A US district court has ruled against a patent held by Shire for Lialda (mesalamine), Shire’s drug for inducting remission in patients with active, mild-to-moderate ulcerative colitis (UC) and for the maintenance of remission of UC. The US District Court for the District of Delaware has informed Shire that a proposed generic version of Lialda by Ahmedabad, India-based Cadilla Healthcare and Pennington, New Jersey-based Zydus Pharmaceuticals does not infringe on US Patent No. 6,773,720 (’720 patent), which relates to the controlled release oral pharmaceutical compositions containing the active ingredient,mesalazine, a 5-amino salicylic acid.

Despite the ruling, Shire said that it believes that the proposed Zydus product infringes the ‘720 patent and will continue to “vigorously defend its intellectual property rights,” the company said in a statement. Shire has 30 days in which to file an appeal to the court of appeals to the federal circuit.

Notwithstanding the judge’s ruling in the trial, Zydus does not have a tentative or final approval of their abbreviated new drug application, which is a prerequisite for Zydus’ commercial introduction of a generic product, according to Shire. 

Source: Shire