TWN Info Service on Intellectual Property (Aug26/02)
31 August 2026
Third World Network

Indonesia's Constitutional Court Restores Safeguards Against Pharmaceutical Patent Evergreening

Penang, 31 August (Third World Network) - In a landmark decision delivered on 28 August 2026, Indonesia’s Constitutional Court reinstated the anti-patent-evergreening provision in Article 4(f) of the 2016 Patent Law. The Court also clarified that civil society organisations and other public interest actors qualify as “interested party” entitled to challenge the grant of patents under Article 70(1) of the Patent Law.

This historic decision (No. 255/PUU-XXIII/2025) is the result of a case brought by ten petitioners to the Constitutional Court of the Republic of Indonesia challenging Law No. 65 of 2024 on the Third Amendment to Law No. 13 of 2016 on Patents, which deleted Article 4(f) of the patent law, an important safeguard against pharmaceutical patent evergreening.  

The petitioners of the Constitutional case are: the Indonesian Dialysis Patients Community (KPCDI), the Indonesian Drug Users Network (PKNI), the Indonesian Positive Women’s Association (IPPI), the Indonesian Pulmonary Hypertension Foundation (YHPI), REKAT Peduli Indonesia Foundation (REKAT), Indonesia for Global Justice (IGJ), Lusiana Aprilawati, a tuberculosis (TB) survivor and activist, Irwandy Wijaya, a HIV activist from the Indonesia AIDS Coalition (IAC); Patrick J. Laurens, a HIV activist and Program Manager at the Indonesia AIDS Coalition (IAC) and Paran Sarimita Winarni, a TB survivor and activist.

Coalition for Patients’ Rights Advocacy for Access to Medicines, a coalition of patient organizations, civil society organizations and individuals, in its press release said the ‘decision marks an important victory for patients, the public and efforts to ensure access to affordable medicines. Through its decision, the Constitutional Court has restored the anti-evergreening provision under Article 4(f) of the Patent Law, which had previously been removed by Law No. 65 of 2024’. 

It further explained that the ‘Court ruled that the removal of the provision was contrary to the 1945 Constitution of the Republic of Indonesia and conditionally unconstitutional. As a result, new uses of existing and/or known products, as well as new forms of existing compounds that do not result in a significant increase in efficacy, are once again excluded from patentable subject matter’.

The coalition stressed that the decision is particularly significant because patent evergreening can be used to extend monopolies through minor changes or modifications that do not provide meaningful therapeutic innovation. When patent monopolies are extended, generic competition is delayed, medicine prices remain high, and ultimately patients and the State bear the costs associated with such monopolies’.

On the matter of ‘interested party’, Rahmat Maulana Sidik, Executive Director of Indonesia for Global Justice (IGJ), said “The Court’s opinion in this case, particularly regarding Article 70 of Law No. 13 of 2016, opens the door to broader interpretation of the legal standing of community groups affected by patents, without limiting such standing only to patent holders or businesses in the pharmaceutical industry. The decision also reminds the Patent Appeal Commission to carefully assess the criteria for determining the relevant legal subjects, so that the public interest is not harmed by pharmaceutical patents that may impede access to medicines. This is therefore a victory for the public at large and, in particular, for patients”. 

The Constitutional Court Case & Ruling

In 2024, Law No. 65 amended Indonesia’s 2016 Patent Law by deleting Article 4(f) of Patent Law No. 13 of 2016, which stated:

(Unofficial Translation)

“Article 4(f): discoveries in the form of:

1. new uses of existing and/or known products; and/or

2. new forms of existing compounds that do not result in a significant increase in efficacy

and have related differences in chemical structure from the known compound.

Explanation of Article 4, Letter F, Subletter f

Item 1

The term “existing and/or known products” includes devices, goods, machines, compositions, formulas, methods, uses, compounds, and systems, whether they are still protected by a patent or have entered the public domain.

