Compulsory license

Copyright law

In a number of countries, copyright law provides for compulsory licenses of copyrighted works for specific uses. In many cases the remuneration or royalties received for a copyrighted work under compulsory license are specified by local law, but may also be subject to negotiation. Compulsory licensing may be established through negotiating licenses that provide terms within the parameters of the compulsory license. Essentially compulsory licensing provide that copyright owners may only exercise the exclusive rights granted to them under copyright law in a certain way and through a certain system.

Berne Convention

Article 11bis(2) and Article 13(1) of the Berne Convention for the Protection of Literary and Artistic Works provide the legal basis for compulsory licensing at the international level. They specify under which conditions members to the Berne Convention may determine or impose conditions under which exclusive rights may be exercised, for example through compulsory licensing. The Berne Convention states that member states are free to determine the conditions under which certain exclusive rights may be exercised in their national laws. They also provide for the minimum requirements to be set when compulsory licenses are applied, such as that they must not prejudice the author's right to fair compensation.

Article 11bis(2) states that:

The "preceding article" mentioned in Article 11bis(2) is Article 11bis(1), which establishes that:

Article 13(1) states that:

In addition to the exclusive rights mentioned in Article 11bis(1) and 13(1) the Berne Convention also provides that members may determine or impose such conditions for the exercise of exclusive rights in cases where an exclusive right is not provided as remuneration right and not as an exclusive right of authorisation, for example in the case of the resale right, or droit de suite (Article 14ter), and the so-called "Article 12 rights" of performers and producers of phonograms. Members to the Berne Convention may also determine or impose such conditions where the restriction of an exclusive right to the mere right to remuneration is allowed, for example the right to reproduction (Article 9(2)), and in the case of "residual rights", that is, a right to remuneration, usually for authors or performers, that survives the transfer of certain exclusive rights.

United States

There are several different compulsory license provisions in United States copyright law, including for non-dramatic musical compositions, public broadcasting, retransmission by cable systems, subscription digital audio transmission, and non-subscription digital audio transmission such as Internet radio. The compulsory license for non-dramatic musical compositions under Section 115 of the Copyright Act of 1976 allows a person to distribute a new sound recording of a musical work, if that has been previously distributed to the public, by or under the authority of the copyright owner. There is no requirement that the new recording be identical to the previous work, as the compulsory license includes the privilege of rearranging the work to conform it to the recording artist's interpretation. This does not allow the artist to change the basic melody or fundamental character of the work. In order to take advantage of this compulsory license the recording artist must provide notice and pay a royalty. The notice must be sent to the copyright owner, or if unable to determine the copyright owner, to the Copyright Office, within thirty days of making the recording, but before distributing physical copies. Failure to provide this notice would constitute copyright infringement. In addition to the notice to the copyright owner, the recording artist must pay a royalty to the copyright owner. This royalty is set by three copyright royalty judges. Though the compulsory license allows one to make and distribute physical copies of a song for a set royalty, the owner of the copyright in the underlying musical composition can still control public performance of the work or transmission over the radio. If the underlying musical work is well known, the work can be licensed for public performance through a performance rights organization such as ASCAP, BMI, or SESAC.

According to Register of Copyrights Marybeth Peters, use of the section 115 license prior to the 1995 enactment of the Digital Performance Right in Sound Recordings Act was extremely rare, with the U.S. Copyright Office receiving fewer than 20 notices of such licenses per year. By 2003, that number had risen to 214, which, while higher, was not considered by the Register to be significant.

Patents

Many patent law systems provide for the granting of compulsory licenses in a variety of situations. The Paris Convention of 1883 provides that each contracting State may take legislative measures for the grant of compulsory licenses. Article 5A.(2) of the Paris Convention reads:

According to historian Adrian Johns, the idea of compulsory licensing "seems to have originated as a serious proposition in the 1830s, although predecessors can be traced back into the eighteenth century," and it was popular in the British anti-patent movement of the 1850s and 1860s. More recently an area of fierce debate has been that of drugs for treating serious diseases such as malaria, HIV and AIDS. Such drugs are widely available in the western world and would help to manage the epidemic of these diseases in developing countries. However, such drugs are too expensive for developing countries and generally protected by patents.

