Regulation Watch · Tourism and Health · Indonesia, including Bali
Indonesia Restores Its Anti-Evergreening Patent Rule
Constitutional Court Decision 255/PUU-XXIII/2025 again excludes new uses of known products and new forms of known compounds without a meaningful efficacy improvement from patentable inventions in Indonesia.
- Published
- Pronounced publicly by the Constitutional Court on 28 August 2026. DJKI published its implementation response on 15 September 2026.
- Effective
- 28 August 2026. Constitutional Court decisions are final and binding from pronouncement.
- Added to Watch
- 16 September 2026
Who is affected
Indonesian and foreign patent applicants and owners, PT PMA companies, pharmaceutical and biotechnology investors, licensors and licensees, research and development businesses, generic-medicine manufacturers, distributors, transaction parties valuing Indonesian patent portfolios, and advisers handling patent prosecution, appeals, enforcement, regulatory strategy, or freedom-to-operate reviews.
Practical impact
The Court restored Article 4(f) of Patent Law 13/2016 and its explanation. A new use for an existing or known product is not a patentable invention, and a new form of an existing compound is also excluded when it does not produce a meaningful efficacy improvement and the related chemical-structure difference is already known. The restored explanation defines known products broadly and gives pharmaceutical guidance on what counts as a meaningful improvement. DJKI has stated that it will translate the decision into patent examination and appeal practice. The decision does not itself identify and cancel individual granted patents.
Late discovery: Constitutional Court Decision 255/PUU-XXIII/2025 was pronounced on 28 August 2026, but DJKI's official 15 September implementation response now makes the operational consequence clear for live patent examination and appeals. The Court partly granted the challenge to Patent Law 65/2024 and restored the anti-evergreening exclusion previously found in Article 4(f) of Patent Law 13/2016.
Two categories are again outside the definition of a patentable invention: a new use for a product that already exists or is known, and a new form of an existing compound that does not produce a meaningful efficacy improvement where the related chemical-structure difference is already known. The restored explanation treats products broadly, covering tools, goods, machines, compositions, formulas, methods, uses, compounds, and systems whether they remain patented or are already in the public domain.
For pharmaceutical compound forms, the official explanation links a meaningful improvement to efficacy rather than a merely minor structural difference. Patent applicants should therefore review claim scope and supporting data before continuing prosecution or appeal. A filing strategy that depended on the broader treatment of second medical use after Patent Law 65/2024 may no longer fit the governing exclusion.
DJKI says the decision will be implemented in patent examination and appeal processes to provide legal certainty. Until more detailed procedures are published, applicants, patent owners, licensees, and investors should assume the restored Article 4(f) test applies to current decision-making and should document how each relevant claim falls outside the exclusion or demonstrates the required meaningful improvement.
The ruling is not an automatic freedom-to-operate clearance for generic or competing products and does not itself cancel every granted secondary patent. Each business should still check the status and scope of all relevant Indonesian patents, contracts, regulatory approvals, and product requirements before manufacturing, licensing, acquiring, enforcing, or entering the market.
Required action
- Review pending and planned Indonesian patent applications, divisional filings, claim amendments, and appeals for claims based on a new use of a known product or a new form of a known compound.
- Where a compound-form claim remains in the strategy, prepare technically robust evidence showing a meaningful efficacy improvement and address the known related chemical-structure differences; do not rely on novelty of form alone.
- Reassess Indonesian patent portfolios, licences, valuations, acquisition documents, and enforcement positions that depend on second-use or incremental compound-form claims, while confirming the status of each granted right rather than assuming automatic cancellation.
- Generic-medicine and market-entry teams should refresh patent-landscape and freedom-to-operate analysis, but must still verify other live patents, regulatory approvals, data requirements, contracts, and sector restrictions before launch.
- Monitor DJKI examination and Patent Appeal Commission procedures for the announced implementation changes, and update filing and appeal templates when the revised practice is published.