WHEN Novartis challenged a section of the patent law in the Madras High Court, it sought to provoke a debate on issues left undecided by the government when the Patent (Amendments) Act was passed in March 2005: How can we balance intellectual property rights with the right to health? What should be the criteria for giving a patent?
Patents are not fundamental rights; they are 20-year exclusive market rights gifted by the state to reward invention. When intellectual property rights come into conflict with the fundamental right to health, the state can take away these gifts.
Parliamentary records of debates on patent amendments necessary to comply with World Trade Organization (WTO) intellectual property rules show that there was widespread fear among members that the common person would be denied access to life-saving drugs through a process they termed evergreening: drug majors could make minor modifications to existing drugs and re-patent them, thereby retaining sole access to the market. As a result, Section 3(d) of the Patent Act was modified: patents would be granted only for new forms or new uses of existing drugs where they were significantly more effective.
But the government, having exceeded its WTO compliance deadline by three months, was in a hurry to pass the rest of the amendments to the Act. The task of defining the exact scope of patentability for chemical entities was passed over to a committee headed by Dr. R.A. Mashelkar, the then Director of the Council of Scientific and Industrial Research (CSIR). This opened the floor for lobbies to push their cases through many fora, including bilateral trade negotiations, business councils and courts. The revelations that Mashelkars report was plagiarised from a multi-national pharmaceutical industry-funded paper is one example of these lobbies strength. Mashelkar withdrew the report and the issue remains unresolved.
Novartis is one of several voices arguing that Indias patent law stifles the research and development of new medicines. Paul Herrling, head of corporate research at Novartis, stated in response to the judgment, Medical progress occurs through incremental innovation. If Indian patent law does not recognise these important advances, patients will be denied new and better medicines.
The point made by the generic companies that have impleaded themselves in the case was that Indian law recognises innovation when the efficacy of the drug is significantly enhanced and not when the change is obvious to any skilled chemist.
D.G. Shah, secretary-general of the Indian Pharmaceutical Alliance, told Frontline in February that granting patents for minor changes would, in fact, derail innovation. People [in the pharmaceutical industry] would focus onl y on these, low-hanging fruits, which are low-risk and high-reward. If everyone can patent small changes, why would anyone go for high-end research? There, the fruits are at the top, where risk is high and rewards are uncertain. If we want medical science to progress, that should be the bar.
Ellen tHoen of the Medecins Sans Frontieres Access to Essential Medicines Campaign told Frontline from Geneva that patents do not necessarily bring better, more innovative medicines. Despite the fact that patent protection has increased, innovation has declined dramatically in terms of new products. Of the 327 drugs listed in the United States Federal Drug Administrations Approved Drug Products and Therapeutic Equivalence Evaluations (the Orange Book), only 58 molecules are eligible for patent in India. If you assess drugs that are given patents from a therapeutic point of view, patents are less and less meaningful. You cannot say more patents leads to more therapeutic benefits.
Despite the latest judgment and despite the fact that Mashelkars report was discredited, the government is, according to news reports, planning to find a way to allow incremental innovation. What was to have been debated in Parliament in 2005 is being forced through courts or discussed away from the public eye.
When the technicalities appear obscure but the consequences are significant, whether for the flows of foreign direct investment, for access to medicines or for the domestic industry, the democratic way would be to invite an open debate in which all can participate.
Sarah Hiddleston
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