By Tove Iren S. Gerhardsen
As a case challenging India’s patent law proceeds this week, pressure is building from politicians, religious leaders and civil society on Swiss pharmaceutical company Novartis to withdraw the case in the name of public health, sources said.

In January 2006, Novartis was denied a patent in India for a special kind of cancer drug, which the company has patented in nearly 40 countries, including China, a company spokesperson told Intellectual Property Watch recently. As a result, it took the Indian government to court arguing that Indian law is not compliant with international trade law, sources said.

A hearing in the India case began on 15 February, and was scheduled to continue on 16 February, sources said. A participant at the hearing posted a comment to the Knowledge Ecology International Ip-health listserv stating that Novartis laid out the non-compliance argument.

The Novartis spokesperson said India signed up to the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1995, and implemented it with its 2005 Patent Act. He also argued that without intellectual property, one will not get investments for new medicines, adding that the pharmaceutical industry in general supports Novartis’s action.

But in the run-up to this, the pressure on Novartis was building, with church leaders such as South Africa Archbishop Desmond Tutu expressing their concerns, according to a press release from the Ecumenical Advocacy Alliance.

In the United States Congress, Representative Henry Waxman, Democrat from California, sent a letter to the Novartis CEO Daniel Vasella, according to Oxfam America. Waxman wrote: “I do not dispute your right to apply for a patent or appeal a denial. I am concerned, however, that your attempt to influence domestic Indian law could have a severe impact on worldwide access to medicines.” He ends the 13 February letter by urging Vasella, “to reconsider your position in this case.”

In Europe, five Members of the European Parliament (MEPs) representing four parties have issued a “declaration” asking Novartis to drop the case and the European Commission and Council to take a position on it, a Médicins Sans Frontières (MSF) spokesperson told Intellectual Property Watch. The declaration (which is only available in French) will be open to signatures among MEPs next week and could become a resolution if the majority of MEPs sign it, the spokesperson said.

The MEPs are: Caroline Lucas (UK-Green Party), Kader Arif (France-Party of European Socialists, PSE), Pierre Schapira (France-PSE), Luisa Morgantini (Italy-European United Left, GUE) and Johan Van Hecke (Belgium-Alliance of Liberals and Democrats, ALDE).

In addition, another set of MEPs sent a letter Vasella, dated 9 February, expressing their “grave concerns” and asking him to withdraw the case. “We acknowledge the importance of patent rights,” they said. “However, they must not go against the interest of millions of people who desperately need access to cheaper drugs.”

These MEPs also wrote to the president of the European Parliament, Hans-Gert Pöttering, as well as the heads of the parliamentary committees for international trade (INTA), environment, public health and food safety (ENVI), and development (DEVE), requesting that they discuss the case, the spokesperson said. The MEPs involved are: Lucas, Anne Ferreira (France, PSE), Dorette Corbey (the Netherlands, Social Democratic Party, PvdA), Max van den Berg (the Netherlands, PvdA) and Carl Schlyter (Sweden, Green Party).

An assistant to Lucas told Intellectual Property Watch that INTA has agreed to organise a hearing on this, but as of yet, no date has been set.

At a meeting of INTA on 26 January, following the hearing, European Trade Commissioner Peter Mandelson was asked about the EU’s position on the Novartis case, a source said. Mandelson replied that the EU is following the issue very closely and will take a position when it will be necessary, the source said. This was confirmed by Mandelson’s spokesperson.

In the letters, these MEPs refer to the EU resolution on “The EU-India relations: A strategic partnership” (2004/2169), which was adopted on 29 September 2005. “Through this resolution the EP stressed the crucial role of India concerning access to medicines for all and the need to ensure that India will implement its IP law in a manner that avoid[sic] barriers to the production, marketing and export of essential medicines for the developing world,” they wrote.

“If Novartis wins its case, a lot of patients in developing countries, in particular those suffering from HIV/AIDS, who mainly rely on affordable drugs from India, would not have access anymore to drugs,” the letter says, stating that it is “completely unacceptable” that commercial interests of a company should “come before the general interests and the right of states to protect and promote public health and access to medicines.”

The Novartis spokesperson told Intellectual Property Watch that this is not a case about access to medicines as the cancer drug, Glivec, or Gleevec (imatinib mesylate), is used in 1-2 people per 100,000, but the case is about intellectual property, and about gaining “clarity about intellectual property rights in India.”

Many nongovernmental organisations (NGO) disagree, and MSF, leader of the campaign, is one of them. It is pressuring Novartis to drop the case and through a campaign it has collected some 290,000 signatures. “Over 89 percent of the medicines we use to treat AIDS come from India. We cannot stand by and let Novartis turn off the tap,” MSF said.

On 23 January, MSF and Oxfam took part in a public hearing on “patients before patents” and the “Novartis case against the Indian law on patents,” organised by MEPs. Representatives from NGOs as well as Novartis attended, they said.

Separately, German Minister of Economic Cooperation and Development, Heidemarie Wieczorek-Zeul, has also asked Novartis to drop the case, according to the German Frankfurter Rundschau newspaper on 19 January 2007. She said Novartis should do this to save lives, according to the article.

Novartis’ View

A hearing in the case was scheduled for 26 January but was very brief and the next court date was 15 February, the Novartis spokesperson said. The status of a report of an expert commission, called the Mashelkar Commission, which states that the position of the government is not compliant with TRIPS was discussed at the hearing, the spokesperson said. A number of NGOs have taken issue with this report.

“The Mashelkar Report reaches conclusions that are neither justified nor accurate,” asserted Achal Prabhala, an IP researcher from Bangalore, India. “Its twisted logic is apparently in ‘national interest’,” he said.

The Novartis spokesperson emphasised on 15 February that the case is not about access to medicines but rather the discussions among all stakeholders should focus on understanding the importance of intellectual property rights.

The company spokesperson said that the Indian middle class of some 50 million people is growing (seven times the population of Switzerland) and these people can afford patented goods, but there are also people of extreme poverty in India. He maintained, however, that generics is not the solution as their average price for a one-year supply can be four to five times the earnings of some.

Further details about the case here (IPW, Public Health, 19 October 2006).

Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.