Journal of Intellectual Property Rights

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Compulsory Licensing of Patented Drugs Under National Emergency


Affiliations
1 National Law School of India University, Nagarbhavi, Bangalore-560072, Karnataka, India
 

Patent protection to pharmaceutical products by the TRIPS Agreement had made serious concerns in the developing countries regarding accessibility, availability and affordability of life saving drugs. TRIPS Agreement, at the same provided flexibilities to the member countries to even off the adverse effects of pharmaceutical patent system especially in cases involving public health. National emergency, being such flexibility allows member countries to invoke compulsory license for accessing life-saving drugs in cases of national emergency without any pre-conditions. By the Doha Declaration the freedom is also vested upon the individual countries to define the term ‘national emergency’. This triggers apprehension among the patentees about the abuse of such wide discretion by these countries. But these concerns are found negative by the analysis of case studies of compulsory license issued on national emergency. Countries are very cautious while invoking this provision.

Keywords

Compulsory License, Patent, National Emergency, TRIPS Agreement, Doha Declaration, HIV/AIDS.
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  • United Nations Secretary-General's High-Level Panel on Access to Medicines - New Deal to Close the Health Innovation and Access Gap, 2016, https://static1.squarespace.com/static/562094dee4b0d00c1a3ef761/t/57d74b232994ca43043e01b4/1473727274910/HLP+Factsheet.pdf (accessed on 6 April 2017).

  • Satyanarayana K & Srivastava S, The inter‐governmental working group on public health, innovation and intellectual property (IGWG)‐‐The way ahead, The Indian Journal of Medical Research, 128 (5) (2008) 577‐58.

  • Beatrice S & Harry T, Learning from practice: Compulsory licensing cases and access to medicines, Pharmaceutical Patent Analyst, 2 (2) (2013) 195–213.

  • Article 31 of the TRIPS Agreement: “Other Use Without Authorization of the Right Holder Where the law of a Member allows for other use7 of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

  • (a) authorization of such use shall be considered on its individual merits;

  • (b) such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;

  • (c) the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi-conductor technology shall only be for public noncommercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive;

  • (d) such use shall be non-exclusive;

  • (e) such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use;

  • (f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;

  • (g) authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;

  • (h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;

  • (i) the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;

  • (j) any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;

  • (k) Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases.Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur;

  • (l) where such use is authorized to permit the exploitation of a patent (“the second patent”) which cannot be exploited without infringing another patent ("the first patent"), the following additional conditions shall apply:

  • (i) the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent;

  • (ii) the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and

  • (iii) the use authorized in respect of the first patent shall be non-assignable except with the assignment of the second patent.”

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  • http://www.who.int/hac/about/definitions/en/ (accessed on 6 April 2017).

  • http://thelawdictionary.org/national-emergency/ (accessed on 6 April 2017).

  • http://www.duhaime.org/LegalDictionary/N/NationalEmergency.aspx (6 April 2017).

  • Henry C B M A, Black’s Law Dictionary (West Publishing Co, St. Paul, MINN), 1968, p.1176.

  • Article 2, Para 1 of Brazil Presidential Decree on Compulsory Licensing DECREE No. 3,201 OF OCTOBER 6, 1999, http://www.cptech.org/ip/health/c/brazil/PresDecree.html (accessed on 6 April 2017).

  • Doha Declaration on the TRIPS Agreement and Public Health 2001, par. 5.c WT/MIN(01)/DEC/2, https:// www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm (accessed on 6 April 2017).

  • Lalitha N, Doha Declaration and public health issues, Journal of Intellectual Property Rights, 13(5) (2008) 401-413.

  • Harish C, Vaibhav C & Kumar V, Current scenario of Patent Act: Compulsory licensing, Indian Journal of Pharmaceutical Education and Research, 47 (3) (2013) 26-30.

