Patent protection is fundamentally intended to provide incentives for inventors to develop and introduce innovations. Through the exclusive rights granted by the State, a patent holder is afforded the opportunity to derive economic benefits from its invention for a specified period. At the same time, such protection must be balanced against the public interest, particularly where the subject matter of the patent concerns essential goods and services such as pharmaceutical products.
The balance between these interests has once again come under scrutiny following the issuance of Constitutional Court Decision No. 255/PUU-XXIII/2025 (“Decision No. 255/2025”) on 28 August 2026. The case concerned a constitutional challenge to provisions of Law No. 65 of 2024 on the Third Amendment to Law No. 13 of 2016 on Patents (“2024 Patent Law”).¹
The decision is particularly significant because the Constitutional Court of the Republic of Indonesia (“Constitutional Court” or “Court”) essentially reinstated the anti-evergreening provision that had previously been removed by the 2024 Patent Law. The Court held that the word “deleted” in Article 4(f) of the 2024 Patent Law was conditionally unconstitutional and therefore had no binding legal effect to the extent that it failed to reinstate the substance of the provision previously contained in Article 4(f) of Law No. 13 of 2016.²
The implications of this decision extend beyond the issue of access to medicines. For pharmaceutical companies, inventors, patent holders, and intellectual property practitioners, the decision has important implications for patent protection strategies, patentability assessments, claim drafting, and pharmaceutical patent portfolio management.
What Is Patent Evergreening?
The term evergreening is generally used to describe strategies aimed at maintaining or extending the commercial exclusivity associated with an existing product through patent applications covering certain developments, modifications, or uses of that product.
In the pharmaceutical sector, the issue is particularly complex because an existing medicine may be subject to various forms of further development, including changes to its formulation, composition, chemical form, or medical use.
It is important, however, to draw a proper distinction. Not every development of an existing pharmaceutical product constitutes evergreening. A development that provides a genuine technical contribution and satisfies the applicable patentability requirements may still constitute a legitimate innovation deserving of patent protection.
The legal issue arises where a modification or development does not provide a meaningful improvement in efficacy, yet is relied upon as the basis for obtaining a new period of exclusivity. Within the Indonesian patent system, this issue is closely associated with Article 4(f) of Law No. 13 of 2016.
The Evolution of Article 4(f) of the Patent Law
Prior to its amendment by Law No. 65 of 2024, Article 4(f) of Law No. 13 of 2016 excluded certain subject matter from inventions eligible for patent protection, namely:
- a new use of an existing and/or known product; and/or
- a new form of an existing compound that does not result in a significant increase in efficacy and where there is a chemical structural difference related to the compound that was already known.³
This provision was subsequently deleted by Law No. 65 of 2024, which constituted the third amendment to Law No. 13 of 2016 on Patents.⁴
The deletion of Article 4(f) was subsequently challenged before the Constitutional Court in Case No. 255/PUU-XXIII/2025.
The Petitioners, among others, linked the deletion of the provision to their constitutional rights to fair legal certainty, as guaranteed under Article 28D paragraph (1) of the 1945 Constitution of the Republic of Indonesia (“1945 Constitution”), and to the right to health, as guaranteed under Article 28H paragraph (1) of the 1945 Constitution.⁵
According to the Petitioners, removing the exclusion could potentially create greater room for evergreening practices, whereby the patent system could be used to obtain additional protection for certain developments of products that were already known. In the pharmaceutical context, such circumstances were considered capable of delaying the market entry of generic products.
The Government’s Position: Preserving Room for Pharmaceutical Innovation
The case essentially brought two competing policy considerations before the Constitutional Court, each of which was supported by a legal and policy rationale.
On the one hand, the Petitioners considered the anti-evergreening provision necessary to prevent the expansion of patent monopolies that could adversely affect public access to medicines.
On the other hand, the Government argued that the deletion of Article 4(f) could provide greater room for research and development in the pharmaceutical sector. From this perspective, new developments involving existing products should not automatically be excluded from the possibility of patent protection.
Accordingly, the issue confronting the Constitutional Court is not merely a conflict between “patent protection” and “access to medicines.” The more fundamental issue concerns the boundary that the law must establish in distinguishing innovations that warrant exclusive rights from developments that no longer embody sufficient technical contribution or therapeutic efficacy to qualify for patent protection.
Constitutional Court Decision No. 255/PUU-XXIII/2025
The Constitutional Court granted the Petitioners’ application in part. In its operative ruling, the Court held that the word “deleted” in Article 4(f), as referred to in Article 1 point 2 of Law No. 65 of 2024, was contrary to the 1945 Constitution and had no binding legal effect on a conditional basis.
