IPAB refuses patent for anti-cancer drug Abraxane

The order comes after a fresh consideration of the issues, following an IPAB order against previous order of Patent Office

The Indian Patent Office has refused to grant patent for the anti-cancer drug Abraxane by US-based Abraxis Bioscience in a pre-grant opposition by Natco Pharma Ltd.

Hyderabad-based Natco in its two representations raised various grounds, including the claims of Abraxis lack of novelty.

After fresh consideration of the claims and the opposition, assistant controller of Patents and Design Nilanjana Mukherjee ordered, “The amended claims (here Abraxis Boisciences) lack inventive step and do not constitute an invention under the Patents Act, 1970.”

The patent application was earlier rejected by the assistant controller of Patents, and Design and in an appeal by Abraxis, the Intellectual Property Appellate Board (IPAB) had remanded the order in January this year for fresh consideration, stating the order was passed in “flagrant violation of principles of natural justice”.

The product was launched in India through a collaboration between Abraxis and Indian biotech major Biocon, in July, 2008, for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

According to the counsel for Abraxis, in January, Abraxis had net sales of $649 million and is expected to reach $1.5-2 billion by 2017.

Abraxis Bioscience was acquired by New Jersey-based Celgene Corporation during 2010 and the upfront payment value of Abraxis BioSciences was at around $2.9 billion.