If the DIPP approves the recommendation, it will be India’s second compulsory licence
A compulsory licence would allow the government to produce a generic version of the patented medicine and sell it at a cheaper price.
New Delhi: An expert committee on compulsory licensing has recommended that the department of industrial policy and promotion (DIPP) issue a compulsory licence for the manufacture of Bristol-Myers Squibb Co.’s anti-cancer drug Dasatinib to two companies.
If the department approves the recommendation, it will be India’s second compulsory licence and a significant blow to the New York-based drug maker. A compulsory licence would allow the government to produce a generic version of the patented medicine and sell it at a cheaper price.
An email sent to the company on Tuesday and calls to its external spokesperson remained unanswered.
In a meeting earlier this month, the committee approved a proposal by the health ministry to make the drug, used in the treatment of chronic myeloid leukaemia, cheaper. A month’s dose currently costs Rs.1.6 lakh.
The decision comes at a time when Indian patent enforcement is under international scrutiny for taking a pro-patient stand in high-profile patent litigations involving multinational pharmaceutical firms.
In March 2012, India issued its first compulsory licence to Natco Pharma Ltd for the manufacture ofBayer AG’s Nexavar, another anti-cancer drug.
Interestingly, there were no further applications for compulsory licences after that. In March, the Intellectual Property Appellate Board upheld the compulsory licence granted to Natco after Bayerappealed the decision of the patent office. Bayer said it would appeal the appellate body’s decision before the Bombay high court.
Under the Indian patents Act, a compulsory licence for manufacture of a patented pharmaceutical product can be issued if the drug is considered unaffordable by the government.
The World Trade Organization’s (WTO’s) TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement allows a country to issue a compulsory licence without the consent of the innovator if it is in public interest.
In January 2013, the health ministry approached DIPP for issuance of compulsory licences for three anti-cancer drugs —Roche Holding AG’s breast cancer treatment Herceptin (Trastuzumab); and Bristol-Myers Squibb’s leukaemia medicine Sprycel (Dasatinib) and chemotherapy drug Ixempra (Ixabepilone). India’s patent office comes under the purview of DIPP.
DIPP forwarded this request to the committee on compulsory licensing, which has reached a decision on all three drugs. A single 50ml vial of 40mg Trastuzumab costs Rs.1.24 lakh, a 45mg vial of Ixempra costsRs.66,430.60 and 60 tablets of 20mg each of Dasatinib are priced at Rs.1.17 lakh.
According to two persons familiar with the matter, in a meeting in the first week of September, the committee decided to issue a compulsory licence for Dasatinib. Neither person wanted to be identified.
One of them seemed to think a sign-off from DIPP was a mere formality. Mint couldn’t independently verify this. “Two companies have already approached the patent office with applications to manufacture generic versions of Dasatinib. We can expect the announcement soon,” said this person.
The committee rejected the proposal to issue a compulsory licence for Herceptin after Rocherelinquished patent claims on its blockbuster breast cancer drug in August.
Europe in 2009 after the drug received a negative opinion from the Committee for Medicinal Products for Human Use. The committee isn’t too keen on Ixempra because of safety and efficacy issues, a third person familiar with the matter said. According to this person, who too didn’t want to be identified, Bristol-Myers Squibb had withdrawn its application to market Ixempra in
There is a history to Dasatinib. In June 2012, the Delhi high court granted an injunction in favour of Bristol-Myers Squibb, directing Natco Pharma to stop manufacturing a generic version of Dasatinib. Natco was selling the generic version of the drug at Rs.9,000 for 60 tablets of 50mg each.
Public health activists have welcomed the committee’s decision. “Since India became TRIPS-compliant, we have had one compulsory licence issued, so India is playing by the rules of WTO. It is wrong to say these decision are in violation of trade rules,” said Leena Menghaney, a lawyer-activist with Médecins Sans Frontières (MSF, or Doctors Without Borders).
“When BMS (Bristol-Myers Squibb) obtained the injunction last year, they left many patients who were on generic version of the drug, without any alternative. Some patients had stockpiled for a few months and the rest were paying the company’s price. So, for patients this decision is a huge relief,” she said, adding that it was now up to DIPP “to either concede to pressure from multinational pharmaceutical companies or to stand by patient rights”.