TNP+, MMA’s partner in Thailand, has filled an opposition against Markush patent claims on lenacapavir, a new, long-acting antiretroviral drug, given (after a short oral lead-in period ) by injection every six months. Lenacapavir has been approved in the European Union and the United States for use with other antiretrovirals in heavily treatment-experienced people with multi-drug resistant HIV. It is also being studied for HIV prevention, and for part of first-line treatment. Lenacapavir may be useful for PLHIV who cannot use currently-available ARVs, as part of second- or third-line regimens. Although a small number of people may need it now, the drug may approved for prevention and first-line treatment in the future.
Chalermsak Kittitrakul, Project Manager for Access to Medicines at TNP+
TNP+ strategically spotted lenacapavir during a scientific and patent analysis of pipeline drugs provided by MMA’s hub. Based on this information, TNP+ began to monitor and identify patent applications related to lenacapavir, looking for opportunities to file a patent opposition. TNP+ held consultations with Thailand’s Division of AIDS and STIs and HIV experts and engaged doctors, Civil Society Organizations, and the Ministry of Public Health, to monitor information on lenacapavir and to consider including it in national treatment guidelines in the future, as part of second – or third-line treatment for PLHIV who cannot use currently available antiretrovirals.
TNP+ opposed the patent application on lenacapavir, claiming lack of novelty and lack of innovative step – which are two key criteria for obtaining a patent.
“Opposing Makrush claims is quite challenging, and quite complicated. But we tried our best to provide technical information to the patent examiner about the application’s lack of novelty, lack of innovative step, lack of clarity, and lack of sufficient information, and that it has not met qualifications for a patent to be granted. We expect that the Thai patent office will decide decision to reject the application.”, says Chalermsak Kittitrakul, Project Manager for Access to Medicines in TNP+.
The battle for access to lenacapavir is not close to an end yet. TNP+’s opposition was primarily on use of lenacapavir for HIV treatment. A second patent opposition would need to be filed against potential claims on the drug’s formula.
“To absolutely win this case, we have to file another patent opposition on another key lenacapavir patent application, with claims on its chemical compound. We have kept monitoring such patent applications in Thailand, but haven’t found it yet in the Thai patent office’s database. If we can file a pre-grant opposition. it will help remove key patent barriers, and allow generics manufacturers to produce it, and competition between them will lower prices. If we are successful in filing a pre-grant opposition, it will support policy-makers and HIV experts, making it easier for them to include lenacapavir in treatment guidelines and the national insurance scheme, by removing concerns about pricing and patent barriers – the idea is to provide policy makers with a scenario where decision-making prioritizes the people, not the profit.”