Item 2

The term “significant” is commonly used in the pharmaceutical field, referring to differences in the chemical structure of related compounds—for example, inventions regarding antibiotics in the penicillin, ampicillin, and amoxicillin classes. The difference between the H (hydrogen) group in ampicillin and the OH (hydroxyl) group in amoxicillin results in antimicrobial efficacy with a broad antimicrobial spectrum and greater stability compared to ampicillin; thus, it can be said that amoxicillin has significantly enhanced efficacy compared to ampicillin.”

Deletion of Article 4(f) in 2024, by Law No. 65, has been justified with the following explanation: 

(Unofficial Translation)

"Letter f: The removal of this provision is intended to accommodate developments related to new uses of existing and/or well-known products that are still considered inventions and may be granted a patent. Such a patent for a new use does not prevent the public from manufacturing the product as long as it does not mention or indicate the patented use. Examples: 1. Dapaglifozin: The first-use patent for diabetes has expired and has entered the public domain, so the public may use Dapaglifozin for the treatment of diabetes without infringing on the second-use patent. The second use patent—for kidney disease—is still within the patent protection period; 2. Gabus Fish Extract: The first use patent for cancer has expired and has entered the public domain, so the public may use Gabus Fish Extract for cancer without infringing on the second use patent. The second use patent—for COVID-19—is still within the patent protection period."

The petitioners argued that the repeal of the provision in Article 4(f) of Law No. 13 of 2016 through the provision in Article 1(2) of Law No. 65 of 2024 creates the potential for the granting of patents on low-quality patent applications—particularly in the pharmaceutical/medicine sector—which hinders public access to affordable medicines, such as new uses for existing products (secondary use of a patent) and the continuous filing of second or secondary patents for the same product with the aim of extending the patent term (patent evergreening), thereby contradicting the provisions of Article 28C(1), Article 28D(1), and Article 28H(1) of the 1945 Constitution of the Republic of Indonesia.

Articles 28C(1), 28D(1) and 28H(1) of the 1945 Constitution of the Republic of Indonesia establish constitutional guarantees relevant to access to health and the determinants of health. Article 28C(1) recognises the right of every person to develop themselves through the fulfilment of basic needs and to benefit from science and technology for the improvement of the quality of life and welfare of humanity. Article 28D(1) guarantees equal treatment and legal protection, while Article 28H(1) expressly recognises the right of every person to receive health services and to live in physical and spiritual prosperity and in a good and healthy environment.

Furthermore, according to the Petitioners, the repeal of the provision in Article 4(f) of Law No. 13 of 2016 through the provision in Article 1(2) of Law No. 65 of 2024 had deprived the public of the right to file a post-grant opposition (post-grant opposition) against products that do not meet the requirements—which is one of the measures to prevent patent monopolies by ensuring that only qualified or high-quality patents receive state protection.

The Petitioners also argued that the phrase “interested party” in Article 70(1) of Article 1, item 29, of Law No. 65 of 2024 had created legal uncertainty because it does not clarify who is considered an interested party that may file a an appeal against a decision to grant a patent, thereby contradicting the provisions of Article 28D(1) of the 1945 Constitution of the Republic of Indonesia.

In its ruling, the Constitutional Court declared that the word ‘deleted’ in Article 4(f), as stipulated in Article 1 Point 2 of Law No. 65 of 2024, is contrary to the 1945 Constitution and has no binding legal force. The court also reinstated the explanatory note to Article 4(f). 

It is reported that Constitutional Justice M. Guntur Hamzah highlighted the legal considerations of the decision and said that the prohibition on second medical use as regulated in the norm of Article 4 letter f of Law 13/2016 is a state protection measure that is far more beneficial and provides more legal certainty for the national generic drug industry. With the prohibition on second medical use that works in the initial phase of patent registration, it will actually strengthen the public health protection system from upstream to downstream, thereby better guaranteeing the realization of national health sovereignty.

