Patent application filed by the US firm Abraxis BioSciences for their anti-cancer drug Abraxane, has been refused by the Indian Patent Office on the ground that, it lacks inventive step, and violates Section 3 (d) of the Indian Patent Act. Decision of Indian Patent Office will now be paving the way for generic companies to launch affordable versions in the domestic market.
The US firm Abraxis BioSciences had filed for a patent on the breast cancer drug formulation in 2006, which was opposed by generic company, Natco Pharma. The invention claimed was found to be obvious in light of the prior art that taught antibody therapy using paclitaxel, and in violation of the provision of Section 3(d), legal sources say.
Earlier in a similar case in 2013, Swiss company Novartis lost the patent on its blockbuster cancer drug, Glivec.
Section 3 of the Indian Patent Act speaks about what does not fall under the category of inventions. Section 3 (d) of the Indian Patent Act, says that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation – For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
Also Read Novartis AG v. Union of India