[Ip-health] Times of India : Government mulls cancer drug patent waiver for Dasatinib
shailly.gupta at geneva.msf.org
Sun May 4 22:58:40 PDT 2014
Sidhartha, TNN | May 5, 2014, 01.51AM IST
NEW DELHI: The health ministry has reopened the issue of waiving a global
drug giant's patent rights for Dasatinib, a
<http://timesofindia.indiatimes.com/topic/Cancer> cancer drug, arguing the
move is needed to deal with an "emergency". The latest development - which
the ministry expects will go through - comes at a time when India has won a
reprieve from the US over its
intellectual property regime but is facing flak from the civil society,
which is critical of the government "going soft" on affordability and
availability of medicines for life-threatening diseases.
In a letter to the department of industrial policy and promotion (DIPP) last
week, the health ministry has answered the concerns raised earlier and said
the cost of the drug produced by pharma major Bristol-Myers Squibb (BMS)
will be met through government schemes. Many experts see BMS along with
Pfizer at the forefront of the battle to get the US authorities to downgrade
India's patent regime by a notch and open it to possible punitive action.
Officials in DIPP refused to comment on the latest move, but health ministry
sources said they plan to use around half-a-dozen schemes to fund the cost
of making the drugs available to patients for what is called public
non-commercial use and the position has been made clear in last week's
letter. Dasatinib is used to treat chronic myeloid leukemia.
If the move goes through, it will be the first instance of the government
invoking emergency provisions in the law to waive the patent rights. So far,
the compulsory licence provisions have been used by the Patents Office,
which waived Bayer Corporation's patent rights over Nexavar, a renal cancer
cms> Natco Pharma to manufacture and sell it at a fraction of the cost.
Natco had offered to sell the medicine at Rs 8,800 for a month's therapy,
compared to Bayer's Rs 2.8 lakh.
But unlike last time, this time the government will itself have to issue the
compulsory licence, which is provided for in the World Trade Organization's
Agreement on Trade-Related Aspects of Intellectual Property Rights (Trips).
Even in this case, the sources said, the government will have to hear the
arguments put forward by BMS to "follow the principles of natural justice".
Once the government issues its order, the Patents Office will be required to
notify the availability of a compulsory licence for the drug and will be
required to go through another round of hearing.
Initially, the health ministry was pushing for compulsory licence for three
cancer drugs, but had to drop plans for two of them.
Given the international scrutiny, the government is treading with caution
and had earlier turned down health ministry's plea that the government issue
a compulsory licence under section 84 of the Indian Patents Act on the
grounds of affordability and had suggested an application be made with the
Patents Office. DIPP is extra cautious over the issue as it will undergo the
legal process and it does not want to be caught doing something which is
against the law.
Last October, the Patents Office had rejected an application from BDR Pharma
to make a generic version of BMS's Dasatinib, which is sold under the
Sprycel brand. The proposal was rejected on the grounds that the Indian
company did not make enough efforts to obtain a voluntary licence for the
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