TWN Info Service on Health Issues (February 07/03)

7 February 2007

Groups urge Novartis to drop patent case against India

Almost a quarter of a million people from more than 150 countries, global health organisations and The Lancet have all asked Novartis to drop the case against India’s patent law. This was in response to an international petition launched by Medicins Sans Frontieres to put pressure on the drug company to drop its legal action against India.

The article below has the story which is reproduced with the permission of South-North Development Monitor (SUNS) #6180, 31 January 2007.

With best wishes
Evelyne Hong

Health: Groups urge Novartis to drop patent case against India

By Kanaga Raja, Geneva, 30 January 2007

Nearly a quarter of a million persons from more than 150 countries have voiced concerns over the negative impact that a legal challenge brought by the multinational pharmaceutical company Novartis against India's patent law could have on access to medicines in developing countries.

The legal challenge brought by the Swiss-based Novartis against the government of India began to be heard in the Chennai High Court on Monday - despite an international petition launched by the international medical humanitarian organization Medicins Sans Frontieres (MSF) last December to put pressure on the company to drop its patent case against India.

According to MSF, nearly a quarter of a million people from 150 countries had signed its petition.

Novartis is seeking to overturn India's refusal to grant a patent on the cancer drug that the company markets as Gleevec/Glivec, and is also challenging the provision in the Indian Patents Act of 2005 which formed the basis for rejecting the Novartis patent.

On Monday, the Indian Network for People with HIV/AIDS (INP+), the People's Health Movement, the Centre for Trade and Development (Centad), and MSF, again called on Novartis to immediately cease its legal action in India.

According to the groups, many developing countries rely on affordable medicines produced in India, and such medicines constitute over half the AIDS drugs used in the developing world. India has been able to produce affordable versions of medicines patented elsewhere because until 2005, the country did not grant pharmaceutical patents.

"Novartis is trying to shut down the pharmacy of the developing world," said Dr. Unni Karunakara, Medical Director of MSF's Campaign for Access to Essential Medicines, in New Delhi.

"Indian drugs account for at least a quarter of all medicines we buy, and form the backbone of our AIDS programmes, in which 80,000 people in over 30 countries receive treatment. Over 80% of the medicines we use to treat AIDS come from India. We cannot stand by and let Novartis turn off the tap," added Dr. Karunakara.

Novartis is challenging a specific provision in India's patent law that restricts patenting of medicines to innovations only. If the provision were overturned, patents would be granted far more widely in India, heavily restricting the production of affordable medicines that has become crucial to the treatment of diseases across the developing world, the groups argued.

"Here in India, the People's Health Movement fought hard to make sure our government implemented a law that put people's health before patents and profits," said Dr. Amit Sengupta. "But now, Novartis is trying to force a change in our patent law, which could deprive people suffering from life-threatening diseases and conditions."

The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) obliged India to begin reviewing pharmaceutical patents in 2005. The TRIPS agreement, however, includes pro-public health safeguards that countries can implement, and India has included some of these in its patent law. The Doha Declaration on TRIPS and Public Health, signed by governments in 2001, reinforced the right of countries to use these safeguards.

"The TRIPS Agreement already makes it difficult for India to produce the affordable drugs that people need," said Gopakumar of Centad. "By challenging the pro-public health safeguards in the Indian law, Novartis is going even further and is trying to undo the Doha Declaration, restricting access to medicines."

According to the groups, one provision of the Indian law states that any interested party can oppose a patent before it is granted in a "pre-grant opposition" process. Such oppositions have been filed against numerous patent applications on essential medicines that do not warrant patents under Indian law.

"We have opposed patent applications for crucial AIDS drugs that we need to be able to access at affordable prices," said Elango Ramchandar, President of INP+. "Our survival depends greatly on winning these patent oppositions. We need everyone, everywhere to join us in our effort to get Novartis to back off here in India."

