Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr. Reddy’s Laboratories alleging that the Indian drug makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (Palbociclib) before the expiration of its patent.
Pfizer filed the possible patent infringement case against Aurobindo Pharma in the United States District Court for the District of Delaware and Dr. Reddy’s in the New Jersey court.
Palbociclib is used to treat a certain type of breast cancer and works by slowing or stopping the growth of cancer cells. Ibrance clocked nearly $five billion revenues globally including $3.25 billion in the USA in 2019, according to Pfizer’s 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 the invalidity and non-infringement of two compositions 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 abbreviated new drug application(ANDA) to the US FDA 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 before 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, before the expiration of that patent, including any extensions and an 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 officials 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.