Doris Estelle Long, TradeRxReport.com, Link
As the COVID-19 pandemic continues to ravage the globe, we need to consider every avenue that could improve access to critical medicines needed to fight this deadly disease. The primary focus on securing patent waivers under TRIPS makes perfect sense because patents have been the traditional basis for protecting pharmaco-medical innovations, including the technologies for production and delivery. As I have argued earlier, compulsory access to both patents and trade secrets is critical. But we overlook a crucial weapon in the fight for vaccine distribution equity when we give short shrift to the equally important role that copyright can play in bringing the full weight of technology to bear on this deadly scourge.
Copyright, AI and Medical Innovation
Artificial Intelligence (AI) plays an increasingly pivotal role in the manufacture and delivery of health goods and services. From shortened drug development times due to quicker data synthesis and analysis through the use of AI predictive modelling; to e-health, including real-time monitoring of high risk COVID patients and online health consultation services; AI is playing an increasingly prominent role in the creation, production and delivery of medical treatments. In fact, AI has become such a crucial element in innovation that South Africa and Australia have both recognized AI as the legal inventor of a patent, although Australia’s decision in Thaler v Commissioner of Patents is currently on appeal. Yet patents are not the only intellectual property rights implicated by AI works and processes. Copyright plays an equally, if not more significant role, in governing the creation and use of Artificial-Intelligence-based works and processes.
There is no debate that AI software is potentially protectable under copyright. So is the software that runs ventilators and other treatment devices. TRIPs Article 10(1) expressly requires that software be protected as a “literary work” under the Berne Convention. But copyright protection related to medical treatments is not limited to software.
Copyright also protects such critical aspects of medical innovation as text and data mining that use copyright protectable works as an integral component of their technology. As the second edition of the Trilateral Report on Promoting Access to Medical Technologies and Innovation recognized in 2020, these works include creations of compilations of thousands of molecules that are later analyzed to predict their suitability for blocking the mechanism of a pathogen; data sets to create the machine learning and neural networks that make up the backbone of artificial intelligence; compiled genetic information and medical records mined to identify linkages between genetic mutations and disease; and collections of scientific journals and other works for trends, patterns or other useful information in conducting medical research. TRIPS Article 10(2) requires that such “compilations of data or other material” be protected where “the selection or arrangement of their contents constitute intellectual creations.” (Emphasis added) In short, where such compilations evidence originality under copyright. All of these copyrightable works would be available for unfettered use under the present TRIPS Waiver proposal.
Copyright Under the TRIPS Waiver Proposal
The TRIPS Waiver proposal, originally tabled by India and South Africa in October 2020, specifically included copyright within its scope. As modified by the May 2021 Revised Decision Text, the proposal seeks a “waiver” from “the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement.” This waiver applies “in relation to prevention, containment or treatment of COVID-19, including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19.” “Section 1” is a specific reference to the copyright section of TRIPS. The remaining referenced sections deal with industrial designs, patents, and trade secrets (undisclosed information), respectively.
Adding Copyright to Health Emergency Legislation
Many countries, such as Canada, Germany, Australia, Israel, Columbia and Indonesia have already enacted special legislation creating compulsory license regimes to combat public health crises like COVID. Yet to date, no legislation has included copyright within the scope of its special public health compulsory licensing regimes. It is time to consider its utility.
Compulsory licenses for copyrights are well established under domestic and international law. Even the United States, who is notoriously reluctant to impose compulsory licenses for patents, grants compulsory copyright licenses for a wide array of purposes, including for distribution of digital musical works on interactive streaming services, for use in distance learning and for certain charitable events.
Admittedly, TRIPS contains no copyright provision equivalent to the extensive controls and restrictions on the patent compulsory licensing provisions of Articles 31 and 31bis. To the contrary, the only copyright compulsory license that it mentions is a grandfathered compulsory rental right under Article 14(4). But TRIPS does incorporate by reference compulsory licenses permitted under the Berne Convention. These include Article 11bis(2) for broadcasting rights and Article 13(1) for sound recordings for musical works. It also includes a compulsory license for developing countries to create and distribute translations of copyrighted works into local languages for purposes of “teaching, scholarship and research” under the Berne Appendix.