A joint NGO statement on Novartis' challenge to the Indian Patents Act said that the stakes of the case reach far beyond India, and are global. Today, Indian generic manufacturers supply over 50% of all antiretroviral drugs given to patients in the developing world. But if Novartis wins and succeeds in getting the provision of the Indian law changed to resemble patent laws in wealthy countries, patents may be granted in India far more broadly.

Over 6,000 drug patents including for AIDS drugs are awaiting examination by the Indian patent offices. Whether patents on these medicines are granted may depend on the outcome of this case. If Novartis prevails, India will cease to be the pharmacy of the developing world, and access to medicines will be further threatened, the NGOs warned.

The statement, released on Monday, urged Novartis to immediately cease its legal action in India.

The NGOs that signed the statement included MSF, Oxfam, Knowledge Ecology International, Health Action International, Third World Network, Delhi Network of Positive People, India, Centre for Trade and Development, India, Instituto Brasileiro de Defesa do Consumidor, Brazil, Associacao Brasileira Interdisciplinar de Aids, Brazil, Grupo de Trabalho da REPRIB sobre Propriedade Intelectual (GTPI), Brazil, and Berne Declaration, Switzerland.

IPS adds from Brooklin, Canada: India did not allow the patenting of pharmaceuticals until 2005, when it was forced to as a condition of its entry into the World Trade Organisation (WTO), said Ellen't Hoen, director of policy advocacy for MSF.

However, the WTO's 2001 Doha Declaration allows developing countries to manufacture generic drugs and override patents in times of public health crises and to export these to others that don't have the ability to make them.

"Big pharmaceutical corporations have been pushing to ignore Doha and obtain higher levels of IP (intellectual property) protection through free trade agreements and lawsuits," Hoen said in an interview.

India's 2005 patent law only allows drug patents on completely new compounds invented after 1995. When Novartis filed for a patent on its leukaemia drug Glivec (Gleevec in some countries), the Indian patent office ruled that the drug was simply a new form of an existing treatment that was developed before 1995. This was India's first-ever drug patent rejection.

Novartis acknowledges that Glivec is an improved version of an older drug. And despite the fact that the company gives the drug away free to anyone in India who can't afford to buy it, it wants the courts to overturn the patent decision and is challenging Section 3d of the Indian Patent Act of 2005.

"The Indian Patent office is creating hurdles to pharmaceutical innovation," says Brandi Robinson, a Novartis spokesperson in New York.

Since the company gives away the drug to "99% of the people who need it", the court case is about patent rights and not access to life-saving drugs, Robinson said in an interview.

Hundreds of thousands of AIDS patients are living today because of India's generic drugs, said Loon Gangte of the Delhi Network of Positive People, an AIDS activist organisation. "If Novartis wins, it will affect the lives of AIDS patients," Gangte told IPS.

Leading medical journals such as The Lancet, global health organisations and officials in many countries have all asked Novartis to drop the case. MSF launched a petition that now has nearly a quarter of a million people from over 150 countries who expressed their concern about the impact of the Novartis case on access to medicines in developing countries.

"It feels like we're back in South Africa in 2001," said von Schoen-Angerer.

Novartis was one of the 39 companies that took the South African government to court five years ago in an effort to overturn the country's medicines act that was designed to bring drug prices down.

"The current economic model of drug R&D doesn't work for the developing world," said Hoen.

Under this model, high levels of patent protection for at least 20 years and often longer means that companies with proprietary products have monopolies and can charge whatever price they want, guaranteeing money for research and plenty of profits.

"In some cases, this works, boosting R&D investment but in many cases, the money doesn't go into research," Hoen noted.

Pharmaceuticals are a $600 billion a year industry and there are "lots of opportunities to make money", she said.

Free handouts from drug companies aren't the answer either. These benefit a few thousand people, but by no means do all drug companies have such donation programmes and they are often short term or one time only offers, said Hoen.

"We need a new and affordable system for drug research and manufacturing," she concluded.