BMJ 2014;348:g1094 doi: 10.1136/bmj.g1094 (Published 24 January 2014)
Page 1 of 1
News
NEWS India to consider raft of new compulsory licences Sanjeet Bagcchi Kolkata
A government appointed panel is set to review over 20 drug patents in India and recommend compulsory licensing so that the country’s generic drug manufacturers can produce the drugs at low cost, the magazine Bloomberg Businessweek has reported.1 The BMJ has found Indian media and the government silent on this issue. To date no announcement or document on this initiative has officially emerged. However, the Bloomberg Businessweek article quoted two anonymous sources who acknowledged the plans.
The article said, “The panel is looking beyond the cancer treatments it studied last year to areas such as HIV and diabetes, according to two people with knowledge of the matter, who asked not to be identified because the discussions are private. It plans to study more than 20 drugs and recommend the government assign about three so-called compulsory licenses to allow local firms to make low-priced copies in India.”
The article said that among the therapies being considered are two diabetes drugs—Merck’s sitagliptin (marketed as Januvia) and Bristol-Myers’ saxagliptin (Onglyza)—and Merck’s HIV drug raltegravir (Isentress) and Bristol-Myers’ arthritis treatment abatacept (Orencia). The panel is also said to be considering other drugs, although it is unclear which, the sources said.
Compulsory licence, according to the World Trade Organization (WTO), refers to a provision under which a government can allow a company to manufacture a patented drug without the consent of the innovator company.2 According to the Indian Patent Act a compulsory licence can be sought if in cases of national emergency, extreme urgency, or for public, non-commercial use. In March 2012 India issued its first compulsory licence to Natco Pharma for the production of Bayer AG’s cancer drug Nexavar (sorafenib).3 In January 2013 the government appointed a panel to review and recommend whether cheaper versions of three cancer drugs—Roche’s trastuzumab, and Bristol-Myers Squibb’s
For personal use only: See rights and reprints http://www.bmj.com/permissions
dasatinib and ixabepilone—could be manufactured under the provision of compulsory licensing. Following that, in mid August, Roche decided not to pursue its patent on trastuzumab in India.4 In October, India’s patent office rejected the application (issued by a Mumbai based company—BDR Pharmaceuticals) for compulsory licensing for dasatinib. To date there has been no decision regarding the compulsory licensing on ixabepilone.
Karan Thakkar, a Mumbai based specialist in clinical pharmacology and therapeutics, told the BMJ: “Compulsory licensing is one of the provisions laid down by the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement at the Doha Declaration to afford each member of the WTO the right to promote access to medicines for all.” He added: “In India, compulsory licensing is being considered only for certain drugs. This should not hamper the intellectual property rights safeguard and the broad outlook of the pharma industry.”
Chandra Gulati, the Delhi based editor of the Monthly Index of Medical Specialities, told the BMJ: “There is no provision to issue a compulsory licence so that ‘cheaper patented products’ are available. This line of argument is over-simplification.” India has the legal right to issue a compulsory licence in case of specified conditions and the innovator companies also have the right to challenge such a decision in an appropriate forum, such as domestic courts or the grievance redressal machinery within the WTO regime, he added. 1 2 3 4
Gokhale K. Merck to Bristol-Myers face more threats on India drug patents. Bloomberg Businessweek 21 Jan 2014. www.businessweek.com/news/2014-01-21/merck-to-bristolmyers-face-more-threats-on-india-drug-patents. Rajagopal D. Compulsory licence likely for three cancer drugs. Economic Times 14 Jan 2013. http://articles.economictimes.indiatimes.com/2013-01-14/news/36331897_1_ compulsory-licence-indian-patent-act-patent-controller. Mudur G. Indian health groups welcome country’s first compulsory licence. BMJ 2012;344:e2132. Limb M. Roche’s decision to drop Herceptin patent in India opens way for generics. BMJ 2013;347:f5197.
