The government launched the Biovalley Project in 2003 as a way of boosting biotechnology in Malaysia. The Project is expected to take off by 2006. In recognition of both the benefits and the dangers that biotechnology offers, and the need to ensure sustainability of its rich biodiversity resources, Malaysia is putting a legal structure in place to address issues peculiar to biotechnology, which includes strengthening intellectual property protection - in particular patent protection - for biotechnology-related inventions.
Intellectual property
The following paragraphs discuss issues peculiar to biotechnology inventions with regard to patents and similar protection - such as petty patents or utility innovations - that would be the main forms of intellectual property protection for these inventions.
Non-patentable subject matter
Section 13 of the Malaysian Patents Act 1983 expressly excludes the patentability of certain types of subject matter, notwithstanding that they may be inventions within the meaning of the Act.
Discoveries
Discoveries are not patentable under Section 13(1)(a) of the Malaysian Patents Act. Thus a newly discovered DNA sequence encoding a naturally occurring protein in an animal would not be patentable per se. However, the Act is silent on whether biological material isolated from its natural environment is patentable. Patents, nevertheless, have been granted in Malaysia for isolated sequences of genes, after having fulfilled the requirements of novelty, inventiveness and industrial applicability and other requirements of the Act, such as those relating to non-contravention of public order and morality. Thus it would appear that biological materials isolated from their natural environment as well as technical processes for their isolation would be patentable provided the applicant complies with the requirements above.
Plants and animals
Patentability of plant and animal varieties and what are essentially biological processes for the production of plants and animals are expressly excluded under Section 13(1)(b) of the Malaysian Patents Act. If a literal interpretation of this subsection were adopted, no plant or animal variety would be patentable. However, the Malaysian Protection of New Plant Varieties Bill 2003 (which, at the time of writing, had not yet been passed as an Act) will afford protection to plant varieties. Processes involving significant human intervention (that is, not essentially biological processes) to produce plants as well as animals may be patentable as long as they fulfill the other requirements of the Patents Act. However, neither the Patents Act nor the Protection of New Plant Varieties Bill makes it clear whether an invention in the form of a genetically modified plant that has, for example, increased resistance to certain types of pests, is patentable if the genetic modification (involving significant human intervention) used to achieve the result can be applied to plants in general and is not confined to any particular variety. It is submitted that such inventions may be patentable, provided they fulfil other requirements of the Patents Act, such as novelty, inventiveness, industrial applicability and requirements relating to non-contravention of public order and morality. The patentability of genetically engineered animals remains unclear but would be subject to the same morality provisions of the Patents Act.
Micro-organisms
Section 13(1)(b) of the Malaysian Patents Act makes it clear that patentability of man-made living micro-organisms, "micro-biological processes" and the products of "such micro-organism processes" is not excluded. However, the Act does not define "micro-organisms," "micro-biological processes" and "micro-organism processes" for the purposes of this subsection. It is likely that these provisions will be revised in the near future to define more clearly which types of inventions involving micro-organisms are patentable and which are not. At the moment, what is clear is that naturally occurring bacteria, viruses and micro-organisms - such as yeast cells in their natural environments - would not be patentable even if they are newly discovered. Patentability of genetically engineered bacteria, viruses and yeast cells is not excluded since they are deemed "man-made".
Methods of treatment and diagnostic methods
Patentability of methods for the treatment of human or animal body by surgery or therapy is excluded under Section 13(1)(d) of the Malaysian Patents Act. Thus a method of treating a patient suffering from AIDS "by administering him" with a new biotechnological drug would not be patentable but the drug itself would be. "Method of treatment" claims may be converted to "Swiss-type" claims that are patentable in Malaysia. Diagnostic methods practised on the human or animal body are also non-patentable subject matter under Section 13(1)(d). However, the products used in such diagnostic methods, such as portable biosensors used to detect DNA sequences of pathogens would be patentable.
Novelty and inventiveness
The requirements for novelty and inventiveness for biotechnology-related inventions are very much the same as for other types of inventions.
Industrial applicability
It is expected that industrial applicability will often be an issue when considering patentability of biotechnology-related inventions in Malaysia. If, for example, a DNA sequence is isolated from the cell of an animal and transplanted into the genome of a bacterium, it is most likely that the isolated DNA sequence would only be patentable if it has industrial applicability (for example, if the DNA sequence encodes a protein with a useful function and thus aids the commercial mass production of the protein via use of the bacterial transcription and translation mechanisms) and it complies with the other requirements of the Patents Act.
Public order and morality
For inventions to be patentable in Malaysia, including biotechnology-related inventions, they must not fall foul of Section 31(1) of the Patents Act. This provides that:
The grant of a patent shall not be refused and a patent shall not be invalidated on the ground that the performance of any act in respect of the claimed invention is prohibited by any law or regulation, except where the performance of that act would be contrary to public order or morality.
Due to the inherent connection that biotechnology-related inventions have with life forms, a number of types of biotechnology-related inventions have sparked controversial debates on ethical issues and the potential dangers these inventions pose to our environment. This is especially so in Malaysia where religion has a great influence in determining the norms of public order and morality. These controversial inventions include those involving the use of stem cells, particularly embryonic stem cells, germ line gene therapy, genetic diagnostic tests, xenotransplantation and genetically modified foods containing genes transplanted from animals.
At the moment, there are no guidelines as to the types of biotechnology-related inventions that would be contrary to public order and morality under Section 31(1). The interpretation of what contravenes public order and morality under Section 31(1) is very much left to the discretion of the Patents Office in cases of patent applications and is to be determined by the courts in the case of granted patents where contravention of public order and morality is used as the ground for challenging validity of the patent. It is expected that relevant guidelines will soon be issued in view of the impact biotechnology has on the daily lives of the Malaysian people. In most cases, once research activities on a certain type of biotechnology-related invention are prohibited by Malaysia's soon-to-be enforced biosafety laws, contravention of public order and morality under Section 31(1) would seldom be an issue because the research could not even reach the patenting stage. It would be pertinent to note that in the Protection of New Plant Varieties Bill, registration of a new plant variety will not be approved if public order or morality is affected or if the plant variety may have a negative impact on the environment.
Other relevant issues
The Malaysian Biosafety Bill seeks to regulate gene technology in this country, among other things. The Bill is expected to become law and be in force by the time the Biovalley Project takes off, in view of genomics and molecular biology being one of the areas of initial focus of the Project.
Malaysia is also expected to accede to the Budapest Treaty soon in order to ensure proper deposit and accessibility of microorganisms involved in biotechnology inventions.
Due to the large amount of time taken to develop biotechnological inventions and to obtain regulatory approval for their commercialization, many countries in other jurisdictions have provided extended terms for patent protection of these inventions. It is hoped and expected that such extended terms will soon be available in Malaysia in order to boost biotechnology research and commercialization in this country.
Yet another current concern of investors and patent applicants for biotechnology-based pharmaceuticals and agribusiness is the extent to which experimental and clinical studies data disclosed to the regulatory authorities - to obtain regulatory approval to exploit the inventions commercially, is kept confidential and not used to process applications from generic manufacturers. Although the regulatory authorities are under a legal obligation to maintain the confidentiality of such data, it is submitted that there is a need for legislative changes to protect data exclusivity of such inventions sufficiently, at least for a limited period.
Enforceability
Once the relevant legislation - including those laws relating to intellectual property protection - that will provide a good legal framework for research and commercialization of biotechnology-related inventions is revised or enacted, it remains to be seen what problems will arise in enforcing it. It is also expected that in the next few years patent litigation on biotechnology inventions will increase. Malaysia's patent laws and practice are very similar to those of the European Patent Convention and the UK. Thus many of the considerations that apply in resolving the patent disputes in these countries are likely to be applied in Malaysia.
Profile: Zaraihan Shaari |
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Zaraihan Shaari is an advocate and solicitor of the High Court of Malaya in Malaysia and a partner in the intellectual property department of Shearn Delamore & Co. She holds a LLB (Hons) degree from the University of London. She was admitted as a barrister at Lincoln's Inn, England, in 1994 and was called to the Malaysian Bar in 1996. She also holds a BSc (Hons) degree in biochemistry from the University of London and a masters degree in Medical Science (Biochemistry) from the National University of Malaysia. Before her career in the legal profession, she was a biochemist in the Medical Faculty of the National University of Malaysia. Prior to joining Shearn Delamore, she served as a federal counsel in the Malaysian Attorney-General's chambers. |
