On March 25, 2016, Judge Donald M. Middlebrooks of the U.S. District Court for the Southern District of Florida ruled that the patent protecting Shire’s drug LIALDA® (mesalamine) was valid and infringed by Watson Pharmaceuticals’ Abbreviated New Drug Application (ANDA). Judge Middlebrooks’ decision follows almost four years of continuous litigation, in which this case went all the way to the U.S. Supreme Court and back.

In April 2013, FLH won the first trial in this case, which was also before Judge Middlebrooks. Back then, Judge Middlebrooks first ruled that the Lialda patent was valid and infringed by Watson. Watson appealed and the U.S. Court of Appeals for the Federal Circuit altered Judge Middlebrooks’ construction of two claim terms. On Shire’s behalf, FLH filed a petition for certiorari to the U.S. Supreme Court, arguing that the Federal Circuit did not give proper deference to Judge Middlebrooks’ factual findings underlying his claim construction. The Supreme Court granted FLH’s petition for certiorari. In a companion case to this one, the Supreme Court agreed that the Federal Circuit “must apply a clear error, not a de novo, standard” when reviewing the “evidentiary underpinnings” of a district court’s claim construction. Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 835 (2015). The Supreme Court then vacated the Federal Circuit’s decision in this case and remanded.

On remand, the Federal Circuit held that there was “no indication” that Judge Middlebrooks made any factual findings that underlie his construction. But rather than remand to determine whether Judge Middlebrooks actually made such factual findings, the Federal Circuit reinstated its earlier claim construction and remanded.

From January 25 through January 27, 2016, Judge Middlebrooks held the second trial in this case, this time with the Federal Circuit’s claim construction. FLH and Shire again prevailed at trial. Judge Middlebrooks disagreed with Watson that the patent lacked a sufficient written description and was not enabling, and entered a judgment that the Lialda patent was valid. Judge Middlebrooks also disagreed with Watson that its ANDA products would not infringe the Lialda patent, and entered a judgment that Watson directly and indirectly infringed the Lialda patent. Judge Middlebrooks further enjoined Watson from marketing its infringing products until the Lialda patent expires.

Lialda is a novel, high-strength, once-daily formulation of mesalamine, which is indicated to treat ulcerative colitis. Industry experts have hailed Lialda as “a major advance in the history of” ulcerative colitis therapy. The claims of the Lialda patent cover those aspects of Lialda’s formulation.

To view the Court's order, please click here.

To view the Court's opinion, please click here.

To view the Law360 article regarding this decision, please click here.