The Madras High Court has rejected a challenge by Swiss pharmaceutical giant Novartis of a provision in the Indian Patents Act that denies patents for minor innovations in known drugs, thereby allowing cheaper generic drugs to be available

On August 6, 2007, the Madras High Court rejected the challenge by Swiss pharmaceutical company Novartis of a provision in the Indian Patents Act that denies patents for minor changes in known drugs. The case has been eagerly followed by both pharma companies and health activists because of the implications it could have for patent laws and for affordable drugs.

Novartis had earlier challenged the rejection of a patent for the anti-cancer drug Glivec (Imatinib mesylate). India had refused the patent under its patents law, which Novartis claims goes against the provisions of Trade-Related Aspects of Intellectual Property Rights (TRIPS). The Indian government rejected the application saying it was insufficiently innovative, a stand it could take under Section 3 (d) of the Indian Patents Act.

Novartis then questioned this provision in the Patents Act itself under international intellectual property rules. The court dismissed the petition saying that it had no jurisdiction on whether Indian patent laws complied with intellectual property rules set by the World Trade Organisation.

Novartis filed its patent application for Glivec back in 1998, in the Chennai Patents Office. Based on the application and a particular provision of the Indian Patents Act, Novartis, at the end of 2003, obtained exclusive marketing rights until the patent was granted.

On the basis of the exclusive marketing rights granted to it in 2003, Novartis filed infringement suits in the Bombay High Court and got injunctions restraining all but one of six generic companies from producing cheaper versions of the product.

In a press statement, Novartis said that the drug in question had been approved by patent offices in 40 countries. And, that generics would not help the poor access the drug. "Based on data from the World Bank, the cost of one year of treatment with generic Imatinib alone is four to five times a person's annual average income," a company spokesperson said.

Novartis argued that there were additional requirements for patentability beyond novelty, commercial applicability and non-obviousness.

In May 2006, Novartis went to the Madras High Court, challenging the order of the Chennai Patent Controller as also the validity of Section 3 (d) of the Indian Patents Act. It argued that this section was not compliant with the TRIPS Agreement.

Section 3 (d) prevents companies from obtaining patents for medicines that are not actual inventions, such as drug combinations, derivatives, new forms or use, or slightly improved formulations of existing medicines.

Health NGOs and activists have been critical of Novartis' questioning of India's patent law, which allows the country to make affordable drugs, particularly anti-retrovirals. A global campaign by civil society saw nearly half-a-million people around the world campaigning against Novartis to drop its case.

Medicins sans Frontieres (MSF) said, at the time, that if Novartis was successful it could affect access to medicines -- including AIDS drugs -- for millions across the world. "We rely on less-expensive, good-quality medicines produced in India to treat as many people with AIDS as possible," said MSF International Council president Dr Christophe Fournier in a statement. "This key source of medicines cannot be allowed to dry up."

Oxfam too pointed out that India is the largest manufacturer and exporter of generic medicines to the developing world.

"The legal action by Novartis challenges steps that the Indian government and Parliament have taken to safeguard people's health," Leena Menghaney, an officer with MSF India, said.

Reacting to the recent ruling Celine Charveriat, head of Oxfam's Make Trade Fair campaign, said: "This (the judgment) is a vindication for India and a victory for campaigners. Developing countries should not be bullied by pharmaceutical companies and forced into having to defend themselves in court for correctly using the safeguards available to them to protect public health."

"This is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India," said the director of MSF.

Novartis prices Glivec at Rs 120,000 (US$ 2,719) per dose, while Indian companies sell it at Rs 8,000 (US$ 181).

Novartis India's managing director said that the court decision would have "long-term negative consequences for research and development and better medicines for patients in India and abroad". However, he said, the company was unlikely to appeal the decision in India's Supreme Court.

Source: www.centad.org, August 7, 2007