In its judgment, the court highlighted that ‘in closing the “backdoor” for re-patenting old drugs is expected to further strengthen research freedom—which, in the context of a developing country, can accelerate the emergence of new, affordable, accessible, and nationally self-reliant, as the pharmaceutical industry will redirect its research and development funding toward discovering molecules or chemical compounds that can truly cure serious diseases for which no cure currently exists. Furthermore, researchers at research institutions, universities, and the national pharmaceutical industry will have greater freedom to conduct clinical trials and repurpose existing drugs, resulting in a meaningful improvement in efficacy. In this context, by distinguishing a “discovery” from the broader concept of an “invention” in patents, the Court seeks to restore the nature of patent protection to genuine innovations and enhance the social function of patent rights'. (unofficial translation)

Justice Guntur also said that the existence of the norm of Article 4 letter f of Law 13/2016 is a conditio sine qua non in realizing a system of intellectual property rights that is proportional, moral, and subject to the supremacy of human rights, especially the obligation to fulfill the right to the highest level of public health as guaranteed in Article 28H paragraph (1) of the 1945 Constitution of the Republic of Indonesia. Therefore, the Court assessed that, although Law 13/2016 and Law 65/2014 have provided alternative efforts in the form of Government Patent Implementation (PPOP), parallel imports and bolar provisions, as well as compulsory licenses, these instruments are more focused on settlements at the downstream level of patents in the pharmaceutical sector, so they are not effective in avoiding the practice of patent evergreening which has a direct impact on limited public access to affordable medicines.

The Court also provided an important interpretation of the phrase ‘interested party’ in relation to oppositions against the grant of patents under Article 70. In its decision, the Court considered that parties representing public interest—including advocacy groups and patient associations, consumer protection groups, non-governmental organizations working to advance the right to health, and independent researchers—have a genuine legal interest and form part of public oversight.

In Indonesia, civil society organisations have encountered barriers when challenging granted patents. In Decision No. 026.2.B/KBP-16/2023, Indonesia's Patent Appeals Commission declared inadmissible IGJ’s appeal against a secondary patent concerning bedaquiline, an important medicine for drug-resistant tuberculosis, as it did not qualify as an “interested party” because it had not incurred loss resulting from the patent grant. This reflected an unduly narrow approach that risked excluding organisations representing patients and the wider public interest from challenging unwarranted patents. 

In reaching its decision, the Constitutional Court also made several observations: 

(Unofficial translation)

"Exclusive rights can indeed provide incentives for research, investment, and the development of innovations. However, exclusive rights simultaneously confer a legal position that allows patent holders to control the use of technology for a certain period of time. The greater the ability to control and dominate a technology, the greater the responsibility that accompanies the exercise of those rights (with great power comes great responsibility). In the context of patents, this power manifests as exclusive rights granted by law. Therefore, patent rights should not be understood merely as an economic privilege, but also as rights that carry a dimension of social responsibility.” 

“Protection for inventors is necessary to ensure the sustainability of innovation, but at the same time, the benefits and impacts of innovation are intertwined with the interests of society. Thus, intellectual property law must strike a balance between recognizing individual creativity, promoting technological progress, and serving the broader public interest.”

“This line of thinking gains a fundamental basis when placed within the framework of the State’s objectives as articulated in the Preamble to the 1945 Constitution of the Republic of Indonesia. In this regard, the State exists not only to maintain order and protect individual interests, but also bears the responsibility to protect the entire Indonesian nation, advance the general welfare, enlighten the nation’s life, and realize social justice.” 

“Moreover, within this framework, science, technology, and innovation cannot be viewed merely as the products of individual creativity but must also be seen as integral to achieving the nation’s objectives as part of its social responsibility. Therefore, patent policy must not be limited to providing protection and incentives to inventors; it must also consider the extent to which such protection can foster the advancement of science and technology and provide benefit to society. The greater the impact of an invention on people’s lives, the stronger the justification for balancing patent protection with the public interest and national objectives.”