The Court consequently construed the provision so that Article 4(f) once again excluded from patentable inventions:
- a new use of an existing and/or known product; and/or
- a new form of an existing compound that does not result in a significant increase in efficacy and involves a chemical structural difference related to the compound that was already known.⁶
Accordingly, in substance, the anti-evergreening provision under Article 4(f) of Law No. 13 of 2016 has been reinstated.
The Constitutional Court also held that the Elucidation of Article 4(f) under Law No. 65 of 2024 had no binding legal effect on a conditional basis to the extent that it failed to reinstate the Elucidation of Article 4(f) under Law No. 13 of 2016.⁷
The decision is legally binding from the time it is pronounced in an open plenary session of the Constitutional Court.⁸
Why Did the Constitutional Court Consider the Anti-Evergreening Provision Necessary?
One of the most significant aspects of the Constitutional Court’s reasoning concerns the relationship between patent protection and the right to health.
The Court considered several mechanisms available under the patent system, including Government Use of Patents, parallel importation, the Bolar provision, and compulsory licensing. According to the Court, these mechanisms primarily operate at the downstream stage.
Consequently, they do not fully address situations in which the issue arises at an earlier stage—namely, where subject matter that should not qualify for patent protection is nevertheless admitted into the patent system.⁹
Against this background, the Court considered the exclusion of second medical use under Article 4(f) to be an instrument that operates at the initial stage of determining patentability.
The Court considered that such an exclusion provides greater protection and legal certainty for the domestic generic pharmaceutical industry while strengthening the protection of public health.¹⁰
Second Medical Use and Skinny Labelling
Two concepts that warrant particular attention following the decision are second medical use and skinny labelling.
In simple terms, second medical use concerns a new medical use of a product that is already known or has previously been used.
Following the reinstatement of Article 4(f), a new use of an existing and/or known product is again included within the category of subject matter excluded from patentable inventions.¹¹
Meanwhile, skinny labelling generally refers to an approach to the labelling or marketing of a pharmaceutical product whereby certain indications that remain within the scope of another party’s patent claims are omitted from the product’s approved label.
The Constitutional Court paid particular attention to this issue. The Court considered that the explanatory provision under the 2024 Patent Law that provided room for a skinny labelling approach could no longer be maintained following the reinstatement of the anti-evergreening provision.
The Court further emphasized that the use of skinny labelling does not automatically exempt a company from potential patent infringement claims brought by the holder of the primary or originator patent.¹²
Accordingly, generic pharmaceutical manufacturers cannot rely solely on labelling strategies. An assessment must still be undertaken with respect to the scope of relevant patent claims, patent status, the activities to be undertaken, and potential infringement risks.
Implications for Pharmaceutical Patent Strategies
1. Not Every Product Development Will Automatically Be Patentable
A development of an existing product may still constitute a patentable innovation if it satisfies the applicable patentability requirements.
However, the mere existence of a development is not sufficient. For subject matter falling within the scope of Article 4(f), particular attention must be given to whether the development constitutes a new use of an existing and/or known product or a new form of an existing compound that does not result in a significant increase in efficacy.
Companies should therefore conduct a comprehensive patentability assessment from the research and development stage, rather than waiting until a patent application is ready to be filed.
2. Technical Data May Become Increasingly Important
For pharmaceutical companies, evidence demonstrating the technical contribution and increased efficacy of an invention may assume strategic importance.
The Elucidation of Article 4(f) reinstated by the Constitutional Court uses examples involving penicillin-class antibiotics, namely ampicillin and amoxicillin. The Court explains that certain differences in the chemical structure of the two compounds may result in a broader antimicrobial spectrum and greater stability, and may therefore constitute a significant increase in efficacy.¹³
This example demonstrates that the analysis does not necessarily end with determining whether a chemical structure has changed. The technical effect and efficacy resulting from that change may also be relevant.
3. Patent Drafting Should Be Approached Strategically
For patent applicants in the pharmaceutical sector, the decision reinforces the importance of drafting specifications and claims in a manner that clearly demonstrates the technical contribution of the invention.
A careful assessment of prior art, the technical characteristics of the invention, and the relationship between changes in structure or formulation and the resulting technical effects should be undertaken.
In other words, patent protection strategies should be developed from the R&D stage rather than being formulated only after the invention has been completed.
4. Patent Portfolios Should Be Reviewed
Companies with existing pharmaceutical patent portfolios should also consider the potential impact of the decision on their protection and product-development strategies.
Such a review may include:
- the types of inventions that have been or are intended to be patented;
- the relationship between primary patents and development patents;
- the technical basis of each invention;
- the scope of the relevant claims;
- the status of patent protection in Indonesia; and
- potential infringement or dispute risks involving other patent holders.
