Pfizer files patent infringement suit over Ibrance against Aurobindo, Dr. Reddy’s

Pfizer has filed a patent infringement petition against Aurobindo and Dr. Reddy's in the United States District Court for the District of Delaware, alleging that the drug makers were planning separately to come out with generic versions of Ibrance (palbociclib) before expiration of its patent.

Palbociclib is used to treat a certain type of breast cancer and works by slowing or stopping the growth of cancer cells.

Ibrance had global revenues of $5 billion, including $3.25 billion in the United States in 2019, according to Pfizer’s 2019 annual report.

In March 2019, several generic companies notified Pfizer that they had filed abbreviated new drug applications with the Food and Drug Administration 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 drug makers had submitted ANDAs to the FDA seeking approval to engage in commercial manufacture, sale and importation of the intended generic drugs of Ibrance capsules, in dosage strengths of 75 mg, 100 mg, and 125 mg prior to the expiration of the 730 patent.

Pfizer sought a preliminary and permanent injunction enjoining Aurobindo and Dr. Reddy's, from commercial manufacture, use, sale, offer for sale, or importation of the ANDA products, or any other drug product covered by a 730 patent into the United States, 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.