Pfizer sues Aurobindo Pharma and Dr Reddy's

American pharma giant Pfizer (NYSE: PFE) and its group companies have filed a petition in a US court against Aurobindo Pharma (BSE: 524804) and Dr Reddy’s Laboratories (BSE: 500124), alleging the Indian generic drugmakers were planning separately to come out with generic versions of its blockbuster drug Ibrance (palbociclib) before expiration of its patent.

Pfizer has filed the patent infringement petition against both the companies in the US District Court for the District of Delaware on two counts.

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

The generic companies assert the invalidity and non-infringement of two compositions of matter patents and a method of use patent covering palbociclib, each of which expire in 2023, according to the annual report.

In its petition, the US drug company said the Indian firms had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration seeking approval to engage in the commercial manufacture, sale and importation of the intended generic drugs of Ibrance capsules, 75mg, 100mg, and 125mg prior to the expiration of the 730 patent.

Last year in March, several generic companies notified Pfizer that they had filed ANDAs with the US FDA seeking approval to market generic versions of Ibrance.

Pfizer has sought, among others, a preliminary and permanent injunction, enjoining the two Indian companies from commercial manufacture, use, sale, or importation of the ANDA products, prior to expiration of that patent, including any extensions and additional period of exclusivity.

Earlier this year, US pharma giant Merck & Co’s (NYSE: MRK) initiated litigation against both these Indian generic drugmakers, alleging they were planning to come out with a generic version of its blockbuster diabetes drug Janumet (metformin hydrochloride and sitagliptin phosphate) before expiration of patent.