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Malaysia – Patents, Nucleic Acids And Microorganisms

The Malaysian Patents Act 1983 (hereinafter referred to as ‘The Act’) requires that an invention, to be patentable, it should be new, involving an inventive step and industrially applicable. Section 13 (1) (b) of ‘The Act’ lists non-patentable inventions and it excludes the patentability of plant or animal varieties or essentially biological products for the production of plants or animals, other than man-made living microorganisms, micro-biological processes and the products of such microorganism processes.

The question is: would microorganisms which are isolated from natural sources and not subjected to any gene transfer or recombinant manipulation be considered “man-made living microorganisms” and therefore be considered as a patentable subject matter?

Isolated microorganisms (which are isolated from natural sources) that are not subjected to any gene transfer or recombinant manipulation can be considered man-made organisms. They are patentable only if they are new, involve an inventive step and is industrially applicable to satisfy the substantive patentability requirements in Malaysia. Nucleic acids and microorganisms which are isolated from natural sources (inclusive of genetically engineered bacteria and viruses) are deemed ‘man-made living microorganisms’ and are patentable subject matter as the Act allows them to be patented in Malaysia as long as they result from human effort.

Advances made in the area of research in the biological sciences by applying genetic engineering such as recombinant DNA technology has been widely used. Is such a method patentable? Yes, in respect of the provisions of the Act, but only if a naturally occurring sequence which differs from nature is being isolated to allow manipulation of the DNA of a particular bacterium as well as other available organisms, for the manufacture of a medicament in the pharmaceutical industry.

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 sequences. Therefore, if a product of nature is new, involving an inventive step and is useful it is patentable, even if it is isolated from natural sources which is considered as man-made products or processes created by humans through genetic engineering.

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