Pfizer alleges that the two Indian pharmaceutical companies are separately planning to develop generic versions of its breast cancer treatment drug, Ibrance (palbociclib), before its patent expires. According to Pfizer’s 2019 annual report, Ibrance brought in almost US$5 billion revenues globally, including US$3.25 billion in the US.

The legal petitions have been filed against Aurobindo in Delaware and Dr Reddy’s in New Jersey district courts. They state that the Indian drugmakers have submitted abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) seeking approval to engage in commercial manufacture, sale and importation of generic versions of Ibrance (in 75 mg, 100 mg, and 125 mg capsules) prior to the expiration of the 730 patent. Pfizer seeks a preliminary and permanent injunction preventing Aurobindo and Dr Reddy’s from commercial manufacture, use, sale, offer for sale, or importation of the products. In addition, the petitions seek to prevent the importation of any other drug product covered by a 730 patent into the US, prior to the expiration of that patent, including any extensions and the additional period of exclusivity.

In response, Aurobindo and Dr Reddy’s have asserted the invalidity and non-infringement of two composition related patents and a method of use patent covering palbociclib, which all expire in 2023. In addition, it has been highlighted that under Paragraph IV Patent Certifications, a company can seek FDA approval to market a generic drug before the expiration of reference drug patents.

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