It was celebration time for health activists and civil society groups after the Supreme Court delivered its judgment dismissing Swiss multinational company Novartis’ appeal for patent for its anti-cancer medicine imatinib mesylate or Gleevec.
“We are happy that the apex court has recognised the right of patients to access affordable medicines over profits for big pharmaceutical companies through patents. Our access to affordable treatment will not be possible if the medicines are patented. It is a huge victory for human rights,” said Y.K. Sapru of Cancer Patients Aid Association, which opposed Novartis’ application.
Novartis was seeking patent for the beta-crystalline form of imatinib mesylate, a drug used to treat chronic myeloid leukaemia (CML), a type of blood cancer.
The Swiss company’s price for its version of the drug, sold under the brand name Gleevec or Glivec, is Rs 1,20,000 or US $ 2,400 per month per patient, while generic versions are available at a cost of Rs. 8,000 (US $ 160) to Rs 12,000 (US $ 240) per month. If Novartis has to stay in business it will have to make the price of the drug more competitive.
The case is pertinent as it involved the interpretation of Section 3 (d) of the Patents Act, 1970, a public heath safeguard introduced by Parliament in 2005 to prevent evergreening or patenting of new forms of already known molecules. Putting an end to the controversy over the provision, the Supreme Court recognised the impact of patents on access to medicines and called for a strict interpretation of this section.
Among others, Section 3 (d) disallows patenting of new forms of already known molecules, unless the patent applicant shows significant enhancement in efficacy of its product.
The Supreme Court held that the section was a key public health safeguard introduced in India’s patent law to ensure that patents were not extended on spurious grounds.
‘Alive and kicking’
Welcoming the ruling, Anand Grover, senior counsel and Director of Lawyer’s Collective Hiv/AIDS unit, who represented CPAA in this matter, said the Supreme Court’s interpretation of Section 3 (d) kept it intact. “It is alive and kicking. It gives life to Parliament’s intent of facilitating access to medicines and incentivising only genuine research. By refusing patent monopolies on minor changes to known molecules, this judgment will facilitate early entry of generic medicines into the market for other medicines and diseases too. The impact will be felt not only in India, but also across the developing world.”
In the past, Section 3 (d) was used to disallow patents for minor modifications of several antiretroviral medicines used to treat HIV patients. “We are extremely pleased and relieved that the Supreme Court has recognised the public health importance of Section 3 (d). This is a crucial victory for people living with HIV and other diseases who can continue to rely on India for access to affordable treatment,’’ said Loon Gangte of the Delhi Network of Positive People. An HIV patient, Mr. Gangte has been taking generic medicines for the past 15 years.
‘Best outcome’
Leena Menghaney of Medecins Sans Frontieres, which relies on Indian-made generic drugs to treat AIDS and other diseases in Africa and many poor countries, said the verdict appeared the best outcome for patients in developing countries. “Novartis’ attacks on the elements of India’s patent law that protect public health have failed. The court’s decision prevents companies from abusing the patent system to get secondary patents on existing medicines, to block price- busting generic competition on HIV and other essential drugs. This confirms that all patent offices in India have to use this interpretation and the law is now clear and must be strictly applied,” she said.
