September 18, 2013

Indian Patent Ruling an Important Victory for Access to Medicines

India 2012 © Claudio Tommasini/MSF

A 2012 demonstration; the effort will have to continue.

India is often called the “pharmacy of the developing world” because companies based there produce affordable generic versions of medicines that are used in developing countries across the globe. More than 80 percent of the antiretroviral medicines (ARVs) used by MSF in its HIV/AIDS programs, for example, come from India, as do 80 percent of the ARVs purchased with donor funds globally. MSF and other treatment providers also rely on quality Indian generics for malaria and tuberculosis treatments.

The generics industry emerged in India because the country did not grant patents on medicines until 2005, which meant generic manufacturers were free to make and market cheaper versions of medicines patented elsewhere. Fierce competition among producers drove prices down dramatically, making once prohibitively expensive treatment regimens affordable. In 2000, for instance, ARVs cost $10,000 per person per year; today, they cost about 1 percent of that figure.

PUSH BACK

The picture got more complex in 2005, however, when India agreed to start granting patents for medicines as a condition of its membership in the World Trade Organization—although the country reserved the right to grant them only to true medical innovations, not merely slightly modified or refashioned formulations of existing drugs. This part of India’s patent law—Section 3(d)—was designed to prevent companies from abusing the patent system and repeatedly finding new ways to extend their patent-protected monopolies on specific medications, a common industry practice called “evergreening.”

In 2006, India rejected a patent sought by Swiss pharmaceutical company Novartis for the leukemia drug imatinib mesylate (marketed as Gleevec), on the basis that this new formulation did not sufficiently differ from a similar compound that already existed and had similar therapeutic effects. In response, Novartis challenged not only the rejection of its patent, but also the entire validity of Section 3(d).

On April 1, 2013, after seven years of legal wrangling, the Indian Supreme Court rejected Novartis’s claims and upheld India’s Patents Act. It was a landmark victory that resonated far beyond India and one particular medicine. “This is a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India, and for treatment providers like MSF,” said Dr. Unni Karunakara, MSF’s international president.

THE ROAD AHEAD

The fight is far from over, however. A group of pharmaceutical companies are mounting a campaign in the US to upend India’s patent regulations, lobbying members of Congress to lean on the country to increase patent protection (even though the US’s own PEPFAR program supporting HIV care around the world overwhelmingly relies on affordable generic medicines, which account for 98 percent of its purchases). It is a well-financed and well-connected campaign that NGOs and other advocates for access to medicines will be hard pressed to match.

“High medicine prices are an issue of life and death for millions of people,” said Rohit Malpani, the director of policy and advocacy at MSF’s Access Campaign, when he testified in front of Congress during hearings on India’s patent laws. India’s April court decision was rightly celebrated, but we all must remain vigilant against further challenges to affordable medicines. And be it in Washington, DC, or New Delhi, or anywhere else, MSF and others have to make sure that no one involved in this debate—not the lobbyists, not the politicians, not the shareholders, and not the practitioners—forgets that patients, actual human beings, in places from Bolivia to Bangladesh, Tanzania to Tajikistan, and Pakistan to Papua New Guinea, are depending on the outcome.
 

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