Cite this as: BMJ 2014;348:g1094 © BMJ Publishing Group Ltd 2014
Subscribe: http://www.bmj.com/subscribe
Page 1 of 1
News
NEWS India to consider raft of new compulsory licences Sanjeet Bagcchi Kolkata
A government appointed panel is set to review over 20 drug patents in India and recommend compulsory licensing so that the country’s generic drug manufacturers can produce the drugs at low cost, the magazine Bloomberg Businessweek has reported.1 The BMJ has found Indian media and the government silent on this issue. To date no announcement or document on this initiative has officially emerged. However, the Bloomberg Businessweek article quoted two anonymous sources who acknowledged the plans.
The article said, “The panel is looking beyond the cancer treatments it studied last year to areas such as HIV and diabetes, according to two people with knowledge of the matter, who asked not to be identified because the discussions are private. It plans to study more than 20 drugs and recommend the government assign about three so-called compulsory licenses to allow local firms to make low-priced copies in India.”
The article said that among the therapies being considered are two diabetes drugs—Merck’s sitagliptin (marketed as Januvia) and Bristol-Myers’ saxagliptin (Onglyza)—and Merck’s HIV drug raltegravir (Isentress) and Bristol-Myers’ arthritis treatment abatacept (Orencia). The panel is also said to be considering other drugs, although it is unclear which, the sources said.
Compulsory licence, according to the World Trade Organization (WTO), refers to a provision under which a government can allow a company to manufacture a patented drug without the consent of the innovator company.2 According to the Indian Patent Act a compulsory licence can be sought if in cases of national emergency, extreme urgency, or for public, non-commercial use. In March 2012 India issued its first compulsory licence to Natco Pharma for the production of Bayer AG’s cancer drug Nexavar (sorafenib).3 In January 2013 the government appointed a panel to review and recommend whether cheaper versions of three cancer drugs—Roche’s trastuzumab, and Bristol-Myers Squibb’s
For personal use only: See rights and reprints http://www.bmj.com/permissions
dasatinib and ixabepilone—could be manufactured under the provision of compulsory licensing. Following that, in mid August, Roche decided not to pursue its patent on trastuzumab in India.4 In October, India’s patent office rejected the application (issued by a Mumbai based company—BDR Pharmaceuticals) for compulsory licensing for dasatinib. To date there has been no decision regarding the compulsory licensing on ixabepilone.
Karan Thakkar, a Mumbai based specialist in clinical pharmacology and therapeutics, told the BMJ: “Compulsory licensing is one of the provisions laid down by the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement at the Doha Declaration to afford each member of the WTO the right to promote access to medicines for all.” He added: “In India, compulsory licensing is being considered only for certain drugs. This should not hamper the intellectual property rights safeguard and the broad outlook of the pharma industry.”
Chandra Gulati, the Delhi based editor of the Monthly Index of Medical Specialities, told the BMJ: “There is no provision to issue a compulsory licence so that ‘cheaper patented products’ are available. This line of argument is over-simplification.” India has the legal right to issue a compulsory licence in case of specified conditions and the innovator companies also have the right to challenge such a decision in an appropriate forum, such as domestic courts or the grievance redressal machinery within the WTO regime, he added. 1 2 3 4
Gokhale K. Merck to Bristol-Myers face more threats on India drug patents. Bloomberg Businessweek 21 Jan 2014. www.businessweek.com/news/2014-01-21/merck-to-bristolmyers-face-more-threats-on-india-drug-patents. Rajagopal D. Compulsory licence likely for three cancer drugs. Economic Times 14 Jan 2013. http://articles.economictimes.indiatimes.com/2013-01-14/news/36331897_1_ compulsory-licence-indian-patent-act-patent-controller. Mudur G. Indian health groups welcome country’s first compulsory licence. BMJ 2012;344:e2132. Limb M. Roche’s decision to drop Herceptin patent in India opens way for generics. BMJ 2013;347:f5197.
Cite this as: BMJ 2014;348:g1094 © BMJ Publishing Group Ltd 2014
Subscribe: http://www.bmj.com/subscribe
![[New patients' rights act--what do we have to consider?].](/assets/img/hold.png)
