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3. Compulsory licensing and government use
36. Compulsory licensing derives from article 31 of TRIPS. It enables member States to
license the use of a patented invention for itself or a third party “without authorization” of the
patentee. Although TRIPS places some restrictions on compulsory licences, member States are
free to determine the grounds upon which to issue a compulsory licence, which can include:
(a) refusal to license; (b) public interest; (c) public health and nutrition; (d) national emergency
or situation of extreme urgency; (e) anti-competitive practices; (f) dependent patents; and
(g) failure to exploit or insufficiency of working.40 Member States also have the freedom to
establish new grounds as they deem appropriate.
37. Paragraph 5 (b) of the Doha Declaration specifically reaffirmed the right of member States
to determine the grounds for issuing compulsory licences. Countries are free to provide grounds
to protect public health and promote access to medicines for all. TRIPS does not restrict the use
of compulsory licences to situations of national emergency or other circumstances of extreme
urgency, or to cases of HIV, tuberculosis and malaria. As such, the issuance of compulsory
licences by Thailand on heart disease, cancer and HIV medicines is in compliance with TRIPS.41
38. Government use is a species of compulsory licence, which allows the use of a patented
invention by or for a government for a public non-commercial use. Countries can issue such
licences to third parties to make patented medicines for governments in order to make the
medicines available to the public. The expression “public non-commercial purpose” is not
defined and countries have the freedom to define and implement such use. The United States of
America and the United Kingdom of Great Britain and Northern Ireland patent laws provide
useful examples of how patents can be broadly used for almost any public non-commercial
purpose.42 The restriction under article 31 of prior negotiations with the patentee does not apply
to government use. This allows for a speedy process that assists governments in meeting their
obligations to provide access to medicines.
39. While many countries have adopted mechanisms to issue compulsory licences, the grounds
for use have varied43 and procedures in national laws are at times cumbersome and need to be
streamlined and simplified to facilitate issuance of such licences.
40
See footnote 37, pages 28-30.
41
F. M. Abbott and J. H. Reichman, “The Doha Round’s public health legacy: strategies for the
production and diffusion of patented medicines under the amended TRIPS provisions”, Journal
of International Economic Law, vol. 10, No. 4, (2007), p. 921.
42
C. Oh, “Compulsory licences: recent experiences in developing countries” International
Journal of Intellectual Property Management, vol. 1, No. 1/2 (2006), p. 22.
43
See footnote 18 above, p. 61, Table 6.
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