Brigham and Women’s Hospital, Inc. v. Perrigo Co. (13-cv-11640).

The Federal Circuit upheld Judge Zobel’s grant of JMOL of non-infringement, agreeing that the evidence presented failed as a matter of law to prove that each limitation of the asserted claims was found in the accused product. The patent covered methods for treatment of episodic heartburn by combining known H2-blockers and known antacids to create a product that provides, as the claims recited, immediate and long-lasting relief from heartburn symptoms. The specification defined “immediate” relief as starting within about 5-10 minutes following ingestion. Brigham and Women’s sought to prove infringement by looking to the efficacy data for the commercialized Pepcid Complete® product, which the Perrigo generic (having the same active ingredients and dosages) would necessarily match. The clinical data did not, however, match up with the claim limitations – a first test measuring esophageal pH failed to correlate any particular pH change with relief from symptoms, and the two tests that addressed symptomatic relief did not begin measuring relief until 15 minutes had passed. Brigham and Women’s had asserted only literal infringement, not infringement by equivalents; accordingly, this difference in time was insufficient to prove the product met the claim limitation. The Court declined to rule on Perrigo’s appeal of the denial of JMOL of invalidity, noting that the strong public interest in resolving questions of patentability were absent because the sole patent in suit had had expired in 2012 and there were no related patents in examination and no other lawsuits involving the patent.

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