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Friday, February 29, 2008

 

India mulls potentially landmark
ruling on generic drugs

 
NEW DELHI: 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 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, 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 expensive 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 Organization 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 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 criticized 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.
-- AFP

   

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Severino O. Frayna Jr., Benjie Dela Rosa
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