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04 December 2023

India mulls potentially landmark ruling on generic drugs

By Agencies

A drug firm asked Indian officials for permission on 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 license" 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 license 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 licenses.


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 (WTO) guidelines on intellectual property.


Compulsory licenses 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 licenses 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 a emailed requests for comment.


Many India activists have complained that the cost of patented drugs is too high and that provisions 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 per cent of India's population will not be able to afford any of the patented drugs," said YK Sapru, the president of the non-profit Cancer Patients Aid Association.


But industry groups object that if Natco is granted a compulsory license for Nepal, then it could lead other firms to push for generic domestic sales of patented drugs.


Pharmaceutical giants often argue protecting patents are crucial to stimulating the research and development of new drugs. (AFP)