25 May 2017Jurisdiction reportsOon Yen Yen

Medical use claims

Section 14(4) of the Patents Act explicitly provides for protection of a new use of a known substance or composition if it was not previously disclosed for use in surgery, therapy or diagnosis (ie, first medical use). Protection of substances or compositions claimed under this format is restricted to the substance or composition when presented or packaged for use.

In practice, the Malaysian Intellectual Property Office (MyIPO) has indicated that it accepts the following formats for purpose-related product claims:

Substance X for use in a method of treating disease Y;

Substance X in a method of treating disease Y; and

Substance X in a method of treatment of disease Y.

This is in contrast to European Patent Office (EPO) guidelines (7.1.2) which state that such claims must include the phrase “for use”.

On the other hand, claims for subsequent therapeutic uses of a known substance or composition (ie, second medical uses), are not specifically provided for in the Patents Act. In line with EPO practice, MyIPO has taken to allowing such claims. In a recent case, the High Court ruled that such claims are patentable in Malaysia (Merck Sharp & Dohme & Anor v Hovid Bhd).

As with the EPO and the UK Intellectual Property Office, MyIPO accepts the following forms of claims for second medical uses:

Substance X for use in a method of treating disease Y; and

Use of substance X for the manufacture of a medicament for treatment of disease Y.

MyIPO currently accepts purpose-limited process (Swiss type) claims and purpose-limited product (EPC 2000) claims for second medical use. However, this is an evolving area of patent law and MyIPO could change its position depending on future local or European decisions.

As established in recent European case law, the scope of Swiss type claims and EPC 2000 claims for second medical use is not identical, with the latter having broader scope. We have observed that MyIPO concurs with this interpretation and in practice allows both Swiss type and EPC 2000 claims on the same subject matter within a single claim set and a single patent family.

The technical features of both types form a general inventive concept within the meaning of section 26 of the Patents Act. The issue of lack of unity of invention does not arise. Since the scope of the two types of claim differs, these claims are acceptable within the same patent family as double patenting also becomes a non-issue.

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