Why has Pfizer filed a petition against Aurobindo Pharma and Reddy Laboratories?

Here is what you must know about the petition filed by Pfizer against the two Hyderabad based pharma companies.

· Pfizer Inc filed a petition in a US court against Aurobindo and Reddy Labs alleging that they were planning to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance even before the patent had expired.

· Effectively, this is a possible patent infringement case against Aurobindo and Reddy Labs in two different US courts. Ibrance is the brand for generic Palbociclib used to treat a specific type of breast cancer. The drug works by slowing the growth of cancer cells.

· Ibrance has clocked $5 billion in revenues globally in 2019 of which $3.25 billion came from the US. In March, several generic companies had filed ANDAs for generic versions of Ibrance.

· In its petition, Pfizer stated that Aurobindo and Reddy Labs had submitted ANDA to the US FDA seeking approval for commercial manufacture of Ibrance capsules well before expiry of patents. Pfizer has sought a permanent injunction against such manufacture.

· However, Aurobindo and Reddy Labs may have a stronger case here. Under Paragraph IV Patent Certifications, the company can seek FDA approval to market a generic drug before expiration of patents pertaining to the brand that it wants to mirror through generic versions.

Most Indian pharma companies are clued into patent litigation and these are common for generic drug makers. Aurobindo and Reddy Labs don’t see any material impact.