Drugs for poor and patent rights at issue in Novartis suit in India

[bluemoon24]

Western drug companies say that if the court upholds Indian patent legislation, it would severely hamper their ability to invest in the research and development of critically needed new medicines.



Novartis, a Swiss pharmaceutical company, appealed Monday in a court in Madras, India, against a decision not to grant it a patent on a modified form of its leukemia drug, Gleevac. The court was asked to clarify new regulations on whether companies can patent new versions of drugs whose patents have expired.



If the company wins the case, Indian companies could be banned from manufacturing generic versions of the drug, which are sold in India and around the world for about a tenth of the $2,600 price for a month's course of treatment charged by Novartis.



Patients' rights organizations say that a ruling in favor of Novartis would eliminate a vital global supply of affordable, generic drugs from India. Aid agencies said this would leave millions of people without access to the cancer treatment. It would also effectively tighten patent legislation passed by India in 2005 to limit the manufacture of generic versions of drugs.



The legislation was introduced to bring India into line with the World Trade Organization's agreement on intellectual property rights.



Unni Karunakara, medical director of Médecins Sans Frontières' Campaign for Access to Essential Medicines, said a ruling in favor of Novartis could obstruct the organization's attempts to provide treatment for AIDS patients globally.



"Novartis is trying to shut down the pharmacy of the developing world," he said at a news conference in New Delhi. "Indian drugs form the backbone of our AIDS programs in which 80,000 people in over 30 counties receive treatment. Over 80 percent of the medicines we use to treat AIDS come from India."



Médecins Sans Frontières and Oxfam have collected nearly 250,000 signatures on a petition asking Novartis to drop the case. Scores of people protested Monday in Delhi against the case.



The 2005 patent law allows patents to be granted on new versions of older, off- patent medicines if the new version can be shown to represent a significant improvement on the original.



Novartis said its new drug could be more easily absorbed by the body. But last year an Indian court rejected the argument that the drug constituted a major development on the earlier version.



The 2005 law states new patents must not be granted to products which represent "incremental innovations."



John Gilardi, a spokesman for Novartis, said by telephone from Switzerland that the company's appeal was in part an attempt to gauge how the law was going to be implemented.



"We are trying to gain clarity as to what guides India's patent laws," he said. The case was about "clarifying intellectual property rights and not about access to medicines," he said, adding that Novartis already gave free supplies of Gleevac to 6,800 patients in India suffering from the rare form of leukemia it was developed to combat. He said that number represented more than 90 percent of all sufferers in the country.



"If there is no patent protection, we will not see billions of dollars being invested in the research of medicines," Gilardi said. "This is not about access to medicines. It is about establishing whether India is going to step up and adopt the minimum international standards required for the protection of intellectual property."



The case was adjourned Monday until Feb. 15.



Thais approve generic drug



Thailand's army-appointed government said Monday it had approved a low-cost, copycat version of a blockbuster heart disease drug — the first time a developing country has torn up the international patent for such a treatment, Reuters reported from Bangkok.



In addition to the decision authorizing generic versions of Plavix, a heart disease drug made by Bristol-Myers Squibb and Sanofi-Aventis, Bangkok approved a generic version of Kaletra, an HIV/AIDS treatment of Abbott Laboratories.



Thai health officials said the move would save the country as much as 800 million baht, or $24 million a year.



Kaynak: SağlıkHaber