United States

In the United States, if the federal government or one of its contractors infringes a patent, the only remedy available to patent holders is a lawsuit in the Court of Federal Claims. It is the policy of the U.S. Department of Defense to allow contractors to infringe patents and to defend the contractor against patent infringement claims at government expense.{{cite journal | author=Brown, Allison | publisher=National Defense Industrial Association | journal=National Defense | date=July 2010 | title=Companies Raise Intellectual Property Protection Issues | url=http://www.nationaldefensemagazine.org/archive/2010/July/Pages/CompaniesRaiseIntellectualPropertyProtectionIssues.aspx | access-date=2012-09-19 | archive-url=https://web.archive.org/web/20110113021521/http://www.nationaldefensemagazine.org/archive/2010/July/Pages/CompaniesRaiseIntellectualPropertyProtectionIssues.aspx | archive-date=2011-01-13 }} Use of this provision by agencies other than Department of Defense is rare. During the 2001 anthrax attacks through the US Postal Service, the US government threatened to issue a compulsory license for the antibiotic drug ciprofloxacin, if the patent owner, Bayer, didn't lower the price to the government. Bayer lowered the price and the government backed down on the threat.{{cite journal | title=Compulsory licensing of patented pharmaceutical inventions: evaluating the options | last=Reichman | first=Jerome H | journal=Journal of Law, Medicine & Ethics | date=Summer 2009| volume=37 | issue=2 | pages=247–263 | doi=10.1111/j.1748-720X.2009.00369.x|pmid = 19493070|pmc = 2893582}}

India

In India, compulsory license may be issued by the Controller General of Patents, Designs and Trade Marks under section 84(1) of The Patents Act, 1970, if:

1. The reasonable requirements of the public with respect to the patented invention have not been satisfied, or,
2. the patented invention is not available to the public at a reasonably affordable price, or,
3. the patented invention is not worked in the territory of India.

In March 2012, India granted its first compulsory license ever to Indian generic drug manufacturer Natco Pharma for Sorafenib tosylate, a cancer drug patented by Bayer.

South Africa

In November 2025, HIV patient advocates called on the South African government to issue a compulsory license for a new HIV prevention medicine called lenacapavir after the Trump administration left South Africa out of a donation program for low-income countries. They warn that excluding South Africa will undermine both the country’s HIV prevention efforts and the World Health Organization’s goal of ending HIV as a public health threat by 2030, stressing that any serious access plan must include South Africa. Their demands follow a U.S. State Department announcement that 1,000 doses of the Gilead Sciences drug were recently shipped to Zambia and Eswatini as the first deliveries in a Global Fund distribution initiative announced late last year.

Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs)

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) also sets out specific provisions that shall be followed if a compulsory license is issued, and the requirements of such licenses. The TRIPS compulsory licensing framework was originally enshrined in its entirety within Article 31. The key tenets of Article 31 have been summarized as follows:

:"First, compulsory licenses can only be granted by governmental bodies, although no restrictions are imposed on their nature, composition, or function (Article 31(a)). Second, each compulsory license application must be considered “on its individual merits.”180 This does not preclude WTO members from enacting laws that establish presumptions in favor of issuing compulsory licenses, but it does exclude “blanket” grants (Article 31(a)). Third, the lawful award of a compulsory license is conditional on the prospective licensee having first undertaken “efforts” to obtain a consensual license from the patentee on “reasonable commercial terms and conditions,” and that such efforts were not “successful within a reasonable period of time.” This requirement does not apply in “circumstances of extreme urgency” or for “public non-commercial use,” though the issuing WTO member must notify the patent holder of such compulsory licenses without delay (Article 31(b)). Fourth, any governmental act awarding a compulsory license must specify its scope and duration, and such limitations must legally bind the licensee (Article 31(c)). Fifth, WTO members can only issue compulsory licenses that are nonexclusive and nonassignable (Article 31(d)-(e)). Sixth, article 31(f) specifies that compulsory licenses must be “authorized predominantly for the supply of the domestic market” of the issuing country. Notably, this provision does not impose a methodology for quantifying such predominance, allowing WTO members to choose their own measuring parameters. Nevertheless, the elasticity of the word “predominantly” is not boundless, making the substance of this restriction unequivocal (Article 31(f)). Seventh, WTO members must confer an “adequate remuneration” to patent holders that are subject to compulsory licenses, based on the relevant circumstances and the economic value of the protected invention (Article 31(h)). Eighth, consistently with the rule of law principle permeating the entirety of TRIPS, WTO members must ensure that patentees have a right to judicially challenge both the issuance of a compulsory license and the amount of compensation received (Article 38(i)-(j)."

All major national patent systems comply with the TRIPs. At national lever, examples of situations in which compulsory license may be granted include lack of working over an extended period in the territory of the patent, inventions funded by the government, failure or inability of a patentee to meet a demand for a patented product and where the refusal to grant a license leads to the inability to exploit an important technological advance, or to exploit a further patent.

