Make Medicines Affordable partner Fundación Ifarma filed a patent opposition in Colombia to the pre-exposure prophylaxis drug (PrEP) MK-8527 developed by the multinational pharmaceutical company Merck & Co.
In its opposition filing in late 2025 with the patent office of Colombia, the Superintendency of Industry and Commerce, Fundación Ifarma states that patent application on MK-8527 does not contain an inventive step, which is required for a patent grant. The civil society organization urges the Colombian government to uphold its responsibility in protecting vulnerable people by stating: “The State is responsible for providing healthcare to all Colombians, particularly those with special constitutional protections [such as] patients diagnosed with HIV, especially minors living with the disease.”
Merck’s investigational drug MK-8527 is being researched for HIV PrEP, with preclinical data showing the drug is an “attractive clinical candidate”. It is currently in clinical trials for once-monthly oral HIV-1 pre-exposure prophylaxis. MK-8527 is a nucleoside reverse transcriptase translocation inhibitor, which is a new class of HIV drugs currently under investigation.
Current HIV PrEP options include daily oral pills or two options for long-acting injections (cabotegravir or lenacapavir). MK-8527 could offer an alternative as a monthly pill, which could address challenges around PrEP delivery and adherence, such as stigma.
While Fundación Ifarma prioritizes the strategies of treatment and cure of HIV over the use of PrEP, the organization’s advocacy efforts aim to oppose unjustified monopolies on medications such as MK-8527 which ultimately profit from limited public health resources when countries such as Colombia procure these drugs from billion-dollar pharmaceutical companies such as Merck.
“PrEP is driven by the profit motive of the pharmaceutical industry, rather than on stopping the epidemic. However, MK-8527, which offers a monthly pill option as PrEP, could represent a shift in global efforts to prevent HIV, but more importantly, in the market and the resources available to address HIV,” stated Juliana López, a social worker, epidemiologist, and director of Fundación Ifarma. “We must ensure that Colombian laws are used to safeguard access to medications and counteract the interests of pharmaceutical companies.”
In its patent opposition, Fundación Ifarma maintains that the application is nothing more than a “selection of compounds” already known in the prior art, which makes the patent fail in complying with the provisions of Article 18 [Andean Community Decision 486/2000] which states: “An invention shall be considered to have an inventive step if, for a person skilled in the art, that invention would not have been obvious or would not have been derived in an obvious manner from the prior art”. Given that there is no general inventive concept linking all the claimed compounds, Fundación Ifarma states that this alone is sufficient to invalidate patentability.
In addition, the patent application violates Article 28 of the Andean Community Decision 486, which requires that the invention be described clearly and completely. Ifarma alleges that the applicant is attempting to protect 227 compounds but only describes the synthesis of 73, leaving the rest without sufficient technical support for an expert to reproduce them.
“It is clear that the patent application pertains to non-patentable subject matter, specifically treatment methods, and lacks an inventive step, as evidenced by the specific technical, scientific, and legal arguments,” said Lopez.
Fundación Ifarma further states that if the Superintendency of Industry and Commerce were to grant Merck a patent on MK-8527, it would unduly expand a monopoly without legal grounds, which would delay the entry of competitors and stifle pharmaceutical innovation.
Andrea Carolina Reyes-Rojas, Coordinator of the MMA project at Fundación Ifarma says that denying this patent is vital for public health in Colombia, and explains the impact it could have: “The drug MK-8527 already has a patent valid in the country until 2035. This new application seeks to extend that monopoly until 2044 without providing any real innovation, a practice known as evergreening. By blocking competition from generic drugs, high prices are maintained, reducing resources for key HIV strategies, such as its treatment and cure. Furthermore, the application claims treatment methods, which are not patentable in our region. Promoting free competition is essential for the optimal use of public resources in our healthcare system.”
In February 2026, Fundación Ifarma filed a complementary document to reinforce its arguments against this patent application by further developing the analysis of the claims requested, expanding the technical basis of the “prior art” — both in terms of molecular structures and the analysis of experimental data — and strengthening the legal arguments.
About Fundacion Ifarma
Fundación Ifarma, which works on issues of access, use, and quality of medicines, is a vital contributor to medicine access policy in Colombia. The organization has documented and supported campaigns for compulsory licenses and medicine price controls, provides community awareness on legal tools to enforce the right to health, and leverages its knowledge of Colombia’s local manufacturing landscape to promote domestic production of vaccines and medicines.