[Ip-health] Livemint: Panel backs compulsory licence on cancer drug

Thiru Balasubramaniam thiru at keionline.org
Wed Sep 11 04:14:13 PDT 2013


http://www.livemint.com/Industry/j4wMuxxqIyYnQZ5HwLHhMP/Panel-backs-compulsory-licence-on-cancer-drug.htmlPanel
backs compulsory licence on cancer drug
If the DIPP approves the recommendation, it will be India’s second
compulsory licence
Vidya Krishnan <http://www.livemint.com/Search/Link/Author/Vidya%20Krishnan>
*First Published: Wed, Sep 11 2013. 12 40 AM IST
*
*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<http://www.livemint.com/Search/Link/Keyword/Natco%20Pharma%20Ltd>
for
the manufacture ofBayer
AG<http://www.livemint.com/Search/Link/Keyword/Bayer%20AG>’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<http://www.livemint.com/Search/Link/Keyword/Natco>
 after Bayer <http://www.livemint.com/Search/Link/Keyword/Bayer>appealed
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<http://www.livemint.com/Search/Link/Keyword/Roche%20Holding%20AG>’s
breast cancer treatment Herceptin (Trastuzumab); and Bristol-Myers
Squibb<http://www.livemint.com/Search/Link/Keyword/Bristol-Myers%20Squibb>’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 Roche
<http://www.livemint.com/Search/Link/Keyword/Roche>relinquished
patent claims on its blockbuster breast cancer drug in August.
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 Europe in 2009 after the
drug received a negative opinion from the Committee for Medicinal Products
for Human Use.
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”.



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