On Thursday, 24 July 2025, the United Kingdom published the text of the Comprehensive Economic and Trade Agreement (CETA) between the United Kingdom of Great Britain and Northern Ireland and India and associated documents. The agreement consists of 30 chapters and the associated documents consist of ten side letters, including six on intellectual property (mainly focusing on geographical indications). The text of CETA can be found here: https://www.gov.uk/government/collections/comprehensive-economic-and-trade-agreement-between-the-united-kingdom-of-great-britain-and-northern-ireland-and-india.
Chapter 13 is entitled, “Intellectual Property Rights” and numbers fifty pages. Chapter 14 is entitled, “Innovation” and is four pages long.
KM Gopakumar, Legal Advisor and Senior Researcher at the Third World Network (TWN) provided the following observations:
The IP chaper undermines policy space to facilitate the access to medicines on two grounds:
1) It explicitly mentions the preference of voluntary licensing over compulsory licensing.
2) It reinforces the precedent contained in the European Free Trade Association – Iceland, Liechtenstein, Norway, and Switzerland – and the Republic of India comprehensive Trade and Economic Partnership Agreement (TEPA) provision which allows the patent holder to withhold information on working of patents for three years .
He noted that the UK-India CETA will establish an “explicit preference on voluntary licensing which will in create a chilling effect on the generic availability of health technologies.”
Leena Menghaney, Lawyer, Public Health & IP, provided the following comments:
As civil society working on access to treatment, we welcome the Indian government’s firm stance against including TRIPS-plus provisions—such as patent term extensions, patent linkage, and data exclusivity—in trade agreements, particularly in the UK-India and India-EFTA negotiations.
However, we are deeply concerned that these agreements represent a serious rollback of India’s patent working disclosure safeguards. Both FTAs exert direct pressure on India to dilute its domestic requirements on the working of patents, favouring multinational pharmaceutical corporations that hold the majority of pharmaceutical patents in the country.
Under Indian law, a pharmaceutical patent that is not being ‘worked’—meaning not adequately made available at affordable prices—can trigger the issuance of a compulsory license to enable generic competition. When working data is delayed or not disclosed, it becomes significantly harder to invoke this critical public interest safeguard, which plays a vital role in improving access to affordable generic versions of patented medicines. These trade agreements threaten to undermine a key TRIPS flexibility that India has effectively used in the past.
For example, in 2012, working data submitted to the Indian Patent Office demonstrated that Bayer was not adequately working its patent for the cancer drug sorafenib, forming the basis for the successful compulsory license granted to Natco, which reduced the price of the drug by over 97%. Weakening such safeguards would be a grave setback for patients relying on affordable medicines.
While the IP chapter of CETA contains no language on test data exclusivity, it contains, inter alia, provisions on “Understandings Regarding TRIPS and Public Health Measures”, “Transparency”, “Exhaustion of Intellectual Property Rights”, “Cooperation”, “Working Group on Intellectual Property Rights”, “WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore”, “Cooperation in the Area of Traditional Knowledge Associated with Genetic Resources”, “Cooperation on Transfer of Technology”, “Patentable Subject Matter”, “Exceptions’, “Regulatory Review Exception”, “Other Use Without Authorisation of the Right Holder”, “Publication of Patent Applications”, “Information Relating to Published Patent Applications and Granted Patents”, “Conditions on Patent Applicants”, “Opposition Proceedings”, “Patent Working Disclosure Requirement”, and “Trade Secrets”.
Much of Article 13.6, Understandings Regarding TRIPS and Public Health Measures, is a recapitulation of language contained in the WTO Doha Declaration on the TRIPS Agreement and Public Health. However, Article 13.6 states:
Article 13.6
Understandings Regarding TRIPS and Public Health Measures
1. The Parties recognise the preferable and optimal route to promote and ensure access to medicines is through voluntary mechanisms, such as voluntary licensing which may include technology transfer on mutually agreed terms.
As noted by TWN, CETA establishes precedent for policymakers in India and the United Kingdom to recognize voluntary licensing on “mutually agreed terms” as the “preferable and optimal route to promote and ensure access to medicines”.
Article 13.9 on transparency states:
1. Each Party shall endeavour to publish online its laws, regulations, procedures, and administrative rulings of general application concerning the protection and enforcement of intellectual property rights.
2. Each Party shall, subject to its law, endeavour to publish online information that it makes public concerning applications for trade marks, geographical indications, registered designs, patents, and plant variety rights.
3. Each Party shall, subject to its law, publish online information that it makes public concerning registered or granted trade marks, geographical indications, designs, patents, and plant variety rights, sufficient to enable the public to become acquainted with those registered or granted rights.
