Biomed Analysis: India mustn’t bow to patent pressure

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The latest round of challenges to India's drug patent laws is a fight that must be won for the world's poor, says Priya Shetty.

India often falls short in tending to the health of its poor — failing to implement water and sanitation programmes and allowing corruption to threaten health initiatives, all the while launching costly and ambitious space programmes.

But the country has no equal in its provision of cheap generics to the poorest in the developing world who cannot afford brand-name drugs. Generics are estimated to make up 90 per cent of India's entire drug market. [1] Yet its capacity to make generics has been constantly threatened by pharmaceutical giants that prefer to keep their drugs under patent.

In the latest challenge to India's generics industry, this month Novartis is battling against clause 3(d) of Indian patent law in the country's Supreme Court. The clause aims to prevent 'evergreening', in which companies continually extend patents by tweaking the product slightly.

This is a trying time for India's patent laws. But it must not crumble under the pressure.

The case continues

Not only is much of the developing world depending on India for lifesaving drugs, but its generics industry is starting to mature into a fully fledged pharmaceutical base capable of innovating new drugs — crucial to the country's healthcare and economy.

This is what makes the Novartis case so compelling. The drug company wants to patent a new form of its cancer drug Glivec (imatinib mesylate), on the basis that it is more effective and therefore 'novel'. Yet while Glivec costs about US$30 (1,640 Indian rupees) for a 100 milligram pill, a generic version costs just one-tenth of that. Most patients need to take the drug continuously for years, and some need it for life.

If Novartis wins the case, it is likely to open the floodgates for other companies to make similar challenges to clause 3(d) — potentially fatal for the country's protection of generics. For instance, Roche has had a patent rejected on a newer version of cytomegalovirus drug Valganciclovir, and GlaxoSmithKline on a modification of the AIDS drug Abacavir; these companies are bound to try their luck if Novartis succeeds in quashing the clause.

It can't be said that Novartis isn't persistent. In 2006 the Indian patent board ruled that its variation of Glivec was not novel enough to be patentable, and in 2007 the Chennai High Court dismissed a further challenge that clause 3(d) was not in line with the global TRIPS intellectual property agreement that India signed up to in 2005.

Novartis was given hope, however, in 2009 when India's Intellectual Property Appellate Board overturned the 2006 ruling and said that the drug was novel and inventive. But it deemed the drug still not patentable because the new version didn't meet the criterion of enhanced efficacy required by 3(d). The company is now using these conflicting rulings, and the 2009 decision, as ammunition to win a patent on Glivec.

Growing generics capacity

Ironically, India has lagged behind countries like Brazil and Thailand in one area of ensuring access to drugs: compulsory licences. These allow a manufacturer to make generic versions of a drug even though it is still under patent, provided there is a major public health imperative. Both Brazil and Thailand have issued several compulsory licences over the past few years.

India issued its first compulsory licence in March, to local generics firm Natco, to produce generic versions of sorafenib tosylate, a Bayer-patented drug to treat kidney and liver cancer.

Despite being slow to grant compulsory licences, India's generics industry has grown to such an extent because of the 1970 Indian Patents Act, which removed patents on pharmaceutical products to keep the costs of medicines down. By the time India joined the international patent regime in 2005, its drug manufacturing capacity was powerful enough to be able to produce drugs to export to other developing countries.

Not an easy fight

There is reason for hope that India will rule in the interest of poor communities.

The Supreme Court has already suggested that Novartis reduce competition against generics by slashing the price of the drug. [2]

This week, India's Intellectual Property Appellate Board in Chennai ruled to keep in place the compulsory licence on Bayer's sorafenib tosylate, after the company challenged the licence on the basis that patents must be upheld to drive innovation.

And earlier this month, the Delhi High Court ruled in favour of Indian generics manufacturer Cipla, which has been battling Swiss drug giant Roche for four years to make Erlocip, a generic version of cancer drug Tarceva. [3]

These are not battles that countries such as Brazil, India or Thailand fight lightly. In 2007, when Brazil issued a compulsory licence on AIDS drug efavirenz, patented by US firm Merck, it risked damaging Brazil–US trade relations. Similarly, India has much to gain economically from having multinational pharmaceutical companies establish themselves in the country.

But these economic gains don't come close to the public health benefit that generic medicines give to the poor. In the law courts, precedent is everything, and the drug industry will pounce on even one false step. India must remember that it has over half a billion people living below the poverty line; it can't afford to get this decision wrong.

Journalist Priya Shetty specialises in developing world issues including health, climate change and human rights. She writes a blog, Science Safari, on these issues. She has worked as an editor at New Scientist, The Lancet and SciDev.Net.