PHA-Exchange> India plans compulsory licensing licensing against Novartis over Gleevec

[claudio at hcmc.netnam.vn]

 from Vern Weitzel <vern at coombs.anu.edu.au> -----

   Centre may resort to compulsory licensing against Novartis over Gleevec

www.pharmabiz.com <http://www.pharmabiz.com>

Monday, May 21, 2007 08:00 IST
Joseph Alexander, New Delhi

As a last resort in its patent tangle with Swiss pharma giant Novartis,
India may take a clue from the Thai Government's successful intervention
to make available life-saving drugs at affordable prices by issuing
compulsory licensing.

Having conveyed open requests to Novartis to withdraw the case against
Indian patent law over its cancer pill Gleevec pending in the Chennai
High Court, the Union Health Ministry is closely watching the
developments and does not rule out invoking compulsory licence.

Officials in the ministry are weighing the options in the wake of the
widespread support from across the globe to Thailand's steps and
pressure from the public interest groups in India, it is learnt.

Enshrined in Article 31 of the WTO agreement on TRIPS, a compulsory
license allows a government, to either produce or authorize someone else
to produce a patented drug without the consent of the patent holder in
the event of a national emergency, extreme urgency or for non commercial
public use. Compulsory licenses are a legally recognised means to
overcome barriers in accessing affordable medicines.

Union Health Minister Dr Anbumani Ramadoss himself recently made it
clear that the Government would be forced to resort to the step as the
last choice. "Till now, India has not used compulsory licensing and we
do have no immediate intention of using it. But, don't force us to use
it," he said recently, while commenting on the possibility.

The 2001 WTO Doha declaration on TRIPS and Public Health extended
support to any government to use TRIPS flexibilities to overcome the
barriers posed by patents. All governments in the WTO, including the
United States, agreed to as much at Doha, clearly stating that "Each
Member has the right to grant compulsory licenses and the freedom to
determine the grounds upon which such licenses are granted."

After two years of failed attempts to negotiate affordable prices on
patented drugs with pharmaceutical companies, the Thai government issued
compulsory licenses on three drugs in the last few months. This allowed
Thailand to import affordable, safe and effective generic versions of
the patented drugs from other countries or produce them on their own
through their Government Pharmaceutical Company (GPO). The move has
reportedly proved successful. Before the issuing of compulsory licence
Thailand was spending 10 times more on first line drug regimen, it is
assessed.

The first license was issued on November 29, 2006 for the HIV/AIDS
medicine, efavirenz (patented by Merck and sold by the brand name of
Storcin). This was followed by additional compulsory licenses on January
26, for the heart disease drug clopidogrel (patent holder is
sanofi-aventis who sells it by the brand name of Plavix) and the
HIV/AIDS drug, lopinavir/ritonavir (patent holder is Abbott who sells it
by the brand name Kaletra).



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