By Wallace Mawire
The Pan African Treatment Access Movement (PATAM) and Third World Network (TWN) have submitted a Third-Party Observation (TPO) before the African Regional Intellectual Property Organization (ARIPO), challenging a patent application by Gilead Sciences covering a broad family of HIV-related compounds.
Gilead’s application, titled Bridged Tricyclic Carbamoylpyridone Compounds and Uses Thereof (PCT/US2023/065401; AP/P/2024/016004), was filed on 5 April 2023 and seeks extensive patent protection over a broad genus of HIV integrase inhibitor compounds for the treatment and prevention of HIV infection. Based on information available on ARIPO’s website, the application is undergoing substantive examination.
In the TPO submission, PATAM and TWN argue that highly similar bridged tricyclic carbamoylpyridone compounds had already been disclosed in earlier patent applications, including by Gilead itself, and that the use of spirocyclic scaffolds and related structural modifications was well established in the scientific literature prior to the filing date. The organizations, therefore, contend that the application raises serious questions regarding novelty and inventive step and warrants scrutiny before any patent is granted.
If granted, the patent could take effect across the 21 ARIPO Contracting States of the Harare Protocol on Patents, Utility Models and Industrial Designs, namely: Botswana, Cabo Verde, Eswatini, The Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mauritius, Mozambique, Namibia, Rwanda, São Tomé and Príncipe, Seychelles, Sierra Leone, Sudan, Tanzania, Uganda, Zambia and Zimbabwe.
“The submission represents an important test of ARIPO’s willingness to receive, consider and transparently engage with third-party evidence during the patent examination process”, said Tapiwanashe Kujinga, director of PATAM. “ARIPO should provide clarity on how the information submitted has been taken into account in the examination process. We are confident that the evidence presented demonstrates serious deficiencies in the patent application and warrants scrutiny before any exclusive rights are granted.”
Unlike some other patent offices, ARIPO does not provide a pre-grant opposition procedure; hence, submission of a TPO is the only way for public-interest organisations, researchers, and generic manufacturers to bring relevant prior art and patentability concerns to the attention of examiners before a patent is granted. While a TPO mechanism can contribute to improving patent quality, it is not equivalent to a pre-grant opposition system, which provides a more transparent and accountable process for challenging patent applications.
Local civil society organizations have repeatedly called for stringent and rigorous application of patentability standards, greater transparency, and more robust mechanisms for public participation in ARIPO’s patent examination process. Evidence suggests that patent-extension strategies involving secondary patents on modifications and the use of existing medicines are widespread in the ARIPO region, raising concerns that current patentability standards and examination practices may not be sufficiently rigorous.
The challenge comes at a time when many African countries are facing growing uncertainty over HIV financing, treatment continuity, and access to medicines following major cuts in aid. Against this backdrop, PATAM and TWN argue that ARIPO must exercise heightened scrutiny when examining pharmaceutical patent applications that could affect the affordability and availability of future HIV treatments.