All three Berne compulsory license provisions require “equitable remuneration” or “just compensation” to the copyright holder. The restrictions imposed on the compulsory licenses under Articles 11 and 13 bear little resemblance to the detailed requirements for patent licenses under TRIPS Article 31. By contrast, the restrictions under the Berne Appendix strongly foreshadow TRIPS Article 31.
Similar to Article 31, the “just compensation” due the copyright holder under the Berne Appendix must be “consistent with standards of royalties normally operating on licenses freely negotiated between persons in the two countries concerned.” The prior negotiation obligation of TRIPS is also reflected in the Berne Appendix. Licenses are only available if the licensee has been denied authorization to make, publish or distribute the translation by the copyright holder, assuming the holder is locatable.
The grant of compulsory licenses under copyright for public health purposes plainly falls with the scope of permissible activities under the Doha Declaration on TRIPS and Public Health. Doha not only recognizes that TRIPS “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,” but also expressly recognizes that Member countries have “the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.” It did not limit this language to patents.
The significance of Doha in providing grounding for extraordinary measures like compulsory licenses to combat COVID was even reaffirmed by the US Government in its 2021 Special 301 Report when it declared: “International obligations such as those in the TRIPS Agreement provide flexibility for trading partners to take measures to address serious public health emergencies and circumstances of extreme urgency within that trading partner’s territory.” (Emphasis added). The reality is that the “flexibilities” at the heart of Doha are even stronger in copyrights than in patents.
Fair Use and Public Health Under TRIPS
Although as I’ve indicated in earlier articles, TRIPS Article 30 establishes an underutilized fair use provision for patents, it is Article 13 that establishes the right to uncompensated compulsory licenses “in certain special circumstances, which do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holder.” The critical role of this three-step test is reflected in its adoption in all subsequent plurilateral copyright treaties – Article 10 of the WIPO Copyright Treaty, Article 16 of the WIPO Performances and Phonograms Treaty and Article 13 of the Beijing Treaty on Audio Visual Performances.
There may be no more flexible provision in TRIPS than Article 13 whose flexibilities relate solely to copyright and related (neighboring) rights. These flexibilities does not establish an unfettered right to ignore copyrights for works that have only a tangential relationship to treating COVID. But it does provide a useful framework for crafting, not only a compulsory licensing scheme for copyright; but also a limited fair use/fair dealing right under domestic law for those works, like AI software and related data compilations, that are critical to the treatment of public health emergencies. One of the clearest international examples of such public interest applications of Article 13 is the Marrakesh Treaty on Visual Impairment that use the three-step test to provide access to copyrighted works for the visually impaired.
Ignoring Copyright Implications of AI and Public Health
We are past the time when we can ignore the reality that AI, and its close companion “big data,” serves a fundamental, perhaps irreplaceable, role in the creation, production and delivery of pharmaceuticals and other medical treatments. While patents and trade secrets might reach many aspects of AI, they do not reach its fundamental building blocks or even all applications of AI in the medical arena.
Given the history of compulsory licenses under copyright for public interest purposes, there is no reason to exclude such licenses, as needed, for copyrighted works necessary to combat the spread and treatment of diseases under a public health emergency.
Limiting Waivers to Protect Equitable Access Under Articles 13 and 30
Perhaps even more significantly, given the strong recognition under copyright fair use/fair dealing doctrines of the right to uncompensated licenses, TRIPS Article 13 actually supports the waiver of any compensation generally required under compulsory licenses for copyrighted works. TRIPS Council is expected to produce a Ministerial Declaration for consideration at the WTO’s 12th Ministerial Conference from 30 November to 3 December 2021. Before then, waiver supporters should except Article 13 from any waiver. Such an exception would provide a clear signal that fair use/fair dealing remains available to help in the critical battle against COVID-19. Adding an exclusion for Article 30, the patent equivalent to Article 13, should be on the agenda as well.
As the use of AI in the medical field continues to grow, its protection under copyright will become a greater barrier to equitable access to medicines. We need to stop ignoring the role of AI and provide countries with a critical weapon to end the deadly onslaught of COVID-19 in all its variations. The time to act is NOW.
