India is facing the aftermath of a new patent law that bans making cheaper copies of new patented drugs.

What exactly can be patented remains to be determined, and there are unallayed fears of a drug price hike that could seriously damage healthcare and battle against HIV in the developing world.

India’s 1970 patent law recognised only patents on processes, not products. This enabled Indian firms to use alternative methods to produce cheap “generic” copies of drugs that were patented in other countries. Multinational companies that spend billions of dollars in research and development complain these “copycat” drugs cause annual losses of over $500 million.

But after joining the World Trade Organization in 1995, India had to change its patent laws by 1 January 2005 to meet its commitments under the WTO’s agreement on Trade Related Intellectual Property Rights (TRIPS). The new bill, finally passed by the Indian Parliament on 23 March, now recognises both product and process patents.

The government argues this will boost Indian pharmaceutical research, attract foreign collaboration and help the nation emerge as a force in global pharmaceuticals.

There are already “winds of change in India”, notes Raghunath Mashelkar, director general of the Council of Scientific and Industrial Research in India. There has been a 400% increase in private research and development spending on drugs and pharmaceuticals in the four years to 2005.

The number of pharmaceutical patents filed by Indians under the Patent Cooperation Treaty (PCT) – a global system for simplified multiple filing of patent applications – has also increased, from 43 in 1999 to 291 in 2003.

But some private and public sector scientists warn of a scarcity of trained pharmacologists, few successes in identifying new candidate drugs and a lack of high-quality animal testing facilities.

The Indian pharmaceutical industry’s reaction has been mixed. Big Indian firms welcomed the changes, but small and medium companies have criticised the grey areas.

These include ambiguous definitions of what can be patented and a weak framework for opposing grants before they are granted. Mashelkar says an expert committee will now look into the exact criteria for inventiveness and patenting.

More here.