HIV Community-Based Organizations are Fighting Patent Monopolies on Lenacapavir

Source : ITPC Global

Despite the world’s efforts, there have been over a million new cases of HIV each year.  Lenacapavir (LEN), a long-acting antiretroviral, could change the trajectory of the global HIV epidemic, but Gilead’s patent monopoly will keep LEN unaffordable in many countries with urgent need for it.

The PURPOSE-1 HIV prevention trial demonstrated the unprecedented effectiveness of LEN. PURPOSE-1 compared twice-yearly injections of LEN to daily oral HIV pre-exposure prophylaxis (PrEP) among 5,338 adolescent girls and young women in South Africa and Uganda. The trial was stopped early, because LEN was significantly more effective than oral PrEP:  there were no new HIV infections among 2,134 participants who received LEN, versus 16 among 1,068 participants who received tenofovir/emtricitabine (TDF/FTC)  and 39 among 2,136 participants who received tenofovir alafenamide/emtricitabine (TAF/FTC). 

On September 12th, Gilead announced interim results from PURPOSE-2, a phase III HIV prevention trial comparing twice-yearly LEN to daily oral pre- exposure prophylaxis (PrEP) among 3,295 cisgender men, transgender men and women,  and gender nonbinary people who have sex with male partners in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US.  An interim analysis found LEN was 89% more effective than oral PrEP:  2 of 2,180 people who received LEN acquired HIV, versus 9 of 1,087 people who received oral PreP. Because LEN was so effective, the trial’s independent Data Monitoring Committee recommended that all participants be offered LEN.

LEN has already been approved as part of treatment for multidrug-resistant HIV, and approval for use as PrEP is anticipated in 2025. Gilead has priced LEN at $40,000 per person, per year (PPPY) in the United States – but it can be produced and sold, at a profit, for a far lower price. Research supported by the Make Medicines Affordable Campaign (MMA) estimates that generic LEN could initially be mass-produced for a price of  $63- $93 PPPY, which would fall to $26- $40 PPPY when volume reaches 10 million.

Gilead has already filed for  primary and secondary patents in many countries, including in Brazil, China, Colombia, India, Kazakhstan, Kenya, Morocco, Mozambique, Russia, South Africa, Tanzania, Uganda, Ukraine, Uzbekistan, and Vietnam. Gilead’s patenting strategy, called “evergreening”, could artificially extend its patent monopoly on LEN for more than the established term of 20 years. 

Although Gilead has announced that it will offer a voluntary license (VL) for LEN, middle-income countries such as Brazil, where there are many new HIV infections, have been excluded from these agreements, and will be forced to pay the price that Gilead demands for LEN, unless they are able to oppose unmerited patents on the drugs – which would enable production of affordable generic versions of LEN.

Gabriela Chaves, who coordinates the MMA Science Team, explains that “…patent oppositions are an important instrument to ensure access to life-saving technologies. They require technical knowledge, so we developed two patent opposition templates for LEN that can be adapted by local community-based organizations.”

MMA partners have been filing patent oppositions in Argentina (Fundacion GEP), India (DNP+), Indonesia (IAC), Thailand (TNP+) and Vietnam (VNP+). 

Lorena Di Giano, from Fundacion GEP in Argentina, said: “Lenacapavir seems to be an important new drug. We will not accept that Big Pharma keep such technology out of reach for people in need”

Dong Do Dang, from Vietnam’s VNP+, added “ We filed a pre-grant opposition against the LEN patent application, because we believe that unjustified patent monopolies on life-saving medicines should not be granted.”

Loon Gangte, from MMA partner DNP+ in India, noted that the country   “…. has a lot of strong manufacturers that supply antiretrovirals worldwide. We started to fight against the LEN patent monopoly in India, as it will permit local manufacturing. We believe that everyone in need in the world should have access to treatment.” 

Chalermsak Kittitrakul, from MMA partner TNP+ in Thailand added, “Preventing evergreening patents is important to ensure local manufacturing, and it encourages more competition particularly from the generics manufacturers that are excluded from the voluntary licenses.”