[Ip-health] India - Generic company applies for CL on cancer drug Dasatinib

leena menghaney leenamenghaney at gmail.com
Mon Mar 18 20:54:09 PDT 2013


Both Times of India and Pharmabiz in India are reporting on the 2nd CL
application under section 84 of the Indian patent law. The CL
application by an Indian generic company BDR is for an anti-cancer
drug Dasatinib. The Indian government procures and reimburses
dasatinib (from BMS) for public sector employees at a very high price.
Dasatinib 50 mg (60 tabs) cost Rs. 141638 and 70 mg (60 tabs) cost Rs.
151902. For information see
http://cghs.nic.in/Life%20Saving%20Medicines.htm and
http://www.scr.indianrailways.gov.in/cris//uploads/files/1327919951035-ami2011-2012polist.xlsx.pdf

News reports:

Indian co seeks compulsory licence for cancer drug of Bristol Myers
Joseph Alexander, New Delhi
Tuesday, March 19, 2013, Pharmabiz

Even as the Government is actively considering the proposal of
allowing compulsory licence (CL) for three more cancer drugs, another
Indian company has filed an application for the compulsory licence for
an anti-cancer drug patented by pharma major Bristol Myers Squibb.

The application, the second such in India so far, has been filed by
Maharashtra-based BDR Pharmaceuticals for selling cancer drug
Dasatinib. BMS sells Dasatinib at around Rs.1,68,000 per month, but
BDR has promised to sell it at Rs.8100, it learnt.

The first application for CL was the one filed by Natco Pharma to sell
the cheaper version of Bayer AG’s cancer Drug Nexavar, triggering a
highly-watched legal battle. The Indian company was granted the CL in
an epoch-making verdict last year and the ruling was recently upheld
by the IPAB recently.

The application also comes at a time when a Government panel is
examining the issue of allowing compulsory licences in three more
drugs - Trastuzumab, Ixabepilone and Dasatinib. The proposal,
originally suggested by Health Ministry and the Department of
Industrial Policy and Promotion has formed the panel to look into it.
The Department of Pharmaceuticals (DoP) had also been asked to give
its comments on the issue. All these three drugs are priced above one
lakh. Interestingly, BMS has the patent also to Ixabelpilone apart
from Dasatinib. Trastuzumab is manufactured by Roche.

BDR Pharmaceuticals had approached BMS for a license in early 2012,
but BMS sought extensive and elaborate set of documentation/ facts.
BDR then sent notice to the patent office, claiming that BMS was not
interested in granting the licence and the information asked for was
nothing more than a delay tactic. After treating it as a refusal by
BMS, the Indian company has now moved the authorities for CL.

The proposal by the Health Ministry is to invoke the rule Sec 92 of
the Indian Patent Act through under which the government can issue a
compulsory licence on certain patents notified in the gazette. After
the same is notified by the government, any company interested in its
manufacture is allowed approach the patent controller for a licence.

http://www.pharmabiz.com/NewsDetails.aspx?aid=74360&sid=1


Leena Menghaney
Tel: 46573730/1, 9811365412




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