Compulsory license

Article 31 applies where the law of a WTO Member allows other use of the subject matter of a patent without the authorization of the right holder, including use by the government or by third parties authorized by the government. Other use means use other than that allowed under Article 30¹. The WTO notes that the Agreement does not list the reasons that may justify compulsory licensing. National emergencies, other circumstances of extreme urgency and anti-competitive practices are mentioned only as cases where some normal requirements do not apply². Where the law allows such use, Article 31 says the following provisions shall be respected¹:

• Individual merits (31(a)). Authorization of such use is considered on its individual merits¹.
• Prior attempt to license (31(b)). The proposed user must first have made efforts to obtain authorization from the right holder on reasonable commercial terms, without success within a reasonable period. A Member may waive this in a national emergency, other circumstances of extreme urgency, or public non-commercial use. In an emergency or extreme urgency the right holder is notified as soon as reasonably practicable, and in public non-commercial use the right holder is informed promptly where the government or its 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 it¹.
• Limits on scope (31(c) to (e)). Scope and duration are limited to the purpose of the authorization. For semi-conductor technology, use is only for public non-commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive. The use is non-exclusive and non-assignable, except with that part of the enterprise or goodwill which enjoys it¹.
• Domestic market (31(f)). Use is authorized predominantly for the supply of the domestic market of the Member authorizing it¹. For members using the Article 31bis system, this condition does not apply to the exporting member to the extent set out in Article 31bis (see below)^3,4.
• Termination (31(g)). Authorization is liable to be terminated, subject to adequate protection of the legitimate interests of those authorized, if and when the circumstances that led to it cease to exist and are unlikely to recur. The competent authority can review that on motivated request¹.
• Remuneration and review (31(h) to (j)). The right holder is paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization. The legal validity of the decision, and any decision on remuneration, is subject to judicial review or other independent review by a distinct higher authority¹.
• Anti-competitive practices (31(k)). Members need not apply the conditions in 31(b) and 31(f) where the use remedies a practice determined after judicial or administrative process to be anti-competitive¹.
• Dependent patents (31(l)). Where the use permits exploiting a second patent that cannot be exploited without infringing a first patent, the second invention must involve an important technical advance of considerable economic significance, the owner of the first patent is entitled to a cross-license on reasonable terms, and the use authorized for the first patent is non-assignable except with the second patent¹.

The Protocol of 6 December 2005 amending the TRIPS Agreement entered into force on 23 January 2017. It inserted Article 31bis, an Annex and an Appendix, which give WTO members the legal basis to grant special compulsory licenses exclusively for the production and export of affordable generic medicines to other members that cannot domestically produce the needed medicines in sufficient quantities³.

The WTO says the amendment became part of the Agreement after acceptance by two thirds of its members, took effect on 23 January 2017 and replaced the 2003 waiver for members that have accepted it. The WTO page, as accessed on 22 October 2026, says members yet to accept the amendment currently have until 31 December 2027 to do so, and that for them the waiver continues to apply until the amendment takes effect for them⁵.

• Importation (5A(1)). Importation by the patentee into the country where the patent was granted of articles manufactured in any country of the Union does not entail forfeiture of the patent⁶.
• Compulsory licenses (5A(2)). Each country of the Union may legislate for compulsory licenses to prevent abuses that might result from exercising the exclusive rights, for example failure to work⁶.
• Forfeiture (5A(3)). Forfeiture of the patent shall not be provided for except where compulsory licenses would not have been sufficient to prevent the abuses. No proceedings for forfeiture or revocation may be instituted before two years from the grant of the first compulsory license⁶.
• Failure to work (5A(4)). A compulsory license cannot be applied for on the ground of failure to work or insufficient working before four years from the filing date or three years from the grant, whichever expires last, and it is refused if the patentee justifies the inaction by legitimate reasons. Such a license is non-exclusive and not transferable, even by sub-license, except with that part of the enterprise or goodwill which exploits it⁶.

The examples below are not a survey of all countries, and each is a summary of the cited text. Check the current text before relying on it.