Protecting pharmaceutical products in Malaysia


Dave Wyatt

The Malaysian Patents Act 1983 protects chemical compounds by way of product claims as well as process of manufacture claims.

The act specifies that an invention may be a product or process, but contains no definition of a product. A chemical compound, including a pharmaceutical’s active ingredient, is treated in the same way as any other kind of product when determining its patentability.

In line with many other countries, and as permitted by Article 27.3(a) of the TRIPS Agreement, Malaysian patent law excludes from patentability methods of therapy, surgery and diagnosis that are performed on the human or animal body. The question arises: how can a novel medicinal or veterinary use of a known chemical product be protected when the product itself lacks novelty?

The use, though novel, is not patentable, as a claim to the use would be tantamount to a claim to the therapeutic method. The answer lies in a special exception included in the novelty section of the act. Section 14(4) states that the provisions defining prior art “shall not exclude the patentability of any substance or composition, comprised in the prior art, for use in a method [of treatment or diagnosis], if its use in any such method is not comprised in the prior art”.

Pharmaceuticals, TRIPS Agreement