Compulsory pharma patent licenses in Indonesia - sourcing the API

 

More information is coming to light about the compulsory licenses granted for various HIV drugs in Indonesia. The Indonesian government has apparently issued compulsory licenses on 7 HIV anti-retrovirals - see here - although details remain sketchy. It appears the government may import or make generic versions. Practically speaking these anti-retrovirals often need to be imported from experienced generic makers such as Indian companies.

Various HIV drug innovators had previously granted a license to the Medicine Patent Pool (MPP), an UNITAID & WHO backed organization which licenses HIV (and other) medicines in exchange for a modest royalty. The terms of this license allow several exceptions. One is that licensees could renounce rights to certain drugs; which would allow them not to be bound by the license's contractual terms and to sell in countries where there is no patent protection. But they would still be subject to patent rights in places where the patents existed, which for some of the drugs included Indonesia.

Several generics makers in India have taken licenses from the MPP. Therefore the Medicine Patent Pool license would not apply to Indonesia since some of the anti-retrovirals in the MPP license are subject to Indonesian patents. However if the Indonesian government has now compulsorily licensed these drugs, then some of the MPP generic licensees (who renounced to supply to other non patent protected markets) can therefore lawfully produce for Indonesia. That means those Indian generic producers who otherwise were restricted by the MPP license, will now be able to supply Indonesia’s purchase of these anti retrovirals.

IP Komodo speculates that Indonesia has already identified an API supplier who would otherwise be subject to an MPP license. So Indonesia needed to put the compulsory license in place to acquire the APIs.