The regulations support the existence of patent linkage in Indonesia. Generic drug approval is therefore subject to patents that are notified to the BPOM. BPOM means Badan Pengawas Obat dan Makanan (National Agency of Drug and Food Control). We discuss below implementation of relevant regulations.
Introduction
Patent linkages are understood to mean the practice of national drug approval agencies “linking” the granting of marketing approval with the patent status of the originator drug. By this definition, patent linkage can be said to be implemented by BPOM based on current practice.
Relevant regulation and practice
Generic drugs that are seeking Marketing Authorization (MA) based on the bioequivalence of an already approved originator drug will need to submit independent patent search results carried out by the DGIP. DGIP means Direktorat Jenderal Kekayaan Intelektual (Directorate General of Intellectual Property).
This is based on the following document checklist in the Appendix XIII (Part A) of BPOM regulation:
Appendix XIII (Part A)
6. Patent-related Drug Documents (if necessary)
6.1. Statement letter related to patents.
6.2. Patent search results from the DGIP.
6.3. Patent independent assessment results.
In cases where the DGIP report does not cite patents that are adverse to the generic drug approval, BPOM might still mention certain patents that they believe are relevant and ask for the generic drug applicant to comment on these patents. Such patent information could have been previously provided by the originator drug MA holder during the application process and remained in the case file of the original drug. It is not likely that BPOM will on its own initiative search the patent database in order to cite these patents.
If the query from BPOM cannot be overcome, it is likely that BPOM will not proceed further until after the expiry of the patent.
Bolar provision
The Indonesian Patent Law provides an exemption for applications that are submitted during 5 year period prior to the expiration of the relevant patent – Article 167 of the Patent Law.
This is also incorporated in the BPOM regulation - Article 21 of the BPOM regulation. It is made clear in Article 21 paragraph (4) that Marketing Authorization will only be granted after the expiration of the relevant patent.
Article 21
(1) Registration of the First Generic Drug with an Active Substance that is still protected by a patent in Indonesia may be filed by a Registrant who is not the owner of a patent in accordance with the provisions of the legislation.
(2) The registration as referred to in paragraph (1) may be filed 5 (five) years before the expiration of patent protection.
(3) Registrants for the First Generic Drug Registration as referred to in paragraph (1), must submit the following documents:
(4) The distribution permit for the application for the registration of the first generic drug as referred to in paragraph (1) is issued after the patent protection period has expired.
Second medical indication
Second medical indication patents would probably be more likely to be overlooked in the search by DGIP. DGIP search is typically for the substance rather than based on whether the new indication is found in the claim of any patent. This could be due to how the search parameter is defined when the request is sent to DGIP, or that DGIP capability is only limited to searching against the compound. In such cases, the originator may wish to consider placing a copy of the patent in the BPOM case file for originator drug approval. As part of the originator drug process, it is open to the originator to submit patent information relating to the drug as part of the document package in the marketing approval. This makes it more likely for BPOM to be alerted to such patents relevant to the originator drug approval – the originator drug that the generic drug is trying to establish having biosimilarity to.
Appendix XIII (Part A)
6.1. Statement letter related to patents.
6.2. Patent search results from the DGIP.
6.3. Patent independent assessment results.
This is probably more important for second medical use where the DGIP might overlook the second indication/swiss type claim patent when the search parameter is set at only the compound name.
It will also be good to consider defining the medical indication as close to the medical use claimed in the Patent to anticipate the argument that the Swiss-type patent claim does not apply. See this article for a discussion on second medical use in Indonesia.
Concluding remarks
Patent linkage regulation is not consistently applied at BPOM. In certain situations, the DGIP search does not cite relevant patents and therefore resulting in favourable reports of the generic drug. BPOM might rely on such reports without further investigation and grant marketing approval. As discussed above, the search report depends to a certain extent on the search parameter provided to DGIP when the search request is made. BPOM might also cite patents that are in the originator drug case file and block the application for the generic drug. Patent information may have been omitted from the originator drug case file because the local commercial partner of the originator was not as vigilant as the originator in setting up a stronger patent linkage for the drug.
