Pfizer Inc and its group companies have moved a US court against Hyderabad-based Aurobindo Pharma Ltd and Dr Reddy's Laboratories (DRL) alleging that the Indian drug makers were seperately planning to launch generic versions of its bestseller breast cancer drug Ibrance (palbociclib) before expiration of its patent.
Pfizer filed a possible patent infringement petition against both companies in the United States District Court for the District of Delaware and two counts last week.
The company's multi-billion-dollar drug Ibrance had logged around $5 billion in revenues worldwide comprising $3.25 billion in the USA in 2019, according to its 2019 annual report.
"In March 2019, several generic companies notified us that they had filed abbreviated new drug applications with the US Food and Drug Administration (FDA) seeking approval to market generic versions of Ibrance. The generic companies assert invalidity and non-infringement of two composition of matter patents and a method of use patent covering palbociclib, each of which expires in 2023," according to the annual report.
Pfizer, in its petition, stated that the Indian drug makers had submitted an abbreviated new drug application (ANDA) to the USFDA seeking approval to engage in commercial manufacture, sale and importation of the intended generic drugs of ibrance capsules, 75 mg, 100 mg, and 125 mg prior to the expiration of the 730 patent.
Pfizer sought, among others, a preliminary and permanent injunction enjoining Aurobindo and DRL, from commercial manufacture, use, sale, offer for sale, or importation of ANDA products, or any other drug product covered by 730 patent into the US, prior to expiration of that patent, including any extensions and additional period of exclusivity.
Under Paragraph IV Patent Certifications, a company can seek FDA approval to market a generic drug before the expiration of patents related to the branded medicine that the pharma company seeks to copy.
(With inputs from PTI.)