The Law That Saved a Billion Lives
On 1 April 2013, Supreme Court Justices Aftab Alam and Ranjana Prakash Desai upheld previous decisions of the Intellectual Property Apellate Board (IPAB) and the Patent Controller in deciding that Novartis’ application covering a modification to the original imatinib compound was not worthy of patent protection—and thereby, market monopoly —in India. It was a judgment heard around the world. Mainstream media exploded with news of the Indian Supreme Court decision, marking a first for a lengthy document that put forth a complex technical argument based on the arcane workings of intellectual property, itself an arcane subject.
The other popular line of argument is that this judgment will have no effect on access to imatinib since most people get it free anyway. These exact words have appeared in the editorials and news reports of several publications over the past few weeks, never mind that the opposite is true. Consider the dissimulation that produces this argument. There are an estimated 42,000 people being treated for CML with imatinib in India today. Of these, Novartis claims 16,000 patients use its brand of imatinib, Gleevec. Novartis further claims that 90 per cent of these Gleevec users—about 15,000 patients—get the medicine free through a charitable programme run by the company. (The Cancer Patients Aid Association—CPAA—disputes these claims). Even if we take Novartis at its word, there are at least 27,000 patients—65 per cent of all people diagnosed with CML—who are paying for their imatinib, either directly or via their employers. Now hear Paul Herrling, head of corporate research at Novartis, conveniently mixing up his numbers, magically expanding the scope of his company’s charity, and setting the narrative: “90 per cent of all people diagnosed with that specific form of leukemia get Gleevec free.”
Regardless of the intent, perhaps we ought to be grateful for the sudden spurt of attention towards Indian patent law. It is well worth understanding. After all, it is the reason we are alive.
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The Nobel Prize-winning relief organisation Médecins Sans Frontières (MSF) calls India ‘the pharmacy of the developing world’. It is a well-deserved distinction, and it took the better part of five decades to achieve. The Indian generic pharmaceutical industry took off in the 1970s, and continues to provide patients across India with what are arguably the cheapest certified medicines available in the world. After an early phase of consolidation, the Indian generic industry looked outwards—and began exporting its medicines with some success. Today, large swathes of Latin America, sub-Saharan Africa and Asia (not to mention some sections of the American and European market) depend on Indian generic medicines to a significant extent. An industry born of a straightforward strategy for pharmaceutical self-sufficiency has transformed into a world-class hub of low-cost medicine production.
It was no accident. Like so many transformations that mark our time, it began in the 1960s. Justice Bakshi Tek Chand and Justice Rajagopala Ayyangar, two pioneering patent law reformers of the period, laid the foundations on which the generic industry would be built. The Tek Chand Committee reviewed the Indian Patents and Designs Act of 1911, and argued that it did not encourage scientific research in India. The committee recommended that patents be put to use for the good of the Indian public, and that patented products be reasonably priced, failing which, compulsory licences ought to be issued (which would legally revoke the time-bound monopoly conferred by patent protection).
The Ayyangar Committee took the argument further, noting that far more patents were being granted to foreigners than Indians, and that Indian patents were not proving commercially successful. The Ayyangar Committee asked for the country’s patent law to be redesigned to respond to India’s needs as a developing country, and drew upon European precedents to exempt food, medicines and chemicals from product patents. This legal provision formed the cornerstone of India’s Patents Act of 1970, and enabled the emergence of the generic pharmaceutical industry we know today... read more:
