Compulsory licensing allows governments to authorize generic competition with patented medicines in exchange for royalty payments to patent holders. It is a flexibility included in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (WTO’s TRIPS, Article 31, “Other Use Without Authorization of the Right Holder”).[1]

The Doha Declaration is the WTO’s unanimous interpretation of the TRIPS agreement and public health, adopted in 2001 during the WTO ministerial conference in Doha, Qatar. The declaration clarifies the scope of several public health flexibilities laid out in the TRIPS agreement.[2]

The Declaration states that the TRIPS agreement “does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all.”[3] 

According to the Doha Declaration, “Each member [of the WTO] has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.”[4]

Compulsory licensing (including government / crown use, as well as court-issued remedies to anti-competitive practices) is a standard and long-standing flexibility in patent rules.  The United States, which has a very open government use statute, may be the world’s most frequent user of compulsory licensing across technology sectors.  Under the TRIPS agreement, several governments have issued compulsory licenses to promote access to medicines. Some examples include:

-In 2004 Malaysia issued government use licenses for lamivudine+zidovidine and others.[6]
-In 2005, the health minister of Brazil proposed to issue a compulsory license for HIV/AIDS medicine lopinavir+ritonavir (Kaletra) on public interest grounds. Abbott, the patent holder, immediately reduced its price by 46%, after which Brazil refrained from issuing the license.[7]
-In 2006 Thailand issued a compulsory license for the HIV/AIDS medicine efavirenz.[8]
-In 2007 Thailand issued another compulsory license for lopinavir+ritonavir and clopidogrel, a treatment for heart disease.[9]
-In 2007 Brazil also issued a compulsory license for efavirenz.[10]
-In 2007 Canada issued a compulsory license using the “August 30th” system to export an ARV  to Rwanda.[11]

-In 2007 Indonesia issued a government use license for efavirenz.[12]
-In 2008 Thailand issued compulsory licenses for anti-cancer treatments, including docetaxel, letrozole, erlotinib, and imatinib.[13]
-In 2010 Ecuador issued a compulsory license for ritonavir.[14]

In 2010, The Public Patent Foundation opposed Abbott’s patents on eight compounds, alleging that prior art proves Abbott’s patents are undeserved.[15]

This year (2011), the pre-grant opposition filed by the Initiative for Medicines, Access & Knowledge (I-MAK) and generics pharmaceutical firms achieved success when the Indian Patent Office rejected Abbott’s patent on lopinavir+ritonavir heat-stable on the grounds that this new form was not an invention which warranted a new patent.[16]

What are march-in rights?

The United States National Institutes of Health (NIH) made R&D grants to Abbott that led to the invention of ritonavir. Under the U.S. law known as Bayh-Dole, the U.S. therefore maintains “march-in” rights over ritonavir – the right to issue a license for the invention to another party, including in cases where the patent holder (Abbott) is not making the product reasonably available.

What is voluntary licensing?

Patent holders may also voluntarily license their patented technology for use by other companies, governments or non-governmental organizations.

This summer (2011), the pharmaceutical company Gilead voluntarily licensed the HIV medicines tenofovir, emtricitabine, cobicistat, and elvitegravir as well as a combination of these products in a single pill known as the “Quad” to the Medicines Patent Pool (MPP).[17] This enables the MPP to grant licenses to generic pharmaceutical manufacturers in exchange for a small royalty fee for Gilead, increasing competition, lowering prices and expanding access.

Additionally, analysts believe the prospect of production under compulsory licenses has helped South Africa achieve more favorable voluntary licensing terms for some ARV treatments.[18]

[1] “Compulsory Licensing of Pharmaceuticals and TRIPS.” World Trade Organization. September 2006. http://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm. 22 June 2011.  
[2] “The Doha Declaration on the TRIPS Agreement and Public Health.” World Health Organization. 2011. http://www.who.int/medicines/areas/policy/doha_declaration/en/index.html. 22 June 22, 2011.
[3] “Declaration on the TRIPS Agreement and Public Health.” World Trade Organization Ministerial Conference. 14 November 2001. http://www.who.int/medicines/areas/policy/tripshealth.pdf. 12 July 2011.
[4] “Declaration on the TRIPS agreement and public health,” section 5(b). World Trade Organization. 20 November 2001. http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm. 22 June 2011.
[5] Love, James Packard. “Recent Examples of the use of compulsory licenses on patents.” Knowledge Ecology International. 8 March 2007. Revised 31 March 2007. http://www.keionline.org/misc-docs/recent_cls_8mar07.pdf 22 June 2011. 12.
[6] Ibid .
[7] Ibid 15.
[8] T’Hoen, Ellen F.M, The Global Politics of Pharmaceutical Monopoly Power (The Netherlands: AMB Publishers, 2009), xii.
[9] Ibid.
[10] Ibid.
[11] Ibid.
[12] “Briefing Note: Access to Medicines.” World Health Organization. 17 March 2008. http://www.searo.who.int/LinkFiles/IPT_Briefing_note_4_country_experiences.pdf. 1 November 2011.
[13] “By Authorizing Generic Competition, Ecuador Cuts Cost of Key HIV/AIDS Drug: Ecuador to Expand Access to Medicines.” Public Citizen. 22 April 2010. http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3116. 22 June 2011.
[14] Saez, Catherine. “Ecuador Grants First Compulsory License, For HIV/AIDS Drug.” Intellectual Property Watch. 22 April 2010.  http://www.ip-watch.org/weblog/2010/04/22/ecuador-grants-first-compulsory-licence-for-hivaids-drug/. 22 June 2011.
[15] “Key HIV/AIDS Drug Patents Challenged by PUBPAT: New Prior Art Proves Eight Abbott Laboratories Patents on Ritonavir are Undeserved.” Public Patent Foundation. 10 August 2010. http://www.pubpat.org/ritonavirfiled.htm. 30 June 2011.

[16] “Patents and HIV Medications: An Overview.” Initiative for Medicines, Access & Knowledge. 3 January 2011. http://www.i-mak.org/storage/IMAK_FINALOverview%201-1-2011.pdf. 19 October 2011.

[17] “Medicines Patent Pool Signs Licenses to Increase Access to HIV/AIDS Medicines.” Medicines Patent Pool. 12 July 2011. http://www.medicinespatentpool.org/LICENSING/Current-Licences/Medicines-Patent-Pool-and-Gilead-Licence-Agreement/Pool-UNITAID-joint-press-release. 19 October 2011.

[18] T’ Hoen, The Global Politics. p. 51.