India rejects Novartis' drug patent claim

Aug 7 2007

AIDS Healthcare Foundation (AHF), which operates free AIDS treatment clinics in India (Mysore, New Delhi and in Guwahati, Assam in collaboration with the National AIDS Control Organization) has applauded the news that an Indian court rejected a legal challenge mounted by the Swiss pharmaceutical company Novartis to a portion of India's Patent Act that restricts certain kinds of patents, a ruling that will protect access to affordable medicines in the developing world.

AHF officials noted that Novartis' action in first bringing the legal challenge against the government of India underscores just how out of touch the pharmaceutical industry is today with public health needs in resource-poor countries around the globe.

According to a news story in today's Kaiser Family Foundation's 'Daily HIV/AIDS Report', "India's patent law, which went into effect in January 2005, allows patents for products that are new inventions developed after 1995, when India joined the World Trade Organization, or for an updated drug that exhibits improved efficacy."

"Preservation of Indian patent law will go a long way in helping to ensure that access to affordable medicines in India is protected," said Chinkholal Thangsing, M.D., Asia Pacific Bureau Chief for AIDS Healthcare Foundation, who is based in New Delhi. "With so many people living with HIV/AIDS today, we must do everything possible to make sure that lifesaving medicines are available and affordable to those in need in India and around the world."

"The filing of this case by Novartis back in May 2006 underscores just how out of touch the entire pharmaceutical industry remains with the public health needs of the developing world," said Timothy Boyd, Policy Research Coordinator for AIDS Healthcare Foundation. "Presented with an opportunity to support the global effort of civil society and create real change in the response to diseases such as HIV/AIDS, the industry instead chooses to fight the world for the sake of small gains in profit. With a straight face, companies like Novartis and Abbott have spent millions fighting the world's poor while simultaneously telling developing countries that they must pay higher prices for medicines in order to offset research and development costs. In fact, through legal challenges like this, the industry continues to seek to exploit the developing world to compensate for an industry-wide lack of new drug innovation."

Novartis' legal action that was rejected today challenged Section 3(d) of India's Patent law. Section 3(d) is a clause in India's patent law that states that modifications or new uses for existing substances are not grounds for a patent unless they significantly increase its effectiveness. Novartis' attempt to have section 3(d) of the Indian patent law removed would have allowed pharmaceutical companies to "evergreen" patents, extending the length of patents beyond the 20 years provided by the World Trade Organization's Trade- related Aspects of Intellectual Property Rights (TRIPS). Essentially, the Chennai court's rejection of Novartis' challenge to Section 3(d) of India's Patent Law protects generic manufacturing in India as well as the ability of Indian companies to export medicines.

Contrary to claims by many drug companies, increased intellectual property protections around the world have not fostered more innovation for better treatment. A 2006 United States Government Accountability Office (GAO) report found that despite increased spending on research and development over the past decade the number of new drug applications (NDAs) had not significantly increased. According to the report, "Although the pharmaceutical industry reported substantial increases in annual research and development costs, the number of NDAs submitted to, and approved by, the FDA has not been commensurate with these investments." Further, the report cited over two- thirds of new drug applications being for modifications to existing drugs. This process of making slight changes to drugs is often used to prolong the life of patents in order to sustain monopolies. With revenue exceeding $1 billion annually for many drugs, the report says, most pharmaceutical companies have been more inclined to pour funds back into "blockbuster" drugs that can yield further profit rather than more innovative treatments including those for diseases affecting the world's poorest populations like HIV/AIDS, Malaria and TB.

AIDS Healthcare Foundation (AHF) is the US' largest and oldest and non- profit HIV/AIDS healthcare, research, prevention and education provider, currently provides medical care, including lifesaving treatment and services to more than 50,000 individuals in 15 countries worldwide in the US, Africa, Latin America/Caribbean and Asia. For more information, visit