• 04 Oct 2024
• Admin
• News Article

Gilead's Licensing Agreement for Lenacapavir a Move to Preserve Its Monopoly, Alleges TWN

Overview

Third World Network (TWN), an independent non-profit international research and advocacy organisation involved in issues relating to development, developing countries, has said that the voluntary licensing agreements of Gilead Sciences with six pharma companies to manufacture and supply generic versions of its long acting HIV drug lenacapavir is strategic move to preserve its monopoly on the drug. 

Voluntary Licensing Agreements with 6 Pharma Companies

• The company announced non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers including Dr Reddy's Laboratories, Emcure Pharmaceuticals and Hetero Drugs to quickly introduce generic versions of lenacapavir for HIV prevention, if approved for pre-exposure prophylaxis (PrEP). 
• The agreement also covers lenacapavir for HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV. 

Statement from the TWN

• "The VL (voluntary licensing) 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," said TWN.
• "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," it added.

Patent Applications for Lenacapavir

It alleged that Gilead has filed numerous patent applications for lenacapavir with the intention to prolong its monopoly beyond the typical 20-year patent term, a practice known as “patent evergreening.”

From the Senior Researcher: Third World Network

• K M Gopakumar, a senior researcher at Third World Network, said, “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 technological advancement.” 
• TWN added that the company is facing widespread opposition from patient groups and civil society movements across India, Argentina, Indonesia, Thailand, and Vietnam. 

Based on License

• Under the license, Gilead retains full control over the licensees' sourcing of the active ingredients, ensuring that Gilead's supply requirements are prioritised, it alleged.
• 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," it added. 

Gilead's Patents

• The terms of the 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, added the Network.
• 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.

Cost Related Allegation

• It alleged that 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, said the organisation.