The Hindu Business Line : Innovation or imitation

As scientists build on existing medicines, they can achieve breakthroughs that significantly improve the medicines, enhancing patients' quality of life.

Novartis has spent the past few months as a corporate dartboard over its bid to patent a cancer drug called Glivec. It's just not cricket. Novartis has received a patent for Glivec in dozens of countries, roughly 40 at last count. But in India, the company, in a bid to patent Glivec, finds itself before the Madras High Court.

Outside the court, Novartis is in a high-pitched, emotional battle with a slew of adversaries worried that a patent for Glivec means death for millions of patients. The thing is, the patients in question don't have chronic myeloid leukaemia or have gastrointestinal stromal tumors, the two conditions for which Glivec offers a remedy. Most of them don't even live here. They have HIV/AIDS, which Glivec isn't even remotely designed to treat, and they live all over the developing world.

As adversaries attempt to broaden the Glivec case beyond its scope, India must find a way to focus on the big picture of real issue at hand — the importance of innovation and the need to preserve it today and for the health of Indians tomorrow.

Generic Copies: A For-Profit Business

But what is the connection and noise then between Glivec and access to HIV drugs in the developing world? Novartis' adversaries, a loose coalition led mainly by non-governmental organisations such as Oxfam and Doctors Without Borders, contend that an Indian patent for Glivec — acting essentially as a proxy for any innovative drug — would limit the ability of our generics industry to produce HIV/AIDS drugs at a cost affordable for export to the developing world.

Just one problem with that argument: It isn't true.

For starters, it is a false premise that our generics industry is the saviour of the Southern Hemisphere's sick. After all, it has its own profit motive, one that precludes it making certain pharmaceuticals at a price low enough to enjoy complete dissemination among affected partners.

Indeed, in a 2007 working paper, the US International Trade Commission noted that the United States is the No 1 country to which India exports its pharmaceutical products, with a value of $575 million in 2005. Other top 10 export countries for Indian pharmaceutical companies include Russia, Germany, the UK, China, Brazil, Nigeria and Canada, Italy and South Africa. Moreover, according to a WHO/UNAIDS report last year, less than 7 per cent of our 785,000 HIV/AIDS patients in India receive antiretrovirals.

India's pharmaceutical companies are hardly the pharmacy of the developing world. They export to markets where they can sell their products at a profit; they sell more in wealthy countries than they do domestically or in poor countries.

The Real Limitations on Access to Medicines

Second, two factors account for access-to-medicines problems, neither of which has much to do with Novartis, Glivec, or patents: A lack of funding from all sources; and a lack of infrastructure for healthcare delivery. In reality, prices, industry structure and patents in the pharmaceutical field have little to do with access to drugs.

Denying patents and giving generic companies a free ride to copy new drugs will not deliver medications to the patients too poor to buy them, in the slums of India, in the jungles of Sierra Leone, in the remotest reaches of Indonesia, anywhere.

If the government really wanted to help the world's poor, there are better ways than denying patents. It could itself fund distribution methods, domestically and internationally. It could push the World Health Organisation and various NGOs to step up their activities. It could encourage and make it easier for pharmaceutical companies to donate medicines (99 per cent of patients who take Glivec get it for free, thanks to a Novartis access to medicines initiative).

It could free up additional resources for basic healthcare facilities and staffing in underserved areas.

Reaching Our Potential to Innovate, Not Imitate

What denying patents does do, however, is bury any reason our smartest pharmaceutical brains have to create new medicines. In fact, if Novartis' adversaries were that concerned about our ability to provide medicines for the world's poor, they would be lobbying New Delhi to grant the Glivec patent.

We do have the physical and intellectual infrastructure in place to be so much more than imitators. Ask our pharmaceutical companies themselves how they feel about patents, and the answer might surprise you.

On its web site, Dr Reddy's proclaims that its vision is "to become a discovery led global pharmaceutical company" as it strives to meet its core purpose, "to help people live healthier lives." Ranbaxy has a similar vision: "To become a research based International Pharmaceutical Company. For Ranbaxy, "R&D is a manifestation of our belief in quality and innovation. Ranbaxy views its R&D capabilities as a vital component of its business strategy that will provide the company with a sustainable, long-term competitive advantage."

India's pharmaceutical companies know what's what; When they began innovating, they sought patent protection in other countries, for example, in 2005, the US Patent Office granted Ranbaxy Laboratories a patent on its controlled-release drug-delivery system, which takes the form of a 'floating' tablet that once swallowed, is retained in the upper gastrointestinal tract to provide maximum drug absorption.

The invention can be used to provide controlled-release delivery of a number of active pharmaceutical ingredients, used in a wide range of medications such as antivirals, antibiotics and H2-antagonists, among numerous other compounds.

This technology provided the potential for significant therapeutic advantages for millions of prescriptions as well as preventing a decrease in a drug's effectiveness and unwanted side-effects. Incremental innovation is critical. It is the way medical research progresses.

As scientists build on existing medicines, they can achieve breakthroughs that significantly improve the medicines, enhancing patients' quality of life. So let's start issuing patents and begin innovating.

(The author is Vice-Chairman and Managing Director, Novartis India Ltd.)

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