Public health and human rights organisations from Kenya, Uganda and Malawi filed a third-party observation with the African Regional Intellectual Property Organization (ARIPO) on August 31, challenging all 43 claims in a Gilead Sciences patent application covering prodrug compounds related to the HIV medicine lenacapavir.
ARIPO, a Harare-based intergovernmental intellectual property organisation grants and administers patents on behalf of states that are party to its Harare Protocol, allowing applicants to seek patent protection in designated countries through a single regional application. ARIPO has acknowledged receipt of the filing which was submitted by KELIN from Kenya, Community Health Rights Advocacy (CHeRA) from Malawi, and the Centre for Health, Human Rights and Development (CEHURD) from Uganda. All three organizations are members of the Make Medicines Affordable campaign.
The contested application, AP/P/2024/015692 (titled Prodrug Compounds of an HIV Capsid Inhibitor), was filed by Gilead in December 2022. It claims a broad class of chemical derivatives designed to convert into lenacapavir after administration, alongside related pharmaceutical compositions and uses. It is designated to cover with potential monopoly 20 ARIPO countries, 11 of which are least-developed countries.
Lenacapavir is a groundbreaking, long-acting antiretroviral. In the phase 3 trial published in the New England Journal of Medicine, conducted among adolescent girls and young women in South Africa and Uganda, there were no HIV infections among 2,134 participants receiving twice-yearly injectable lenacapavir. The WHO recommended long-acting injectable lenacapavir as an additional HIV prevention choice in 2025, and Kenya became the first country in East Africa to begin rolling it out in February 2026.
Within the Make Medicines Affordable Campaign, several community-based organizations are challenging Gilead’s patent applications in various LMICs (Fundacion GEP in Argentina, ABIA in Brazil, Ifarma in Colombia, DNP+ in India, ITPC-EECA in EAPO, TNP+ in Thailand, VNP+ in Vietnam, 100% Life in Ukraine).
Challenging secondary patenting
Gilead’s application fails key patentability standards including novelty and inventive step, because the company’s earlier patent applications had already disclosed lenacapavir. Additionally, civil society groups who filed the third-party observation also raise objections regarding the drug’s industrial applicability, sufficiency of disclosure, clarity and unity of invention.
According to the filing, the application contains a broad “Markush” claim potentially encompassing thousands of compounds, while preparation methods and biological data are provided for only 71 specific compounds. Oral bioavailability data are available for only 24 of those 71, while the observers identify six compounds that they say failed to demonstrate improved solubility or bioavailability over lenacapavir.
Granting secondary claims for minor modifications and various aspects of use of known substance is known as patentevergreening – a practice which artificially extends exclusivity for existing medicine and potentially delaying independent generic competition, thereby making medicines and treatments more costly and inaccessible.
“Strong patent systems are not measured by the number of patents granted, but by the quality and legitimacy of the patents that survive rigorous examination,” said Pesa Okania, Programme Officer for HIV/TB and KAPS at KELIN. Okania said the filing also comes as “global health financing is under unprecedented pressure,” increasing the importance of ensuring new health technologies remain affordable.
“Communities across Malawi and the region deserve access to medicines based on genuine innovation—not extended exclusivity through incremental modifications that do not meet the standards for patentability. We are calling on ARIPO examiners to scrutinise this application with the same rigour applied to any patent claim of this scope. The most vulnerable populations in our region should not have to wait longer or pay more for an HIV prevention tool that has already shown its potential to change the trajectory of the epidemic,” said Aniz Mitha, CHeRA, Malawi
ARIPO will now send the observation to Gilead for a response before conducting substantive examination, taking both the TPO and the applicant’s response into account. It will ultimately decide whether to grant or reject the application, a process the filing team expects could take between six and 18 months.
“We urge the ARIPO to exercise maximum care and caution while examining the patent application, following established standards set out in the UNDP Guidelines for the Examinations of Patent Applications Relating to Pharmaceuticals (2016), while keeping the best interests of member states in paramount consideration,” stated Seth Nimwesiga, CEHURD’s Legal and Policy Advocacy Officer.
“Targeting 11 least-developed countries with this application is a strange strategy on its face. The TRIPS LDC waiver exists precisely because these countries have the least capacity to bear patent monopolies and the most to lose in terms of public health and local manufacturing opportunities. Pursuing exclusivity here anyway — on claims that fail ARIPO’s own patentability threshold — works against the very rationale the international community built into the TRIPS Agreement,” emphasized Othman Mellouk, Access to Medicines and Health Technologies Lead at ITPC.