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Press Release: Patent Opposition against HIV Drug Lenacapavir Patient Groups Advocate for Generic Production and Affordable Access to HIV Drug Lenacapavir

October 4, 2024
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Jakarta, October 4th – The Indonesia AIDS Coalition (IAC), a community-based organization focusing on HIV issues, along with its partners, have appealed to the Patent Appeal Commission at the Indonesian Ministry of Law and Human Rights to revoke the patent granted to Gilead Sciences, a multinational pharmaceutical company, for the HIV drug Lenacapavir. The proceedings have been ongoing since early 2024, with the next hearing scheduled for Tuesday (08/10) in Jakarta.

The appeal is extremely important to ensure PLHIV have access to optimal HIV treatments, including through local production, as well as for the sustainability of Indonesia’s national HIV-AIDS program. 

Gilead’s announcement of voluntary licenses to six generic companies for the production of generic Lenacapavir falls short of ensuring sufficient access. The license excludes Indonesian generic manufacturers and includes several restrictive anti-competitive conditions that allow Gilead to maintain its market monopoly and keep high prices for many years to come. The patent, if rejected, will provide freedom to operate for local manufacturers, facilitate early entry of generic competitors, and significantly lower prices for Lenacapavir. 

Aditya Wardhana, IAC Executive Director, stated that this action was taken to ensure affordable access for People Living with HIV (PLHIV) in Indonesia, as the patent under appeal is a poor quality secondary patent. He emphasized that one of the key factors in achieving the global 95-95-95 targets and ending the AIDS epidemic by 2030 is access to new-generation drugs that are more effective, efficient, and have fewer side effects.

Lenacapavir is a long-acting antiretroviral (ARV) drug produced by the U.S. pharmaceutical company Gilead Sciences. As a long-acting ARV, it does not require daily dosing, with Lenacapavir being administered via two injections per year. “Access to treatment is crucial, and Lenacapavir, as stated by UNAIDS, has the potential to help end the AIDS epidemic,” Aditya added.

Meanwhile, Lutfiyah Hanim, Senior Researcher at the Indonesia for Global Justice (IGJ), highlighted that large pharmaceutical companies often file multiple patents around the same component, a practice known as patent evergreening, which extends patent protection beyond the standard term of 20 years. Lenacapavir’s patent is set to expire in Indonesia in 2034, but if the secondary patent is granted, the monopoly will extend until 2037. “This patent opposition effort done by the HIV community is crucial to stop the monopoly,” Hanim explained.

In Indonesia, Gilead has filed four patents for Lenacapavir, two of which have been granted. One patent application claims a general chemical structure (Markush claim), and the rest of the three patent applications (including the one granted) claim the compound Lenacapavir and its injectable form. In their opposition, IAC argues that Gilead’s patent lacks novelty and inventive steps, which are required for the grant of a patent under Law No. 13 of 2016 concerning Patents.

Patent monopolies lead to high drug prices due to a lack of competition. Currently, Lenacapavir is sold at $42.250 per person per year (PPY), or approximately 640 million Indonesian rupiah. This exorbitant price makes Lenacapavir unaffordable for millions of PLHIV worldwide, including in Indonesia. In contrast, a study by the University of Liverpool estimated that generic Lenacapavir could be mass-produced at a price of $63-$93 PPY and could even be reduced to $26-$40 PPY, or 1/1000th of the current price.

Currently, Indonesia’s national HIV-AIDS program, which serves 503.261 PLHIV, is fully subsidized by the government. However, the government cannot accommodate the procurement of ARVs priced at hundreds of millions of rupiah per person.

Consistent ARV treatment is vital for PLHIV, not only to maintain their health but also to prevent transmission. “ARV therapy has allowed me to reintegrate into society and contribute to others. If a more efficient, practical, and affordable ARV is available, living with HIV will no longer limit me from living a better life,” said Ayu Oktariani, National Coordinator of the Association of Positive Women Indonesia (IPPI) and a woman living with HIV, in Jakarta (04/10).

“Lenacapavir offers many advantages, which is why we must ensure that it is accessible to everyone without exception. Gilead’s patent monopoly limits generic competition and hinders access to affordable medicines in Indonesia,” said Ferry Norila, Communication, Campaign, and Advocacy Coordinator of IAC.

IAC’s patent appeal is part of a broader advocacy effort to challenge patent monopolies by large pharmaceutical companies that impede access to essential medicines in developing countries. Through the Make Medicines Affordable Consortium, led by ITPC, various community-based organizations in India, Argentina, Indonesia, Vietnam, and Thailand have filed nine patent cancellation requests for Lenacapavir. These organizations include the Thai Network of People Living with HIV (TNP+), the Delhi Network of Positive People (DNP+), Fundación Grupo Efecto Positivo, the Vietnam Network of People Living with HIV (VNP+), and the Indonesia AIDS Coalition (IAC).

Background

ARV Lenacapavir

Despite global efforts to combat HIV-AIDS, the epidemic persists, with 1.3 million new infections recorded in 2023. If made affordable, Lenacapavir could significantly contribute to global efforts to curb HIV, particularly in countries with high infection rates. Currently, infections continue to rise among key populations in low- and middle-income countries (LMICs).

Lenacapavir is a long-acting ARV that only needs to be administered twice a year via injection. This type of ARV is considered more practical, flexible, and suitable for PLHIV who either cannot or prefer not to take daily medication. Lenacapavir is also being investigated for use as PrEP, or HIV prevention. Given its potential, UNAIDS has declared Lenacapavir as part of the world’s hope for ending AIDS, provided that access is available to all, without exception.

Access to Lenacapavir is currently hindered by its prohibitive price, reaching $42.250 PPY.

The CAPELLA clinical trial found that Lenacapavir, when used in conjunction with other ARV therapies, showed positive results in suppressing viral load (VL) for PLHIV with drug resistance. Equally positive results were observed in the PURPOSE 1 clinical trial, which demonstrated 100% efficacy of Lenacapavir in preventing HIV among cisgender women and young people in Sub-Saharan Africa. This success was followed by the PURPOSE 2 clinical trial, where efficacy reached 96% among cisgender men and people from diverse gender and sexuality groups in Latin American, Asian, and South African countries.

It is unfortunate that despite its numerous advantages, Lenacapavir remains inaccessible to millions of people in need due to its exorbitant price.

About the Indonesia AIDS Coalition:

Indonesia AIDS Coalition (IAC) is a community-based organization dedicated to enhancing transparency, accountability, and community participation in the national HIV-AIDS response through collaboration with key stakeholders. For more information, visit: iac.or.id/en.

About the Indonesia for Global Justice:

Indonesia for Global Justice is a CSO focusing on the issue of free trade and its impact on society, including the health sector. For more information, visit: igj.or.id

Contact

Budi Larasati, Project Officer, Indonesia AIDS Coalition

E: blarasati@iac.or.id

P: +62 877 7749 4801

Agung Prakoso, Program Officer, Indonesia for Global Justice

E: agung.prakoso@igj.or.id

P: +6285788730007

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