The Chennai High Court has adjourned the hearing on Novartis legal challenge against the orders of the Patent Controller invalidating the patent claim on Novartis' blockbuster anti-cancer drug Glivec (Imatinib Mesvlate) to 15th February 2007.
The case came up for hearing at the Chennai High Court today, and the court deferred the case for next hearing.
The Novartis petition questions the constitutional validity of Section 3(d) of the Patents Act 1970 and pleads that any decision considered under Section 3 (d) should be considered legally non-tenable. The Glivec was the only drug that had received exclusive marketing rights (EMR) during the mailbox period. Further examination of the patent application showed that the patent specification of Novartis AG does not bring out any improvement in the efficacy of the beta-crystal form over the known substances.
As per Section 3(d) of the patents act, any salt, polymorph or derivative of known substance is not patentable unless such salt, polymorph or other substance shows enhanced efficacy of the substance. Giving its ruling in January 2006, patent office had stated that Glivec is only a new form of a known substance. Further, stating that Novartis AG failed to prove enhanced efficacy of the beta-isomer over the known substance, the patent office had concluded that, the subject matter of this (patent) application (filed by Novartis AG) is not patentable under Section 3(d) of the Patents Act 1970 as amended by the Patents (Amendment) Act, 2005.
Meanwhile, the NGO groups, which are opposing the Novartis initiative, have stepped up pressure on the company to withdraw the case. They said, nearly a quarter of a million people from over 150 countries have expressed their concern about the negative impact the company's actions could have on access to medicines in developing countries. The Indian Network for People with HIV/AIDS (INP+), the People's Health Movement, the Centre for Trade and Development (Centad), together with the international medical humanitarian organisation Médecins Sans Frontières (MSF) called upon the company again today to immediately cease its legal action in India, NGO sources informed.
They noted that 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. "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 per cent of the medicines we use to treat AIDS come from India. We cannot stand by and let Novartis turn off the tap," he added.
MSF notes that Novartis is challenging a specific provision in India's patent law that restricts patenting of medicines to innovations only. If the provisions 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.
"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," he said.
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, and India has merely 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."
NGOs like Médecins Sans Frontières (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, Associação Brasileira Interdisciplinar de Aids, Brazil, Grupo de Trabalho da REPRIB sobre Propriedade Intelectual (GTPI), Brazil, Berne Declaration, Switzerland, etc. are in the process of pressurizing the company to withdraw the case. They claim 91 organisations and personalities from around the world, in an open letter in October 2006 to Daniel Vasella, Chairman and CEO of Novartis, had called upon Novartis to drop the case.