Indonesia’s Constitutional Court (Mahkamah Konstitusi) has reinstated a key provision limiting pharmaceutical patent protection, signaling a renewed commitment to balancing patent rights with public access to medicines. In its ruling to Case No. 255/PUU-XXIII/2025, the court partially granted a petition for judicial review of Law No. 65 of 2024, which had amended the country’s Patent Law, and ordered the restoration of a provision that had excluded certain pharmaceutical inventions from patentability. The decision took effect immediately upon its pronouncement at the court’s plenary session on August 28, 2026.

Background

The petition challenged the removal of article 4(f) from Law No. 13 of 2016 concerning Patents (Patent Law), as amended by Law No. 65 of 2024. Article 4(f) had excluded from patentability certain inventions relating to new uses of known substances. The petitioners argued that removing this provision would open the door to patent protection for second medical use inventions and facilitate patent evergreening—practices that can extend exclusivity periods, delay generic market entry, and reduce public access to affordable medicines.

The petitioners included several patient advocacy and public-interest organizations: the Indonesian Dialysis Patients Community Association, the Indonesian Association of Drug Abuse Victims (PKNI), the Indonesian Pulmonary Hypertension Foundation (YHPI), the Rekat Peduli Indonesia Foundation, and the Indonesian Positive Women’s Association (IPPI), along with the Indonesia for Global Justice Association and four individual petitioners.

The petitioners also challenged the constitutionality of the phrase “interested party” in article 70(1) of the Patent Law, arguing that it should be construed expressly to clarify who has standing to appeal a decision to grant a patent before the Board of Patent Appeal, and to allow a broader range of parties—such as patent holders, licensees, consumer organizations, prosecutors, aggrieved third parties, and others who may suffer direct or indirect harm from the grant of a patent—to challenge patents alleged to cover subject matter excluded under article 4(f).

The Court’s Ruling

The Constitutional Court emphasized the need to maintain an appropriate balance between inventors’ rights and the broader public interest, particularly in healthcare. While recognizing that patent protection incentivizes innovation, the court found that the removal of article 4(f) had the potential to weaken public health protection by enabling evergreening. Specifically, the court considered that the following types of inventions should not be patentable:

• A new use of an existing product; and
• A new form of a known compound that does not provide a significant enhancement of efficacy.

The court held that granting patent protection for such subject matter could undermine the balance between private patent rights and the public interest. It further found that the deletion of article 4(f) failed to guarantee legal certainty and protection, and could hinder the fulfillment of constitutional rights relating to science, healthcare, and legal certainty under the 1945 constitution.

However, the court rejected the challenge to the phrase “interested party” in article 70(1), finding that the provision offers sufficient legal certainty and does not impede the constitutional rights the petitioners relied upon. In the court’s view, the concept is broad enough to be applied on a case-by-case basis without requiring further legislative clarification.

The court thus partially granted the petition, ordering the reinstatement of article 4(f) and its corresponding elucidation. The previous exclusion from patentability is therefore once again in effect. The challenge to the phrase “interested party” in article 70(1) was rejected, leaving that provision unchanged.

Implications for Patent Protection in Indonesia

The decision is an important development for pharmaceutical patent practice in Indonesia. With article 4(f) restored, the following consequences apply:

• Claims directed solely to a new use of an existing or known product, including second medical use claims, are not patentable in Indonesia.
• New forms of known compounds that do not demonstrate a significant improvement in efficacy are not patentable.
• Patent applicants in the pharmaceutical sector may face stricter limitations when seeking protection for incremental innovations based on known substances.

The ruling signals the court’s commitment to ensuring that the patent system serves not only the interests of innovators but also broader public health objectives.

Patent applicants in the pharmaceutical sector should carefully assess claim strategies involving new therapeutic uses, dosage regimens, formulations, or modified forms of known compounds. Following the reinstatement of article 4(f), such subject matter may face increased scrutiny during examination. Claims directed at genuine technical innovations that demonstrate meaningful technological or therapeutic advances are more likely to withstand examination under the restored framework.

Impact on Access to Medicines

The decision is expected to strengthen access to generic medicines and support the availability of more affordable healthcare products. By limiting opportunities to extend patent exclusivity through incremental modifications that do not provide meaningful therapeutic benefits, the court seeks to promote market competition while preserving incentives for genuine innovation. The decision may therefore have a significant impact on both patent prosecution strategies and healthcare policy in Indonesia.