Vietnam’s Network of People Living With HIV (VNP+), a Make Medicines Affordable (MMA) partner, is working to improve access to, and affordability of long-acting HIV prevention and treatment. In September 2024, VNP+ filed a pre-grant opposition to a patent application on long-acting cabotegravir (CAB-LA), an injectable antiretroviral recommended by the World Health Organization (WHO) for HIV prevention (and as part of long-acting HIV treatment).
If granted, the patent application on CAB-LA would artificially extend ViiV Healthcare’s monopoly on the drug (a practice known as evergreening), limiting opportunities for local manufacturing of CAB-LA, and undermining efforts to combat HIV/AIDS in Vietnam.
According to Dong Dang Do, Chairman of VNP+, Viiv’s attempt to extend the patent on CAB-LA is “a common strategy of the pharmaceutical industry to maximize profits – even if it limits access to important and affordable treatments. The monopoly on CAB-LA could have a significant impact on Vietnam’s goals of ending AIDS by 2030.”
In clinical trials, CAB-LA was 79% more effective at preventing HIV than oral pre-exposure prophylaxis (PrEP) – mainly because study participants missed doses of oral PrEP, while ’protection from CAB-LA injections lasts for two months. But access to CAB-LA is limited by
ViiV Healthcare’s high prices: in the United States, CAB-LA is $22,200 per person, per year (PPPY), and in the United Kingdom, it is £7100 PPPY. In most low- and middle-income countries, including Vietnam, ViiV’s price for CAB-LA remains secretive.
Generic versions of CAB-LA could be far more affordable than what ViiV is charging donors and low-income countries (~ $180 USD PPPY). An analysis from Clinton Health Access Initiative estimates that generic versions of CAB-LA could be profitably mass-produced for $14 to $40 USD PPPY, which is 500 times lower than ViiV’s US price.
“If ViiV is successful in evergreening CAB-LA, it will lead to higher drug prices and limited access to this essential drug, which could impact existing HIV prevention and treatment programs,” said Do.
VNP+’s patent opposition filing states that the patent grant does not meet patentability requirements. Specifically, VNP+ states that ViiV Healthcare’s claimed patent application lacks novelty and inventive steps, which are essential for a patent under the country’s current laws. Vietnam’s National Office of Intellectual Property is currently reviewing reports submitted by VNP+ regarding the opposition of the patent grant. The office is consulting with both parties and is expected to announce its decision in the coming months.
“We need to have solutions promoting the local production of generic drugs and improving drug pricing regulations to reduce the negative impact of these monopolies,” said Do, adding that intellectual property and pharmaceutical policies should consider balancing the interests of companies with ensuring patients’ access to medicines.
