[Ip-health] DIPP defers decision on issuance of compulsory licence for cancer drug Dasatinib

Manon Ress manon.ress at keionline.org
Thu Oct 16 12:23:28 PDT 2014

DIPP defers decision on issuance of compulsory licence for cancer drug
By Dilasha Seth & Soma Das, ET Bureau | 16 Oct, 2014, 04.00AM IST1

NEW DELHI: The department of industrial policy and promotion, or DIPP, has
delayed a decision on issuing a compulsory licence for cancer drug
Dasatinib by seeking fresh clarification from the health ministry early
this week.

Through compulsory licensing -- provided under the Indian Patent Act -- the
government can allow someone else to produce Dasatinib without the consent
of the patent owner, Bristol-Myers Squibb. If the DIPP had agreed to issue
such a license on health ministry's recommendation, it would have cheered
the public health activists, but would have had adverse repercussions on
Indo-US relations.

While the health ministry has repeatedly urged DIPP to issue the first
government initiated compulsory license (CL) for Dasatinib after an expert
panel made out a case for the same, the latter doesn't seem convinced yet.
"DIPP has sought further information to justify the issuance of a CL under
Section 92 of Indian Patents Act," said an official privy to the matter. In
a 10-question letter to the health ministry, it has sought information on
the total cost that government incurs on procurement incurs on procurement
of Dasatinib -- used for treatment of chronic myeloid leukaemia -- through
its arms such as defence ministry, Central Government Health Scheme and
Indian Railways.

The health ministry had earlier argued that many public institutions
including Indian Railways, CGHS, Army Hospital Research and Referral are
procuring the drug, but in small quantities partially because of its high
price. It pointed out that a CL for 'public non-commercial use' will allow
the government to source generic versions of Dasatinib at a fraction of the

"In its letter, DIPP has pointed out that the probability of this type of
cancer is just 0.001% and there is no visible incidence of an increase in
the trend and sought the rationale for dubbing it a 'national emergency' or
'extreme urgency'," said the official quoted earlier. Under Indian laws,
criteria for permitting a CL include cases of 'extreme urgency', 'national
emergency' and 'public non-commercial use'.

DIPP has also sought information on whether this drug serves as the first
line of treatment and can be considered as a cure for the disease it is
used to treat. The development comes at a time when the US Trade
Representative's office has just begun an out-of-cycle review (OCR) of
India's intellectual property regime. The OCR follows its annual Special
301 Report that came out in April, in which the USTR had placed India on
the 'Priority Watch List' containing countries whose IP regimes are a
serious concern. The next level of 'priority foreign country', which is
USTR's worst classification, can trigger trade sanctions.

In its release announcing the unilateral review this week the USTR,
however, said, "The OCR will not revisit India's designation on the 2014
Priority Watch List."

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Manon Ress, Ph.D.
Knowledge Ecology International, KEI
manon.ress at keionline.org, tel.: +1 202 332 2670
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