DOLUTEGRAVIR - ADULT (DTG) for AZ, BY, KZ and MY

Patent Holder: ViiV Healthcare

Date: November 2020

In November 2020, MPP and ViiV Healthcare signed a new voluntary licensing agreement to enable greater access for dolutegravir (DTG) based regimens in certain upper-middle-income countries (UMICs). This new licensing agreement includes Azerbaijan, Belarus, Kazakhstan and Malaysia. Recognising the specific challenges faced by these countries and in response to feedback from the HIV community and the governments, ViiV Healthcare and MPP developed this first-of-its-kind agreement to enable increased access and affordability to generic DTG-based HIV treatment regimens, while also supporting continued investment in much needed innovation.

— Licence Agreement

— Sublicence Agreement - Form

Key Features

Eligibility for sublicences

Sublicences can be issued to qualified entities worldwide to a maximum of three sublicensees (in view of the small market size), each of which must (i) be an existing licensee for DTG via MPP or ViiV, (ii) have already obtained WHO PQ or FDA tentative authorization for DTG, (iii) have existing infrastructure in the four countries, and (iv) have an efficient batch tracing procedure to track diversion. If the demand changes the number of sublicensees can change too.

Manufacturing

Allows manufacturing of active pharmaceutical ingredient and finished formulations anywhere in the world.

Geographical scope for sale

4 UMICs countries – Azerbaijan, Belarus, Kazakhstan, Malaysia. Public market sales only.

Sales outside the licensed territory

Given that the Sublicensee must be existing DTG licensee, under the DTG Adult licence the sales outside the licensed countries are permitted, where there is no granted patent in force and where sales of a generic version do not infringe on an existing patent, such as in cases in which a compulsory licence has been issued.

Royalties

Tiered per-pack royalty rates based on percentage of PLHIV treated with DTG. The royalty rate is kept confidential.

Quality assurance

Licensees must obtain approval from WHO Pre-qualification, or a Stringent Regulatory Authority. Where such approval is not yet available, temporary approval from a WHO Expert Review Panel may be obtained.

Access

MPP and ViiV must agree to an annual “Engagement Plan” to work to address any barriers to access (e.g. of a regulatory nature) and support greater DTG uptake in the four countries. Possibility of termination in the event that the Licensee does not achieve access within 24 months.

Combinations

Sublicensees have the right to combine DTG with other ARVs and to develop suitable new fixed-dose combinations.

Data exclusivity

Data exclusivity is waived in countries with such form of protection, thus facilitating regulatory approval of generics.

Patent disclosure

The licence discloses the list of pending and granted patents in the territory.

Additional flexibilities for licensees

Licensees can challenge any of the licensed patents.