Patents are limited monopolies regulated by the World Trade Organization (“WTO”). In theory, the logic is deceptively straightforward: the discovery of new medicines costs money; companies need an incentive to make this investment; patents provide that protection. As research and development of novel drugs within these pharmaceutical multinations 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’ translates into an infinite monopoly or a lifetime of artificially high priced medicines as only one manufacturer is allowed to supply the abovementioned tweaked drug to the existing market for such pharmaceutical companies. As a result of this trend the furor over 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) 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. This concept is very distinctive to the Western Patent laws, as they still lack such kind of provisions in order to prevent “Evergreening”.

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 filed cases in the Chennai High Court. Challenging the order of rejecting the Gleevec patent as well as challenging the constitutional validity of the Indian Patent Law.
Moreover, Novartis challenged the constitutionality of section 3(d) of the Indian Patents Act, which was specifically introduced by the Indian parliament as a safeguard against the misuse of the product patent regime. Novartis, in its petition, claimed that the section is not in compliance with the TRIPS agreement and hence should be declared unconstitutional. Presently, the petition is pending in the Chennai High Court and a judgment is yet awaited.

Conclusion:

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', 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, Indian Patent Act by incorporating provisions for product patent of drugs not only protects the interest of pharmaceutical companies but also provides protection against the concept of “Evergreening”. The Act effectively balances the health related issues of public against the product patent provisions and also provides encouragement for research and development of novel drugs in India.