US pharma majors are putting pressure on the Government to stop issuing permits to domestic companies for making low-priced copies of patented life saving drugs.
Top officials from a number of US drug makers such as Pfizer, Mylan and Merck recently met the Department of Industrial Policy & Promotion (DIPP) Secretary to lobby against use of compulsory licences by India, a DIPP official told Business Line .
A compulsory licence is a permit issued by a Government to local industry for producing copied versions of patented medicines without the consent of the patent holder.
The delegation, organised by the US India Business Council (USIBC), also tried to dissuade the Government from putting in place restrictions on foreign direct investment in pharmaceuticals and urged it to enforce stricter intellectual property rules.
India has been maintaining that it is not against intellectual property protection and considers issuing compulsory licences only under extreme conditions abiding strictly by global rules on intellectual property prescribed by the TRIPS Agreement, the official said.
“The US companies were extremely worried that their patented drugs face threat in the Indian market as compulsory licences allowing their local production could be issued anytime. We assured them that such licences are not issued on a day-to-day basis and are guided by prescribed rules,” the official said.
The DIPP informed the delegation that it had sent back three proposals for compulsory licences forwarded by the Health Ministry as it was not satisfied with the arguments given and wanted more evidence on why there was a need to issue them. Some experts are of the view that India may already be wilting under pressure from the US industry and Government.
“The US industry thrives on employing pressure tactics to get its way. The fact that India has visibly gone slow in its drive to ensure availability of cheap life-saving medicines to the public through compulsory licences shows that all the noise being made might be working,” a WTO expert from a Delhi-based research institute pointed out.
India has been facing huge protests from the US and the EU after it issued its first compulsory licence last year to Hyderabad-based company Natco for selling generic or copied versions of Bayer’s anti-cancer drug Nexaver.
The Indian Patent Office allowed Natco to sell the copied version at Rs 8,800 for a month’s treatment compared to Bayer’s version priced at Rs 2.8 lakh, making treatment affordable to thousands of patients afflicted with kidney cancer.
With patents worth an estimated $150 billion held by drug majors set to expire between 2010-2017, companies are desperate to protect their valid patents all across the globe and also renew their old patents.
The US companies also want India to be less stringent while deciding on granting fresh patents. Last year, the Indian Patent Office revoked Pfizer’s patent for cancer drug Sutent as it was seen as being obvious and not inventive. This led to a lot of heartburn between the two countries.
India’s proposed legislation to restrict take-overs of existing pharmaceutical companies by foreign companies is now a fresh worry for the West.
“The pharmaceutical companies did not want restrictions to be in place for FDI in the sector, either in greenfield or brownfield projects,” the official said.