On Wednesday, a case was filed in the District of Delaware by Acerta Pharma B.V., AstraZeneca Pharmaceuticals, and Merck Sharp & Dohme B.V. against Natco Pharma Limited and Natco Pharma Inc. The case is regarding allegations of patent infringement regarding the product Calquence.
The drug, which contains acalabrutinib as its active ingredient, is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and as a first-line treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The defendants are accused of filing an Abbreviated New Drug Application (ANDA) prior to the expiration of the patents for Calquence. The plaintiffs note that they have reached out to the defendants, but have not reached terms for license of the patent, or for permission to produce the drugs prior to the patents expiration.
Plaintiffs are suing for patent infringement and seek declaratory judgment regarding the infringement of the patents and injunctive relief preventing the production or sale of the generic products prior to the expiration of the patents. Plaintiffs are represented by McCarter & English LLP and Williams & Connolly LLP.