Such a review is particularly relevant for companies developing products based on compounds or pharmaceutical products that are already known.
What Does the Decision Mean for Generic Pharmaceutical Companies?
From the perspective of the generic pharmaceutical industry, the decision provides clearer boundaries concerning certain types of subject matter that cannot qualify for patent protection.
The decision does not, however, mean that all generic products are automatically free from patent risks.
Generic pharmaceutical companies should continue to conduct comprehensive freedom-to-operate (“FTO”) analyses before manufacturing or commercializing a product. Such analyses should consider, among other matters, patents that remain in force, the relevant territorial scope, the scope of the claims, and the activities to be undertaken by the company.
Accordingly, the Constitutional Court’s decision should not be interpreted as an “automatic authorization” for generic manufacturers to commercialize every known pharmaceutical product.
Does the Decision Hinder Innovation?
This is one of the most important questions arising from the Constitutional Court’s decision.
The answer should be considered carefully and proportionately.
The decision does not eliminate patent protection for pharmaceutical innovation. Rather, the Court reinstated limitations concerning certain categories of subject matter that, under Article 4(f), are excluded from patentable inventions.
Accordingly, innovations that provide a genuine technical contribution and satisfy the applicable patentability requirements remain capable of receiving patent protection.
From an intellectual property perspective, this distinction is important. The patent system does not merely confer exclusive rights on inventors; it also establishes the boundaries as to which subject matter merits such exclusive rights.
In this context, the balance between incentives for innovation, legal certainty, competition, and public health interests is central to understanding the Constitutional Court’s decision.
The Next Challenge: Harmonization of the Patent Law
Another noteworthy aspect of the decision is that the Constitutional Court did not merely reinstate Article 4(f), but also identified a potential inconsistency between that provision and the definition of “invention” under the 2024 Patent Law.
The 2024 Patent Law incorporates the terms “system, method, and use” into the definition of an invention. According to the Constitutional Court, if the term “use” were interpreted separately without taking into account the reinstated exclusions, a conflict of norms could arise and potentially create room for evergreening in practice.¹⁴
The Court therefore emphasized the need for the legislature to adjust the Patent Law in accordance with Decision No. 255/PUU-XXIII/2025.¹⁵
This point is particularly relevant for businesses because the implications of the decision do not end with the operative ruling itself. Its practical implementation will also depend on how the relevant provisions are applied by the competent authorities and how the legislature subsequently harmonizes the statutory framework.
What Should Patent Owners and Applicants Do?
Following Constitutional Court Decision No. 255/PUU-XXIII/2025, pharmaceutical companies and businesses operating in related technological fields should consider several practical measures.
First, companies should conduct more comprehensive patentability assessments, particularly for inventions that constitute developments of existing products or known compounds.
Second, companies should strengthen the documentation of technical data and research results demonstrating the technical contribution or increased efficacy of the invention.
Third, companies should conduct prior-art searches and freedom-to-operate analyses before making significant commercial investments.
Fourth, companies with existing patent portfolios may consider conducting a portfolio review to assess the position of their patents following the Constitutional Court’s decision.
Fifth, patent drafting and prosecution strategies should take into account the legal framework following the reinstatement of Article 4(f), including the relationship between the statutory definition of an invention and the exclusions applicable to certain subject matter.
Conclusion
Constitutional Court Decision No. 255/PUU-XXIII/2025 represents a significant development in Indonesian patent law, particularly for the pharmaceutical sector.
By reinstating Article 4(f) of the Patent Law, the Constitutional Court reaffirmed that patent protection must be balanced against public interests and the constitutional right to health. The provision once again excludes new uses of existing products and certain new forms of existing compounds that do not result in a significant increase in efficacy from the category of patentable inventions.¹⁶
For the pharmaceutical industry, the decision does not mean that the scope for innovation has been closed. Rather, companies will need to demonstrate more clearly the technical substance and innovative value of developments for which patent protection is sought.
The decision also sends an important message to patent owners and applicants: intellectual property protection strategies cannot be separated from developments in legislation and judicial decisions. Patent drafting, patent prosecution, portfolio management, and freedom-to-operate analysis should all be undertaken with a comprehensive understanding of the applicable legal framework.
Ultimately, the post-decision challenge is to strike an appropriate balance between providing meaningful incentives to innovators and ensuring that the patent system continues to support competition, legal certainty, and public access to essential healthcare needs.
Footnotes
- Constitutional Court of the Republic of Indonesia, Decision No. 255/PUU-XXIII/2025, concerning the judicial review of Law No. 65 of 2024 on the Third Amendment to Law No. 13 of 2016 on Patents, decided on 28 August 2026. See also the Constitutional Court’s official database of decisions, which records the case number, subject matter, date of decision, and operative ruling.
