In Nuvo Pharmaceuticals, In. v. Dr. Reddy’s Laboratories Inc., the Federal Circuit reversed the district court and found the asserted patents invalid for failing to satisfy the written description requirement. This decision caught my attention because the court found the disclosure insufficient to show possession of the efficacy of the claimed compositions. 

The Vimovo Patents At Issue

The patents at issue were U.S. Patents 6,926,907 and 8,557,285, which are two of multiple patents listed in the Orange Book for Horizon Medicines’ Vimovo® (naproxen / esomeprazole magnesium) product. The court considered claim 1 of each patent:

1. A pharmaceutical composition in unit dosage form suitable for oral administration to a patient, comprising: 
(a) an acid inhibitor present in an amount effective to raise the gastric pH of said patient to at least 3.5 upon the administration of one or more of said unit dosage forms; 
(b) a non-steroidal anti-inflammatory drug (NSAID) in an amount effective to reduce or eliminate pain or inflammation in said patient upon administration of one or more of said unit dosage forms; 
and wherein said unit dosage form provides for coordinated release such that: 
i) said NSAID is surrounded by a coating that, upon ingestion of said unit dosage form by said patient, prevents the release of essentially any NSAID from said dosage form unless the pH of the surrounding medium is 3.5 or higher;
ii) at least a portion of said acid inhibitor is not surrounded by an enteric coating and, upon ingestion of said unit dosage form by said patient, is released regardless of whether the pH of the surrounding medium is below 3.5 or above 3.5. 

1. A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of: 
(a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating; and 
(b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher; 
wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium.

The Federal circuit determined that “[b]oth patents-in-suit … recite claims requiring amounts of uncoated PPI [(acid inhibitor, e.g., esomeprazole)] effective to raise the gastric pH to at least 3.5.”

Dr. Reddy’s and several other generic companies challenged the patents in Abbreviated New Drug Applications seeking FDA approval to market generic versions of Vimovo®. The district court upheld the patents against enablement, written description, and obviousness challenges.

The Missing Description Of Efficacy

The Federal Circuit decision was authored by Judge Clevenger and joined by Chief Judge Prost and Judge Wallach. 

The generic companies had raised several written description challenges, but the Federal Circuit focused on whether there was adequate written description support for the efficacy of uncoated proton pump inhibitors (PPI). While such issues usually are addressed under the enablement requirement, as noted in the opinion, the generic companies did not appeal the district court decision upholding enablement.

After “scour[ing]” and “search[ing] the specification for written description support for the efficacy of uncoated PPI,” and reviewing Nuvo’s expert’s testimony, the Federal Circuit found “statements … calling generally for effective amounts of uncoated PPI.” However, the Federal Circuit cited its 2002 decision in Enzo Biochem, Inc. v. Gen– Probe Inc. for the proposition that “the written description requirement … is [not] necessarily met as a matter of law because the claim language appears in ipsis verbis in the specification.” 

The court acknowledged no requirement for experimental data, and no requirement for an “explanation of how or why a claimed composition will be effective,” but emphasized the requirement that the specification show the inventor’s “possession” of the claimed subject matter. The Federal Circuit cited one of the policies behind the requirement (internal quotations omitted) as supporting this standard: 

"[T]he written description requirement incentivizes ‘actual invention,’ and thus a mere wish or plan for obtaining the claimed invention is not adequate written description."

Referring to Nuvo’s non-obviousness arguments, the Federal Circuit concluded: 

"In light of the fact that the specification 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."

The Federal Circuit rejected Nuvo’s argument that the written description requirement is satisfied because “the specification … teaches how to make and use the claimed invention.” In particular, the court agreed with the generic companies that “[t]eaching how to make and use” pertains to the enablement requirement, but does not satisfy the possession element of the written description requirement.

The Federal Circuit therefore reversed the district court’s finding that the patents satisfied the written description requirement.

Possession Of Efficacy?

If Nuvo seeks review of this decision at the Supreme Court, it might challenge the Federal Circuit’s finding that the specification described the invention in so many words, enabled those skilled in the art to make and use it, but somehow still failed to satisfy the statue:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

Is it reasonable to characterize a specification that enables the claimed invention as merely setting forth a “wish or plan”?