Pharmaceutical patent applicants in Indonesia must once again contend with a statutory exclusion covering new uses and new forms of known substances. In Case No. 255/PUU-XXIII/2025, Indonesia’s Constitutional Court (Mahkamah Konstitusi) partially granted a request for judicial review of Law No. 65 of 2024, which amended the country’s Patent Law, and ordered that the deleted Article 4f be reinstated. Because the decision took effect when it was pronounced at the court’s plenary session on August 28 2026, the exclusion is already in force.
A challenge to the 2024 amendment
Law No. 65 of 2024 removed Article 4f from Law No. 13 of 2016 concerning Patents (the Patent Law). Before its removal, the provision had placed certain inventions involving new uses of existing products and new forms of known compounds that did not significantly enhance efficacy outside the scope of patentable subject matter. The petitioners contended that the deletion would make second medical use inventions eligible for protection and encourage evergreening, allowing exclusivity periods to be prolonged, delaying the entry of generics, and making medicines less affordable for the public.
The petition was brought by a coalition of patient advocacy and public-interest organisations – the Indonesian Dialysis Patients Community Association, the Indonesian Association of Drug Abuse Victims, the Indonesian Pulmonary Hypertension Foundation, the Rekat Peduli Indonesia Foundation, the Indonesian Positive Women’s Association, and the Indonesia for Global Justice Association – together with four individuals.
A second limb of the petition targeted the phrase “interested party” in Article 70(1) of the Patent Law, which determines who has standing to appeal a patent grant before the Board of Patent Appeal. The petitioners asked the court to construe the phrase expressly to cover a wider group – including patent holders, licensees, consumer organisations, prosecutors, aggrieved third parties, and others who may suffer direct or indirect harm from a grant – so that patents alleged to claim subject matter excluded under Article 4f could be challenged more readily.
The decision
In assessing the deletion of Article 4f, the court weighed the incentive that patents provide for innovation against the wider public interest, with particular attention to healthcare. It concluded that removing the provision risked weakening public health protection by facilitating patent evergreening and identified two categories of inventions that should remain unpatentable:
New uses of existing products; and
New forms of known compounds that do not significantly enhance efficacy.
According to the court, extending patent protection to these categories could upset the balance between private patent rights and the public interest. It also found that the deletion failed to guarantee legal certainty and protection, and could obstruct the fulfilment of constitutional rights relating to science, healthcare, and legal certainty under the 1945 Constitution.
The challenge to Article 70(1), by contrast, was unsuccessful. The court held that “interested party” already provides adequate legal certainty and does not interfere with the constitutional rights invoked by the petitioners. In its view, the phrase is broad enough to be applied case by case, without the need for further legislative clarification.
As a result, Article 4f and its elucidation have been reinstated, restoring the earlier exclusion from patentability, while Article 70(1) remains unchanged.
What changes for applicants
The reinstatement of Article 4f has several direct consequences for pharmaceutical patent practice in Indonesia:
Claims whose only contribution is a new use of an existing or known product, second medical use claims included, fall outside patentable subject matter;
New forms of known compounds that do not result in a significant enhancement of efficacy fall within the restored exclusion; and
Incremental innovations built on known substances are likely to face tighter limits on the protection available.
Applicants and their advisers should revisit claim strategies built around new therapeutic uses, dosage regimens, formulations, or modified forms of known compounds to assess whether the claimed subject matter falls within the restored exclusion, as such claims may now attract closer scrutiny during examination. Claims that capture a genuine technical contribution, supported by evidence of a meaningful technological or therapeutic advance, are better placed to survive examination under the restored framework.
Wider policy implications
The ruling signals the court’s commitment to ensuring that Indonesia’s patent system serves public health objectives as well as the interests of innovators. By restricting the use of incremental modifications without meaningful therapeutic benefit to extend exclusivity, the court seeks to promote market competition while preserving incentives for genuine innovation.
The decision is expected to strengthen access to generic medicines and support the availability of more affordable healthcare products, and its effects are likely to be felt in both patent prosecution strategy and healthcare policy in Indonesia.
