Indonesia Moves to Curb Drug Patent ‘Evergreening’: What to Know

Indonesia’s Top Court Revives Key Patent Restriction, Opening Door to Cheaper Generic Drugs

Tempatdonasi.com – In a decision that patient advocates describe as a watershed moment for pharmaceutical access in Southeast Asia, Indonesia’s Constitutional Court has restored a long-standing provision that bars certain incremental drug modifications from receiving patent protection. The move, announced on August 28, 2026, effectively dismantles a loophole introduced by recent patent-law amendments that critics argued allowed pharmaceutical firms to prolong market exclusivity over medicines already available in generic form.

The ruling lands at a moment when millions of Indonesians depend on chronic therapies — dialysis, pulmonary hypertension treatments, tuberculosis regimens — where even modest price increases compound into severe household financial strain over years of continuous use. By narrowing the scope of patentable pharmaceutical claims, the court has signaled that public-health considerations will weigh against purely incremental extensions of monopoly rights.

The Legal Path to the Ruling

The case, registered as Case No. 255/PUU-XXIII/2025, was filed in December 2025 by civil society organizations and individual petitioners aligned with the Coalition for Patient Rights Advocacy for Access to Medicines. They challenged Law No. 65 of 2024 — the third amendment to Law No. 13 of 2016 on Patents — which had struck the words of Article 4(f) from the statute. That article had previously excluded from patent eligibility certain new uses of existing products and new forms of existing compounds that did not deliver a meaningful therapeutic improvement.

On August 28, 2026, the court partially granted the petition, declaring the word “deleted” inserted into Article 4(f) by the 2024 amendment unconstitutional. The practical effect: the original exclusionary language is back in force, closing the pathway through which minor modifications could be locked behind new patent claims.

Understanding “Evergreening” and Why It Matters

Patent evergreening is a strategy in which a company files successive patent applications covering small tweaks to an existing medicine — a new salt form, a slightly altered dosage schedule, an additional indication — rather than a fundamentally new molecule. Each filing can extend the effective monopoly window by years, delaying the entry of lower-cost generic competitors. In markets where patented drugs carry prices several times higher than their generic equivalents, those delays translate directly into reduced access for patients who must take medication daily or weekly over extended periods.

The coalition argued that the 2024 amendment’s removal of Article 4(f) had created precisely the regulatory space for such practices within Indonesia’s pharmaceutical sector. With the provision restored, claims that merely repurpose an existing compound without a demonstrable efficacy gain fall outside patentable subject matter again.

What the Restored Provision Specifically Covers

Under the revived Article 4(f), two categories of pharmaceutical claims are excluded from patent eligibility:

First, new uses of an existing product and new forms of an existing compound that do not produce a meaningful improvement in therapeutic efficacy. Second, what is commonly termed a “second medical use” — applying an already-marketed medicine to a different disease indication. During the oral ruling, Justice M. Guntur Hamzah noted that limiting second-medical-use patents would furnish greater legal certainty for Indonesia’s domestic generic manufacturers, who have long operated under uncertainty about whether a rival’s new-indication filing could block their market entry.

The court framed the decision in public-health terms: by constraining patent claims that extend exclusive rights without a corresponding therapeutic benefit, the provision reinforces protections for patients who rely on affordable treatment options.

Patient Voices Behind the Petition

For the individuals and communities who brought the case, the stakes are personal and immediate. Tony Richard Samosir, chairman of the Indonesian Dialysis Patients Community (KPCDI), framed the issue in blunt terms in a joint coalition statement issued on Tuesday, September 1:

“Patents are meant to protect innovation, not lock medicines into high prices.”

Arni Rismayanti, chairwoman of the Indonesian Pulmonary Hypertension Foundation (YHPI), emphasized that the ruling could help strike a balance between rewarding genuine pharmaceutical research and preserving patients’ ability to obtain affordable therapy:

“For pulmonary hypertension patients, this is not an abstract issue. Access to medicines and their prices can affect patients’ financial burden and quality of life.”

Lusiana Aprilawati, a tuberculosis survivor and one of the original petitioners, pointed to the broader horizon beyond branded drugs. Once patent protections lapse, she explained, generic manufacturers can enter the market, and the same principle extends to vaccines, preventive treatments, and diagnostic tools — technologies whose cost barriers affect entire populations rather than individual patients.

Patents Remain; the Target Is Incremental Extension

The coalition was careful to stress that the ruling does not oppose patents or pharmaceutical innovation. Patent protection continues to serve its core function: providing the incentive structure and recognition that make substantial R&D investment viable. The concern, as the coalition articulated it, is narrowly aimed at situations where exclusive rights are sustained through minor modifications to existing products — extensions that add little therapeutic value while keeping prices elevated and generic competition at bay.

Implementation and What Comes Next

The coalition has called on both the executive branch and the House of Representatives (DPR) to translate the court’s decision into concrete amendments of Indonesia’s patent law and subordinate regulations. Until implementing legislation or ministerial guidance is issued, patent examiners at the Directorate General of Intellectual Property will face interpretive questions about how to apply the restored Article 4(f) to pending and future applications.

For Indonesia’s generic pharmaceutical industry — a sector that has grown steadily over the past decade and now supplies a significant share of domestic prescriptions — the ruling removes a structural uncertainty that had made long-term investment planning difficult. For patients on chronic therapies, the longer-term effect should be a faster transition from branded to generic supply once existing patents expire, narrowing the price gap that currently separates access from exclusion.

The decision also positions Indonesia as a reference point for neighboring ASEAN markets grappling with similar evergreening pressures, where patient-advocacy coalitions are watching closely to see how the restored provision operates in practice over the coming patent cycles.