Indian Patent Office rejects anti-cancer drug patent

The Indian Patent Office (IPO) has rejected a patent application for an anti-cancer drug for the second time, paving the way for generic versions to potentially enter the market.

The IPO denied the application by US-based Abraxis Bioscience for Abraxane, a chemotherapy drug used to treat breast cancer that has spread to other parts of the body.

Hyderabad-based generics company Natco Pharma initiated two representations against the applications claiming that Abraxis’s claims in the patent lacked novelty.

The IPO initially denied the patent in 2009 on the grounds of obviousness and lack of inventive step prompting the US company to appeal against the ruling at the Intellectual Property Appellate Board (IPAB).

But, in January this year, the IPAB asked for the case to be reheard at the IPO for fresh consideration resulting in a second rejection last week, according to the Times of India.

Abraxane was first launched in India through a collaboration between Abraxis and Indian biotech major Biocon, in July, 2008.

The company was acquired by New Jersey-based Celgene Corporation in 2010 for more than $2 billion.

Earlier this month, LSIPR’s sister publication WIPR, reported that Nirmala Sitharaman, a trade minister with the newly-elected Bharatiya Janata Party government, had said the country would be willing to “constructively engage” with US officials over its IP regime.

Sitharaman’s pledge came just weeks after India was named on the ‘priority watch list’ in the US Trade Representative’s  Special 301 Report, an annual rundown of US trading partners’ efforts to protect and enforce IP.

Abraxis did not respond immediately to a request to comment on the ruling and whether it was planning an appeal.