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2022 MarsdenLR 1001

HIGH COURT MALAYA SHAH ALAM
MERCK SHARP & DOHME CORPORATION & ANOR – Appellant
Versus
HOVID BHD – Respondent


Petitioner Advocates:Indran Shanmuganathan,Michelle Loi Choi Yoke,Zaraihan Shaari,Yap Khai Jian,Elisia Engku Kangon ,Respondent Advocate: Cindy Goh Joo Seong,Heidi Lim Ai Yuen,Samantha Siow San San,Nigel William Kraal

Judgement Key Points

Key Points: - The judgment discusses whether dependent claims must be evaluated separately and not automatically invalidated when the independent claim is invalid, detailing a Second Judicial Exercise for Dependent Claims. (!) (!) (!) (!) - The court holds that dependent claims are not automatically invalidated and may survive if they have independent validity, requiring assessment of form (Type 1 or Type 2) and consideration of prior art and CGK/POSITA evidence. (!) (!) (!) (!) (!) - The court classifies Dependent Claims 14, 15, and 20 as Type 1 claims but conducts a Second Judicial Exercise to determine whether prior art has all features of the independent claim and whether the dependent claims have inventive step, rather than automatically invalidating them. (!) (!) (!) (!) (!)

What is the test for determining whether dependent patent claims are valid when an independent claim is invalid?

What is the court's conclusion on whether dependent claims automatically fall if the independent claim is invalid?

What is the appropriate approach to assessing inventiveness and validity for dependent claims (type 1 vs type 2) in this case?


JUDGMENT

Wong Kian Kheong J:

A. Background

A(1). Parties And Products

[1] The first plaintiff company (1st 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 1st 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 (2nd plaintiff) is a Malaysian company which holds an exclusive licence from the 1st 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" 70mg tablets (defendant's Alendronate 70mg 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 reproduce below Independent Claim 1 as well

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