CABOTEGRAVIR LONG-ACTING (LA) FOR HIV PRE-EXPOSURE PROPHYLAXIS (PrEP)

Patent Holder: ViiV Healthcare
Date: July 2022

In July 2022, ViiV Healthcare and the Medicines Patent Pool signed a new voluntary licensing agreement for patents relating to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) to help enable access in 90 countries.

Through this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP, the first long-acting HIV prevention medicine, in these countries, subject to required regulatory approvals being obtained. It is expected that this agreement will help to enable at-scale access to generic cabotegravir LA for PrEP. This announcement comes just seven months after the first regulatory approval of cabotegravir LA for PrEP in the world, by the US Food and Drug Administration (US FDA).

— Licence agreement

— Sublicence agreement - Form

Key Features

Eligibility for sublicences	Sublicences can be issued to any qualified entity worldwide. The number of sublicensees is up to three, with a possibility to have additional sublicensees if the evidence demonstrates a public health need for it.
Manufacturing	Allows manufacturing of cabotegravir anywhere in the world in the form of a tablet containing 30 mg of cabotegravir as its sole active pharmaceutical ingredient; and/or an extended-release injectable suspension form.
Geographical scope for sale	Allows for sale of cabotegravir in all low-income countries, lower middle-income countries, sub-Saharan African countries, least-developed countries (as defined by the UN), amounting to at least 90 countries. Sales in royalty countries (see below) are allowed only in the public market.
Sales outside the licensed territory	Nothing in this Agreement shall be construed to prevent the Licensee from undertaking any activity anywhere in the world where such activity is (1) outside the scope of the Patent Rights or (2) is permitted pursuant to a compulsory licence of the Patent Rights.
Royalties	The licence is royalty free for most countries within the Territory for both private and public market. It is royalty-bearing for 10 countries where ViiV holds patent rights (i.e. Algeria, Egypt, India, Indonesia, Kyrgyzstan, Morocco, Philippines, Tajikistan, Ukraine, Vietnam). In those royalty countries the rate is 5% of net sales of the product in the public market. As for the private market of the royalty countries, ViiV may apply a differentiated royalty rate for private market sales, if any private markets are subsequently permitted.
Quality assurance	Licensees must obtain World Health Organization (WHO) Pre-qualification (PQ), or approval from a Stringent Regulatory Authority (SRA). Where such approval is not yet available, provisional or emergency use authorisations available through WHO or an SRA may be obtained.
Data exclusivity	Data exclusivity is waived in countries of the Territory with such form of protection, thus facilitating regulatory approval of generics.
Patent disclosure	The licence discloses the list of PCT patent applications at the time of licence signing.