Though the India office here of Swiss pharma giant Novartis wore a gloomy look following the Supreme Court rejection of its Glivec patent application, Indian pharmaceutical companies and patients’ associations are in celebration mood.
D G Shah, secretary general, The Indian Pharmaceutical Alliance (IPA), comprising leading research-based Indian pharma companies, said, "We welcome the upholding of the refusal by the patent office to grant a patent to Novartis for the â-polymorphic form of imatinib mesylate."
The verdict has increased the significance of section 3(d) in the Patents Act, as a crucial safeguard against the extension of patent monopolies in known drugs and the consequent delay in the availability of affordable generic versions, said a statement from IPA.
Anand Grover, a lawyer for the Cancer Patients Aid Association (CPAA), said, "The judgement clearly puts across that new forms of known substances should not be patented if they are not significantly efficacious."
The Chennai patent office had rejected the patent application of Novartis for the â-polymorphic form of imatinib mesylate on various grounds in 2006. Among these were that a patent could not be granted for the said form under section 3(d), as it did not have any increase in efficacy over the previously known substance. Novartis appealed to the Intellectual Property Appellate Board in 2007 and this was dismissed in 2009. Novartis then went to the SC.
Y K Sapru, chairman and chief executive officer (CEO) of the CPAA, said: "The verdict will avoid patenting of older compounds & avoid ever-greening of patented products. More than that, it will make anti-cancer life saving drugs affordable and, consequently, result in saving of many lives. And, this will happen not only in India but over 75 other countries where India exports generic drugs."
India has already been facing flak from American and European multinational companies for its decision to issue compulsory licences to Indian pharma firms for launching generic versions of patented cancer drugs.
Last month, John Castellani, President and CEO, PhRMA, the powerful US-based body for pharma MNCs, said, "In the absence of the investment made by our members, and the resulting research and development, there would be no generic medicines for the world’s patients. The responsibility to promote development of new drugs lies with all countries, not solely those in the developed world."
Pratibha Singh, advocate, who appeared for Indian drug firms Ranbaxy and Cipla, which had opposed Novartis' plea, said the claims by MNCs that patented drug launches in India would get affected was not true. "We are not against the patent of drugs made by MNCs but against getting patents with minor modifications. India is a huge market which can’t be ignored by MNCs," she said.
According to the SC decision, to obtain a patent for a new form of a known substance in India, the applicants must show sufficient proof that the new form of a base compound of a known substance is therapeutically more efficacious than the base compound or known substance.