In yet another major patent blow to the multinational pharma companies, the Indian Patent Office has rejected the US drug company Abraxis BioSciences’ patent claim on anti-cancer drug Abraxane.
According to sources, the Abraxis BioSciences’ application for patent for its cancer drug Abraxane was rejected by the patent office on the grounds of Section 3 (d) of Indian Patent Act, which prohibits ‘evergreening’, the practice of multinational pharma companies to extend their patent terms by making small and trivial changes to existing molecules and thereby preventing manufacture of generic drugs.
The patent office’s rejection of patent on this drug will pave the way for the Indian domestic pharma companies to launch the generic, affordable version of the drug in the Indian market.
It may be recalled that it was under the Section 3 (d) of Indian Patent Act that Novartis had also lost patent protection on its blockbuster drug Glivec last year. The Patent Office relied on the decision of the Supreme Court in the landmark Glivec case while hearing the application.
According to sources, the Patent Office had earlier denied the patent on Abraxane in 2009 on the grounds of obviousness and lack of inventive step. After that Abraxis BioSciences appealed against the order in the Intellectual Property Appellate Board (IPAB). In January this year, the IPAB directed the matter to be reheard by the Patent Office for fresh consideration, and to be decided within a specific time frame. The matter was heard afresh in April this year, and an order was passed on June 18, rejecting the application again,
The US company has now the option of filing an appeal in the Intellectual Property Appellate Board (IPAB) or a writ petition in the high court.