Protecting pharmaceutical products in Malaysia

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”.

This exception provides a firm legal basis for the so-called ‘first medical use’ claims of the kind ‘Substance X for use in medicine’. Section 14(4) mirrors similarly worded provisions in the UK Patents Act 1977 and the European Patent Convention. This provides Malaysian counsel with a wealth of pertinent case law from Europe.

“Although the validity of Swiss-type claims has not been tested in court, this claim format is indicated as allowable in MyIPO’s examination guidelines for both first and subsequent therapeutic applications.”

The next question is how to protect a novel second or further medical use of a known substance or composition? This question was addressed by the Enlarged Board of Appeal (EBA) of the European Patent Office in its landmark 1984 decision G5/83. The EBA took note of the practice of the Swiss Federal Intellectual Property Office of allowing protection for claims directed to the “use of a substance or composition for the manufacture of a medicament for a specified (new) therapeutic application”.

This format of claim was found not to be in conflict with the European Patent Convention and was authorised by the EBA. As a result, claims of the so-called ‘second medical use’ or ‘Swiss-type’ format came into common use in Europe. Claims of this format have also been permitted by the Malaysian IP Office (MyIPO).

Although the validity of Swiss-type claims has not been tested in court, this claim format is indicated as allowable in MyIPO’s examination guidelines for both first and subsequent therapeutic applications.

In Europe, an amended version of the European Patent Convention, EPC 2000, entered into force in 2007. Article 54 of EPC 2000 sets out novelty requirements and includes a new paragraph (5). This states that the definition of the state of the art “shall not exclude the patentability of any substance or composition for any specific use in a method [of treatment or diagnosis], provided that such use is not comprised in the state of the art”.

This provision allows for the protection of second and subsequent medical uses by way of purpose-limited product claims rather than through the established and more convoluted Swiss-type claim format. Following on from this, in its recent decision G2/08, the EBA announced that the practice of filing Swiss-type claims shall be phased out for future European patent applications.

In practice, the new claim format under Article 54(5) EPC 2000 and the old Swiss-type format are believed to afford the same scope of protection. The new format is more readily comprehensible. Therefore, one reason for the EBA’s pronouncement may be to avoid a proliferation of patents containing claims of both format, since many European practitioners have continued to include Swiss-type claims.

Nevertheless, a difference is now developing in both the law and practice between Europe and Malaysia in the protection of further medical indications, which may eventually give rise to confusion. Hopefully, Malaysia will act to maintain the harmonised position of recent years.

Dave A. Wyatt is executive director and head of the patents department at Henry Goh & Co Sdn Bhd. He can be contacted at: dave@henrygoh.com