“Respect for inventors’ rights remains a vital component of the patent system, but the exercise of those rights operates within a legal framework that ensures technological progress does not stop at individual achievements but also contributes to the well-being, intellectual advancement, and social justice of the entire society. This becomes increasingly relevant when inventions are directly related to basic human needs, particularly health. In the field of health, medicines, vaccines, medical devices, diagnostic technologies, and therapeutic technologies not only hold economic value as the result of innovation but are also directly linked to human life, safety, and dignity. This nature places health-related inventions in a unique position, as their inherent value extends beyond economic value and technological benefits to directly address the fulfilment of basic human needs.” 

“Therefore, when an invention relates to health, discussions regarding patents must take into account the interplay between the protection of inventors’ rights, the promotion of innovation, and the public’s need to benefit from advancements in health technology—which ultimately leads to the protection of the right to access health services as guaranteed in Article 28H(1) of the 1945 Constitution of the Republic of Indonesia.”

Reactions from Indonesia

Arni Rismayanti, Chairperson of the Indonesian Pulmonary Hypertension Foundation (YHPI) appreciated the decision, stating, “This is an important step towards ensuring that the patent protection system maintains a proper balance between innovation and people’s right to access affordable treatment. For patients with pulmonary hypertension, this is not an abstract issue. Based on patients’ experiences, access to medicines and their prices can directly affect the financial burden they face and their quality of life”. 

Maria Wastu Pinandito, S.H., one of the Petitioners’ attorneys, describing the decision as appropriate, fair, and protective of Indonesian citizens’ constitutional rights, said - “This decision serves as a reminder that pharmaceutical patents do not only have an economic function, but also a social function: enabling people to benefit from science and healthcare services, as guaranteed under Article 28C(1), Article 28D(1, and Article 28H(1) of the 1945 Constitution of the Republic of Indonesia,” 

“At its core, this decision is about balancing intellectual property protection with the public’s right to health. A patent is a social contract: the State grants a temporary exclusive right in exchange for an invention being disclosed to the public. When patents are used to maintain monopolies without meaningful innovation, what is at stake is patients’ access to life-saving treatment. Patient groups strongly welcome this decision and hope to work together to ensure its effective implementation,” said Aditya Wardhana, Chairperson of the IAC Governing Board.

Another Petitioner, Lusiana Aprilawati, a TB survivor, added, “This decision creates opportunities for patients, including people affected by TB, to access more effective medicines. Once patent protection expires, generic versions can be produced and made available at more affordable prices, allowing more patients to receive treatment. This is not limited to medicines, but also extends to prevention tools, vaccines, and diagnostic technologies.”

The Coalition further emphasized the importance of the Government and the House of Representatives (DPR) taking the necessary steps to implement the decision by making the required amendments in accordance with the Court’s ruling.

In the Coalition’s view, this case is not merely a dispute over technical provisions of intellectual property law, adding that the ‘Government and the DPR must implement the decision as a means of safeguarding citizens’ constitutional right to access healthcare services and affordable medicines, as guaranteed under Article 28H(1) of the 1945 Constitution of the Republic of Indonesia.’

“For millions of patients in Indonesia, this issue is not simply about patents. It is about whether they can obtain the medicines they need to survive,” stressed a representative of the Coalition.

The decision is a historic victory for patients, public health, access to affordable medicines and the integrity of the patent system. It affirms that patent protection is not an end in itself: exclusive rights must be confined to genuine innovation and applied consistently with constitutional and human rights, national health sovereignty and the wider public interest. 

The Coalition also expressed its appreciation for the collaboration and support of its partners, Third World Network (TWN) and the Make Medicines Affordable (MMA) Coalition, as international partners in advancing efforts to ensure affordable access to essential medicines in Indonesia.

Original Documents related to the Constitutional Court are available at https://www.mkri.id/berita/mk-hidupkan-kembali-norma-anti-evergreening-dalam-uu-paten-25657

Unofficial Translation of the Constitutional Court Decision is available at      https://drive.google.com/file/d/1bXSwrqDt3E0JkEy8oIlQOOdn8Vz_AXrd/view?usp=sharing