Patent Infringement Petition Filed by Pfizer against Aurobindo, Dr Reddy's

Patent Infringement Petition Filed by Pfizer against Aurobindo, Dr Reddy's

A petition has been filed by Pfizer against Aurobindo Pharma and Dr Reddy's Laboratories in a US court alleging that the two were planning on separately coming out with generic versions of Pfizer's cancer drug Ibrance (Palbociclib) before expiration of its patent.

The likely patent infringement suit was filed last week on two counts by Pfizer against the duo in the US District Court for the District of Delaware. A certain type of breast cancer is treated by Palbociclib which works by slowing down or halting the growth of cancer cells. According to Pfizer's 2019 annual report, Ibrance clocked around $5 billion in revenues globally, including $3.25 billion in the US in 2019.

The Indian companies had submitted an abbreviated new drug application (ANDA) to the USFDA seeking approval for the commercial manufacture, sale and import of the intended generic drugs of Ibrance capsules 75mg, 100mg, and 125mg before expiration of the 730 patent, Pfizer claimed. A preliminary and permanent injunction forbidding Aurobindo and DRL from the commercial manufacture, use, sale, offer for sale or import of ANDA or any other drug products covered by the 730 patent into the US before expiration of the patent was sought by Pfizer.

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 under Paragraph IV Patent Certifications.

Patent litigation cases are common for generic drug manufacturers in the US, according to a city-based pharma company senior official.