Supreme Court dismisses Novartis’ appeal
By IPA Special Correspondent
In a major victory for patients fighting for access to medicines, a division bench of the Supreme Court of India comprising Hon’ble Justice Aftab Alam and hon’ble Justice Ranjana Desai, today dismissed Swiss MNC Novartis’ appeal for a patent to Novartis for its anti-cancer medicine, imatinib mesylate (Gleevec). The case is especially pertinent because it involved the interpretation of section 3(d) of the Patents Act, 1970, a public health safeguard introduced by Parliament in 2005 to prevent evergreening. Putting an end to the controversy over the provision, the Supreme Court has recognised the impact of patents on access to medicines and called for a strict interpretation of section 3(d).
Rejoicing at the decision, Mr. 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. ”
The Supreme Court’s ruling turned on the interpretation of section 3(d), a key public health safeguard introduced in India’s patent law by Parliament in recognition of the impact of product patents on access to medicines. Amongst others, section 3(d) disallows patenting of new forms of already known molecules, also known as evergreening, unless the patent applicant shows significant enhancement in efficacy for its product.
The Supreme Court held that Section 3(d) was introduced in the Patents Act, 1970 to ensure that patents were not extended on spurious grounds. The Supreme Court’s judgment that was delivered by Hon’ble Justice Alam stated that patent applicants also have to meet the standard of Section 3(d) before they can get patents under the Indian law.
Novartis also argued that section 3(d) only applies for new forms of already approved medicines. It also argued that better physico-chemical qualities, such as shape of the molecule, stability, hygroscopicity and solubility, would satisfy the test of enhanced efficacy.
Rejecting Novartis’ argument, the Supreme Court has held that the physio-chemical properties of the beta crystalline form of imatinib mesylate i.e. flow properties, decreased hygroscopicity and thermodynamic stability may be beneficial for patients in some manner but they do not meet the standard of efficacy required by Section 3(d).
Welcoming the ruling, Mr 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.” (IPA Service)