/ 5 April 2013

Impoverished patients benefit from rejected drug patent

After a seven-year battle, India's government has successfully defended its right to reject drug patents if a medicine doesn't deserve one.

On Monday, India's Supreme Court upheld decisions by lower courts to reject a patent on Gleevec, or Glivec, a cancer medicine produced by the Swiss drug company Novartis. The court claims that Gleevec is simply a new version of an old medicine, and one that does not provide significantly enhanced therapeutic benefit. It is therefore not considered "innovative," as defined by Section 3(d) of the country's patent law, and not deserving of a monopoly-protecting patent.

The ruling was seen as a victory for access to medicines campaigners and poor patients across the developing world. India is called the "pharmacy of the developing world" because it supplies the majority of the generic medicines used in poorer countries. Eighty percent of Africa's HIV patients are treated with Indian-made generic antiretroviral drugs, and Indian manufacturing of the drugs helped to lead to a significant price drop, from nearly R10 000 per person per year over a decade ago, to under R1 200 per person per year today.

At the end of 2012, eight million people were receiving treatment worldwide, including nearly two million South Africans. "This case is extremely important for people living in low- and middle-income countries outside India," said Jennifer Cohn, medical coordinator of the Geneva-based Médecins Sans Frontières (MSF) Access Campaign. "The Supreme Court's decision to uphold the section 3(d) of the Indian patent law helps to maintain access for generics for millions."

Advocates say the case provides a positive precedent for other developing countries. Julia Hill, who is based in Johannesburg with MSF's Access Campaign, said that South Africa should consider implementing similar provisions in its own law. The government is currently conducting a review of its intellectual property legislation. "As South Africa's new patent law is drafted, including provisions similar to India's Section 3(d), and implementing a patent examination system will better ensure small changes to existing medicines do not warrant new patents that keep them out of reach of those in need," said Hill.

South Africa currently allows for multiple patents on a single drug, and does not review patent applications before they are granted. Gleevec is patent protected in South Africa, and sells for R876 a pill here. Generic versions from India are available for just R86.

Like India, other developing countries have also incorporated pro-public health provisions into their patent laws. Since 2011, the Chinese government has announced a series of price-cutting reforms for key drugs. Last year, Indonesia announced that it would issue compulsory licenses for seven HIV and hepatitis B drugs, allowing generic versions of patented medicines to be procured. Earlier this year, India's Intellectual Property Appellate Board upheld a government decision to grant a compulsory license to the Indian company Natco. The company can now produce generic versions of the cancer drug Nexavar, patented by Bayer, a Germany pharmaceutical company. Despite the fact that South African law allows for compulsory licenses, the government has never issued such a license for a medicine. 

Meanwhile, big-name pharmaceutical companies, and the countries' that house them, are seeking to protect their hold on the industry worldwide. With pharmaceutical profits decreasing in the Northern Hemisphere, companies are increasingly looking to the global South to expand profits: it's expected that over the next five years, one-third of the industry's total sales will be in emerging markets.

According to Brook Baker, a professor of Human Rights and the Global Economy at Northeastern University School of Law in Boston, developed countries are pushing developing countries to adopt stricter patent provisions through international trade agreements. "India's strict standards of patentability are under attack in both EU and US free trade agreements," he said. South Africa, as part of the Southern African Customs Union, is currently in negotiations with the European Union on an economic partnership agreement, but pharmaceutical-related intellectual property does not seem to be on the cards.

In a reaction to the Supreme Court decision, Novartis threatened to pull out entirely from India, and said that the court's decision will stymie innovation in the country. An article published earlier this week in the Swiss newspaper Tages Anzeiger suggested that then country could take India to the World Trade Organization's Dispute Settlement Body, given that Novartis is a Swiss company. Escalating trade disputes that are not solved bilaterally can be taken to the WTO.

If the body were to find fault with the Indian court's ruling, India could be obligated to change at least part of its patent laws. An analyst following the case said that Switzerland would be unlikely to challenge India on its own, and would likely look to the likes of the US and EU for help – countries that are home to many pharmaceutical companies. But bringing the case to the WTO may not be in Switzerland's best interests, as it is part of a block of countries attempting to sign a Free Trade Agreement with India. Bringing the dispute to the Settlement Body could hinder these negotiations.

Mara Kardas-Nelson is a journalist at the M&G Health Journalism Centre. Her stories are produced with the support of the Open Society Foundation but are editorially independent of any sponsorship.