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 drugmakers 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 US District Court for the District of Delaware and Dr Reddy’s in the New Jersey court.
ANDAs filed
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 $5 billion in revenues globally, including $3.25 billion in the US 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 (ANDAs) 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 composition of matter patents, and a method of use patent covering palbociclib, each of which expire in 2023, according to the annual report.
Pfizer in its petition stated that the Indian drugmakers had submitted ANDAs 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.
Injunction sought
Pfizer sought, among other actions, 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 the 730 patent into the US, prior to the 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.
A city-based pharmaceutical company senior official said patent litigation cases are not uncommon for generic drugmakers in the US and the lawsuit will not have any implications on the performance of the company.