iNDICA NEWS BUREAU-
American drug major Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy’s Laboratories.
Pfizer alleges that the two Indian drug makers were planning separately to develop generic versions of its best-selling drug Ibrance (palbociclib) before the expiration of its patent.
Pfizer filed the possible patent infringement petition against both the companies in the United States District Court for the District of Delaware on two counts last week.
According to Pfizer’s 2019 annual report, Ibrance brought nearly $5 billion in revenues globally including $3.25 billion just in the USA in 2019.
The generic companies assert the invalidity and non-infringement of two compositions of matter patents and a method of use patent covering palbociclib, each of which expire in 2023, according to the annual report.
In its petition, the US drug company stated that the Indian drug makers had submitted an abbreviated new drug application to the USFDA seeking approval to engage in the 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 the ANDA products, or any other drug product covered by 730 patent into the US, prior to the expiration of that patent, including any extensions and the 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.
A city-based pharmaceutical company senior official said patent litigation cases are not uncommon for generic drug makers in the US and the lawsuit will not have any implications on the performance of the company.