On Novartis and Patents

Dead Man Walking
Published in The Times of India
By Dr. Richard Rockefeller
Chairman, Médecins Sans Frontières Board of Advisors

Chances are you have never heard of the drug, imatinib mesylate, let alone Section 3 (d) of India's Patent Amendment Act of 2005.

But a court case in India this month involving both could determine whether people throughout the world have access to life-saving medicines for diseases like HIV/AIDS for decades to come.

I am intimately familiar with the drug, marketed by the Swiss-based multinational Novartis as Gleevec, because my life depends on it.

In October 2000 doctors diagnosed me with chronic myelogenous leukaemia (CML), a rare and deadly form of cancer. Six months later, the Federal Drug Administration approved Gleevec.

Years of taxpayer and privately funded research went into the drug's development, and it has all but eliminated my cancer.

Novartis has filed suit against India's government because an Indian court rejected its patent application for a new form of the original compound. The company is challenging both the patent office decision and a key public health safeguard within India's Patents Act that aims to reserve patents for real innovations only.

If Novartis succeeds, a surge of additional patents is likely, resulting in further restrictions on the production of generic drugs in India and inordinately high prices for newer medicines. India's generic medicine industry is often called "the pharmacy to the developing world" because it produces quality drugs at dramatically more affordable prices.

Generic competition is what brought prices down for antiretroviral (ARV) medicines for people living with HIV/AIDS from a staggering $10,000 to $136 a year.

Most AIDS treatment programmes throughout the world rely on generic ARVs made in India, including more than 80 per cent of the 80,000 patients treated by Doctors Without Borders in more than 30 countries.

And 70 per cent of the ARVs purchased by UNICEF, the International Dispensary Association, the UN Global Fund, and the Clinton Foundation to treat patients in 87 developing countries come from generic Indian sources as well.

In Malawi, the importance of generic ARVs was brought home to me a few years after i was diagnosed with leukaemia. I saw first-hand how hope had replaced despair for thousands of people throughout the impoverished country when, just a short time earlier, AIDS devastated whole communities.

Like me, without treatment, many of the people i met most likely would have been dead. And without a generic source of ARVs, only dozens would have been treated, not thousands.

Even as millions around the world still have no access to treatment, these fortunate few are put at risk by Novartis's legal attack in India.

A constant flow of affordable newer medicines will be particularly important for AIDS treatment, as patients inevitably become resistant to first-line therapies and need newer drug combinations.

This lawsuit threatens the supply of these medicines because of the precedent it could set for future patenting decisions.

Novartis says that concern with its lawsuit is misplaced because the company gives Gleevec for free to patients in India.

Of course, those receiving it do not represent the total number of leukaemia sufferers, and in any event, a drug delivery system based solely on donations is vulnerable to shifting political winds and the drugs can be withdrawn for any reason.

The company also claims on their website that their court case is actually about increasing access to medicines because strict intellectual property (IP) protection lays "the foundation for the massive investments made by the pharmaceutical industry in R&D that are vital to medical progress".

While this may sound good in a press release, it is just not true for most people in the world. A growing body of evidence - most recently the WHO's Commission on Innovation, Intellectual Property and Public Health - indicates that increased patent protection has done little or nothing to increase innovation in treatments for the afflictions of the developing world.

Of the 1,556 new chemical entities marketed worldwide between 1975 and 2004, only 20 were for diseases that affect 90 per cent of the world's population.

To many people, Novartis' lawsuit is a case of deja vu. Novartis was one of 39 drug companies that sued South Africa in 1997 to block legislation aimed at improving that country's access to essential medicines.

At the time, the companies trotted out the same arguments, predicting the sky would fall - on them and us - if South Africa were allowed to shop around for the lowest-priced medicines.

Since that unsuccessful court case, though, Novartis has posted billions of dollars in profits, including $6.1 billion in 2005 alone.

I am grateful everyday that a treatment was found to prolong my life. But one can't be as cheerful about this as one would like, knowing that AIDS kills more people each year - nearly three million - than the number of people in my home state of Maine.

Or when one thinks of the people in Malawi and around the world who would be most affected if Novartis gets its way today in India. Quite simply, the company should drop its case.