Indonesia's Constitutional Court Restores the Bar on Second Medical Use Patents

Photo: pina messina / Unsplash

Pharmaceutical patent owners gained ground in Indonesia in 2024 and lost much of it in 2026. On 28 August 2026, the Constitutional Court (Mahkamah Konstitusi) ruled that Parliament's deletion of a key exclusion in the Patent Law was conditionally unconstitutional. The practical effect is that new uses of known products, including second medical uses, and new forms of known compounds without significantly improved efficacy are again outside what counts as a patentable invention.

What the 2024 amendment changed

Law No. 65 of 2024, the third amendment to Patent Law No. 13 of 2016, was enacted on 28 October 2024. Among other changes, it deleted Article 4(f). In its original form, Article 4(f) excluded from the definition of invention any discovery in the form of a new use of an existing or known product, or a new form of an existing compound that does not result in a significant increase in efficacy.

The Elucidation of the 2024 law explained the deletion with examples. It said that a second-use patent, for example for dapagliflozin in kidney disease after the first-use patent for diabetes had expired, would not stop the public from making the product for the original use. Law firm commentary at the time, including from Rouse, read the change as opening Indonesia to second medical use patents.

The challenge

A coalition of patient groups and individuals, including the Indonesian dialysis patients' community KPCDI, the Indonesian Pulmonary Hypertension Foundation, the Indonesian Positive Women's Association (IPPI) and Indonesia for Global Justice, filed a judicial review petition on 12 December 2025. They argued that the deletion removed a safeguard against low-quality patents that extend monopolies on medicines, and that it breached Articles 28D(1) and 28H(1) of the 1945 Constitution on legal certainty and the right to health services. The court heard submissions from the government, the House of Representatives, the Indonesian Pharmaceutical Companies Association (GPFI), the Food and Drug Authority (BPOM) and the consumer foundation YLKI.

The decision

In Decision No. 255/PUU-XXIII/2025, the court granted the petition in part. It held that the word "deleted" in Article 4(f), as amended, is unconstitutional and not binding unless it is read as restoring the exclusion of discoveries in the form of:

1. a new use of an existing and/or known product; and/or
2. a new form of an existing compound that does not produce a significant increase in efficacy and where there is a difference in chemical structure related to the known compound.

The court also revived the 2016 Elucidation of Article 4(f). Under it, an existing or known product covers tools, goods, machines, compositions, formulas, methods, uses, compounds and systems, whether still patented or in the public domain. It also keeps the 2016 example of significant efficacy: the hydroxyl group that distinguishes amoxicillin from ampicillin, giving amoxicillin a broader antimicrobial spectrum and greater stability.

According to the Antara news agency's report of the court's press release, Justice M. Guntur said the ban on second medical use is a protective step that brings more benefit and legal certainty to the national generic drug industry. The court rejected the remaining claims.

Indonesia's patent regime after the ruling

The rest of the 2024 amendment stands. Points that foreign applicants should keep in view include:

• Computer programs remain excluded, except computer-implemented inventions (Article 4(d)).
• The novelty grace period for disclosures at official exhibitions and similar events is 12 months.
• A missed 12-month priority deadline can be restored if the application is filed within 4 months after it, with a fee (Article 30(5)).
• Early substantive examination can be requested before publication (Article 54).
• Annual fees: the first payment is due within 6 months of the grant date and covers every year from filing to grant plus the following year. Later fees are due 1 month before each filing-date anniversary. A late payment gets a 6-month grace period with a fine of 100% of the fee owed (Article 126).
• Patent holders must file a statement on the working of the patent in Indonesia by the end of each year (Article 20A).

What this means for applicants

Pending and future Indonesian applications with claims directed to a new use of a known compound face refusal under Article 4(f) as now read. Claims to new salts, polymorphs or other forms will need data showing a significant increase in efficacy. Owners who filed second-use claims after October 2024 should review them with Indonesian counsel. Because Constitutional Court decisions are final and take effect when read, there is no further appeal against the ruling itself.

Sources

• Constitutional Court of Indonesia, Decision No. 255/PUU-XXIII/2025 (official PDF)
• Literasi Hukum Indonesia, decision record and operative part of No. 255/PUU-XXIII/2025
• ANTARA, "MK mengabulkan sebagian permohonan uji materiil UU Paten soal harga obat terjangkau" (31 August 2026)
• Law No. 65 of 2024 amending Law No. 13 of 2016 on Patents, text and Elucidation (Pasal.id, sourced from peraturan.go.id)
• JDIH DJKI, record of Law No. 65 of 2024
• Rouse, "Major Changes to Indonesia's New Patent Law" (5 November 2024)
• DJKI, "UU Paten Terbaru: Pemohon Tidak Perlu Menunggu 18 Bulan" (26 January 2026)