Malaysia is home to some of the largest populations of wild orangutans in their natural habitat. But what you might not know is that Malaysia is also a quickly developing nation that currently has the fourth largest economy in the South East Asian region.
Malaysia’s economy is highly robust and diversified with the export value of high-tech products estimated at more than USD60 billion per year, the second highest behind Singapore in the region. Indeed as the economy develops, the focus on the natural environment and the protection for wildlife, such as orangutans has grown.
With a combined GDP of over USD3 trillion dollars, the South East Asian economies are of growing importance to the global economy. In line with economic growth, World Intellectual Property Office (WIPO) statistics show that non-resident patent filings in Malaysia have increased by 37% from 2009 to 2018.
In this article, we discuss the fundamentals of the Malaysian patent system, strategies for efficient patent prosecution, and ways to leverage the granted Malaysian patent in other South East Asian countries.
The application process
The deadline for National Phase entry is 30 months from the earliest claimed priority date, or for a Convention application, 12 months from the earliest claimed priority date. This deadline cannot be extended. The patent application and its documents may be filed in English.
Malaysia has a 12 month US style grace period from the date of first disclosure by the inventor/applicant. A PCT application may be filed to take advantage of the grace period.
Examination of a Malaysian patent application
The deadline to request examination is either 18 months from the Convention filing date (deferrable up to 30 months), or four years from the international filing date (deferrable up to five years). Broadly, the application may be subjected to a modified examination process or a standard substantive examination process.
An efficient process: modified examination
Modified examination is based on a granted Australian, US, Japanese, Korean, UK, or European patent.
Of these countries, Australia is most preferred as it is likely that the broadest claim scope will have been obtained in that jurisdiction. In addition, the patent will be in English, whereas Korean and Japanese patents would require translation.
Under modified examination, examination of the application is limited to the grounds of novelty, patentable subject matter and whether any amendments made go beyond the scope of the original disclosure. It is unusual for an adverse examination report to issue, as any objections based on these grounds will likely have been addressed in prosecution of the patent on which the modified examination request is based. Allowance of the application generally occurs within six to 12 months.
Standard substantive examination
Under standard substantive examination, the Malaysian Intellectual Property Office (MyIPO) will conduct its own search and substantive examination of the application, often guided by the results of any search and examination reports in recognised foreign jurisdictions such as Australia, the United Kingdom, Europe, Japan, Korea, and the United States.
Prosecution can be accelerated by requesting expedited examination based on commercial needs or by an application to participate in one of the various Patent Prosecution Highway (PPH) agreements. MyIPO has PPH agreements with the Japanese Patent Office (JPO), European Patent Office (EPO) and the China National Intellectual Property Administration (CNIPA).
If an adverse examination report issues, the applicant has two months (extendible by three months) from the date of the report to respond to the objections.
Applications which undergo standard substantive examination typically take between four to six years to proceed to grant, as measured from the Malaysian filing date.
ASEAN Patent Examination Cooperation (ASPEC)
ASPEC is a regional cooperation programme between the participating patent offices of Cambodia, Indonesia, Lao PDR, Malaysia, the Philippines, Singapore, Thailand, and Vietnam. Importantly, an application through the ASPEC programme is filed in English, reducing what is often a significant barrier to seeking patent protection in multiple non English language countries.
Applicants may use the search and examination (S&E) reports of participating offices to accelerate the examination process in any one of the other participating IP offices. While not bound by the findings of other member offices, in practice average pendency rates are greatly reduced and excellent allowance rates achieved. A granted Malaysian patent is therefore very useful tool if you wish to expedite examination in one of the other ASEAN countries.
Patentable subject matter
According to Malaysia’s Patents Act 1983, an invention is patentable in Malaysia if it is new, involves an inventive step and is industrially applicable. The Act excludes the patentability of discoveries, scientific theories, mathematical methods, plant or animal varieties or essentially biological products for the production of plants or animals, other than man-made living microorganisms, microbiological processes and the products of such microorganism processes.
Other non-patentable subject matter includes 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 the subject of a Malaysian patent application.
First and second medical use claims are allowable and MyIPO tends to adopt the EPO approach. Nucleic acid sequences can be considered patentable subject matter only if they are new, involve an inventive step, and there is a specific use for the sequence.
Patent term extension and pharmaceutical data exclusivity laws
A term of a standard patent in Malaysia is 20 years. Malaysia does not allow for patent term extensions but does have a data exclusivity system. Accordingly, a person can apply for data exclusivity for:
- A new drug product containing a new chemical entity, if an application is made in Malaysia within 18 months from the date the product is first registered or granted marketing authorisation, and is granted data exclusivity protection in the country of origin. The maximum data exclusivity period is five years.
- A second indication of a registered drug product, if an application is made in Malaysia within 12 months from the date the application for the second indication is approved and granted date exclusivity or test data protection in the country of origin. The maximum data exclusivity is three years (for date concerning the second indication only).
The data exclusivity period runs from the date the new drug or the second indication is first registered or granted marketing authorisation and data exclusivity or test data protection in the country of origin or any country recognised by the Director of Pharmaceutical Services.
An efficient patent prosecution strategy for Malaysian patent applications is to utilise modified examination based on a granted patent preferably from Australia. Applicants can then leverage the allowed claims in Malaysia as the basis of an ASPEC request in the remaining ASEAN countries including Cambodia, Indonesia, Lao PDR, the Philippines, Singapore, Thailand, and Vietnam. This prosecution strategy also has the advantage that English is used for the Malaysian filing and the ASPEC request.