India denies patent to US pharmaceutical firm Abraxis BioSciences' anti-cancer drug "Abraxane"

June 24, 2014

The Indian Patent Office (IPO) has denied a patent on US firm Abraxis BioSciences’ anti-cancer drug ‘Abraxane’. The application was rejected on the grounds that the drug lacked invention, not being patentable and insufficient.
While rejecting the patent IPO took into account Section 3 (d) – the same provision under which Novartis lost protection on its megahit drug Glivec in 2013. The IPO relied on the decision of the Supreme Court in the significant Glivec case while deciding on the application.
Section 3(d) of the patent law is an important safeguard of this law specifically applicable to pharma and chemical industries, which forbids grant of patents to new forms of known substances unless it results in enhanced efficacy over the known substance.
Background:
Earlier, the IPO had refused the firm to provide the patent in 2009 on the grounds of obviousness and lack of inventive step. The US firm appealed against the decision in the IPAB (Intellectual Property Appellate Board). The IPAB directed the issue to be heard afresh by the IPO within a specific time frame. The matter was reheard in April 2014 and an order was passed on June 18, 2014, rejecting the application again. This time the application was rejected on the basis of Section 3(d) besides the ground of rejections in 2009.
The decision would benefit the domestic pharmaceutical companies to launch affordable versions of the drug in the local market.