In a recent decision, the Federal Circuit reversed the District of New Jersey’s final judgment that two patents directed to methods of administering NSAIDs were adequately described under § 112. Nuvo Pharm. (Ir.) Designated Activity Co. v. Dr. Reddy’s Labs. Inc., 2019 U.S. App. LEXIS 14345 (Fed. Cir. 2019).

Both of the asserted patents are listed in the Orange Book for Vimovo® and “have nearly identical specifications.” They are directed to the use of uncoated proton pump inhibitor (PPI) in combination with an enteric coated NSAID. PPIs, which are indicated to treat gastroesophageal reflux, are generally enteric coated because they are acid labile. So the fact the claims required uncoated PPI was unique.

The defendants raised invalidity arguments based on three written description issues that were all rejected by the district court, as well as obviousness arguments which the court also rejected. The defendants did not appeal the finding of nonobviousness, and instead focused on their § 112 defenses.

The Federal Circuit found that the specification failed to satisfy the written description requirement because “the inventor chose to claim the therapeutic effectiveness of uncoated PPI, but he did not adequately describe the efficacy of uncoated PPI so as to demonstrate to [a POSA] that he possessed and actually invented what he claimed.” And a POSA, “based on the disclosure of a formulation containing uncoated PPI,” would not conclude “that it would be efficacious because he or she would not have expected uncoated PPI to raise gastric pH.”

The Federal Circuit explained that the specification must “demonstrate that the inventor possessed more than a mere wish or hope that uncoated PPI would work.” “Patents are not rewarded [sic] for mere searches, but are intended to compensate their successful completion.” If “the inventor expressly claims [a] result,” then “that result must be supported by adequate disclosure in the specification.” Since “the specification provides nothing more than the mere claim that uncoated PPI might work, even though [a POSA] would not have thought it would work, the specification is fatally flawed.”

In addition to the guidance Nuvo provides on the issue of written description, the decision shows that it is possible to pursue both obviousness and written description defenses through trial. Here, because a POSA would not have expected the claimed result (it was not obvious) the defendant was able to win under § 112 by asserting the lack of an adequate written description, even after arguing, at the district court, that it was obvious. This result supports the maintenance of § 112 defenses simultaneously with an obviousness defense as a means for leveraging any extreme positions a patentee may take to fend off an obviousness challenge.

Thanks to Christopher Johnson, law student at the University of Notre Dame Law School, for his contributions to this post.