Court Bars Watson Copy of Shire's Lialda Until 2020

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By Dana A. Elfin

March 28 — Shire Development LLC won a block on Watson Pharmaceutical Inc.'s proposed generic version of Lialda until 2020 after a court ruled in its favor March 25.

In an opinion released March 28, Judge Donald M. Middlebrooks of the U.S. District Court for the Southern District of Florida found that Shire's patent on the inflammatory bowel disease treatment was valid and would be infringed by Watson's generic version.

The ruling means that Shire's Lialda franchise, which brought in $684.4 million in sales last year, will be protected from generic competition from Watson until June 8, 2020, when Shire's U.S. Patent No. 6,773,720 (the '720 patent) expires. 

Lialda is used to treat inflammatory bowel diseases such as ulcerative colitis and Crohn's disease.

Watson is now part of Allergan Inc.

The '720 patent covers mesalazine controlled release oral pharmaceutical compositions.

Shire's case against Watson has bounced between the district court, the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court.

“Shire is pleased the court has once again ruled in our favor,” a Shire spokesperson told Bloomberg BNA March 28. “This decision reaffirms the strength of the patent protecting Lialda, and supports the innovation and value we bring to patients who benefit from this important treatment option.”

Other Fights Brewing

But the outcome in this case doesn't mean that Shire's fight to block generic versions of Lialda is over. Shire is battling with other generics over the same Lialda patent in other district courts.

For example, a trial against Zydus Pharmaceuticals (USA) Inc. over the same patent has just begun in the U.S. District Court for the District of Delaware, a lawyer for Shire told Bloomberg BNA March 28.

In addition, Shire also has patent infringement suits pending against generic Lialda filers Lupin Ltd., Amneal Pharmaceuticals LLC, Mylan Pharmaceuticals Inc. and Osmotica Pharmaceutical Corp., according to a March 28 search of Bloomberg Law.

Kyle Bass Challenge Up Next?

Shire also is fighting off a challenge to the patent brought by hedge fund manager Kyle Bass's Coalition for Affordable Drugs. The Coalition is challenging the validity of the Lialda patent before the Patent and Trademark's Office Patent Trial and Appeal Board (PTAB).

Oral argument in the Coalition's case is set for June 24, but a decision isn't expected until the fall.

The review process at the PTO, known as inter partes review, is a cheaper alternative to traditional district court patent litigation. The process was created as part of a comprehensive revamp of the U.S. patent system in 2011.

“Shire has a strong track record in protecting its patents,” Gwen Fisher, a spokeswoman for Shire, told Bloomberg BNA when the PTO agreed to hear the challenge last October. “This patent in particular has already been upheld despite a previous attack on its validity,” she said at that time.

The law firm of Frommer Lawrence & Haug, LLP in New York represented Shire and coplaintiffs Shire Pharmaceutical Development, Inc.; Cosmo Technologies Ltd. and Nogra Pharma Limited (formerly Giuliani International Ltd).

The law firm of Maddox Edwards, PLLC in Washington represented Watson.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Nancy Simmons at nsimmons@bna.com