Wong Kian Kheong J:

JUDGMENT

(Trial of issue remitted by Federal Court)

A. Background

A(1). Parties and products

[1]The first plaintiff company (1^st Plaintiff) is a company incorporated in the United States of America (USA) which has been granted a Malaysian Patent No. MY-118194-A (Patent 194) under the Patents Act 1983 (PA). Based on Patent 194, the 1^st Plaintiff produced a pharmaceutical product of alendronic acid or a pharmaceutically acceptable salt (Alendronate) under the trade name “Fosamax” (Fosamax Tablets). Fosamax Tablets are prescribed by doctors to inhibit bone resorption in humans.

[2]The second plaintiff company (2^nd Plaintiff) is a Malaysian company which holds an exclusive license from the 1^st Plaintiff to distribute and sell Fosamax Tablets in Malaysia.

[3]The defendant company (Defendant), a Malaysian company, has been granted approval by the National Pharmaceutical Control Bureau to market “Alendronate” 70 mg tablets (Defendant’s Alendronate 70 mg Tablets).

A(2). Patent 194

[4]There are 22 “Claims” in Patent 194. Claim 1 is the only “independent” Claim in Patent 194 (Independent Claim 1). Claims 2 to 22 are “dependent” Claims in Patent 194 (Dependent Claims).

[5]I reprodu