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From Intellectual Property Law Daily, February 28, 2019

District court correctly threw out $10M infringement verdict in gastric drug patent case

By David Yucht, J.D.

Company that failed to show that its own product provided "instant and sustained relief" could not succeed on claim that generic product infringed by providing "instant and sustained relief."

The U.S. Court of Appeals for the Federal Circuit has upheld the ruling of a federal district court in Massachusetts that substantial evidence did not support a jury’s infringement verdict in favor of Brigham and Women’s Hospital, Inc. in its case against Perrigo Company for infringement of U.S. Patent No. 5,229,137 ("the ’137 patent"), which covers the use of an antacid together with an H2-receptor antagonist for "providing humans with instant and sustained relief from the pain, discomfort, and other symptoms associated with episodic heartburn." The appellate court held that Brigham failed to prove that Perrigo’s accused generic products infringed the patent’s "instant and sustained relief" limitation because Brigham, itself, was unable to prove that its own product provided "instant and sustained relief" (Brigham and Women's Hospital, Inc. v. Perrigo Co., February 28, 2019, Lourie, A.).

Brigham’s ’137 patent is directed to a method for treating episodic heartburn by co-administering two known types of heartburn medications, H2-receptor antagonists (known as H2-blockers) and antacids. Antacids were known to provide fast but momentary relief from heartburn; in contrast, H2-blockers were known to provide slower but longer-lasting relief. Perrigo marketed a generic drug that also combined an antacid with an H2-blocker. Brigham sued for, among other things, willful infringement. A district court, sitting in Boston, held a jury trial resulting in a verdict in favor of Brigham as to: (1) direct, induced, contributory, and willful infringement by Perrigo of all asserted claims of the ’137 patent; (2) an effective priority date of March 1990; and (3) validity of all asserted claims. The jury awarded Brigham over $10 million in damages. The district court granted Perrigo’s motions for judgment as a matter of law. Brigham appealed.

After determining that it had jurisdiction over this matter, based on the law of the case doctrine, the Federal Circuit held that Brigham failed to present sufficient evidence to prove direct infringement. The main dispute hinged on whether Brigham successfully proved that its product met the "immediate and sustained relief" limitation of the ’137 patent. As did the district court, the appellate court examined a chart and found that none of the participants in the study had a low enough esophageal pH to indicate "symptoms from episodic heartburn." Thus, the graph did not prove that participants were provided immediate relief, as asserted. Brigham could not prove that its product, Pepsid Complete, read on all claims of the patent, and therefore Brigham could not show that Perrigo’s accused product infringed. Accordingly, no reasonable jury could have found direct infringement, and the lower court was correct to award Perrigo judgment as a matter of law on direct infringement.

This case is Nos. 2017-1950, 2017-2021, 2017-2555, and 2018-1243.

Attorneys: James M. Bollinger (Troutman Sanders LLP) for Brigham and Women's Hospital, Inc. and Investors Bio-Tech, L.P. Jeffrey R. Gargano (Morgan, Lewis & Bockius LLP) for Perrigo Co. and L. Perrigo Co.

Companies: Brigham and Women's Hospital, Inc.; Investors Bio-Tech, L.P.; Perrigo Co.; L. Perrigo Co.

MainStory: TopStory Patent FedCirNews

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