Brigham & Women's Hosp., Inc. v. Perrigo Co. United States Court of Appeals of the Federal Circuit, 2019 2019 WL 990816 (Nonprecedential decision) Edited for Biotechnology Law Report by CHRISTOPHER M. HOLMAN*

Pepcid Complete is a product marketed by Johnson & Johnson for alleviation of the symptoms of episodic heartburn. It combines the immediate relief of an antacid with the sustained relief of an H 2 -blocker. In 2008, Perrigo launched a generic version of Pepcid Complete, and in 2013 Brigham brought the present suit accusing Perrigo's generic product of infringing a patent that issued in 1993 and which expired in 2012. After a jury found the patent infringed and not invalid, the district court issued a judgment of noninfringement as a matter of law, and the Federal Circuit affirmed. Critically, the claimed method of treatment requires that coadministering an antacid and H 2 -blocker achieves a certain clinical result: "immediate and sustained relief from pain, discomfort and/or symptoms associated with episodic heartburn." The district court construed the term "immediate and sustained relief" to mean "relief obtained from pain, discomfort and/ or symptoms associated with episodic heartburn which starts within about 5-10 minutes following ingestion of the active ingredients and continues for at least about 4-6 hours." The main evidence proffered by the patent owner regarding this limitation came from clinical data underpinning FDA approval of Pepcid Complete. Brigham argued that the clinical data demonstrated that Pepcid Complete provides immediate relief, and since Perrigo's generic product has the same active ingredients and dosages as Pepcid Complete, Perrigo's generic product must also provide immediate relief. However, the district court found, and the Federal Circuit agreed, that the clinical data failed to explicitly demonstrate symptom relief within 5-10 minutes of ingesting the drug. © 2019, Mary Ann Liebert, Inc.