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Malaysia Update: Swiss-Type Second Medical Use Claims Patentable in Malaysia

The acceptance of second medical use claims in “Swiss-Type” claim format has attracted significant attention internationally as different jurisdictions vary in their approach. In Merck Sharp & Dohme & Anor v Hovid Bhd , the issue was first raised in the High Court (Civil Trial No. 22IP-71-12/2014) where the Appellants initiated an infringement action against the Respondent for infringing the Appellant’s Malaysian Patent No. MY-118194-A entitled “Pharmaceutical Compositions for Use in Inhibiting Bone Resorption” (“the 194 Patent”) by means of importation, manufacture, offer for sale, sale and stocking for the purpose of sale or offer for sale of the Respondent’s Alendronate 70 mg Tablets. The Respondent counterclaimed through an action of Invalidation against the Appellant’s 194 Patent.

One of the grounds raised by the Respondent was that the 194 Patent constituted “A method for the treatment of human body by therapy” which is deemed as a non-patentable invention under Section 13(1) (d) of the Patents Act 1983 (“PA”). The question which arose is whether the 194 Patent is considered a second medical use of a known product (i.e. Swiss-type Claim) which is patentable under Section 14(4) of the PA. The High Court dismissed the issue raised by the Respondent and decided that the claims of the 194 Patent are to be read as a “Swiss-type medical use claim” which does not fall under Section 13(1) d of the PA and instead is governed by Section 14(4) of the PA.

Swiss-Type second medical use claims are patentable in Malaysia following the European Patent Office’s Board of Appeal and Enlarged Board of Appeal decision on the patentability of the use of a known compound in the manufacture of a medicament for the treatment of a disease also known as a Swiss Style Claim. The Claims of the 194 Patent relate to the “use” of alendronate for the manufacture of a medicament to inhibit bone resorption in humans which is adapted for oral administration of certain dosages according to certain continuous schedules. The 194 Patent is not a Treatment method in itself but it is instead a known compound (i.e. alendronate) in the manufacture of medicament resorption to inhibit bone resorption. Accordingly, Section 13(1) (d) of the PA does not bar the patentability of such Swiss-Style Claims.

On the remaining grounds, the High Court decided in favour of the Respondent that the 194 Patent was invalid on the ground that Claim 1 of the MY 194 Patent lacked an inventive step and as such, all of its dependent claims were found to be similarly invalid.

The Appellants appealed unsuccessfully to the Court of Appeal on the ground that the Judge erred in law on inventive step, relevant skilled person in the art, and common general knowledge.

Although claims for Swiss-Type second medical use are not provided in the PA, MyIPO has approved such claims in the practise of patent prosecution in Malaysia. The precedent set through this case gives significant value to the pharmaceutical industry and strengthens the matter on patentability of the use of a treatment method.

By: Ian Mirandah

A version of this article was first published in the membership journal of the Chartered Institute of Patent Attorneys – see more at http://www.cipa.org.uk/