A drugs firm asked Indian officials for permission Thursday to make cheaper generic copies of cancer drugs for export to poor countries in a case watched closely by global pharmaceutical giants.
Indian firm Natco Pharmaceuticals made the plea for the country's first so-called 'compulsory licence' to the patent office as it bids to make generic copies of Pfizer's Sutent and Roche's Tarceva cancer drugs.
'This is the first case in India. A compulsory licence will allow companies like ours to manufacture and export drugs to least developing countries,' said M. Adinarayana, the secretary of Natco Pharmaceuticals, as the hearings began.
The global drugs patent system allows countries to make cheaper generic copies of patented drugs in certain situations, such as public health emergencies, under compulsory licences.
Experts said Natco's request for permission to make and export copies of Sutent and Tarceva to Nepal tested those regulations, amid a wider debate about whether poor countries have enough access to key but often pricey medicines.
Tarceva was granted a patent in India in 2007 following a new patent law passed in 2005, which brought the world's largest maker of generic drugs in line with World Trade Organisation guidelines on intellectual property.
The laxer rules before 2005 had encouraged generic drugs manufacture in India, which campaigners had welcomed as good for the poor.
Compulsory licences have been granted since 2005, but so far none have been issued in India, making Hyderabad-based Natco's plea a potentially landmark case.
Canada allowed a generic copy of a patented AIDS drugs to be exported to Rwanda in October. Thailand also issued domestic compulsory licences last year, but was criticised over claims it was not responding to a public health emergency.
An Indian Patent Office official, who declined to be named, said the hearing had started over the Roche case and that the Pfizer case would be held Friday. He expected representatives from Roche and Pfizer to attend.
Roche or Pfizer did not immediately respond to emailed requests for comment.
Many Indian activists have complained that the cost of patented drugs is too high and that provision should be made to allow generic drugs to be supplied to the country's legion of poor.
'If compulsory licensing is not resorted to, 98 percent of India's population will not be able to afford any of the patented drugs,' said Y.K. Sapru, the president of the non-profit Cancer Patients Aid Association.
But pharmaceutical giants often argue protecting patents are crucial to stimulating the research and development of new drugs.
Industry groups object that if Natco is granted a compulsory licence for Nepal, then it could lead other Indian firms to push for more sales of generic drugs domestically.
Natco has reportedly offered Roche a five percent royalty on generic versions of Tarceva exported to Nepal, one of the world's poorest nations. The Indian firm stopped sales of an earlier generic copy of Tarceva after Roche won its 2007 patent.
But Indian firm Cipla, based in the financial capital Mumbai, started making a generic version of Tarceva a few months ago. Roche has filed a court case to halt further domestic sales by the firm.
One tablet of Tarceva, which fights lung cancer, costs about 4,800 rupees (120 dollars) in India, where tens of thousands of people need the medicine. Cipla's generic copy sells for nearly one-third that price.
The cost difference is crucial for poor people, a Medecins Sans Frontieres official said.
'India is the only source for generic drugs for developing countries. It has the capacity to manufacture and has many generic producers,' said Leena Menghaney, a campaigner for the group in India.