NGO Statement on Patent Ruling

Joint Statement by CPAA, MSF, DNP+ and Lawyers Collective on Novartis Judgment the Cancer Patients Aid Association (CPAA), the Lawyers Collective HIV/AIDS Unit, the Delhi Network for Positive People (DNP+) and Médecins Sans Frontières.

Contacts:
 
Lawyers Collective: Anand Grover:  +91.9820184788; Chan Park: + 91.9899452377

DNP+: Loon Gangte +91.9871029514       

CPAA: Mr YK Sapru + 91.9821061571
 
MSF: Leena Menghaney:  +91.9811365412; Anjolie Singh: + 91.9871875574
    
Mumbai/New Delhi, 7 August 2007 – The landmark decision by the Madras High Court upholding India’s Patents Act in the face of the challenge by Swiss pharmaceutical company Novartis is a major victory for patients’ access to affordable medicines in developing countries, stated the Cancer Patients Aid Association (CPAA), the Lawyers Collective HIV/AIDS Unit, the Delhi Network for Positive People (DNP+) and international medical humanitarian organisation Médecins Sans Frontières (MSF).

Novartis took the Indian government and cancer patients to court over critical public health safeguards included in the 2005 amendments to India’s Patent law. Novartis claimed that India’s Patents Act did not comply with the TRIPS Agreement and was in violation of the Indian Constitution. All of Novartis’ claims were rejected by the High Court.

“We fought for patients' rights in this litigation, and we are greatly relieved that the Court has ruled in our favour, and recognised that patients need protecting more than patents,” said Y. K. Sapru, founder and Chairman of the CPAA. “The issue is not merely of providing affordable drugs to patients in India, but also to patients in other countries, as India is the source of generic drugs to over hundred countries. This landmark victory will help avoid many deaths from life-threatening diseases in India and other countries.”

In 2005 India amended its patent law to comply with WTO rules, but 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 extend their monopolies on existing drugs, would be unsuccessful in India. The particular amendment in question – Section 3(d) ­– was enacted to this end and it was this aspect of the law that Novartis was seeking to have removed. A ruling in favour of the company would have drastically restricted the production of affordable medicines in India that are crucial for the treatment of diseases throughout the developing world.

“Novartis went to the Madras High Court claiming that India's Patents Act did not meet rules set down by the World Trade Organization and was in violation of the equality provision of the Indian constitution,” said Anand Grover, Director of the Lawyers Collective HIV/AIDS Unit, who argued the case for the CPAA.  “The Madras High Court ruled that it had no jurisdiction to examine if there was any violation of the WTO rules and it was for the WTO dispute settlement mechanism to determine this. The Court also upheld the constitutional validity of section 3(d). The Court clearly recognized that Section 3(d) was enacted by the Indian Parliament to provide easy access to life saving drugs and to meet its constitutional obligation to provide good healthcare to its citizens,” he added.

Developing countries and international agencies like UNICEF and the Clinton Foundation rely heavily on importing affordable drugs from India, and 84% of the antiretrovirals that MSF prescribes to its patients worldwide come from Indian generic companies. The judgment means that India will continue to be the ‘pharmacy of the developing world.’

“This decision means that safe, effective and affordable generic medicines will continue to be produced in India. The majority of drug patent applications before the Indian patent office are for new forms or new uses of already known drugs. Section 3(d) will ensure that frivolous patents will not be granted at the cost of public health,” added Chan Park of the Lawyers Collective HIV/AIDS Unit.

“This is really exciting news for activists in India and across the world who rallied together to support India’s public health safeguards. The decision gives me and many others fresh hope for life,” said Loon Gangte of DNP+. “Many of us need newer HIV drugs which are still far too expensive. I now expect generic competition to change that and bring prices down. The case has also shown us that the Government is clearly taking patients lives seriously by its defense of the public health safeguards in the Indian Patents Act.”

“The judgment means patients around the developing world can continue to look to India for life saving medication,” said Leena Menghaney, MSF Campaign for Access to Essential Medicines. “The statement by Novartis that the Court’s ruling will hinder innovation is false. Despite the fact that patent protection has increased world-wide in the last two decades, pharmaceutical innovation has actually declined. We encourage Novartis to contribute to international discussions on alternative incentive systems for health needs driven R&D that ensure both the availability and the affordability of new drugs and vaccines.”

Nearly half a million people worldwide voiced their concern about the impact Novartis’s case could have on access to medicines in the developing world.  Among them 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.  An MSF petition urging Novartis to drop the case gathered over 420,000 signatures.