- A U.S. district court judge ruled Allergan's Watson division infringed on a patent on Shire's Lialda, and blocked further sales of generic Lialda by Allergan, Shire said on Tuesday.
- Lialda was approved in 2007 and is used to treat mild to moderate ulcerative colitis (UC) and maintain remission of UC. It is the only UC drug that is used for both induction and maintenance of remission in UC.
- Revenues from Lialda currently represent a significant portion of Shire's overall revenues. Total sales for 2015 were $684.4 million, roughly 11% of Shire's total revenues.
The ruling will block Allergan from selling generic Lialda through 2020—when Shire's patent expires—reports Reuters. Judge Donald Middlebrooks also entered an injunction prohibiting the FDA from approving Allergan's formulation until after patent expiry.
This case has been ongoing for some time. Shire attempted to take the case to the U.S. Supreme Court, but the case was kicked back to district court where Judge Donald Middlebrooks ruled in Shire's favor. An earlier ruling had favored Shire but the verdict was thrown out by an appeals court in March 2014.
"Shire is very pleased that the court has once again ruled in our favour, reaffirming the validity of the patent protecting Lialda,” said James Harrington, Global Head of Intellectual Property at Shire.
Lialda is part of a class of drugs, 5-aminosalicylates, commonly used to treat inflammatory bowel disease (IBD). UC is a prevalent type of IBD. Patients with UC generally start with a drug such as Lialda because it is orally active and less expensive then biologic treatments and other TNF-inhibitors.