  • Cornelius D, Understanding the basis for compulsory licensing for public health reasons, CUTS C-CIER, 2009, http://www.cuts-ccier.org/pdf/Understanding_the_Basis_for_Compulsory_Licensing_for_Public_Health_Reasons.pdf (accessed on 13 April 2017).

  • General Notice 240 of 2002: Declaration of Period of Emergency, http://www.cptech.org/ip/health/c/zimbabwe/zim05242002.html (accessed on 6 April 2017).

  • Zimbabwe Government takes emergency action against HIV/AIDS Overriding patents will dramatically cut price of treatment for patients, Medicins Sans Frontieres, 29 May 2002, http://www.cptech.org/ip/health/c/zimbabwe/msf05292002.html (accessed on 6 April 2017).

  • http://www.cptech.org/ip/health/c/mozambique/moz-cl-en.pdf (accessed on 6 April 2017).

  • WHO, WHO Drug Information, 18(2) (2004)141, http://apps.who.int/iris/bitstream/10665/72914/1/18_2_2004.pdf (accessed on 7 April 2017).

  • Compulsory License no. 01/MIC/04,http://www.cptech.org/ip/health/c/mozambique/moz-cl-en.pdf (accessed on 7 April 2017).

  • Global Report: UNAIDS Report on the Global AIDS Epidemic 2010, http://www.unaids.org/globalreport/documents/20101123_GlobalReport_full_en.pdf (accessed on 12 April 2017).

  • http://www.who.int/hiv/HIVCP_SWZ.pdf (accessed on 12 April 2017).

  • Compulsory License no. 1/2004, http://www.cptech.org/ip/health/c/zambia/zcl.html (accessed on 7 April 2017).

  • This period of compulsory license is not provided in Compulsory License no. 1/2004 and it specified that the grant will be expired as soon as conditions of national emergency and extreme urgency created by the HIV/AIDS pandemic will come to an end. But the period of 5 years is specified in the letters sent to Boehringer-Ingelheim and Bristol-Myers Squibb notifying the companies of the issuance of thecompulsory license, http://www.cptech.org/ip/health/c/zambia/zambia-bms09302004.html (accessed on 7 April 2017).

  • http://www.cptech.org/ip/health/cl/Eritrea.png (accessed on 12 April 2017).

  • http://www.cptech.org/ip/health/cl/Ghana.png (accessed on 11 April 2017).

  • Nations’ incomes were classified using the World Bank’s GNI listings for the year closest to that of the CLcase study (data is available for 2000, 2005, 2007, and 2008). “Low” income is $975 or less per capita per year. Beall, Reed F,Trends in international compulsory licensing of pharmaceuticals since the institution of the trade-related aspects of intellectual property protection (TRIPS) agreement,Electronic Theses and Dissertations, Paper 760,(2010), http://digitalcommons.du.edu/cgi/viewcontent.cgi?article=1759&context=etd (accessed on 14 April 2017).


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  • Compulsory Licensing of Patented Drugs Under National Emergency

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Authors

Aswathy Asok
National Law School of India University, Nagarbhavi, Bangalore-560072, Karnataka, India

Abstract


Patent protection to pharmaceutical products by the TRIPS Agreement had made serious concerns in the developing countries regarding accessibility, availability and affordability of life saving drugs. TRIPS Agreement, at the same provided flexibilities to the member countries to even off the adverse effects of pharmaceutical patent system especially in cases involving public health. National emergency, being such flexibility allows member countries to invoke compulsory license for accessing life-saving drugs in cases of national emergency without any pre-conditions. By the Doha Declaration the freedom is also vested upon the individual countries to define the term ‘national emergency’. This triggers apprehension among the patentees about the abuse of such wide discretion by these countries. But these concerns are found negative by the analysis of case studies of compulsory license issued on national emergency. Countries are very cautious while invoking this provision.

Keywords


Compulsory License, Patent, National Emergency, TRIPS Agreement, Doha Declaration, HIV/AIDS.

References