- Constitutional Court of the Republic of Indonesia, “MK Hidupkan Kembali Norma Anti-Evergreening dalam UU Paten,” 28 August 2026. The Constitutional Court explained that the word “deleted” in Article 4(f) was declared conditionally unconstitutional and that the provision was consequently reinstated.
- Republic of Indonesia, Law No. 13 of 2016 on Patents, Article 4(f).
- Republic of Indonesia, Law No. 65 of 2024 on the Third Amendment to Law No. 13 of 2016 on Patents.
- Constitution of the Republic of Indonesia of 1945, Articles 28D paragraph (1) and 28H paragraph (1).
- Constitutional Court of the Republic of Indonesia, Decision No. 255/PUU-XXIII/2025, operative ruling.
- Ibid., concerning the reinstatement of the Elucidation of Article 4(f) of Law No. 13 of 2016.
- Constitutional Court of the Republic of Indonesia, Decision No. 255/PUU-XXIII/2025. Under Indonesian constitutional law, Constitutional Court decisions are legally binding from the time they are pronounced in an open plenary session.
- Constitutional Court of the Republic of Indonesia, Decision No. 255/PUU-XXIII/2025, legal considerations concerning Government Use of Patents, parallel importation, the Bolar provision, and compulsory licensing.
- Ibid. The Constitutional Court considered the exclusion of second medical useat the initial patent-application stage to provide greater protection and legal certainty for the domestic generic pharmaceutical industry.
- Ibid., concerning the reinstatement of Article 4(f) of Law No. 13 of 2016.
- Ibid., concerning skinny labelling. The Constitutional Court considered that the explanatory provision allowing skinny labellingcould no longer be maintained following the reinstatement of the anti-evergreening provision and emphasized that skinny labelling does not automatically shield a company from patent infringement claims.
- Ibid., concerning the reinstated Elucidation of Article 4(f), particularly the examples involving ampicillin and amoxicillin and the interpretation of a “significant increase in efficacy.”
- Ibid., concerning the definition of “invention” under Law No. 65 of 2024, including “system, method, and use”, and the potential conflict with the reinstated Article 4(f).
- Ibid. The Constitutional Court emphasized the need for the legislature to adjust the Patent Law in accordance with Decision No. 255/PUU-XXIII/2025.
- Constitutional Court of the Republic of Indonesia, Decision No. 255/PUU-XXIII/2025.
Bibliography
Legislation
- Republic of Indonesia. Constitution of the Republic of Indonesia of 1945.
- Republic of Indonesia. Law No. 13 of 2016 on Patents.
- Republic of Indonesia. Law No. 65 of 2024 on the Third Amendment to Law No. 13 of 2016 on Patents.
Judicial Decision
- Constitutional Court of the Republic of Indonesia. Decision No. 255/PUU-XXIII/2025 concerning the Judicial Review of Law No. 65 of 2024 on the Third Amendment to Law No. 13 of 2016 on Patents. Decided and pronounced on 28 August 2026.
Official Sources
- Constitutional Court of the Republic of Indonesia. “MK Hidupkan Kembali Norma Anti-Evergreening dalam UU Paten.”28 August 2026.
- Constitutional Court of the Republic of Indonesia. Constitutional Court Decisions Database.
- Audit Board of the Republic of Indonesia (Badan Pemeriksa Keuangan Republik Indonesia). Regulatory Database: Law No. 65 of 2024 on the Third Amendment to Law No. 13 of 2016 on Patents.
- Audit Board of the Republic of Indonesia (Badan Pemeriksa Keuangan Republik Indonesia). Regulatory Database: Law No. 13 of 2016 on Patents.
Secondary Sources
- “UU Paten Digugat ke MK, Penghapusan Norma Anti-Evergreening Dinilai Langgar Hak atas Kesehatan.”
- id. “Putusan MK Nomor 255/PUU-XXIII/2025: Menutup Pintu Evergreening.”
- Media Indonesia. “MK Pulihkan Norma Anti-Evergreening, Monopoli Paten Obat Dibatasi.”
- Metro TV News. “MK Pulihkan Norma Anti-Evergreening dalam UU Paten.”
- Indonesia for Global Justice (IGJ). “Kemenangan dari Hak Pasien atas Obat: MK Pulihkan Norma Anti-Evergreening dalam UU Paten dan Perkuat Perlindungan terhadap Akses ke Obat.”
- “Putusan MK soal UU Paten: Hapus Norma Anti-Evergreening Obat.”
