Trade Agreements & IP

Jonathan Band             The full text of the Intellectual Property Chapter of the United Kingdom-India Comprehensive Economic and Trade Agreement, signed on July 24, 2025, is now available for review. Overall, it is much more favorable to balanced copyright protection and user rights than previously released drafts and summaries.             The provision for copyright exceptions is the same limited language that first appeared in the UK’s proposed text for the IP chapter leaked in 2022. Article 13.68 Limitations and Exceptions 1. A Party may provide limitations or exceptions in its law to the rights provided for in this Section, but shall confine those limitations or exceptions to certain special cases that do not conflict with a normal exploitation of covered subject matter, and do not unreasonably prejudice the legitimate interests of the right holder. 2. This Article is without prejudice to the scope of applicability of the limitations and exceptions to any rights permitted by the TRIPS Agreement and WIPO administered treaties to which a Party is party.             However, the Chapter contains other important language that promotes balance. Thus, Article 13.2(a), setting forth the Objectives of the Chapter, states: the objectives of this Chapter are … that the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations….  (Emphasis supplied.)             The Chapter then sets forth Principles the Parties may follow in formulating amending their laws. First, the Article 13.3(1) provides that a Party may adopt measures necessary “to promote the public interest in sectors of vital importance to its socio-economic and technological development….” Presumably these sectors would include cultural heritage, research, and education.             Second, Article 13.3(2) incorporates language similar to TRIPs Article 40 that appropriate measures may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.             Next, Article 13.4 recites a list of Understandings in respect of the Chapter: [T]he Parties recognise the need to: (a) promote innovation and creativity; (b) facilitate the diffusion of information, knowledge, technology, content, culture and the arts; (c) foster competition and open and efficient markets; (d) maintain an appropriate balance between the rights of intellectual property right holders and the legitimate interests of users and the public interest; (e) establish and maintain transparent intellectual property systems; and (f) promote and maintain adequate and effective protection and enforcement of intellectual property rights to provide confidence to right holders and users, through their respective intellectual property systems, while respecting the principles of transparency and due process, and taking into account the interests of relevant stakeholders, including right holders, service providers, users, and the general public. (Emphasis supplied.) The parties reached these Understandings “having regard to the underlying public policy objectives of their national systems, while recognizing the different levels of economic development and capacity and differences in national legal systems….”             As noted above, the Agreement does not contain detailed obligations concerning copyright exceptions. Nonetheless, Article 13.71 requiring each Party to provide adequate legal protection against unauthorized circumvention of effective technological measures does permit the Parties to take appropriate measures to ensure that beneficiaries may enjoy exceptions and limitations provided for them. Similarly, Article 13.103 requires each Party to maintain a system to limit the liability of Online Service Providers for infringements of copyright committed by users of their services.             Moreover, the language concerning Objectives, Principles, and Understandings provide both the UK and India with sufficient flexibility to adopt robust exceptions that effectively balance the interests of all stakeholders.

Brook K. Baker, Prof. Emeritus, Northeastern U. School of Law, Senior Policy Analyst, Health GAP The MEEPA is a tentatively concluded trade agreement between Malaysia and EFTA (the European Free Trade Association of Iceland, Liechtenstein, Norway and Switzerland) that may soon be signed by the Malaysian government. Malaysian negotiators have accepted intellectual property (IP) protections above those required by the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which will adversely and needlessly affect affordable and equitable access to medicines in Malaysia for generations.  The Malaysian government should instruct its negotiators to reject all of the TRIPS-plus measures discussed below. The TRIPS-plus demands of EFTA are in line with similar demands from the European Union and the United States in their trade agreements that seek to extend monopoly power for Northern biopharmaceutical companies.  These companies seek to expand IP that prevents competition so that they can impose exorbitant (and often secret) prices on middle-income countries like Malaysia.  The result is gross profiteering at the expense of governments, insurers, and patients, who are often priced out of the market. Contrary to MEEPA Article 7.1, Malaysia Should be Permitted to Retain its Existing Right to Issue Compulsory Licences for Failure to Work a Patent Locally Article 7.1 of MEEPA would prevent Malaysia from relying on Section 49 of its Patent Law to issue compulsory licences for failure to work the patent through local manufacture when such manufacture is feasible. Article 7.1 of MEEPA states: ‘In line with TRIPS Article 27 (1), importation and offering on the market shall be considered a way of exploiting the patent in the country of importation. Accordingly, a compulsory licence may not be granted on the sole ground that a product protected by a patent or a product incorporating a patented process is being imported and not locally produced or used.’ In contrast, Section 49(1) of the Malaysian Patents Act states: At any time after the expiration of three years from the grant of a patent, or four years from the filing date of the patent application, whichever is the later, any person may apply to the Registrar for a compulsory licence under any of the following circumstances: (a)  where there is no production of the patented product or application of the patented process in Malaysia without any legitimate reason; (b)  where there is no product produced in Malaysia under the patent for sale in any domestic market, or there are some but they do not meet public demand without any legitimate reason. Article 5A(2) of the Paris Convention, which is incorporated by reference into the TRIPS Agreement via Article 2.1, authorizes countries to provide for compulsory licences in case of failure by the patentee to work the patent domestically. [1] There are time limits affecting when such licences can be issued: the last of either four years from the filing of the patent application or three years after it grant. Although the scope of working rules is not without some controversy,[2] an interpretation that local working requires at least some degree of in-country manufacturing and is TRIPS compliant, at least with respect to the issuance of compulsory licences, has broad support.[3] India, Brazil, Malaysia itself, and other countries, including the Philippines, still have laws allowing compulsory licenses when a patent is not worked via local manufacture or licensed to a local producer.[4]  Likewise, Malaysia should fight to retain the right to issue compulsory licences on the grounds that a patent is not manufactured locally even though it is economically feasible to do so.  Allowing compulsory licenses for failure to manufacture locally enables Malaysia to secure technology transfer, to expand its biopharmaceutical manufacturing capacity, and to help ensure security of supply, including it cases like the COVID-19 pandemic when foreign producers preferentially supplied high-income country demand. Contrary to MEEPA Article 7.3(a), Malaysia Should Maintain the Right to Have an Exception to Patent Rights for Therapeutic Uses of Patented Products. Article 7.3(a) of the MEEPA IP Chapter permits excluding methods of treatment from patentability: “Each Party may also exclude from patentability: any invention of a method for treatment of the human or animal body by surgery or therapy or for diagnostic methods practised on the human or animal body.”  But subsection (a) also adds a disabling exception to this exclusion that would ultimately require Malaysia to issue evergreening use patents on biopharmaceutical products: “This provision (i.e. the exclusion) shall not apply to products, in particular substances or compositions, for use in any of these methods.” Article 27.3(a) of the TRIPS Agreement allows each WTO Member State, including Malaysia, to exclude from patentability: “diagnostic, therapeutic and surgical methods for the treatment of humans or animals.”  This exclusion has been consistently interpreted to allow countries to disallow patents on uses, including new uses, of previously patented biopharmaceutical products.  As a result, many countries limit patents on new or additional uses of known substances (in the pharmaceutical context new indications), and many experts and expert reports have recommended that low- and middle-income countries adopt per se exclusions for patents on new uses or methods of use.[5]  Exclusion of new use or method of use patents is expressly permitted by Article 27.3(a) of the TRIPS Agreement, which permits exclusions of patents on “diagnostic, therapeutic and surgical methods.” Under this approach, “there is no real difference between patent claims relating to the use of a substance and those relating to a therapeutic method: in both cases a new medical activity is claimed, i.e. a new way of using one or more known products.”[6] Andean Community patent law explicitly stipulates that both products and processes already patented and included in the state of the art may not be the subject of a new patent on the sole ground of having been put to a use different from that originally contemplated by the initial patent.  India explicitly prohibits patenting of all new uses and methods of use under section 3(d) of its Amended (2005) Patents Act as does Argentina, Pakistan, and the

