Photographer : Huang Zhu
In May 2006 Swiss pharmaceutical company Novartis took the Indian government to court over its 2005 Patents Act because it wanted a more extensive granting of patent protection for its products than was offered by Indian law. Novartis claimed that India's Patents Act did not meet rules set down by the World Trade Organization and was in violation of the Indian constitution. In a landmark High Court decision in August 2007, all of Novartis’ claims were rejected.
Why was Novartis suing the Indian Government?
Novartis applied for a patent in India for the cancer drug imatinib mesylate, which the company markets under the brand name Gleevec/Glivec in many countries. In January 2006 the patent was rejected on the grounds that the drug was a new form of an old drug, and therefore was not patentable under Indian law. Novartis sought to have the patent decision overturned so that it could sell Gleevec at the same price in India as in other countries. In other countries where Novartis has obtained a patent, Gleevec is sold at $2,600 per patient per month. In India, generic versions of Gleevec are available for less than $200 per patient per month.
Novartis was challenging a provision in India's Patents Act that restricts patenting of medicines to innovations. This provision made it more difficult for companies to obtain patents on changes to combinations of drugs or slightly improved formulations of existing drugs. Novartis claimed that this provision was not compliant with WTO rules and with the Indian constitution.
Does India have a right to have this particular patent law? Rules of 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. The Doha Declaration on TRIPS and Public Health, signed by governments in 2001, reinforced the right of countries to use these safeguards.
India began giving patents on medicines to comply with these WTO rules; however it designed its law with safeguards so that patents can only be granted for real innovations. This means that companies seeking a patent for modifications to a molecule already invented, in order to further extend their monopolies on existing drugs, would be unsuccessful in India.
Why do millions of people rely on India for affordable medicines?
India has been able to produce affordable versions of medicines patented elsewhere because until 2005, the country did not grant pharmaceutical patents. India is one of the few developing countries with production capacity to manufacture quality essential medicines.
By producing cheaper generic versions of drugs that were patented in other countries, India became a key source of affordable essential medicines for developing countries, such as antiretroviral medicines to treat HIV/AIDS.
Drugs produced in India have been used for the country's domestic market and are also imported by many developing countries that rely on India to provide the medicines needed such as to run national AIDS treatment programmes. Over half the medicines currently used for AIDS treatment in developing countries come from India and such medicines are used to treat over 80% of the 80,000 AIDS patients in Médecins Sans Frontières projects today in more than 30 countries.
What was the court ruling? What are the implications of this court decision?
The High Court in Chennai, India, made a landmark decision in Agust 2007 to uphold India's Patents Act and rejected all of Novartis’s claims. In upholding India’s patent laws, the ruling represents a major victory for people's access to affordable medicines in developing countries. The decision makes Indian patents on essential medicines less likely. If Novartis had won the case, drug patents would have likely been granted far more widely in India, restricting generic competition and thus also restricting access to affordable medicines in the developing world.
A constant flow of affordable newer and improved medicines is especially significant for the treatment of AIDS, as patients inevitably become resistant to their medicines and need to be switched to newer "second-line" drug regimens. MSF's project in Khayelitsha, South Africa, illustrates this growing need: 17.4% of people on treatment there for five years have had to switch to a newer drug combination. However, these newer drugs are largely still only available from originator companies holding patents, which keeps prices high thus reducing the availability.
“For people like me, who live with HIV/AIDS, a win by Novartis will mean a step back in time to the days when we could not afford our medicines,” said Loon Gangte of the Delhi Network of Positive People, at a press briefing in New Delhi. “Generic competition is what has made first-line AIDS drugs affordable for people and for governments. Novartis needs to stop standing in the way of our right to access the medicines we need to stay alive.”
What action was taken on this issue?
Mèdecins Sans Frontiéres (MSF), an international medical humanitarian organisation, coordinated a ‘drop the case’ petition requesting Novartis to drop the case because of the devastating impact Novartis's actions could have on access to essential medicines. Over 420,000 people from over 150 countries signed the petition. Among the signatories were the Indian Health Minister Anbumani Ramadoss, Archbishop Desmond Tutu, Global Fund Director Michel Kazatchkine, members from the European Parliament and the US Congress, former Swiss President Ruth Dreifuss, former UN Special Envoy for AIDS in Africa Stephen Lewis, German Development Minister Heidemarie Wieczorek-Zeul, Norwegian Development Minister Erik Solheim, as well as authors John Le Carré and Naomi Klein.
Other NGOs including CARE and Oxfam were involved in advocacy and rasising awareness of the Novartis case and related trade and patent issues.
How do I know this?
MSF Australia 2007, Indian court ruling in Novartis case protects India as the 'Pharmacy of the Developing World', 6 August,
http://www.msf.org.au/stories/twfeature/2007/176-twf.shtml
MSF 2007, After Indian court ruling, MSF hands over petition with 420,000 signatures to Novartis, 8 August
http://www.msf.org/msfinternational/invoke.cfm?objectid=44F15E6E-15C5-F00A-259D389F047DF3EA&component=toolkit.
pressrelease&method=full_html
MSF 2006, Q&A on patents in India and the Novartis case, 20 December,
http://www.msf.org/msfinternational/invoke.cfm?objectid=A05B02CF-5056-AA77-6CA9A174A5C4E2F7&component
=toolkit.article&method=full_html
MSF 2007, Nearly a quarter of a million people urge Novartis to drop its court case in India, 29 January,
http://www.msf.org/msfinternational/invoke.cfm?objectid=6D778807-5056-AA77-6C0E9E5162B557F0&component=toolkit.
pressrelease&method=full_html
MSF 2006, MSF urges Novartis to drop its case against the Indian Government, 20 December,
http://www.msf.org/msfinternational/invoke.cfm?objectid=9FAA7B79-5056-AA77-6CBDF17A968A6DD7&component=toolkit.
pressrelease&method=full_html
MSF 2006,
http://www.msf.org/petition_india/international.html
