Updated on 4 January 2013
These judgments have been received differently by the Indian public. On one hand, patient advocacy groups say that reduced prices will make the drugs more accessible. On the other hand, pharma companies opine that such decisions disincentivize and stifle innovation.
The Section 3(d) debate
Today, Indian pharma seems to be in a similar transitory phase, akin to the crucial period in 2005, when India shifted over from 'process-to-product' patent regime. The move, although considered to be a blow to India's booming generics industry, was deemed necessary for India to comply with existing WTO norms. However, in order to address India-specific needs, a Section 3(d) was added in the Indian Patent Law to prevent ever greening (or getting patents-based on minor modifications). The interpretation of the Section 3(d) remains a grey area and is a topic of much debate, as far as pharma is concerned, with parties on both sides of the fence equally voicing their opinions.
Mr Ravi Bhola, partner, K&S Partners, Intellectual Property Attorneys, says, "Most of the rulings or patent rejections, in recent times are concerning Section 3(d) in conjunction with the issue of obviousness. The legal sanctity of Section 3(d) has been validated by the parliament after severe discussions. However, the next few months will be worth watching out for, when the Supreme Court will discuss its constitutional validity and its various interpretations at length under the Novartis case. It will be very critical and can determine the future course of action for pharma in India."
Novartis' Glivec case
The Novartis Glivec case has caught the eye of industry onlookers worldwide. Novartis is currently appealing to the Supreme Court for the grant of a patent for its anti cancer drug, Glivec, on the basis of an incremental innovation resulting in an increased efficacy. The contentious issue here is if an increase in efficacy can be considered as an incremental innovation.
On this matter, Mr Ranjit Shahani, vice chairman and managing director, Novartis India and president, Organization of Pharmaceutical Producers of India (OPPI), an association of research and innovation driven pharmaceutical companies in India, says," The active substance of Glivec is the beta crystal form of Imatinib mesylate, being claimed in our patent application. Many leukemia patients had no treatment option, before Glivec became available. The drug turned a fatal disease killing its victims within three-to-five years into a non-fatal chronic disorder. From a patient perspective this was not a minor modification."
In reality, however, the issue of pricing is said to be the principal cause for these cases being pursued by non governmental organizations (NGOs) and civil society. In case of Pegasys, the discounted treatment cost would be $5,718 (Rs314,496) and would have to be taken in combination with another drug Ribavarin costing $857 (Rs47,160). Sankalp argued that this price would make it unaffordable to most of its target population and hence took up the cause of fighting the patent.