Indonesia: Constitutional Court restores the prohibition on second medical use patents

September 8, 2026
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Articles

In brief

On 28 August 2026 the Constitutional Court of the Republic of Indonesia struck down the 2024 deletion of Article 4(f) of the Indonesian Patent Law and ordered its restoration, together with its original interpretation, in full. The decision was unanimous across nine Justices, with no dissenting or separate opinion, and is final. There is no appeal from a Constitutional Court decision.

The practical consequence is that Indonesia has restored an express statutory exclusion for new uses of existing or known products and for certain new forms of known compounds. Claims directed to second medical uses, including claims cast in Swiss type form, should again be expected to fall within the Article 4(f)exclusion. For new forms, the Court's reasoning links eligibility to both a meaningful increase in efficacy and a new chemical structural difference. The period in which the 2024 amendment allowed scope for second medical use protection, from 28 October 2024, has therefore closed after 22 months.

A separate challenge in the same proceeding, directed at the undefined term “interested party” in Article 70(1), was dismissed. Article 70(1) therefore stands unamended, but the Court's reasoning on the meaning of that phrase is likely to widen the range of parties able to appeal a patent grant in practice. We address that in section 4 below.

1. What the Court decided

Article 4(f) of Law No. 13 of 2016 excluded from the definition of a patentable invention any discovery comprising:

●      a new use for an existing or known product; and/or

●      a new form of an existing compound that does not result in a meaningful increase in efficacy, where the related difference in chemical structure from the compound is already known.

Law No. 65 of2024, the Third Amendment to the Patent Law, deleted Article 4(f) outright with effect from 28 October 2024 and put nothing in its place. The interpretation to the amended provision expressly contemplated second medical use protection and endorsed the skinny label approach, giving dapagliflozin and snakehead fish extract as worked examples.

The Court held that deletion of Article 4(f) is contrary to Articles 28C(1), 28D(1) and 28H(1)of the 1945 Constitution and conditionally without binding legal force unless the 2016 text is restored. It reasoned that Article 4(f) was the only upstream,filing stage safeguard against patent evergreening in the statute, and that the mechanisms which remain available, namely government use of patents, compulsory licensing, parallel importation and the Bolar exception, operate too far downstream to prevent evergreening at source. It also struck down the 2024 interpretation and ordered restoration of the 2016 interpretation in full, including its ampicillin and amoxicillin illustration of what constitutes a meaningful increase in efficacy.

The Court distinguished sharply between new uses and new forms. Restored Article 4(f)(1)excludes new uses of existing or known products without an efficacy exception and applies whether the underlying product remains patent protected or has entered the public domain. New forms fall under Article 4(f)(2) and require separate assessment under the restored text and interpretation.

2. Effect on pending applications and national phase entries

Constitutional Court decisions are final and take effect from pronouncement. The restored Article 4(f) should therefore be treated as operative from 28 August 2026. Its application to individual pending applications, particularly those filed or examined during the period in which the 2024 deletion was in force, will need to be seen in Directorate General of Intellectual Property (DGIP) practice.Clients should nevertheless plan based on the expectation that restored Article4(f) may be applied in ongoing examination. We will update clients as practice settles.

Clients with pending Indonesian applications should expect the following:

●      Second medical use and Swiss type claims. Applicants should expect patentable subject matter objections under restored Article 4(f). Efficacy evidence does not create an exception for a claim whose substance is a new use of an existing or known product. Where the specification supports it, amendment to claim categories that independently satisfy Indonesian patentability requirements should be considered.

●      New forms of known compounds. These claims require individual assessment under restored Article 4(f)(2). The Court's reasoning links eligibility to a meaningful increase in efficacy and anew chemical structural difference. Applicants should review both the claimed structural distinction and the supporting efficacy evidence. The restored example use ampicillin and amoxicillin as illustration, but does not prescribe a universal evidential protocol, so DGIP examination requirements will need to be confirmed in practice.

●      Definition of “invention”. The 2024amendment inserted the word “use” into the definition of invention in Article1, point 2. The Court directed that this general definition must be read consistently with restored Article 4(f) and called on the legislature to align the Patent Law with the decision. Until that is done, the word “use” should not be relied upon as a route to protection for new uses excluded by Article 4(f).

For matters not yet filed, including national phase entries with an approaching thirty-one-month deadline, the claim set should be reviewed against the restored Article 4(f) exclusion before entry rather than after the first examination report.

