Pfizer sues Aurobindo Pharma & Dr Reddy’s for patent infringement against cancer drug

Pfizer has filed a patent infringement case in the New Jersey against pharma giants Aurobindo Pharma and Dr Reddy’s in the United States District Court for the District of Delaware.

Pfizer alleged that the Indian drug makers were planning separately to come out with generic versions of its multi-billion-dollar drug Ibrance (Palbociclib) before the expiration of its patent in 2023.

Palbociclib is used to treat a certain type of breast cancer and works by slowing or stopping the growth of cancer cells. Ibrance gained nearly $5 billion revenues globally including $3.25 billion in the USA in 2019, according to Pfizer’s 2019 annual report.

Several generic companies in March 2019 notified us that they had filed new drug applications with the US Food and Drug Administration (FDA) seeking approval to market generic versions of Ibrance. They are stating the invalidity and non-infringement of two compositions of matter patents and a method of use patent covering palbociclib.

Pfizer asserts in its petition 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 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 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.

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