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.

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.

"We strongly advise applicants of Malaysian patent applications in the life sciences sector to vigorously examine the scope of claims allowed in their patent applications."

When more than one subsequent therapeutic use is simultaneously disclosed in an application, MyIPO has taken to allowing second medical use claims of either the Swiss or EPC 2000 type directed to the different uses within a single claim set. They must, however, form a general inventive concept.

The EPC 2000 type claim has a broader scope than the Swiss type claim and this can result in issues when considering post-grant amendments of Malaysian patents. Section 79A(2) of the Patents Act allows for post-grant amendments provided the amendment does not result in insertion of new subject matter not previously disclosed in the specification (added matter) and/or extension of the scope of protection conferred at the time of grant. 

Any attempt to amend Swiss type claims (narrower scope) to EPC 2000 type claims (broader scope) post-grant would not be allowable, whereas amending EPC 2000 type claims to Swiss type claims remains allowable. 

Much like in Europe, we strongly advise applicants of Malaysian patent applications in the life sciences sector to vigorously examine the scope of claims allowed in their patent applications. Voluntary amendments should be submitted before grant, should any change of scope be desired. 

The Patents Act provides for, and MyIPO accepts, voluntary amendments at any time during the pendency of a patent application. However, MyIPO has consistently considered an allowed patent application to be “no longer pending” for the purposes of voluntary amendments. In effect, amendments submitted post-allowance are not entertained, and the patent is granted with the claims as allowed.

However, MyIPO has recently relaxed this stance by accepting voluntary amendments within a two-month period, post-allowance, for applications where the first examination report issued is a notice of allowance.

MyIPO has also confirmed that dosage and/or administration protocols in Swiss type claims are acceptable. However the dosage and/or administration protocols have to meet the standard patentability requirements of novelty, inventive step and industrial applicability. This is in contrast to the previous stance that recitation of dosage and/or administration protocols within Swiss type claims directs the meaning of such claims to a method of treatment, rendering the claim unpatentable.

Oon Yen Yen is a patent manager at Henry Goh. She can be contacted at: yen@henrygoh.com