Jonathan Band On May 6, 2025, the United Kingdom (UK) and India announced that they had reached agreement on a bilateral free trade deal that includes a chapter on intellectual property.However, no agreement text was released. Rather, the UK Department for Business & Trade issued a summary of the agreement’s terms, and the summary acknowledged that “work is continuing to finalise the legal text and resolve the last issues.” In other words, at this point there is just an agreement to agree, rather than a real agreement. According to the summary, the IP chapter “will support our economies through effective and balanced protection and enforcement of IP rights.” The chapter will cover copyright and related rights, designs, trademarks, geographical indications, patents, and trade secrets, as well as the enforcement of IP rights. The summary provides little detail concerning copyright and related rights. It simply states that India will also commit to engaging on aspects of copyright and related rights, addressing the interests of UK creators, rights holders, and consumers. This includes around public performance rights and artist’s resale rights, which acknowledge the importance of royalty rights. India will also conduct an internal review of their copyright terms of protection.    Further, the summary notes that the chapter “will not commit the UK to domestic legislative change, nor will it undermine the UK’s own IP system or our international positions on IP.” Significantly, the summary is silent on copyright exceptions and limitations. In 2022, a draft of the UK’s proposed text for the IP chapter was leaked. The language concerning copyright exceptions and limitations was limited to the Berne Three Step Test and other treaties: Article H.7: Limitations and Exceptions   1. Each Party may introduce limitations or exceptions in its domestic law to the rights provided for in this Section [H]. but shall confine such limitations or exceptions to certain special cases that do not conflict with a normal exploitation of covered subject matter, and do not unreasonably prejudice the legitimate interests of the right holder.   2. This Article is without prejudice to the limitations and exceptions to any rights permitted by international agreements such as the TRIPS Agreement, the Berne Convention, the Rome Convention, the WCT. or the WPPT.   ​The summary asserts that the agreement would support the economies of the UK and India through “balanced protection” of IP rights, but nothing in the summary, or the UK’s 2022 draft text, reflects balanced protection with respect to copyright. The Three Step Test, by itself, is too ambiguous to provide meaningful balance. Hopefully India insisted upon language that clarified that both parties had the flexibility to adopt more open-ended fair dealing or fair use provisions, like those recently adopted by former British colonies such as Singapore, Malaysia, and Nigeria. For example, the agreement could include language similar to Article 11.18 of the Regional Cooperation for Economic Partnership (RCEP), signed in 2020. That language provides that  3. Each Party shall endeavour to provide an appropriate balance in its copyright and related rights system, among other things by means of limitations and exceptions consistent with paragraph 1, for legitimate purposes, which may include education, research, criticism, comment, news reporting, and facilitating access to published works for persons who are blind, visually impaired, or otherwise print disabled. 4. For greater certainty, a Party may adopt or maintain limitations or exceptions to the rights referred to in paragraph 1 for fair use, as long as any such limitation or exception is confined as stated in paragraph 1. India initially participated in the RCEP negotiations, but withdrew in 2019 over issues unrelated to intellectual property.