TWN Info Service on Intellectual Property Issues (Oct24/02)
2 October 2024
Third World Network

Gilead’s Voluntary License on Lenacapavir, A Strategic Move to Maintain Monopoly

Kuala Lumpur, 2 October (Third World Network) – Gilead Sciences announced today the signing of voluntary licensing agreements (VL) with only six pharmaceutical manufacturers to produce and supply generic versions of lenacapavir to 120 low and middle income countries. However this VL announcement can also be seen as a strategic move by Gilead to preserve its monopoly on lenacapavir, especially in light of weak and questionable nature of its patent claims that are being challenged globally.

Gilead has filed numerous patent applications for lenacapavir with the intention to prolong its monopoly beyond the typical 20-year patent term, a practise known as “patent evergreening”. One key example is Gilead’s attempt to patent the salt form of lenacapavir, which offers little technological innovation. In India, for instance, where patient advocacy groups have filed patent oppositions to these frivolous claims, Gilead’s claims appear fragile. K.M. Gopakumar, a senior researcher at Third World Network, noted “The Indian Patents Act does not grant monopolies on established science, such as the salt forms of lenacapavir, which do not make a significant contribution to the technological advancement”. Gilead is facing widespread opposition from patient groups and civil society movements across India, Argentina, Indonesia, Thailand, and Vietnam.

The VL announced by Gilead is a strategic move to counter global opposition against its frivolous patent claims. The VL aims to increase access to lenacapavir for HIV prevention in high incidence, resource-limited countries but the devil is in the details of the license agreement. The license excludes supply to many developing countries categorised as Upper Middle-Income Countries (UMICs), which account for 41% of new HIV infections and 37% of the global population living with HIV, according to UNAIDS. Even Brazil which hosted clinical trials for PURPOSE 2 trials of lenacapavir, is excluded from supply.

Under the license, Gilead retains full control over the licensees’ sourcing of the active ingredients, ensuring that Gilead’s supply requirements are prioritized. Additionally, the license imposes obligations on licensees, such as the submission of monthly reports to Gilead with detailed information on production and supply of products. It also includes draconian anti-diversion clauses and prohibits licensees from supplying the product to countries not covered by the license, even in cases of compassionate use or when a country has issued a compulsory license to import generics.

The terms of the voluntary license (VL) underscore the company’s primary objective of safeguarding its monopoly and, by extension, its profits. In this context, challenging Gilead’s patents becomes even more crucial. If these patents are rejected, it will encourage real market competition, increase production diversity, and ultimately drive down prices, ensuring wider access to lenacapavir for those who need it. Currently, the cost remains prohibitively high. Gilead has set the price of lenacapavir as high as $42,250 dollars per year. However, a study by Liverpool University estimated that generic lenacapavir could be reduced to a fraction, initially at $100 per person per year and then at $40 per person per year.

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