PRIVATE PATENTS AND PUBLIC HEALTH
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TABLE 4 RETAIL PRICE OF A DASATINIB (50MG) TABLET IN US$<br />
BR<strong>AND</strong> NAME COMPANY PRICE PER TABLET (50MG)<br />
Dasanat Natco Pharma Ltd. 2.33<br />
Sprycel Bristol-Myers Squibb 52.20<br />
SOURCE<br />
Mims.com (2013).<br />
<strong>PRIVATE</strong> <strong>PATENTS</strong> <strong>AND</strong> <strong>PUBLIC</strong> <strong>HEALTH</strong><br />
BMS and Natco had been engaged in a patent infringement battle over<br />
dasatinib. A Delhi High Court injunction in June 2012 prohibited Natco<br />
from continuing to sell the product. 102 At least 2,500 patients were on<br />
treatment using Natco’s generic dasatinib, until it was withdrawn<br />
following the Delhi High Court order in June 2012.<br />
Independent of the DIPP process, in 2013 the generic company BDR<br />
Pharmaceuticals also applied for a compulsory licence to be able to<br />
produce and market dasatinib. 103 BDR said its generic dasatinib would be<br />
available to patients at Rs. 135 (US$ 2.20) per tablet. BMS’s estimated<br />
comparable price is about Rs. 2,761 (US$ 43.57) per tablet. BDR offered to<br />
pay a royalty and make the product available for free to a certain percentage<br />
of patients. This request for a compulsory licence, however, was rejected<br />
on procedural grounds — failure to meaningfully engage in obtaining a<br />
voluntary licence from the patent owner — on 29 October 2013. 104<br />
The DIPP in October 2014 deferred the decision to grant a compulsory<br />
licence for dasatinib. The CL was recommended by the Ministry of Health. 105<br />
Trastuzumab (brand name Herceptin) is used to treat breast cancer. In<br />
August 2013, in the face of mounting pressure, Roche relinquished its<br />
patent for trastuzumab in India making the issuance of a compulsory<br />
licence redundant. 106 Roche did this after the Kolkata patent office had<br />
revoked patents related to trastuzumab.<br />
107, 108<br />
A few months later in 2013, generic companies Biocon and Mylan<br />
received marketing authorisation in India for their biosimilar trastuzumab<br />
products, which they each market under separate brand names. 109<br />
As of May 2015, trastuzumab is on the WHO Model List of Essential<br />
Medicines (EML). In November 2012, Knowledge Ecology International<br />
(KEI), the University of California, San Francisco, Universities Allied for<br />
Essential Medicines (UAEM) and the Young Professionals Chronic Disease<br />
Network submitted trastuzumab for inclusion in the EML. In their<br />
application they point out that one possible supplier of trastuzumab<br />
69
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