Grover represented the Cancer Patient Aid Association through his pro bono work with the Lawyers Collective, an India-based NGO that focuses on human rights. The patient association and the generic companies in the case made the argument that Glivec, the beta crystalline form of a known substance, did not satisfy section 3(d) of the Patents Act. Section 3(d) states that a new form of a known substance may not be patented unless it shows greater efficacy.
“The key issues in the Novartis case were whether less hygroscopicity, thermodynamic stability, free flow, higher processibility as also higher bioavailability of the beta crystalline form of imatinib mesylate as compared to imatinib, the base form, as Novartis claimed, meant that the beta crystalline of imatinib mesylate was more efficacious,” he explains. “Ultimately the Court found that physical properties of hygroscopicity, thermodynamic stability, free flow, processibility do not relate to efficacy.”
The court also found that on the issue of higher bioavailability, the patent applicant had to show through in vivo animal studies that the new form is more efficacious, which Novartis did not do.
Not just patents
A self-described activist lawyer, Grover says that his work concerning access to medicines grew out of his involvement with the rights of those associated with HIV, including sex workers, drug users and the LGBTI community. He works on these issues through the Lawyers Collective, as well as his role as UN special rapporteur on the right to health.
Grover points out that the issue of access to medicines goes far beyond patents. For example, as part of his work with the UN, he is working on reports on topics such as the effect of violent conflicts on the right to health. He is also doing research on the interplay between access to medicines and free trade agreements, which also has intellectual property angles.
“When dealing with access to medicines, there are many important issues, such as supply chain and procurement challenges,” he says. “IP is important, but it is just one aspect.”
Grover also says that there have been a number of positive developments improving access to medicines in developing nations. He points to an ambitious programme in Rajasthan, the largest state in India, that provides 500 key medicines cost-free to patients.
“Because of a push from civil society, the government has been pushed to roll out programmes to increase access to needed medicines to its population,” explains Grover.
Alternatives to patents
Though the Glivec decision has caused alarm among multinational pharmaceutical companies about the state of patent protection in India, Grover argues that section 3(d) of the Patents Act actually encourages innovation.
“One has to appreciate that in the US and Europe 76% of the drugs which are patented are simply new forms of known substances without any improvement in the therapeutic efficacy,” he says. “The law in the US, EU and Japan gives the same incentives for innovating a totally new chemical entity [NCE] and a new form of an existing known substance. As a result over the last two decades there is slowing down of innovation of NCEs.”
In fact, he says that he would encourage more countries to adopt section 3(d)-style provisions, arguing that it would incentivise research into new chemicals. With increasing concern over evergreening and patent thickets affecting drug prices, it is not inconceivable that a government may soon follow Grover’s advice.
Grover also argues that other systems of research and development may be more effective than patents in developing new drugs. He points to increased government involvement in researching new drugs such as through university and government labs. By tailoring to the needs of specific countries, such as tuberculosis in India, he says that public research may do a better job at developing new drugs to address public health challenges.
