Introduction
Indonesia is on the cusp of a significant transformation in its biopharmaceutical sector, driven by reforms aimed at enhancing patent laws and attracting foreign direct investment. Understanding the nuances of patentability, enforceability, and the scope of claims is crucial for stakeholders looking to navigate this evolving landscape.
The Importance of Patent Reforms
The Indonesian government has recognized the need to align its patent laws with international standards to boost biopharmaceutical innovation and manufacturing. The 2020 Omnibus Bill and amendments to the 2016 Patent Act are key initiatives in this direction[1].
Patentability Criteria
For a biopharmaceutical invention to be patentable in Indonesia, it must meet the standards of novelty, inventive step, and industrial applicability.
Novelty
The invention must be new and not disclosed to the public anywhere in the world before the filing date[4].
Inventive Step
The invention must not be obvious to someone skilled in the relevant field[4].
Industrial Applicability
The invention must be capable of being applied in industry[4].
Challenges with Current Patent Law
The current Indonesian Patent Law of 2016 has several limitations that hinder the patentability of biopharmaceutical inventions.
Restrictions on New Use Claims
Article 4(f) of the amended Indonesian Patent Law of 2016 states that a new use of a known or existing product is not patentable. However, new guidelines allow for the patentability of a second medical use under specific conditions, such as using the purpose-limited product claim or EPC2000 format[2].
Requirement for Specific Disease Identification
New use claims must identify a particular disease and include clinical or experimental data to support the claim. Claims based on a compound's mechanism without specifying a disease are considered too broad[2].
Draft Amendments and New Guidelines
The draft amendments to the 2016 Patent Act aim to address some of the existing limitations.
Allowing Second Medical Use Claims
The new guidelines permit the patentability of second medical use claims if the claim is written in a specific format and includes necessary experimental data. This is seen as a positive development, especially in the context of the COVID-19 pandemic, where protecting investment in new medical uses is crucial[2].
Eliminating Improper Patentability Restrictions
Countries successful in innovation allow patents for all forms of inventions that meet patentability criteria without sector or technology discrimination. The Indonesian government is moving towards this direction by considering the elimination of improper patentability restrictions in the biopharmaceutical sector[1].
Enforceability of Patents
Enforceability is a critical aspect of patent law, and several factors influence it in Indonesia.
Exemptions from Patent Infringement
The law includes exemptions such as the importation of pharmaceutical products legally marketed in another country without the patent owner's permission and the "Bolar exemption," which allows manufacturing of a patented product for licensing and marketing after the patent expires[3].
Compulsory Licenses
The scope of compulsory licenses has been expanded to include the production, importation, and exportation of patented pharmaceutical products for the treatment of diseases, particularly in response to public health needs[3].
Scope of Claims
The scope of claims in biopharmaceutical patents is being refined through new examination guidelines.
Purpose-Limited Product Claims
Claims must be written in a format that specifies the use, such as "compound X for use in the treatment of disease Y." This format helps in distinguishing the new use from existing ones[2].
Clinical and Experimental Data
Claims must be supported by clinical or experimental data, including in vivo or in vitro data, to demonstrate the new use and any increased efficiency or decreased side effects[2].
Regulatory Review and Patent Term
The process of patent examination and regulatory review significantly impacts the effective patent term.
Delays in Patent Examination and Regulatory Review
Despite reforms, examination delays of up to four years and regulatory review by the National Agency of Drug and Food Control (NA-DFC) taking approximately 4.4 years can erode the 20-year patent term, undermining its value[5].
International Alignment and Collaboration
Aligning Indonesia's patent laws with international standards is essential for promoting innovation and collaboration.
Consistency with TRIPS Agreement
Indonesia's patent laws need to be consistent with the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to ensure that biopharmaceutical innovations are protected appropriately[5].
Promoting R&D Collaboration
The COVID-19 pandemic has highlighted the importance of patents in promoting Research and Development (R&D) collaboration. By providing legal security over commercial assets, patents facilitate cross-border and inter-organizational collaborations[5].
Key Takeaways
- Patentability Criteria: Biopharmaceutical inventions must meet novelty, inventive step, and industrial applicability standards.
- New Use Claims: Second medical use claims are allowed under specific conditions, including the use of purpose-limited product claims and supporting experimental data.
- Enforceability: Exemptions from patent infringement and expanded compulsory licenses are key aspects of enforceability.
- Scope of Claims: Claims must be specific and supported by clinical or experimental data.
- Regulatory Review: Delays in patent examination and regulatory review can significantly reduce the effective patent term.
- International Alignment: Aligning with international standards and the TRIPS Agreement is crucial for promoting innovation and collaboration.
FAQs
Q: What are the key criteria for patentability in Indonesia?
A: Inventions must meet the standards of novelty, inventive step, and industrial applicability.
Q: Can new uses of existing products be patented in Indonesia?
A: Yes, but only under specific conditions, such as using the purpose-limited product claim or EPC2000 format and including necessary experimental data.
Q: What are the exemptions from patent infringement in Indonesia?
A: Exemptions include the importation of legally marketed products from other countries and the "Bolar exemption" for manufacturing patented products before the patent expires.
Q: How do regulatory reviews impact the patent term in Indonesia?
A: Delays in patent examination and regulatory review can erode the 20-year patent term, significantly reducing its effective duration.
Q: Why is international alignment important for Indonesia's biopharmaceutical sector?
A: International alignment ensures consistency with global standards, promoting innovation, collaboration, and the protection of biopharmaceutical inventions.
Sources
- Geneva Network: Amending Indonesia's 2016 patent act will drive biopharmaceutical investment.
- Asia IP Law: Indonesia's new patent examination guidelines for new use claims.
- Spruson & Ferguson: Amendments to the Indonesian Patent Law.
- Ambadar: Patent Registration in Indonesia: Global and Local Strategies.
- Geneva Network: Why patents matter to Indonesia.
