A Win for Public Health: Indonesia’s Constitutional Court Strikes Down Evergreening to Protect Affordable Medicines

In its decision, the Constitutional Court declared the deletion of Article 4(f) conditionally unconstitutional, effectively restoring the anti-evergreening safeguard. Under the reinstated provision, new uses of existing products and new forms of known chemical compounds that do not demonstrate significant therapeutic efficacy remain expressly excluded from patentability. For practitioners, the “conditional” nature of this ruling matters: the Court did not simply strike out the deleting clause but read Article 4(f) back into the law as expressly defined in its verdict so examiners and applicants should refer to the Constitutional Court’s decision itself, not only the pre-2024 wording, when assessing patentability. The Court also declared the Elucidation of Article 4(f) in Law No. 65 of 2024 conditionally unconstitutional and reinstated the Elucidation contained in Law No. 13 of 2016. The petitioners’ second challenge, to the phrase “interested party” in Article 70(1) (who may appeal a patent grant), was not granted: as reported, the Court found that the phrase already carries an inclusive meaning, a view recorded in its considerations rather than in the operative ruling. The Court also called on the legislature to align the Patent Law with its decision.

The Court’s reasoning emphasized the need to balance patent protection with constitutional rights and public health. Its key considerations included: 

1. Preventing Evergreening at the Patent Stage: The Court distinguished between “upstream” safeguards, which prevent undeserving patents from being granted in the first place, and “downstream” measures, such as compulsory licensing or government use of patents, parallel imports and the Bolar exception, which can be applied after a patent has already been granted. The Court found that downstream measures alone cannot effectively address evergreening because they do not prevent weak or low-quality patents from being granted in the first place. 
2. Protecting Public Health and Access to Medicines: The Court recognized that patent rights can encourage innovation, but held that these exclusive rights must be balanced against constitutional rights to health and access to essential medicines. Patent protection should not come at the expense of access to affordable medicines, particularly where extended patent protection does not reflect significant therapeutic innovation. 
3. Legal Certainty and National Health Sovereignty: The Court considered that a prohibition on second medical use, operating at the early stage of patent filing, is a more beneficial state safeguard and gives greater legal certainty to the national generic medicines industry, strengthening health protection from upstream to downstream and supporting national health sovereignty.
4. Alignment with International Standards (commentary): Although public reports of the decision focus on constitutional and domestic-law grounds, the outcome is also consistent with international frameworks that recognize the need to balance intellectual property protection with public health objectives, including the 2001 Doha Declaration on the TRIPS Agreement and Public Health and recommendations of the UN High-Level Panel on Access to Medicines.