Article 31 has been highly divisive. Some Commentators have posited that it unjustifiably hinders WTO members’ sovereign prerogatives to issue compulsory licenses to pursue public policy objectives and remedy abusive conduct by entrenching impregnable safeguards for patentees. However, other commentators have suggested that the Article 31 "regime is built on the premise that WTO members may subject any patent, including patents on pharmaceuticals, to a compulsory license, regardless of the nature of the invention or whether it covers a product or a process at any moment in time during their protection term. Article 31 does not curtail the grounds on which a WTO member may issue compulsory licenses, nor does it dictate minimum substantive or evidentiary thresholds for such grants. Furthermore, all procedural and substantive protections for patentees mandated by this provision are built around broad and general standards, such as “reasonable commercial terms and conditions,” “circumstances of extreme urgency,” “purpose,” and “adequate remuneration,” that afford ample flexibility in their implementation. In our view, article 31 unequivocally enshrines into international intellectual property law the principle that compulsory licenses are a highly adaptable instrument that countries are free to tailor as broadly or narrowly as they deem appropriate for their domestic socioeconomic milieu. It is this ample discretion that constitutes the normative core of the TRIPS compulsory licensing regime, not the relatively narrow safeguards that it affords to patentees."

Doha Declaration

At the 2001 Fourth Ministerial Conference in Doha, bolstered by swelling support from scholars and activists, a group of WTO members submitted a proposal to fundamentally reform articles 27 and 31 of TRIPS. Though this initiative was resisted by developed WTO members, it laid the ground for the unanimous adoption of the WTO Declaration on the TRIPS Agreement and Public Health the “Doha Declaration”. The opening paragraphs of the Doha Declaration recognized the importance of patent protection for medical inventions but coextensively acknowledged “concerns about its effects on prices.” (“We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices.” Doha Declaration ¶ 3). This was followed by a statement reaffirming the sovereign prerogative of WTO members to grant compulsory licenses and their “freedom to determine the grounds” on which they are issued. (Doha Declaration ¶ 5) Expressing the key concern of the Doha Declaration, paragraph 6 accepted the difficulties faced by countries with insufficient pharmaceutical manufacturing capabilities in “making effective use of compulsory licensing under the TRIPS Agreement,” and it instructed the Council for TRIPS to develop an “expeditious solution.” (Expressing the key concern of the Doha Declaration, paragraph 6 accepted the difficulties faced by countries with insufficient pharmaceutical manufacturing capabilities in “making effective use of compulsory licensing under the TRIPS Agreement,” and it instructed the Council for TRIPS to develop an “expeditious solution.”). This was an explicit admission that the original TRIPS framework was flawed.

In 2003, after two years of contentious negotiations,217 the TRIPS Council adopted the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health [the “Waiver Decision”], under which it instituted a temporary “waiver” allowing WTO members to grant compulsory licenses free from the obligations imposed by articles 31(f) and 31(h) (General Council Decision, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WTO Doc. WT/L/540). In 2005, the WTO's General Council adopted the Protocol Amending the TRIPS Agreement (the “Amendment Protocol”), which incorporated the substance of the Waiver Decision into TRIPS via the addition of article 31bis, its annex, and the appendix to the annex [the “Article 31bis System”] (General Council Decision, Amendment of the TRIPS Agreement, WTO Doc. WT/L/641 (Dec. 6, 2005)). The Amendment Protocol entered into force in 2017 after ratification by two-thirds of WTO members.

On 17 May 2006 the European Commission's official journal published Regulation 816/2006, which brings into force the provisions of the Doha Declaration. This means that the declaration now has legal effect in the European Union, and also in Canada who implemented it in 2005.

Article 31bis compulsory licensing has been described as follows:

