Medical Use Claims in Singapore

Section 14(7) of the Singapore Patents Act provides an exception to the general understanding of novelty as it says that the fact that a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body is not new, this fact shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art.

The aforesaid section has the effect that a known substance or composition may be patented “for use in” a method of treatment by surgery or therapy or of diagnosis provided that the substance or composition has not been known to be used in any such method before (i.e. first medical use). This is an exception to the general rule that a claim to a substance for a particular purpose is construed as a claim to the substance per se. Under Singapore law, first medical use claims are not construed as claims to the substance per se. Therefore, the claims are not anticipated by an earlier non-medical disclosure to the substance.

On the other hand, second and subsequent medical use in a non-Swiss type claim format of the form “substance X, for use in treating disease Y” will not be allowed. A known substance can only be claimed for use in a method of medical treatment the first time such a use is disclosed. Once the use of the substance in any method of medical treatment or diagnosis has been disclosed, it destroys the novelty of a subsequent claim to the substance for use in a second or further medical use.

Another medical use provision in Singapore is Section 16(2) of the Patents Act, which stipulates that a method of treatment by surgery or therapy or methods of diagnosis performed directly on the human or animal body are not industrially applicable. Such “method” claims have the following forms:

A method of treating ……….

A compound X when used ……….

Use of compound X to treat/for treating ………

The above types of claims are construed as “method of treatment” claims and therefore are not patentable under Section 16(2).

However, claims drafted in the first or second medical use forms are not considered to be methods of treatment or diagnosis and are therefore industrially applicable. Claims of the following forms may be allowable:

First Medical Use

“Substance or composition X for use as a medicament”,

“Substance or composition X for use as an antibiotic”, or

“Substance X for use in treating disease Y”

“Substance or composition for use in therapy”

Second Medical Use

“Use of compound X for the manufacture/preparation of a composition/medicament for the treatment of a specific disease.”

To understand better the difference between the medical use provisions in Singapore, UK and EPC, a comparative table is shown below:

Comparison of Medical Use Provisions

 

Singapore UK EPC
Section 16(2) (2) An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application. Section 4A 4A.-(1) A patent shall not be granted for the invention of- (a) a method of treatment of the human or animal body by surgery or therapy, or (b) a method of diagnosis practised on the human or animal body. Article 53 (c) European patents shall not be granted in respect of: (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.
Section 14(7) (7) In the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art. Section 4A (2) Subsection (1) above does not apply to an invention consisting of a substance or composition for use in any such method.
(3) In the case of an invention consisting of a substance or composition for use in any such method, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art.
(4) In the case of an invention consisting of a substance or composition for a specific use in any such method, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if that specific use does not form part of the state of the art.
Article 54(4) (4) Paragraphs 2 and 3 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art.
Article 54(5) (5) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.

Presently, Singapore does not have a provision which corresponds to Section 4A(4) of the UK Patents Act. Hence, Examiners continue to examine the Swiss type claim format in Singapore patent applications. Second or subsequent medical use claim in the “Swiss type” format is acceptable. However, claims drafted in a manner that corresponds to Section 4A(4) of the UK Patents Act would not be novel if substance or composition had been used in any medical method in the prior art.

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