Esomeprazole & Naproxen – USA

Esomeprazole & Naproxen – USA

On Feb. 24, 2022, New Jersey district court granted summary judgment motion and found two patents invalid under issue preclusion.

 

This Hatch-Waxman case is related to the product, Vimovo® in which Nuvo/Horizon (Plaintiffs) sued Dr Reddy’s (Defendant) for infringement. DRL moved for summary judgment on issue preclusion and claim preclusion based on previous litigation concerning different patents, US 6,926,907 and US 8,557,285. These patents have been found to be invalid for failure to satisfy the written description requirement (Nuvo v DRL; FC2019). You can read the summary “here” on this blog. The two patents presently at issue descend from US’907: US 8,858,996 and US 9,161,920.

 

DRL contended that the identical issue of invalidity for lack of adequate written description was litigated and decided in Nuvo. In that litigation “[t]he ‘907 and ‘285 patents claim uncoated PPI effective to raise the gastric pH to at least 3.5” and that “the claimed effectiveness of uncoated PPI” is not supported by adequate written description. DRL argued that, for the claims asserted in the instant case, the issue of invalidity for lack of written description is identical. The patent specifications are identical, esomeprazole is a PPI and effective esomeprazole is required to raise gastric pH to at least 3.5. DRL argued that, given these undisputed propositions the issue preclusion question turns on whether the esomeprazole disclosed in the claims at issue is materially the same as the uncoated PPI of the Nuvo claims, for purposes of the written description issue.

 

Court said that there is no material difference because the parties stipulated that all of the claims presently at issue require non-enteric-coated esomeprazole. Moreover, other requirements of claims also appear materially identical to the claims in Nuvo. Plaintiffs contended that the claims presently at issue are narrower (specific dosage range and dosage form), whereas the claims in Nuvo are broader and more general. But, court said that there is no “material difference in scope” between the narrowest Nuvo claims and the narrowest Asserted claims. Moreover, Plaintiff’s position is unsupported. Plaintiffs point to no valid basis to materially differentiate the claims presently at issue from those at issue in Nuvo. While there are minor differences in wording, there are no relevant limitations in the present claims that are not present in some claims in Nuvo. These patents use slightly different language to describe substantially the same invention.

 

Court finally said that DRL has made a demonstration that the patents use slightly different language to describe substantially the same invention. Plaintiffs have failed to explain how any differences in claim wording change the invalidity analysis. As a result, the motion for summary judgment of invalidity based on issue preclusion was granted. With respect to claim preclusion, court partially granted the motion.

 

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