NGOs working in the health sector have welcomed the landmark judgement by the Supreme Court dismissing the Swiss drug major Novartis’ appeal for a patent for its anti-cancer drug imatinib mesylate (Glivec).
The landmark decision by the Indian Supreme Court in Delhi to uphold India's Patents Act in the face of the seven-year challenge by Swiss pharmaceutical company Novartis is a major victory for patients' access to affordable medicines in developing countries, the international medical humanitarian organisation Médecins Sans Frontières (MSF) stated.
“This is a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India, and for treatment providers like MSF," said Dr Unni Karunakara, MSF International President. “The Supreme Court's decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.”
India began granting patents on medicines to comply with international trade rules, but designed its law with safeguards – including a clause known as Section 3(d) -that prevent companies from abusing the patent system. Section 3(d) prevents companies from gaining patents on modifications to existing drugs, in order to ever extend monopolies.
“Novartis's attacks on Section 3(d), one the elements of India's patent law that protect public health, have failed,” said Leena Menghaney, India Manager for MSF’s Access Campaign. “Patent offices in India should consider this a clear signal that the law should be strictly applied, and frivolous patent applications should be rejected.”
Welcoming the Supreme Court decision, Y K Sapru of Cancer Patients Aid Association (CPAA), which had opposed Novartis’ patent application, said, “We are very 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.”
Welcoming the ruling, Anand Grover, Senior Counsel and Director of Lawyers Collective HIV/ AIDS Unit, who represented CPAA in this matter, said, “The Supreme Court’s interpretation of Section 3(d) keeps it intact. It is alive and kicking. It gives life to Parliament’s intent of facilitating access to medicines and of incentivizing 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) has also been used as one of the grounds to disallow patents for minor modifications of several antiretroviral (ARV) medicines used to treat people living with HIV.
Loon Gangte of the Delhi Network of Positive People (DNP+) said, “We are extremely pleased and relieved that the Supreme Court has recognised the public health importance of Section 3(d). We have been filing several oppositions to patent applications on ARV medicines on the basis 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.”