In the recent case of Merck Sharp & Dohme Corp & Anor v Hovid Bhd (“Merck”), the IP High Court at Kuala Lumpur confirmed that Swiss-type claims are allowed in Malaysia. A “Swiss-type claim” is a claim intended to cover the second or subsequent medical use (or indication) of a known substance or composition.
The Plaintiffs’ claimed that the Defendant had infringed the Merck Patent by selling the Alendronate tablets. The Defendant, a generic drug manufacturer counterclaimed for invalidity on the grounds that the Merck Patent is non-patentable, not novel, lacked inventive step and/or not industrially applicable under the Patents Act 1983 (“the Act”).
Decision of the High Court
In summary, the Honourable Judicial Commissioner decided that: The High Court is bound by Federal Court’s judgment in SKB Shutters Manufacturing whereby upon the invalidation of Claim 1 for lack of an inventive step, all the Dependent Claims shall be consequentially invalidated without a need for the Defendant to adduce evidence to invalidate each Dependent Claim. Consequentially neither is there a requirement for the Court to consider separately the validity of each Dependent Claim;
s. 56(3) PA only allows the Court to invalidate some independent claims or part of an independent claim. Unlike ss. 63 and 75 PA 1977 (UK), the Malaysian Court has no power under s. 56(3) PA to amend a dependent claim when the independent claim in question is invalid.
The decisions of European Patent Office (“EPO”), Board of Appeal (“BOA”) and Enlarged Board of Appeal (“EBOA”) are not binding on Malaysian Courts. They are, however, persuasive and may be applied in Malaysia in respect of a particular issue if the applicable provision is similar or identical to our Patent’s Act.
s. 13(1)(d) PA bars the patentability of a “method” of treatment of human body by therapy (Treatment Method). Having said that, the Court is of the view that 14(4) PA allows the patentability of the “use” of a Treatment Method. The Merck’s 194 Patent is not a Treatment Method in itself but is instead a “use” of a Treatment Method to inhibit bone resorption. Accordingly, s. 13(1)(d) PA does not bar the patentability of Merck’s 194 Patent.
The Merck’s case appears to be the first judicial interpretation of ss. 13(1)(d) and 14(4) PA and has affirmed the current MyIPO practice.