI to work for the purpose stated in the patent, and that the patent provides no data or explanation for why it should or would work.

Although the patent’s claims recited a tablet containing an uncoated PPI, the patent did not provide data or any explicit disclosure supporting uncoated PPI’s effectiveness to raise pH. Rather, the specification recognized that coating PPI was known to be necessary to protect the PPI from the stomach.

The United States District Court of New Jersey ruled in favor of Nuvo, finding the patent valid.  The generics appealed.

The Federal Circuit reversed, holding the patent invalid for failure to satisfy the written description requirement.  The court noted that Nuvo’s patent supplied only general effectiveness and dosage information and nothing to support the efficacy of uncoated PPI.  The court held that since the record showed a person of skill in the art would not have known or understood uncoated PPI to be effective and the specification contained nothing to demonstrate effectiveness of uncoated PPI or explain why it might be effective, it was not clear that the inventors actually possessed what was claimed.

Key takeaway: When a pharmaceutical result is claimed and it would not be obvious to one of skill that such a result could be obtained by the claimed invention, data demonstrating the result or an explanation of why it would/might be obtained are needed to satisfy written description.