Judicial Analysis Court Copy Headnote Facts Arguments Court observation

2022 MarsdenLR 1001

HIGH COURT MALAYA SHAH ALAM
MERCK SHARP & DOHME CORPORATION & ANOR – Appellant
Versus
HOVID BHD – Respondent
[Civil Suit No: 22IP-72-12-2014]

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

Dependent patent claims do not automatically fail if the independent claim is invalidated; each claim's validity must be assessed individually, respecting nuances in patent law.

Headnote:(A) Patents Act 1983 – Sections 11, 14, 15, and 36 – Patent 194, claims 14, 15 and 20 relating to alendronic acid – Independent Claim 1 deemed invalid due to lack of inventive step – Dependent claims must be assessed separately; automatic invalidation of dependent claims rejected based on Majority Judgment in previous case – The validity of dependent claims is reaffirmed through evidential analysis and expert testimony. (Paras 56-84)

(B) Patent Infringement – To establish infringement, all essential elements of the claims must be met; defendant's product found to infringe dependent claims after applying essential integers, improver’s, and Actavis tests. (Paras 58-60)

Facts of the case: The case involves an appeal by the plaintiff regarding the validity of dependent claims and the infringing actions of the defendant concerning their alendronate products. The first trial established that an independent claim was invalid, leading to the counterclaim on dependent claims. (Paras 11-12)

Findings of Court: The court found that the dependent claims were valid, not automatically invalid due to the independent claim's status, and that the defendant infringed these claims. (Paras 81-84)

Issues: The main questions addressed were the validity of dependent claims despite the independent claim's invalidity and whether the defendant's actions constituted patent infringement. (Paras 20-21)

Ratio Decidendi: The court held that dependent claims should be evaluated on their own merits regardless of the independent claim’s status, indicating a need for a nuanced approach to patent claim interdependencies. (Paras 169-176)

Result: The appeal was allowed, the counterclaim dismissed, and a post-trial discovery order was made in favor of the plaintiff. (Paras 82-83)

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 as Dependent Claims 14, 15 and 20:

(1) Independent Claim 1 - use of alendronic acid or a pharmaceutically acceptable salt thereof, or a mixture thereof, for the manufacture of a medicament for inhibiting bone resorption in a human [Medicament (Inhibition of Bone Resorption)] wherein the Medicament (Inhibition of Bone Resorption) is adapted for oral administration, in a unit dosage form which comprises from about 8.75mg to 140mg of alendronic acid or a pharmaceutically acceptable salt thereof, on an alendronic acid active weight basis, according to a continuous schedule having periodicity from about once every 3 days to about once every 16 days;
(2) Dependent Claim 14 - use according to any one of Claims 1 to 9 for the manufacture of a medicament for treating osteoporosis in a human in need thereof [Medicament (Osteoporosis)];
(3) Dependent Claim 15 - use according to Claim 14 wherein said unit dosage comprises about 70mg of alendronic acid or a pharmaceutically acceptable salt thereof, on an alendronic acid active weight basis; and
(4) Dependent Claim 20 - use according to any one of Claims 1 to 19 wherein said medicament is in the form of a tablet.

[6] The priority date of Patent 194 is 15 April 1998 (Priority Date).

A(3). Effect of SKB Shutters Manufacturing Sdn Bhd v. Seng Kong Shutter Industries Sdn Bhd & Anor, 2015 MarsdenLR 2238 ('SKB Shutters').

[7] In SKB Shutters, at [24] and [26]-[30], Zulkefli CJ (Malaya) (as he then was) had decided as follows in the Federal Court:

"[24] It is noted that claims (1) and (11) of the appellant's Patent 431 are independent claims. Claims (2) to (10) of the appellant are dependent claims, being dependent on the preceding claims. All are ultimately dependent on claim (1).
...
[26] As regards the rest of the claims which are dependent claims (claims (2) to (10)), we are of the view that having considered claim (11) and claim (1) and found them to be invalid, the Court of Appeal was entitled to then hold that the appellant's Patent 431 was invalid as the rest of the claims, being claims dependent on claim (1), would also fall.
[27] The dependent claims in essence incorporate all the features of the claim upon which it depends but are drafted to only make reference to the claim upon which it depends without expressly setting out all the features of that claim. As such, in the event that the independent claim upon which they depend is invalid, the only way the dependent claims can survive and stand if at all is if the dependent claims are redrafted to incorporate the features of the claim upon which they are dependent and are made an independent claim. They cannot remain as "dependent claims" when the claim upon which they depended is invalid. We agree with the contention of the respondents as that was not done in the present

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