The Indian Patent Office on 23 June 2014 refused to grant a patent on anti-cancer drug Abraxane of US firm Abraxis BioSciences.
The application was refused on the grounds that US firm's claims lacked inventive step, not being patentable and insufficient.
One of the main grounds under which the patent plea of US firm was rejected was Section 3 (d) of the Patent Act, 1970 under which Novartis lost protection on its blockbuster drug Glivec in 2013.
The Patent Office relied on the decision of the Supreme Court in the landmark Glivec case while hearing the application.
In 2013, Supreme Court ruling defended Section 3(d), which led to Novartis losing protection on its blockbuster drug Glivec in 2013.
Earlier, the Patent Office had denied the patent to the US firm in 2009 on the grounds of obviousness and lack of inventive step. The US firm appealed against the order in the IPAB (Intellectual Property Appellate Board).
In January 2013, 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 2014, and an order was passed on 18 June 2014. It rejected the application again. In addition to the grounds upon which the application was rejected in the 2009 order, the application was rejected for being a new form of a known substance under Section 3(d) as it failed to exhibit enhanced therapeutic efficacy.
Section 3 (d) of the Patent Act, 1970
It is an important safeguard in the patent law specifically relevant for pharma and chemical industries, which prohibits grant of patents to new forms of known substances unless it results in enhanced efficacy over the known substance.
When: 23 June 2014