Drug patent struggles in Asia

TAKING STEPS that are emblematic of patent struggles in the future, Thailand's military government will revoke the patents on Plavix, a Sanofi-Aventis anti-blood-clotting pill, and on Kaletra, an HIV treatment supplied by Abbott Laboratories. Separately, Novartis has filed a court appeal in Chennai, India, to obtain patent protection for its leukemia drug Gleevec.

"If Novartis gets its way and India's patent laws are tightened, then it will affect the availability of [generic] AIDS drugs," says Yusuf K. Hamied, the chairman and managing director of the Indian drug manufacturer Cipla.

In fact, the India case has given rise to protests from AIDS patients and sympathizers worldwide. They fear that it could set a precedent that will eventually force Indian generic producers to stop supplying AIDS drugs to poor patients in developing countries.

"Indian drugs account for at least a quarter of all medicines we buy and form the backbone of our AIDS programs, in which 80,000 people in over 30 countries receive treatment," a statement from the nongovernmental organization Doctors Without Borders said. "We cannot stand by and let Novartis turn off the tap." The group says that it obtains 80% of its AIDS medications from India.

Novartis counters that its main aim is to clarify India's new patent rules, in effect since 2005. The firm says that the majority of Gleevec users in India get the drug at no cost under a Novartis program to assist the poor. It insists, however, that it does intend to impede Indian producers' right to supply other countries that have suspended patent rules in the face of health emergencies. The firm further contends that lax patent protection will, over time, reduce patients' access to pharmaceuticals.

India's Office of the Controller General of Patents, Designs & Trade Marks ruled one year ago that the active ingredient in Gleevec was invented in 1993 and that it therefore could not get patent protection. The regulator said that Novartis had filed patent protection for its crystal modification of the free base of the drug in 1998. India's new patent laws protect new chemical entities but not their modifications (C&EN, Jan. 29, page 29).

In Thailand, meanwhile, the health ministry says it will resort to compulsory licensing for both Plavix and Kalestra as it is allowed to do under the rules of the World Trade Organization. Minister Mongkol Na Songkla told journalists that "we don't have enough money to buy safe and necessary drugs for the people," the Financial Times reports.

The International Federation of Pharmaceutical Manufacturers & Associations says Thailand's decision, the first case of compulsory licensing by a developing country, is counterproductive. "When a country is grappling with severely limited resources in health care, the long-term interest of patients will be best served by the government initiating direct discussions with the companies that invent, develop, and market innovative medicines," it said in a statement.

Thailand's health ministry estimates that it cares for 20,000 patients who require Plavix, the Financial Times reports. Doctors Without Borders estimates that about 1.5% of Thailand's population, about 1 million people, has AIDS.