:“The Article 31bis System allows a WTO member with “insufficient or no manufacturing capacities in the pharmaceutical sector” (the “Importing State”) to import patented “pharmaceutical products” produced under a special export compulsory license granted by another WTO member (the “Exporting State”). Procedurally, this mechanism is structured as a dialogical interaction between an Importing State and an Exporting State. At the outset, the Importing State must send a notice to the TRIPS Council. This notice document is not subject to approval but must contain determinate information, including the pharmaceutical product(s) that will be imported and the “expected quantity” required. Moreover, unless the Importing State is an LDC, it must self-certify its lack of capabilities to produce the drug in question domestically and confirm that it has granted, or intends to grant, a compulsory license in accordance with article 31 for the patented pharmaceutical product in question. Once the TRIPS Council has received the Importing State’s notification, the Exporting State can issue an export compulsory license that must still conform with article 31 but which, crucially, is exempt from article 31(f) “to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s).” The terms of this compulsory license must bind the licensee both to manufacture the patented pharmaceuticals in a quantity no greater than that notified to the TRIPS Council and to export all of them to the Importing State. Additionally, these products must be clearly identifiable “through specific labelling or marking,” as well as distinguishable through special “packaging and/or colouring/shaping of the products themselves.” The Exporting State must also promptly notify the TRIPS Council that it has issued the export compulsory license and provide its terms. Prior to shipment, the licensee must create a website through which it discloses the exact quantities of pharmaceuticals supplied to the Importing State and the markings that render them distinguishable. The Exporting State is required to pay compensation to the patent holder, “taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member.” Notably, a WTO member is eligible to be an Importing State only if it has notified the TRIPS Council of its intention to use the Article 31bis System. At the time of writing, thirty-seven developed WTO members have elected either not to rely on export compulsory licenses or to only rely on them in circumstances of extreme urgency. These opt-outs were expressed when the Amendment Protocol was adopted, almost as an informal political pact among technologically advanced countries not to encroach on pharmaceutical patentees’ rights. Ironically, the COVID-19 pandemic has exposed the short-sightedness of this accord. As several developed WTO members began to confront the inadequacy of their mRNA vaccine production capabilities and struggle to secure sufficient supplies to protect their populations, sensitivity toward the plight of patentees appears to have suddenly diminished.”

References

References

1. Copinger & Skone James on Copyright, Volume 1, Pg: 1589
2. (2004). "WIPO Guide on the Licensing of Copyright and Related Rights". World Intellectual Property Organization.
3. Gervais, Daniel. (December 2023). "Collective management of copyright and related rights". Wolters Kluwer.
4. (2004). "WIPO Guide on the Licensing of Copyright and Related Rights". World Intellectual Property Organization.
5. Gervais, Daniel. (January 2024). "Collective management of copyright and related rights". Wolters Kluwer.
6. Gervais, Daniel. (December 2023). "Collective management of copyright and related rights". Wolters Kluwer.
7. {{usc. 17. 115
8. {{USCSub. 17. 118
9. {{USCSub. 17. 111. c
10. {{USCSub. 17. 114. d. 2
11. {{USCSub. 17. 114. d. 1
12. {{USCSub. 17. 115
13. {{USCSub. 17. 115. a. 1
14. {{USCSub. 17. 115. a. 2
15. {{USCSub. 17. 115. b
16. {{USCSub. 17. 115. c
17. {{USCSub. 17. 106. 4
18. Peters, Marybeth. (2004-03-11). "Statement of Marybeth Peters The Register of Copyrights before the Subcommittee on Courts, The Internet and Intellectual Property of the House Committe {{sic". U.S. Copyright Office.
19. [https://www.wipo.int/wipolex/en/text/288514#P123_15283 Article 5A.(2) of the Paris Convention]. [[WIPO Lex]]. Retrieved 2025-05-22
20. Johns, Adrian: ''Piracy. The Intellectual Property Wars from Gutenberg to Gates''. The University of Chicago Press, 2009, {{ISBN. 978-0-226-40118-8, p.274
21. {{USCSub. 28. 1498
22. Nayanikaa Shukla. (January 18, 2019). "Compulsory Licensing In India".
23. Sameer Avasarala. (April 27, 2019). "Government Use of Patents: Understanding of Limits & Evolving Indian Jurisprudence in Comparative Light".
24. Maricel Estavillo. (March 12, 2012). "India Grants First Compulsory Licence, For Bayer Cancer Drug". Intellectual Property Watch.
25. Silverman, Ed. (2025-11-20). "South Africa is urged by advocates to issue a compulsory license for Gilead's HIV prevention drug".
26. Hill, Andrew. (2025-10-06). "The Need for Lenacapavir Compulsory Licences in Ending the HIV Epidemic". Clinical Infectious Diseases.
27. "Digital Press Briefing on breakthrough HIV drug Lenacapavir's Delivery and the America First Global Health Strategy".
28. (January 2023). "Access to Medicines and Pharmaceutical Patents: Fulfilling the Promise of TRIPS Article 31bis". Fordham Law Review.
29. (2011). "TRIPS Was Never Enough: Vertical Forum Shifting, FTAS, ACTA, and TPP". J. Intell. Prop. L..
30. (2008). "Over 5 Billion Not Served: The TRIPS Compulsory Licensing Export Restriction". U. Ottawa L. & Tech. J..
31. [http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:157:SOM:EN:HTML EUR-Lex L 157 Volume 49], 9 June 2006, p.1: ''Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems''
32. J. Cornides, European Union Adopts Regulation on Compulsory Licensing of Pharmaceutical Products for Export, The Journal of World Intellectual Property 10.1 (2007): 70-77.