Shire Wins Block of Actavis’s Lialda Copy Until 2020

Shire Plc (SHP) won a court ruling that will help it prevent Actavis Inc. (ACT) from selling generic versions of the ulcerative colitis drug Lialda in the U.S. until 2020.

A patent on the medicine would be infringed by the Actavis version, U.S. District Judge Donald Middlebrooks in Ft. Lauderdale, Florida, said in an opinion today. The judge rejected claims the patent was invalid. Actavis said in a statement it is reviewing the decision and “will evaluate all available options, including an appeal.”

Lialda, whose active ingredient is mesalamine, generated $400 million in sales last year for Shire, or 8.6 percent of the company’s revenue, according to Bloomberg data. Efforts to expand the use of the drug to patients with diverticulitis to boost sales failed, London-based Shire said in March.

The ruling “supports the innovative therapies that we develop in order to improve the lives of ulcerative colitis patients,” Roger Adsett, head of Shire’s gastrointestinal business unit, said in a statement.

The patent, issued in 2004, is for a controlled-release composition of mesalamine. Parsippany, New Jersey-based Actavis had claimed the patent didn’t adequately describe what Shire claimed it covered. The judge, who issued his ruling after a five-day non-jury trial last month, said Shire is entitled to an order that would block the generic version until the patent expires.

Shire said no generic-drug companies have received regulatory approval to sell versions of the medicine. The patent expires June 8, 2020, according to information posted on the U.S. Food and Drug Administration’s website.

The case is Shire Development LLC v. Watson Pharmaceuticals Inc., 12cv60862, U.S. District Court for the Southern District of Florida (Ft. Lauderdale).

To contact the reporters on this story: Susan Decker in Washington at; Catherine Larkin at

To contact the editor responsible for this story: Bernard Kohn at

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