Patent is the exclusive right given to the right holder to reap benefits out of his invention. Internationally, it is the TRIPS Agreement that regulates the law relating to copyrights, patents, trademarks and other forms of IPR. In theory, the logic behind patent is that, for the discovery of new medicines, companies need an incentive to make this investment; patents provide that protection. As research and development of novel drugs within pharmaceutical multinationals has slowed down, they have focused their energies on patenting minor tweaks to existing drugs in order to extend monopolies, whenever possible. In international trade circles, this is called ‘Evergreening‘.
‘Evergreening’ results in infinite monopoly or a lifetime of artificially high-priced medicines, as only one manufacturer is allowed to supply the drug in the market during the existence of patent right. As a result of this trend, the need to have affordable medicines intensified in 2005, when India amended its patent laws to comply with the TRIPs agreement. Indian patent law has provisions to prevent ‘Evergreening.’
Section 3(d) of the Indian Patent Act, 1970, states that 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, unless such known process results in a new product or employs at least one new reactant, is not an invention within the meaning of the Patents Act.
Section 3(d) is aimed at preventing pharmaceutical companies from obtaining patents on minor variations of existing patented medicines; this effectively prevents trivial patenting or mere workshop improvement of already patented drugs in India.
The concept of ‘Evergreening’ was highlighted in the recent case of Novartis’ patent application on ‘Gleevec’. The patent law allows for any person or group to oppose a patent application and, accordingly, several pre-grant to oppositions had been filed against the patent application of Novartis. As a result of pre-grant opposition filed by civil society groups and Indian drug companies, who contested the novelty and inventiveness of Gleevec, the patent application was rejected under Section 3(d) of the Indian Patent Law in January 2006 on the ground that the drug was only a new form of an old drug. Consequently, the Exclusive Marketing Rights [EMR] stood automatically terminated. Rejection of the patent brought relief to thousands of cancer patients, as it prevented a patent monopoly till 2018.
Novartis’ litigation has raised concerns among other patent groups, as the Gleevec patent order set a precedent for the examination of crucial drugs patent applications, including those for AIDS treatment. If a patent is sought on an improvement, that improvement must actually make the medicine more effective. India, while complying with the TRIPS agreement and introducing a product patent regime for ‘new drugs that were invented’, had made patent examination norms a little stringent, also coupled its law with a safeguard of refusing patents on discovery of new forms or new uses of older drugs to prevent ‘Evergreening’.
The, the Indian Patent Act, by incorporating provisions for product patent of drugs not only protects the interest of pharmaceutical companies, but also provides protection against ‘Evergreening’. But the judiciary has proactively tried to maintain a balance keeping public interest aspect in view.