Celgene's Abraxane denied by India patent office, local generics seen ahead

Makers of generic drugs in India are expected to start producing local versions of Celgene's ($CELG) oncology drug Abraxane after a consecutive denial of a patent.

On June 1, the Indian Patent Office said Celgene was refused a patent because the formulation lacked an inventive step and therefore was at odds with Section 3(d) of the Indian Patent Act.

Abraxane is a key product for Celgene in the U.S. and Europe, as well as internationally.

The law under which the ruling was made is the same that saw Novartis ($NVS) lose a 2013 bid for an Indian patent on cancer drug Glivec/Gleevec that went to the nation's Supreme Court. The move followed a compulsory license for Bayer's cancer drug Nexavar and the revocation of other patents held by companies such as Pfizer ($PFE) and Roche ($RHHBY).

The current patent application for Abraxane was made in June 2014 and a patent on the breast cancer drug formulation in 2006 was opposed by India's Natco Pharma, according to the Times of India.

Natco had filed an opposition to the grant of patent in 2008, the Times of India said.

Celgene can however challenge the decision before the Intellectual Property Appellate Board in India.

- here's the India patent ruling
- and the Singh & Associates legal note
- get more from the Times of India