Introduction to Malaysian Patent Law
In Malaysia, the patent system is governed by the Patents Act 1983, which has undergone significant amendments, including the Patents (Amendment) Act 2022. This framework is crucial for understanding the patentability, enforceability, and scope of claims for biopharmaceutical patents.
Patentability Criteria
For a biopharmaceutical invention to be patentable in Malaysia, it must meet three main criteria:
- Novelty: The invention must be new and not have been disclosed to the public before the filing date of the patent application[3][4][5].
- Inventive Step: The invention must involve an inventive step, meaning it must be non-obvious to a person skilled in the relevant field[3][4][5].
- Industrial Applicability: The invention must be capable of being used in an industry[3][4][5].
Non-Patentable Subject Matter
Certain subject matters are excluded from patentability under the Patents Act 1983. These include:
- Discoveries, scientific theories, and mathematical methods.
- Plant or animal varieties or essentially biological products for the production of plants or animals, except for man-made living microorganisms, microbiological processes, and the products of such microorganism processes.
- Methods for the treatment of a human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body. However, products used for any such method may be patentable[3].
Utility Innovation (UI) Patents
In addition to standard patents, Malaysia offers Utility Innovation (UI) patents, which provide a simpler and faster form of protection. UI patents do not require the invention to demonstrate inventive progress but must still be novel and industrially applicable. The protection period for UI patents is 10 years from the date of application[4].
Modified Substantive Examination
The Patents (Amendment) Act 2022 has introduced changes to the examination process. Deferment of substantive examination is no longer available, but deferment of modified substantive examination can be applied if the prescribed corresponding patent has not been granted. This allows applicants to leverage granted patents from other jurisdictions to expedite the examination process in Malaysia[1][5].
Data Exclusivity
Malaysia has implemented data exclusivity laws since 2011, which protect undisclosed, unpublished, and non-public domain pharmaceutical test data. For new chemical entities, data exclusivity is granted for five years, and for second indications, it is granted for three years. This protection is awarded to the originator, but generic companies can rely on bio-equivalence (BE) to obtain marketing authorization[5].
Protection and Enforcement of Pharmaceutical Patents
The protection and enforcement of pharmaceutical patents in Malaysia are critical for innovator companies. The current system allows for the registration of generic products while the innovator product is still under valid patent protection, provided that the generic product is not marketed until the patent expires. However, this often leads to legal disputes that are costly and time-consuming[2].
To address this, a proposed mechanism involves a self-declaration by the generic company that they will not market the product until the innovator's patent has expired or is invalidated. Additionally, notification to the patent holder by the generic company is recommended to ensure transparency and respect for patent rights[2].
Scope of Claims
For biopharmaceutical patents, the scope of claims is crucial. First and second medical use claims are allowable in Malaysia, and the Intellectual Property Office of Malaysia (MyIPO) tends to adopt the European Patent Office (EPO) approach. Nucleic acid sequences can be patentable if they are new, involve an inventive step, and have a specific use[3].
Term of Patent Protection
The term of a standard patent in Malaysia is 20 years from the filing date. There are no provisions for patent term extensions, but data exclusivity provides additional protection for pharmaceuticals[3][4][5].
Opposition and Infringement Proceedings
Opposition proceedings are available under the Patents (Amendment) Act 2022, although these provisions have yet to come into force. Infringement proceedings can be initiated, and relief includes preliminary injunctions, damages, and account of profits. Alternative dispute resolution methods such as mediation and arbitration are also available[5].
International Treaties and Compliance
Malaysia's patent laws comply with several international treaties, including the TRIPS Agreement, the Regional Comprehensive Economic Partnership Agreement (RCEP), and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). These compliance measures ensure that Malaysia's patent system aligns with global standards and commitments[1].
Statistics and Trends
The number of patent applications in Malaysia has been increasing steadily, with a 14.5% increase in 2021 and a further 14% increase in 2022. The sectors with the most patent applications include electronics, computers, chemistry, pharmaceuticals, and biotechnology, reflecting the strong development of these industries in the Malaysian economy[4].
Conclusion
In summary, the patentability, enforceability, and scope of claims for biopharmaceutical patents in Malaysia are governed by a robust legal framework. Key insights include the necessity for inventions to meet novelty, inventive step, and industrial applicability criteria, the availability of data exclusivity, and the importance of compliance with international treaties.
Key Takeaways
- Patentability Criteria: Biopharmaceutical inventions must be novel, involve an inventive step, and be industrially applicable.
- Non-Patentable Subject Matter: Certain subject matters like methods for treatment or diagnostic methods are excluded.
- Data Exclusivity: Protects pharmaceutical test data for new chemical entities and second indications.
- Modified Substantive Examination: Allows leveraging granted patents from other jurisdictions.
- Protection and Enforcement: Mechanisms to ensure respect for innovator patents and prevent premature marketing of generics.
- Scope of Claims: First and second medical use claims are allowable, and nucleic acid sequences can be patentable with specific use.
- Term of Patent Protection: 20 years with no extensions but additional data exclusivity protection.
- International Compliance: Aligns with TRIPS, RCEP, and CPTPP agreements.
FAQs
Q1: What are the main criteria for a biopharmaceutical invention to be patentable in Malaysia?
A1: The invention must be novel, involve an inventive step, and be industrially applicable.
Q2: Can methods for the treatment of a human or animal body be patented in Malaysia?
A2: No, methods for the treatment of a human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body, are not patentable. However, products used for any such method may be patentable.
Q3: What is the term of protection for a standard patent in Malaysia?
A3: The term of protection for a standard patent in Malaysia is 20 years from the filing date.
Q4: How does data exclusivity work for pharmaceuticals in Malaysia?
A4: Data exclusivity protects undisclosed, unpublished, and non-public domain pharmaceutical test data for five years for new chemical entities and three years for second indications.
Q5: Can opposition proceedings be initiated against a granted patent in Malaysia?
A5: Yes, opposition proceedings are available under the Patents (Amendment) Act 2022, although these provisions have yet to come into force.
Sources
- Spruson & Ferguson, "Malaysia's New Patents (Amendment) Act 2022".
- PhAMA, "Protection and Enforcement of Pharmaceutical Patent Rights in Malaysia".
- FB Rice, "How to optimise Malaysian patent prosecution".
- Viet An Law, "Patent registration in Malaysia".
- Mirandah Asia, "Patent Application Malaysia | Malaysia Patent System".
