The Relationship Between Drug Registration and Patent Protection

JAKARTA – On Wednesday, 6 May 2026, the Constitutional Court held a substantive review hearing on Article 4 and the phrase “interested party” in Article 70(1) of Patent Law No. 65 of 2024, taking testimony from the relevant parties — Indonesia's Food and Drug Authority (BPOM) and the Indonesian Consumers Foundation (YLKI). BPOM explained the relationship between drug registration and intellectual property.

BPOM highlighted the concept of the Bolar provision as an important tool in Indonesia's health and pharmaceutical legal framework. This policy is an exception to the patent holder's exclusive rights, allowing generic-drug manufacturers to use a still-patented drug invention before the patent expires, for the purposes of research, development and registration preparation (bioequivalence testing).

“Its purpose is to speed up the launch of affordable generics after the innovator patent expires,” said Andriana Krisnawati, head of BPOM's Bureau of Law and Organization, at the Jakarta hearing.

From a normative standpoint, Article 167(b) of the Patent Law permits an exception to the use of a patent for the purposes of research, testing and analysis to obtain marketing authorization for a drug. This provision provides the legal basis for implementing the Bolar provision in Indonesia, enabling pharmaceutical companies — especially generic manufacturers — to prepare for registration before patent expiry.

Consistent with this, within the technical regulatory framework, through BPOM Regulation No. 24 of 2017 on the Standards and Procedures for Drug Registration, Article 21 sets out the mechanism and transition phase from patented drugs to generics, including arrangements related to the preparation of marketing-authorization applications, specifically: for the marketing-authorization application of the first generic whose active ingredient is still under patent protection, an applicant who is not the patent holder may submit it five years before the patent protection expires, on the condition that the marketing authorization is granted only after the patent protection ends. This shows that the regulatory framework in the patent field and the drug-registration policy complement each other.

This regulation ensures that, after patent expiry, generics can immediately obtain marketing authorization and be supplied to the public without legal obstacles, thereby safeguarding the principles of public accessibility and affordability. BPOM's drug-registration provisions reflect the Bolar concept in principle, as embodied in the technical regulations on drug registration, making it possible to prepare a marketing-authorization application before patent expiry.

This regulation aligns with the Patent Law, in particular the exception provided in the interpretation of Article 167(b) — an exception to the patent holder's exercise of exclusive rights for the purposes of research, testing and analysis to obtain marketing authorization. Although the specific provision on the five-year period before patent expiry is no longer explicitly stated, the substance of the exception remains valid. Therefore, at the normative level, BPOM's drug-registration policy remains consistent with the Bolar principle under Indonesian patent law.

Andriana further stated that drug-registration provisions are closely linked to the patent-protection system, particularly in the exercise of the Bolar provision, which is embodied in both Law No. 65 of 2024 and BPOM Regulation No. 24 of 2017. Although technical details — such as time limits — are no longer explicitly stipulated, the exception embodied in Article 167(b) provides companies with the opportunity to prepare for drug registration before patent expiry.

“At the same time, BPOM's drug-registration policy, in particular Article 21 of BPOM Regulation No. 24 of 2017, also sets out a transition mechanism from patented drugs to generics, so that these two systems ultimately work together to support the accelerated launch of safe, high-quality and affordable generics without undermining patent protection,” Andriana said.

Drug accessibility

Sudaryanto, appearing as an expert for YLKI, said there are at least two important issues related to intellectual property and consumer rights. First, copyright and access to knowledge. Copyright often poses an obstacle to access to knowledge, especially in developing countries; therefore, exceptions to copyright are essential for education, research and libraries.

Second, patent law and access to medicines. Patent law, especially in the pharmaceutical industry, significantly restricts access to medicines by creating temporary monopolies, leading to high prices and limited availability. On the other hand, consumers have the right to access essential goods and services, including medicines.

Access to medicines is a core component of the right to health. However, Sudaryanto said, one-third of the world's population faces poor access, high prices, and poor and inaccurate quality of healthcare services. “Patients in poor countries often receive little or no benefit from healthcare,” Sudaryanto said.

He stressed that essential medicines must be accessible to everyone, which requires a well-functioning healthcare system and sound infrastructure. The pharmaceutical industry also bears responsibility for limited access to medicines.

Patent regulation stems from the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), adopted by the World Trade Organization (WTO) in 1994, which provides that the drug itself (not just its manufacturing process) should be protected by a patent. This grants the patent holder the exclusive right to produce for 20 years, during which drug prices soar, leaving poor populations unable to obtain them.

The Doha Declaration of 2001 ensures that governments can issue compulsory licenses for patented drugs, or take measures to protect public health. However, parallel imports in other countries often lead to severe trade sanctions, making this tool difficult to use.