Indonesia’s Constitutional Court restores limits on pharmaceutical patent protection
07 September 2026
Indonesia’s Constitutional Court has reinstated a key restriction on pharmaceutical patent protection, ruling that certain inventions involving known pharmaceutical substances should remain excluded from patentability.
In its decision in Case No. 255/PUU-XXIII/2025, issued on August 28, 2026, the court partially granted a petition challenging amendments to Indonesia’s Patent Law and ordered the restoration of Article 4(f) of Law No. 13 of 2016 concerning Patents, as amended by Law No. 65 of 2024.
The provision, which had been removed by the 2024 amendment, excludes certain inventions involving new uses of known substances from patent protection. The court’s decision took effect immediately upon its pronouncement in plenary session.
Court stresses balance between innovation and public health
In reaching its decision, the court emphasized the need to balance the rights of inventors with the broader public interest, particularly in the healthcare sector.
While recognizing the importance of patents in encouraging technological and pharmaceutical innovation, the court found that removing Article 4(f) could create opportunities for patent evergreening – where additional patent protection is sought for incremental changes to existing products, potentially extending exclusivity and delaying generic competition.
The court determined that two categories of inventions should remain excluded from patentability: new uses of existing products and new forms of known compounds that do not provide a significant improvement in efficacy.
According to the court, allowing patent protection for such inventions could disrupt the balance between private patent rights and the public interest. It also found that the deletion of Article 4(f) did not adequately guarantee legal certainty and protection and could affect the fulfilment of constitutional rights relating to science, healthcare, and legal certainty under Indonesia’s 1945 Constitution.
The ruling therefore restores Article 4(f), together with its corresponding elucidation, bringing the previous limitations on pharmaceutical patentability back into effect.
Challenge to “interested party” provision rejected
The court, however, rejected another part of the petition concerning Article 70(1) of the Patent Law and its reference to an “interested party.”
The petitioners had sought greater clarity on who may challenge the grant of a patent before the Board of Patent Appeal. They argued that the provision should expressly recognize a broader range of parties, including patent holders, licensees, consumer organizations, prosecutors, aggrieved third parties and others who may suffer direct or indirect harm from the grant of a patent.
The court found no constitutional defect in the existing provision. It held that the term “interested party” provides sufficient legal certainty and can be applied on a case-by-case basis, without requiring additional legislative clarification.
As a result, Article 70(1) remains unchanged.
Implications for pharmaceutical patents
The restoration of Article 4(f) is expected to have a direct impact on pharmaceutical patent practice in Indonesia.
Claims directed solely to a new use of an existing product – including second medical use claims – will again fall outside the scope of patentability. Likewise, new forms of known compounds that do not demonstrate a significant improvement in efficacy will remain excluded.
The ruling may require pharmaceutical patent applicants to reassess strategies involving new therapeutic uses, formulations, dosage regimens and modified forms of known compounds.
Applicants seeking protection for incremental pharmaceutical innovations may face greater scrutiny, particularly where the claimed invention is based on an existing substance and does not demonstrate a meaningful improvement in efficacy.
At the same time, the decision does not eliminate patent protection for pharmaceutical innovation generally. Genuine technical advances that satisfy Indonesia’s patentability requirements remain capable of receiving protection.
Potential impact on access to medicines
The court’s decision also carries broader implications for access to medicines and generic competition.
By limiting patent protection for certain incremental modifications of known pharmaceutical products, the ruling could reduce opportunities to extend exclusivity through inventions that do not deliver significant therapeutic improvements. This may support earlier generic competition and the availability of more affordable medicines.
The decision therefore reinforces the role of Indonesia’s patent system in balancing incentives for pharmaceutical innovation with public health considerations.
For pharmaceutical companies and patent practitioners, the restoration of Article 4(f) marks an important change in the country’s patent landscape and may require a reassessment of patent prosecution and portfolio strategies involving known pharmaceutical substances.
- Excel V. Dyquiangco