Article 13.9 on transparency is undermined by Article 13.56 – Patent Working Disclosure Requirement.
Article 13.56 states:
1. Neither Party shall require a patent owner to provide annual disclosure of information concerning the working of a patent. Where a Party provides for periodic disclosure of information concerning the working of a patent, the periodicity shall not be less than three years and confidential information contained in the disclosure shall not be made available in the public domain, other than in exceptional circumstances.
2. Notwithstanding paragraph 1, a Party may require a patent owner to provide a disclosure concerning the working of a patent, in a given case, in accordance with its law.
3. Pursuant to paragraphs 1 and 2, failure to disclose information concerning the working of a patent shall not result in imprisonment.
Leena Menghaney provided this analysis on Article 13.56:
The UK-India CETA removes a vital tool for early detection of non-working patents and obscures information on patented technologies, limiting public interest interventions. The CETA ends annual disclosure, and weakens oversight. The reduced frequency and transparency benefits large patent holders at the cost of public access and accountability.
In Indian law, a patent not being “worked” can trigger a compulsory license: Delayed or missing working data makes it much harder and slower to invoke this public interest safeguard. The FTAs therefore obstruct a key TRIPS flexibility that India has successfully used in the past. How: Non-working can lead to CL but delayed data + less transparency = delayed and more difficult compulsory licensing process for expensive patented medicines. Form 27 disclosures have played a crucial role in enabling compulsory licenses—e.g., in the Natco vs Bayer case (Nexavar). Civil society, health groups, and academics routinely use Form 27 data to monitor whether patentee is working the patent in a manner that meets the needs of patients and public health. In the past, treatment activists used the data to monitor Otsuka’s failure to work the patent on delamanid in India as it failed to supply the drug for DR-TB patients desperately in need of new TB drugs in their treatment regimens.
Conclusion: TRIPS-Plus and Rollback of Indian Law
The provisions in Article 12 (EFTA-India) and Article 13.56 (UK-India) represent a clear rollback of India’s public health-oriented patent safeguards. These FTAs have put direct pressure on India to weaken its domestic rules on working of patents to favour pharmaceutical corporations who hold majority of pharmaceutical patents in India.
Article 13.14 on Cooperation vitiates India’s policy space in relation to international harmonization and the positions India advocates for at the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO).
Article 13.14(2) states:
2. In addition, the Parties shall endeavour to cooperate in relation to activities for improving the international intellectual property regulatory framework, including by:
(a) fostering international harmonisation, administration and enforcement of intellectual property rights; and
(b) working together at the WTO and WIPO on relevant activities including in relation to relevant multilateral intellectual property agreements.
Article 13.15 establishes a Working Group on Intellectual Property Rights to “review and monitor the implementation and operation” of the IPRs chapter.
In terms of its composition, Article 13.15(1) states:
The Parties hereby establish a Working Group on Intellectual Property Rights composed of government representatives of each Party. The Working Group may also invite experts to attend meetings and advise the Working Group on any matter falling within its functions.
In relation to its periodicity, Article 13.(15(4) states:
Without prejudice to other provisions under this Chapter, the Working Group shall meet within one year of the date of entry into force of this Agreement and thereafter annually if requested by either Party.
On WIPO’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, Article 13.20 states:
The Parties affirm their commitment to work together through discussion and by the exchange of information at the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore.
Article 13.21 establishes “Cooperation in the Area of Traditional Knowledge Associated with Genetic Resources” between India and the United Kingdom.
In relation to patent examination, Article 13.21(2) provides a shall endeavour clause which references India’s Traditional Knowledge Digital Library.
2. The Parties shall endeavour to pursue quality patent examination, which shall
include:
(a) that in determining prior art, relevant publicly available documented information related to traditional knowledge associated with genetic resources may be taken into account;
(b) an opportunity for third parties to cite, in writing, to the competent examining authority prior art disclosures that may have a bearing on patentability, including prior art disclosures related to traditional knowledge associated with genetic resources; and
(c) the use of databases or digital libraries containing genetic resources and associated traditional knowledge, such as India’s Traditional Knowledge Digital Library, if reasonably accessible, applicable and appropriate.
With respect to cooperation on transfer of technology, Article 13.22 states:
The Parties agree to exchange views and information on their practices and policies affecting the voluntary transfer of technology. This may include measures to facilitate information flows, business partnerships, licensing and subcontracting deals, on a voluntary basis.
With respect to the transfer of technology, the Parties shall ensure that the legitimate interests of intellectual property right holders are protected.