MK Limits Evergreening of Pharmaceutical Patents, but Not All Parties May Challenge Them

The Constitutional Court (Mahkamah Konstitusi or “MK”), through Decision No. 255/PUU-XXIII/2025 pronounced on Friday, 28 August 2026, partially granted the petition for judicial review of Law No. 65 of 2024 concerning the Third Amendment to Law No. 13 of 2016 concerning Patents (the “Patent Law”). The petition was filed by a coalition of civil society organizations and patients, comprising the Indonesian Kidney Dialysis Patient Community Association (Perkumpulan Komunitas Pasien Cuci Darah Indonesia or “KPCDI”), chaired by Tony Richard Samosir; Perkumpulan PKNI; the Indonesian Pulmonary Hypertension Foundation (Yayasan Hipertensi Paru Indonesia or “YHPI”), chaired by Arni Rismayanti; Yayasan Rekat Peduli Indonesia; the Indonesian Positive Women’s Association (Ikatan Perempuan Positif Indonesia or “IPPI”); Indonesia for Global Justice (IGJ); as well as several individual petitioners, including Lusiana Aprilawati.

Nevertheless, it is important to note that, of the two constitutional issues raised, the MK granted only one, namely the restoration of the anti-evergreening provision under Article 4 letter f of the Patent Law. The second petition, concerning the expanded interpretation of legal standing (“interested parties”) under Article 70 paragraph (1), was instead declared legally unfounded and rejected.

Case Background: Repeated Patenting Practices Concerning Essential Medicines

The Petitioners argued that the removal of the exceptions under Article 4 letter f of the Patent Law, which previously prohibited patents on (i) new uses of existing products, and (ii) new forms of existing compounds without a significant increase in efficacy, had lowered the patentability threshold. As a result, originator pharmaceutical companies could file low-quality secondary patents merely to extend their monopoly periods while simultaneously hindering the entry of generic medicines into the market. This practice is known as patent evergreening.

PKNI presented a concrete example: the primary patent for Sofosbuvir, an essential medicine for Hepatitis C, in Indonesia expired on 21 April 2024. However, through the registration of four secondary patents covering crystal forms, preparation processes, and drug combinations, the patent protection period was extended until 30 January 2034, nearly a decade after the primary patent should have entered the public domain (public ownership).

The Court’s Considerations: Balancing Patent Rights and the Right to Health

In its considerations, the Court emphasized that the patent system fundamentally distinguishes between an “invention” and a “discovery”: the discovery of something that already exists in nature but has only newly been revealed by science does not satisfy the element of novelty and is therefore not patentable. Based on this construction, Article 4 letter f of the Patent Law was deemed a conditio sine qua non for a proportionate intellectual property system subject to the supremacy of human rights, particularly the right to the highest attainable standard of health as guaranteed by Article 28H paragraph (1) of the 1945 Constitution.

The Court considered that alternative instruments available under the Patent Law, such as Government Use of Patents, parallel imports, the Bolar provision, and compulsory licensing, are effective only in addressing issues at the downstream level and therefore cannot prevent evergreening practices at the upstream stage of patent registration. On this basis, the prohibition of second medical use was deemed a State protection measure that would provide greater benefits to the national generic pharmaceutical industry while simultaneously strengthening health sovereignty from upstream to downstream.

As a legal consequence, the Court also declared the Elucidation of Article 4 letter f of the new Patent Law to be contrary to the 1945 Constitution, because the Elucidation was formulated specifically to create room for second medical use, contrary to the restored provision. In its place, the Court reinstated the elucidation of the article as set forth in the previous Patent Law (Law No. 13 of 2016).

Legal Standing: Inclusive Interpretation Affirmed, but Petition Nevertheless Rejected

On the second issue, the Petitioners requested that the phrase “interested parties” in Article 70 paragraph (1), which determines who may appeal the grant of a patent to the Patent Appeal Commission, be interpreted broadly to include patient organizations, consumer protection institutions, and independent researchers, rather than being limited to competitors within the same industry.

Interestingly, in its considerations, the Court actually agreed with the spirit of this petition: the parameter of “legal interest” may not be reduced solely to direct economic loss, and where the subject matter of the dispute concerns public health impacts, patient advocacy groups, consumer institutions, and independent researchers “within the bounds of reasonable reasoning” already possess an actual and direct overlap of legal interests. However, the Court concluded that the existing phrase already encompasses such an inclusive interpretation without requiring a conditional interpretation through a judicial decision; accordingly, the Petitioners’ argument concerning the unconstitutionality of this provision was declared legally unfounded and rejected.

The implication is that the Court’s view regarding this inclusive interpretation is recorded in its legal considerations (rather than in the operative part/dictum of the decision), meaning that its binding force as an interpretive guideline for the Patent Appeal Commission is not as strong as it would have been had it been incorporated into the operative part of the decision, which has erga omnes effect.

Impact on Patients

According to reports by Tempo and Metro TV, KPCDI Chairman Tony Richard Samosir welcomed the decision, emphasizing that patents are essentially created to protect innovation, not to lock medicines into continued high prices. YHPI Chairwoman Arni Rismayanti likewise stated that access to and the high cost of medicines are not abstract issues, but concern the financial burden and day-to-day survival of patients with chronic diseases.

Addressing Gaps in Evergreening Practices

With the anti-evergreening provision restored, attention now turns to the implementation stage: how the Directorate General of Intellectual Property (DJKI) will apply this substantive standard in future pharmaceutical patent examinations, including with respect to secondary patent applications already awaiting examination.

MK Decision No. 255/PUU-XXIII/2025 does not merely restore the anti-evergreening provision, but also affirms the fundamental limitation that patent rights must not be transformed into a means of restricting public access to medicines. However, a victory at the normative level will only be meaningful if it is followed by tangible changes in patent examination practices by the DJKI and greater openness to participation by patients, consumers, and researchers. This is because, patents should constitute recognition of innovation, not legitimization of an extended monopoly without meaningful innovation.