The US-based Abraxis BioSciences’ anti-cancer drug Abraxane has been denied patent by the Indian Patent Office (IPO) on grounds that the new drug does not constitute a fresh innovation.
Citing Section 3 (d) in the Indian Patents Act, which prohibits grant of patents to new forms of known substances unless it results in enhanced efficacy over the known substance, the IPO struck down the patent application June 18.
The patent office based its decision on the Supreme Court’s ruling in the landmark Glivec case. Swiss drugmaker, Novarti, had sought patent protection for Glivec, a cancer drug. However, the application was rejected by the Supreme Court of India in April 2013, citing section 3 (d) in the Indian Patents Act.
Background
The IPO had first quashed the patent application filed by Abraxis in 2009. Subsequently, the US-based pharmaceutical company lodged an appeal against the order with the Intellectual Property Appellate Board (IPAB), which referred the case back to the IPO for fresh consideration in January 2014. The application was rejected for a second time on June 18.
The rejection of the patent application is not the only problem that has clouded the fate of Abraxane in India. Even before Abraxis received patent protection from the US, Indian pharma company Natco had challenged its patent application on the basis that it had already launched an indigenous version of the drug called Albupax in 2008. Albupax was the first nanotech-based cancer drug developed indigenously, but has evoked safety concerns. Natco is yet to launch the drug again.
Winners and Losers
The rejection of the patent to the US-based company will encourage the Indian pharmaceutical companies in making generic versions of the drug available to India and other developing countries at a fraction of the original cost. The Indian pharmaceutical industry, worth 15 billion USD a year, is already mired in a controversy over the production and export of cheaper varieties of drugs that have been reportedly pioneered by the western countries. Abraxis’ loss will deal another blow to the western pharmaceutical companies looking to improve sales in India and elsewhere, while marking a victory for local generic drug-makers.
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