At the beginning of 2025, Indonesia once again drew global attention as it joined international efforts to fight tuberculosis (TB), an ancient infectious disease. The collaboration between the Indonesian government and the Bill & Melinda Gates Foundation became a major highlight following news that Indonesia was selected as one of the sites for late-phase clinical trials of a TB vaccine.
This spotlight presents an intriguing paradox. Despite having one of the world’s highest TB burdens, Indonesia is now emerging as a leading candidate in medical innovation. How did this happen?
Indonesia: From Market to Innovation Player
The collaboration with the Gates Foundation opens significant opportunities for new TB-related inventions—ranging from active compounds, drug or vaccine formulations, manufacturing methods, to diagnostic solutions. Patents play a key role in:
- Strengthening exclusive rights
- Supporting development and production,
- Facilitating commercialization.
Indonesia’s pharmaceutical and biotech industries, therefore, cannot remain idle. This momentum must be leveraged to actively participate in research and Patent filing, through both local and global collaboration.
Clinical Trial Progress: What Is Happening in Indonesia?
Vaccine development follows strict standardized stages:
| Pre-clinical | Initial testing on animals |
| Phase I | 3–80 healthy volunteers; determines safe dosage |
| Phase II | 20–200 volunteers; tests early efficacy & immune response |
| Phase III | Hundreds–thousands of participants; confirms effectiveness & safety |
| Phase IV | Post-marketing long-term monitoring |
According to the Ministry of Health (May 2025), the TB vaccine candidate M72/AS01_E has entered Phase III and involves 2,095 Indonesian participants as part of a global study.
The Gates Foundation has contributed more than US$300 million to Indonesia since 2009 to support health, nutrition, sanitation, and vaccination systems—including TB vaccine research.
This positions Indonesia not merely as a research site, but as a part of the global innovation ecosystem.
Open = Not New? Disclosure Risks to Novelty
Participation in late-phase clinical trials carries both scientific and legal consequences. In Phases III–IV, transparency is required, including:
- Clinical trial registration, and
- Disclosure of research plans and results.
However, transparency can be a double-edged sword. Barcombe et al. (2024) notes that in Europe and the U.S., excessive disclosure can threaten novelty, a core patentability requirement.
Why? Various forms of publication, including:
- Trial protocols,
- Informed consent forms (ICF),
- Press releases,
- Study registry entries,
can be considered prior art if they contain technical information enabling others to practice the invention.
If information such as vaccine composition or dosage is revealed too early, it may even be categorized as public prior use, invalidating novelty.
Regulatory Framework Exists — But Not Enough
Clinical trials in Indonesia are governed by:
- BPOM No. 8/2024 (Clinical Trials)
- BPOM No. 24/2025 (Drugs & New Drug Development)
Both adopt ICH–GCP and CUKB (Good Clinical Practice) principles, emphasizing:
- Confidentiality of data for both parties,
- Protection of sponsor & subject information,
- Quality control and distribution safety.
The informed consent mechanism does not require sponsors to disclose detailed formulas or compositions to participants.
However, regulatory protection alone does not guarantee Patent novelty. Information leaks may still occur through:
- Scientific publications,
- Recruitment materials,
- Trial registries identifying compounds or dosage regimens,
- Test subjects not bound by NDAs,
- Third parties, such as CROs, laboratories, logistics vendors, or IT providers, lack strong confidentiality clauses.
Even simple items like:
- Open-label packaging,
- Certificates of Analysis (CoA),
- Batch-to-subject records,
may reveal sensitive technical information.
Thus, non-regulatory strategies are crucial to ensure confidentiality and preserve novelty.
TB Patent Landscape in Indonesia: Dynamic & Expanding
International collaboration has created a “domino effect,” driving more TB-related Patent filings in Indonesia. Directorate-General IP (DJKI) data shows several emerging categories:
- Active Compound
Examples:- IDP000065523: Quabodepistat compound with strong antibacterial activity against Mycobacterium tuberculosis
- IDP000028943: Quinoline derivatives; protection expires in 2025, opening opportunities for generics and new formulations
These demonstrate that Indonesia is no longer just a market, but a site for testing and adapting global molecules.
- Formulations & Compositions
Examples:- IDP000058680: Live-attenuated Mycobacterium vaccine formulation
- P00202402878: Fusion-protein & nucleic-acid vaccine platform
- P00202314496: Bone implant composition for post-TB complications
Innovation extends beyond molecular discovery to optimizing therapeutic forms and platforms.
- Manufacturing Methods & Processes
Some inventions protect synthesis and production techniques that improve efficiency and stability, offering additional protection over manufacturing technologies. - Diagnostics
Example:- IDP000067942: Liposomal KIT to detect mycolic acid, a key biomarker of M. tuberculosis
Diagnostics research is paving the way to precision therapy.
- IDP000067942: Liposomal KIT to detect mycolic acid, a key biomarker of M. tuberculosis
When Should You File a Patent?
Because disclosure may threaten novelty, the best time to secure a Patent is before technical information is made public.
It is important to note:
- Patent filing does not require BPOM marketing authorization.
- Pre-clinical data is often sufficient to support a Patent application.
In other words, the pre-clinical stage is the golden window to file a Patent.
Delaying until research results are published increases the risk of losing novelty.
What Industry & Researchers Must Do
With TB-related research and patenting on the rise, industry players and researchers must balance:
- Scientific innovation,
- Disclosure management,
- Legal protection strategies.
Without proper strategies, valuable inventions may lose their Patent value.
From Experiment to Investment
Indonesia now stands at a crucial crossroads. Once a country with one of the highest TB burdens, Indonesia is evolving into a center of research and innovation for TB vaccines and therapies. To maximize this opportunity, the local industry must actively protect research results through smart and structured Patent strategies.
AFFA is ready to be your strategic partner to:
- Map Patent pathways,
- Conduct freedom-to-operate (FTO) analyses,
- Preserve the novelty of inventions,
- Prevent overlapping Patent rights.
“Innovation without strategy is only experimentation — but innovation with protection is an investment.”
For more information on Patent filing and protection in Indonesia, please contact us through the channels below:
📩 E-Mail : [email protected]
📞 Book a Call : +62 21 83793812
💬 WhatsApp : +62 812 87000 889
