Something patently wrong

Dr R A Mashelkar, one of India's leading science administrators resigned from a government technical committee, last week, in wake of personal and politically motivated attacks from certain quarters. In this article, "Something patently wrong", published in the Hindustan Times, on 20 March 2007, I look at the misguided debate over ever-greening of patents, when there are much more serious problems faced by patients in India.

Last Sunday, Indians woke up to mourn the unexpected loss of its team to Bangladesh in India’s first World Cup match. The news that ought to wake up the nation is the situation that led to the resignation of RA Mashelkar from the technical committee formed to look into India’s patent law. Mashelkar resigned because of personal attacks and political machinations. Among his critics were political activists who put their populist agenda ahead of the country’s interest, and social activists who make a career in perpetuating ill-health.

Mashelkar is one of India’s most respected scientists and a pioneering administrator of its public sector scientific establishment. Most importantly, he encouraged scientists to file patents to harness the commercial potential of innovations. Mashelkar truly realised the potential of the scientific community and foresaw the need for a good intellectual property (IPR) law that could provide an institutional framework for new opportunities.

But over the last few weeks, his critics have portrayed Mashelkar as a Bollywood-style villain. The Mashelkar committee was formed to review technical aspects of the Indian Patent Amendment Act, 2005. From the time it was passed, recognising among others things product patent in pharmaceuticals, there have been questions. One contentious issue was Section 3(d), which states that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant”.

The issue here is of ‘ever-greening’ of patents, or an attempt to extend the life of a patent by incorporating cosmetic changes. The Indian law complicated things by using terms like “mere discovery” or “efficacy of the substance” — difficult to define and easy to misinterpret.

The contentious nature of these provisions was also brought to light by a case filed by Novartis before the Chennai High Court. It challenged an order of the patent registrar who refused a patent for ‘Glivec’, although the same product has been granted a patent in other countries. In its report two months ago, the Mashelkar committee had noted that the said provision would be a violation of the Agreement on Trade-Related Aspect of Intellectual Property Rights (Trips).

Unfortunately, this technical recommendation got mired in a new controversy over plagiarism. Certain sections of the recommendations had been directly taken from another study submitted to the committee during its deliberations. Mashelkar immediately apologised to the author whose work was incorporated without due acknowledgement. He also requested the government to withdraw the report and offered to redo it.

The debate over pharmaceutical product patent has always been politicised. Politicians are eager to seize an opportunity to bash MNCs. It is a convenient tactic to divert attention away from India’s dismal healthcare. After all, in a country which has not recognised patent in medicines for over three decades — where 97 per cent of medicines is believed to be off-patent — India is quite far from becoming the world’s healthcare capital.

About 70 per cent of Indians never access modern healthcare systems. No doctor in public sector healthcare can claim that patients’ problems are related to patents. But rather than looking into the whole chain of delivery — medical professionals, diagnostic facilities, dispensaries and hospitals — it is easier to wave the national flag. The reality is that even if there were no patents, or if medicines were distributed free, many patients would still not benefit. Nothing else can explain the failure to provide ORS to diarrhoea patients, or the failure to vaccinate children against polio.

Mashelkar has been criticised by the Indian pharmaceutical industry — an industry so concerned about Indians that they see their growth potential in markets abroad. Indeed, the aspects of the patent law that these businesses are opposed to are similar to the ones under US law, where some of the Indian companies are rapidly filing for their own incremental patents. The US patent law has been criticised but it can hardly be a coincidence that a stable patent law has contributed to making the US the most attractive destination for research and development, hosting some of the largest and best pharmaceutical research establishment, and at the same time being the largest market for patented medicines as well as generic drugs. The US pharmaceutical market today is close to $100 billion, about half of which is generic, and the total Indian market is just about a fifth of the US generic market.

One may differ on the interpretation of Section 3(d). The court is expected to rule on it. But IPR will assume even greater significance in the knowledge economy. And to engage in character assassination of Mashelkar, in an attempt to undermine IPR, will neither improve our healthcare system nor lay the foundation for our entry in to the knowledge era. That surely will not be cricket.