We are delighted to welcome this blog post from Emmanuel Oke, PhD candidate here at the Centre for Criminal Justice and Human Rights, UCC.
THE INDIAN NOVARTIS CASE: FINDING THE RIGHT BALANCE BETWEEN ACCESS AND INNOVATION
Earlier this year, in April, 2013, the Indian Supreme Court delivered the much awaited judgment in the appeal filed by Novartis against the refusal of the Indian patent office to grant a patent on its cancer drug, Glivec. The patent office and the Indian Intellectual Property Appellate Board had both decided that Novartis’ patent application failed to meet the requirements of section 3(d) of the Indian Patents Act. Section 3(d) prohibits the grant of patents on new forms of known drugs unless the patent applicant can demonstrate that the new form has ‘enhanced therapeutic efficacy’ over the previously known drug. In its decision, the Indian Supreme Court equally held that Novartis had failed to meet the requirements of section 3(d).
The active ingredient in Glivec is a derivative of a drug compound called ‘imatinib’. Novartis had improved upon ‘imatinib’ by converting it into a salt form called ‘imatinib mesylate’ and it was from ‘imatinib mesylate’ that Novartis derived the most stable version of the drug compound, a particular polymorphic form called the ‘beta crystalline form of imatinib mesylate’. This beta crystalline form is the active ingredient in Glivec. The argument of Novartis was that Glivec could not be denied a patent based on section 3(d) because the active ingredient in Glivec was more effective than ‘imatinib’ as it was absorbed easily in the bloodstream and there was a 30% increase in bioavailability (bioavailability is the degree and rate at which a drug is absorbed into a living system or is made available at the site of physiological activity). The Indian Supreme Court however held that Novartis failed to provide evidence to establish that the increase in bioavailability results in ‘enhanced therapeutic efficacy’ (para. 189). But what exactly is ‘enhanced therapeutic efficacy’? How can a patent applicant establish ‘enhanced therapeutic efficacy’? These questions will be addressed later on in this post.
It is important to note that section 3(d) was introduced into the Indian Patents Act in 2005 when India had to amend its patent law to provide patent protection for pharmaceutical products as required by the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). Prior to 2005, India had previously amended its patent law in 1970 to exclude pharmaceutical products from patent protection. This exclusion of patent protection for pharmaceutical products enabled the local pharmaceutical companies in India to develop the capability to produce cheaper generic versions of drugs that were patented in other countries. The production of cheaper generic drugs within the country thus ensured that drugs were not prohibitively priced beyond the reach of poor patients. Besides, Indian drug companies have become major suppliers of generic drugs to several developing countries, hence the description of India as the ‘pharmacy of the developing world’. The objective behind the introduction of section 3(d) was to ensure that only ‘genuine’ pharmaceutical innovations were granted patent protection in India. Section 3(d) was essentially designed to prohibit what is known as ‘ever-greening’ where a drug company obtains several layers of patents on different forms of the same drug. Section 3(d) therefore raised the bar for drug patent applicants and this was designed to ensure that local drug companies in India could still continue to produce generic versions of drugs that failed to meet the requirements of the patent law.
To be sure, there is a huge problem of lack of access to essential medicines in India. In actual fact, it has once been reported that India has the largest number of citizens with no access to essential medicines. Also, as noted above, several developing countries are dependent on supplies of cheaper generic drugs (including anti-retroviral drugs) from Indian drug companies. This therefore explains why Indian lawmakers introduced several provisions (including section 3(d)) into the Indian patent law in 2005. The lawmakers wanted to ensure that compliance with the requirements of the TRIPS Agreement would not have a negative impact on access to medicines and the right to health of Indians and other poor patients in other developing countries. It should be quickly added that the TRIPS Agreement permits countries, when formulating or amending their laws, to adopt measures necessary to protect public health (Article 8(1) TRIPS). This was subsequently reaffirmed in the Doha Declaration on the TRIPS Agreement and Public Health of 2001. Therefore, India has not breached its international obligations by introducing section 3(d) into its patent law.
There is no doubt that the decision of the Indian Supreme Court in the Novartis case is a triumph for the right to health, particularly the right to have access to affordable medicines. It is however crucial to also consider whether a provision like section 3(d) can potentially have a negative impact on access to essential medicines in the long term. While section 3(d) serves as a prohibition against ‘ever-greening’, there is a significant risk that certain useful incremental pharmaceutical innovations (i.e. useful improvements of known drugs) may also fail to meet the requirements of this provision. It should be noted that most domestic drug companies in India do not currently possess the capability to produce highly innovative drugs and they can only engage in incremental pharmaceutical innovation. It is therefore essential to encourage these domestic drug companies to engage in incremental pharmaceutical innovation as this will consequently lead to the development of the capability to produce highly innovative drugs and it can also encourage these domestic companies to invest in the development of drugs for treating diseases that primarily affect patients in India.
This brings us back to the earlier questions regarding what constitutes ‘enhanced therapeutic efficacy’. Unfortunately, the Indian Supreme Court failed to define or describe the scope of what constitutes ‘enhanced therapeutic efficacy’. The court was content to hold that it was unnecessary to decide this crucial issue because on the facts before it, Novartis had failed to provide evidence to demonstrate ‘enhanced therapeutic efficacy’. The implication of this is that, right now, no one actually knows the exact requirements that one has to fulfill before the demands of section 3(d) can be satisfied. Though the court was of the view that its decision was not a bar against incremental pharmaceutical innovations (para.191), by failing to specify what constitutes ‘enhanced therapeutic efficacy’, there is a risk that potentially useful incremental pharmaceutical innovations may not meet the requirements of section 3(d). It should always be remembered that fostering pharmaceutical innovation and facilitating access to medicines are both crucial to securing the right to health.
*PhD Candidate, Faculty of Law, University College Cork.