Indonesian Constitutional Court Reinstates Patent Law Provision Limiting Protection for New Uses and Forms of Known Substances

Indonesia’s Constitutional Court (Mahkamah Konstitusi) has issued a landmark ruling in Case No. 255/PUU-XXIII/2025, restoring a key statutory exclusion in the country’s patent regime that restricts patentability of new uses and new forms of known substances. The decision, announced on August 28, 2026, reinstates Article 4f of Law No. 13 of 2016 concerning Patents, which had been removed by Law No. 65 of 2024.

Prior to its deletion, Article 4f excluded from patentable subject matter inventions involving new uses of existing products and new forms of known compounds that do not demonstrate a significant enhancement of efficacy. This provision was designed to prevent patent evergreening — the practice of extending patent monopolies through minor modifications — which can delay generic drug entry and adversely affect medicine affordability.

The petition challenging the deletion was filed by a coalition of patient advocacy and public-interest organizations, including 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, alongside four individuals.

The petitioners argued that removing Article 4f would allow second medical use inventions to be patented, encouraging evergreening, extending exclusivity periods, and undermining public health interests by restricting access to affordable medicines.

In its assessment, the Constitutional Court balanced the incentives patents provide for innovation against broader public health concerns. It concluded that the removal of Article 4f risked weakening protections for public health by facilitating evergreening. The court identified two categories of inventions that should remain excluded from patentability: new uses of known substances, including second medical uses, and new forms of known compounds lacking significant efficacy improvements.

The court emphasized that extending patent protection to these categories could disrupt the balance between private patent rights and the public interest. It further found that the deletion failed to ensure legal certainty and could obstruct constitutional rights related to science, healthcare, and legal certainty under Indonesia’s 1945 Constitution.

Separately, the petition sought to expand the interpretation of the phrase "interested party" in Article 70(1) of the Patent Law, which governs who may appeal patent grants before the Board of Patent Appeal. Petitioners requested that this term be construed broadly to include patent holders, licensees, consumer organizations, prosecutors, aggrieved third parties, and others potentially harmed by patent grants, to facilitate challenges against patents allegedly claiming excluded subject matter.

The court rejected this request, holding that the existing term "interested party" already provides sufficient legal certainty and flexibility to be applied on a case-by-case basis. It found no constitutional infringement warranting legislative clarification.

Consequently, Article 4f and its elucidation have been reinstated, restoring the exclusion of certain new uses and new forms of known substances from patentability. Article 70(1) remains unchanged.

This ruling carries significant implications for pharmaceutical patent practice in Indonesia. Claims solely directed to new uses of known products, including second medical use claims, are now excluded from patentable subject matter. Similarly, new forms of known compounds that do not demonstrate a significant enhancement of efficacy fall within the restored exclusion.

Incremental innovations based on known substances will face stricter limitations on patent protection. Applicants and patent practitioners are advised to carefully review claim strategies involving new therapeutic uses, dosage regimens, formulations, or modified forms of known compounds to ensure compliance with the reinstated exclusion. Claims supported by evidence of meaningful technological or therapeutic advances will have a stronger chance of surviving examination under the restored legal framework.

The court’s decision underscores Indonesia’s commitment to balancing innovation incentives with public health priorities, aiming to prevent patent evergreening practices that can hinder access to affordable medicines.