ET Bureau & Agencies. 2013. What is Section 3(d) o
MUMBAI - In a hearing on April 1, 2013, Monday, the Indian Supreme Court ruled against the patenting of Novartis’ cancer drug ‘Glivec’. The verdict was celebrated locally as a favourable situation for domestic pharmaceutical companies as it served to secure the production and distribution of generic drugs in India, assuring the availability of affordable quality drugs, especially to the poor.
The case that ended last April 1, 2013 got its start when Novartis first filed for a patent for its innovative cancer drug ‘Glivec’ in 2006 [The Wall Street Journal]. According to India’s Patent Law, specifically sections 3(b) and 3(d), Glivec did not meet requirements to make it novel and worthy of a patent. Section 3(b) and 3(d) state that:
(b) an invention the primary or intended use or commercial exploitation of which could be contrary public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment; ...
(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. ... [ET Bureau & Agencies]
By these statements, minor alterations with insignificant changes to efficacy are not considered innovations and are thereby undeserving of patents.
In the argument against Novartis, ‘Glivec’ was declared to be just a modified form of a known compound [Reuters]. Having been denied the patent, the company felt the need to challenge the decision and attempt to clarify the Indian Patent Law and its seemingly narrow definition of innovation. It finally did so by filing another appeal to the Supreme Court in 2009. However, Novartis once again lost its case.
The ruling was hailed as a sort of milestone in upholding the general public’s rights to easily accessible and affordable essential drugs such as ‘Imatinib’, a generic alternative of ‘Glivec’. The result held much weight considering the importance of Imatinib, which is formally listed as a national essential drug used to treat several forms of blood and stomach cancers. The patent rejection now allows for the continued marketing of Imatinib by local Indian companies at a much lower cost [PTI].
Consequently, the decision is said to bring much relief among suffering patients in need of the medication [PTI].
Moreover, the significance of the Supreme Court’s verdict extends beyond India herself. When international costs for the branded Glivec range from an estimated $23.00 - $35.00 for 100mg tablets, the option for the generic Imatinib which costs $3.00 - $13.00 [PharmacyChecker.com] is a considerable reprieve. India is known for supplying a significant amount of generic drugs for poor and developing countries [The Associated Press]. Following the implications of India’s view on innovation patents, these countries will stand to benefit directly from the continued provision of affordable generic medication and from the protection from patenting of existing medication [Reuters].
The general opinion of the ruling is one of good judgment as it is perceived to favour the poor, favour domestic pharmaceutical companies, protect against drug patent monopolies, and maintain the availability of generic drugs [PTI].
Nevertheless, despite these positive implications of the verdict, Novartis firmly stated that the decision discourages future medical or drug innovations, which in turn may hinder future drug development in India. The reason for this being that the lack of patents may make it difficult for innovating companies to regain the heavy expenses used in research and development, clinical trials and perfecting products like drugs or medication to make them suitable and effective for human consumption. This lack of funding may, subsequently, slow down future research and development activities for new drugs and medication for other diseases without effective cures. As a result, developed countries may suffer in terms of developmental progress in the medical and pharmaceutical fields.
Thus, the company also stressed the need to recognize the importance of innovation patenting as it serves to encourage investment in further development of new drugs and medication.
Although Novartis had its patent rejected, it will carry on bringing in products to the country. It has decided, however, to relocate its research and development activities.
Meanwhile, Novartis India Ltd., a local subsidiary, will continue to file for patents for innovative products in the future [PTI].
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