A Ministerial Regulation No. 39 of 2018 on Procedures for Compulsory Patent Licensing took effect on 28 December 2018. This Regulation mainly gives a clear structure to compulsory licensing in accordance with TRIPS.
Article 3 of the Compulsory Licensing Regulation sets out that the Minister may grant a compulsory license in several cases. One is that the patent holder did not manufacture his product or use his process in Indonesia within 3 years after the patent was granted. Another is the patent was used in a form or manner detrimental to the public interest. A third is that a patent for an improvement cannot be implemented without another party's patent which is still under protection.
Various categories of applicants for a compulsory license are possible. An applicant must submit an application to the Directorate General of IP. There is an examination process. The grant is conditional as follows:
a. It is a non-exclusive compulsory license.
b. Consideration must be paid for the grant to the patent holder.
c. Evidence and information or an explanation for the compulsory license grant must be given
d. A time period of the compulsory license is provided.
e. Conditions on expiry and termination must be provided.
f. The decision will specify what part of the patent is granted a compulsory license.
The Regulation covers when the Minister may grant compulsory license for pharma products, specifically:
a. Manufacturing pharmaceutical products to treat human diseases.
b. To import pharmaceutical products if Indonesia is not yet capable to manufacture it to treat human diseases.
c. To export pharmaceutical products outside Indonesia based on developing countries requests (the Doha system related to import and export mechanisms).
The Minister must record the grant of any compulsory license and notify applicants and patent holders. It is not clear whether Indonesia is simply implementing TRIPS or whether applications to manufacture medicines for third countries are likely.
