Court Upholds Ulcerative Colitis Drug Patent

The pharmaceutical company Shire won a patent trial concerning mesalamine (Lialda), an ulcerative colitis drug, according to a company press release.

Lialda is a delayed release tablet designed to induce remission of ulcerative colitis in patients with active, mild-to-moderate cases—it also can help maintain remission of ulcerative colitis.

According to the news release, the prescription medication’s the “only once daily mesalamine product indicated for both the induction of remission of mild to moderate ulcerative colitis and the maintenance of remission of ulcerative colitis.”

Shire and its subsidiary companies were undergoing litigation against Watson Pharmaceuticals about their Abbreviated New Drug Application for a generic version of Lialda, the statement explained.

Judge Donald M. Middlebrooks of the United States District Court for Southern Florida decided that holding Watson’s proposed application formula infringed on Shire’s Lialda patent. He additionally entered an injunction prohibiting the FDA from approving Watson’s generic application until the Lialda patient expires in June 2020. Furthermore, the company cannot make, use, sell or import their proposed product until after the Lialda patent expires.

The statement added that this was the second patent infringement trial that Watson’s proposed generic was found to infringe on the Lialda patent.

“Shire is very pleased that the court has once again ruled in our favor, reaffirming the validity of the patent protecting Lialda,” said James Harrington, Senior Vice President, Global Head of Intellectual Property at Shire. “This ruling supports the innovation and value we continue to bring to the patients who benefit from this important medicine that allows them to lead better lives.”

After the case was decided, Shire acknowledged petitions filed with the US Patent and Trademark Office in a subsequent press statement. Shire said they planned to “defend vigorously its patents and pursue all legal options available to protect its products.”

The petitions were not only against Lialda but teduglutide (Gattex) as well, another of Shire’s drugs. This drug was designed to be used as injection and the first prescription medicine for the long term treatment of adults with short bowel syndrome, dependent on parenteral support, the statement explained.