After District Court Invalidates Pharmaceutical Product Patent Based On Clinical Trials, Federal Circuit Reverses Because Clinical Trial Was Not Public

Sunovion Pharmaceuticals, Inc. ("Sunovion") and Dey L.P., Dey, Inc., and Mylan, Inc. (collectively, "Dey") develop pharmaceutical products to treat lung disease. Sunovion filed a patent application, followed by an application to test its products in human subjects. After it received a patent, it held a series of clinical trials before it finally released a commercial product, known as Brovana, in 2007.

Dey also filed a series of patent applications, for which it received several patents. It also ran clinical trials and ultimately released a commercial product. Dey's patent applications were filed after Sunovion's, and its patents were issued after Sunovion's patent was considered.

As explained by the Federal Circuit, "[b]oth parties own patents and sell products concerning the treatment of chronic obstructive pulmonary disease ("COPD") by storing the compound formoterol in an aqueous solution and administering it through a nebulizer. Sunovion owns U.S. Patent No. 6,040,344 (the "Gao patent"), which issued in March 2000 from an application filed in 1998. Dey owns two families of patents, the second of which includes U.S. Patent Nos. 7,348,362; 7,462,645; 7,465,756; 7,473,710; and 7,541,385. The patents in the second Dey family all issued in 2008 or 2009 but claim the benefit of an application filed on July 10, 2003. According to Dey, the significant difference between the two companies' patents relates to the stability of the formulations during long-term storage."

During the case, the parties stipulated that the formulation of a particular batch of the product, Batch 3501A, is identical to the formulation that Sunovion ultimately marketed as Brovana. As part of the clinical trials, a total of 587 subjects participated in the study. Of those, 124 received Batch 3501A. At least some of those individuals received Batch 3501A prior to July 10, 2002, which was more than one year before Dey filed the patent application that led to its second family of patents.

In March 2007, before Brovana launched, Dey filed a patent infringement action asserting that Sunovion infringed its first and second families of patents. Sunovion moved for partial summary judgment, and the district court granted the motion. As explained by the Federal Circuit, as part of that motion, Sunovion conceded that "the Batch 3501A composition [fell] within the asserted claims stemming from Dey's second family of patents," which meant that the composition would anticipate Dey's...