3. Effect on patents granted during the 2024 to 2026 window

The decision does not expressly determine the transitional treatment of patents granted, or applications examined, during the period in which the 2024 deletion was in force. This remains the most significant open point for clients, and we would caution against assuming either outcome.

The judgment does not itself revoke individual patents or determine the transitional treatment of rights granted while the 2024 amendment was in force. Affected patents should be identified and assessed before enforcement, licensing or other material reliance. Clients should not assume either automatic invalidity or immunity from challenge. The applicable grounds and procedural route for any challenge will require advice under Indonesian law.

We will circulate a further update once DGIP practice or judicial treatment of the transitional position becomes clear.

4. Standing to appeal a patent grant

The applicants also asked the Court to read a defined list of qualifying entities into the phrase “interested party” in Article 70(1), which governs who may appeal a grant to the Patent Appeal Commission. That request was refused because the Court considered the existing phrase already capable of an inclusive meaning.

The Court held t hat the relevant test is a real and direct legal interest in the granted patent. That interest is not confined to direct commercial or economic loss.Where a pharmaceutical claim creates a risk of impeded generic availability,the resulting threat to public health can itself amount to a real and direct legal interest. The Court identified advocacy groups and patient associations,consumer protection bodies, health focused non governmental organisations and independent researchers as examples of entities that may have the required interest.

The Court's interpretation is significant against the background of a 2023 Patent Appeal Commission decision concerning a tuberculosis medicine patent. In that case the Commission rejected the civil society appellant after finding both that it did not fall within the relevant qualifying categories and that it had not shown concrete loss from the grant. The Constitutional Court has now made clear that Article 70(1) is to be read inclusively and that public health interests may qualify. The Commission is directed to assess the relevant legal interest carefully so that public interests are not prejudiced.

Practical effect: originators holding Indonesian pharmaceutical patents, particularly for high value or high profile products, should prepare for post grant appeals from a broader range of public interest applicants. Prosecution files should be kept appeal ready.Where a new form is claimed, the record should address both the claimed structural distinction and the evidence supporting any asserted meaningful increase in efficacy.

5. What this means depending on where you sit

●      Originators and research based companies. Indonesia should now be treated as a jurisdiction where lifecycle strategies built on new indications will generally not translate into patent protection. Portfolio strategy should focus on primary compound claims and genuinely distinct formulation, process or other claim categories that independently satisfy Indonesian patentability requirements. Where a new form of a known compound is claimed, the application should address the restored Article 4(f)(2) requirements concerning meaningful efficacy and chemical structural distinction.

●      Generic and biosimilar companies. The restored Article 4(f) exclusion may reduce barriers arising from secondary claims directed to subject matter now excluded, but the decision does not itself revoke existing patents and does not replace a product specific freedom to operate assessment. The judgment does not amend the Bolar provision. In evidence before the Court, the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, BPOM) described a mechanism under which an application for marketing authorisation for a first generic may be submitted up to five years before patent expiry, with authorisation issued after expiry.Regulatory requirements should be checked separately in each case.

●      Associates instructing us on Indonesian filings. Claim sets prepared for other jurisdictions (such as Europe or United States) will require review and further adaptation for Indonesia. We are happy to review draft claim sets against the restored provision before filing or national phase entry.

6. Recommended next steps

●      Identify pending Indonesian applications containing second medical use, Swiss type, or new form claims and assess amendment options now.

●      Review Indonesian national phase entries falling due in the coming months and adjust claim strategy before entry.

●      Identify Indonesian patents granted between 28 October 2024 and 28 August 2026 claiming subject matter now excluded, and assess their position before enforcement, licensing or other material reliance.

●      For applications or patents containing new form claims, review the claimed structural distinction and the evidence supporting any asserted meaningful increase in efficacy for examination and potential post grant challenge.

●      Where Indonesian enforcement is contemplated on an affected right, take advice before issuing proceedings or a letter of demand.

Further information

We are monitoring DGIP post decision examination practice and will update clients as the position settles. If you would like us to review a specific portfolio,application or claim set against the restored provision, or if you have any questions arising from this alert, please contact your usual Voyage IP contact.

We hold an English language copy of the decision and are happy to provide it on request.Please let us know if you would like us to send it through. The English text is an unofficial translation and the Indonesian original remains controlling.

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This alert is provided for general information and reflects the position as at the date above. It is not legal advice and should not be relied upon in relation to any specific matter without taking advice on the particular facts.

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