1. ) Merck Sharp & Dohme Corporation v Hovid Bhd. Co. No.: 58476-A) (21IP-72-12/2014)

1.

MERCK SHARP & DOHME (M) SDN. BHD. (Company No. 60181-P) … PLAINTIFFS AND HOVID BHD. (Co. No.: 58476-A) … DEFENDANT JUDGMENT (Trial of issue remitted by Federal Court) A. Background A(1). Parties and products

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.

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

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).

I reproduce below Independent Claim 1 as well as Dependent Claims 14, 15 and 20:

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 8.75 mg to 140 mg 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;

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)];

Dependent Claim 15 - use according to Claim 14 wherein said unit dosage comprises about 70 mg of alendronic acid or a pharmaceutically acceptable salt thereof, on an alendronic acid active weight basis; and

Dependent Claim 20 - use according to any one of Claims 1 to 19 wherein said medicament is in the form of a tablet.

The priority date of Patent 194 is 15.4.1998 (Priority Date). 3 A(3). Effect of SKB Shutters Manufacturing Sdn Bhd v Seng Kong Shutter Industries Sdn Bhd & Anor [2015] 6 MLJ 293 7. In SKB Shutters, at [24] and [26]-[30], Zulkefli CJ (Malaya) (as he then was) has 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 case and as it could not be redrafted, the dependent claims must fall. (See the case of E I Du Pont De Nemours & Co v. Imperial Chemical Industries Plc & Anor (2007) FCAFC 163). 4 [28] The position in Malaysia relating to amendments of patent claims must be distinguished from the position in the United Kingdom. In the United Kingdom, the patent claim can be amended pending litigation in respect of its validity. (See s 75 of the UK Patents Act 1977). There is a further provision which gives the court in the United Kingdom express power to enforce the part of the patent which is found to be valid. Section 63(1) of the UK Patents Act 1977 states as follows: If the validity of a patent is put in issue in proceedings for infringement of the patent and it is found that the patent is only partially valid, the court or the comptroller may, subject to subsection (2) below, grant relief in respect of that part of the patent which is found to be valid and infringed. [29] There is no such provision in the Malaysian Patents Act 1983 similar to the provisions of ss. 63 and 75 of the UK Patents Act

It is clearly by reason of the said provision of s. 63 in the United Kingdom that one can enforce a partially valid patent without amendment. Section 56(3) of our Patents Act 1983 is clearly not the equivalent of s. 63 of the UK Patents Act 1977. It merely states that some claims or part of a claim may be declared invalid which in our view it can only refer to the independent claims of a patent. [30] On the issue of lack of inventive step we agree with the submissions of respondents that each of the 11 claims lacked an inventive step. Although the Court of Appeal did not expressly state that they dealt with each of the said claims, it should be obvious it must have been so dealt with in light of the submission of the 5 respondents and the finding of a lack of inventive step in the appellant’s Patent 431 with regard to claims 1 and 11.” (emphasis added). A(4). First trial 8. In this case -

the 1st and 2nd Plaintiffs (collectively referred to in this judgment as the “Plaintiffs”) had claimed that the import, manufacture, offer for sale, sale and stocking for the purpose of sale or offer for sale of the Defendant’s Alendronate 70 mg Tablets have infringed Patent 194 (Original Action); and

the Defendant had counterclaimed for a declaration that Patent 194 was invalid on certain grounds (Counterclaim).

I conducted a joint trial of the Original Action and Counterclaim (1st Trial). At the 1st

the Plaintiffs had called the following three witnesses -

Professor Michael Brian Fennerty (Prof. Fennerty);

Mr. Nicholas Edge; and

Encik Abu Bakar bin Hussein; and

the following two experts testified on behalf of the Defendant -

Professor Ego Seeman (Prof. Seeman); and

Professor Dr. Robert S. Langer.

After the 1st Trial, I have decided as follows, among others [High Court’s Decision (1st Trial)] - 6

Patent 194 -

concerns a “use” of a treatment method or a “Swiss-type Claim” which is patentable under s 14(4) PA; and

is not a method for human treatment which is prohibited by s 13(1)(d) PA;

the description in Patent 194 has complied with both limbs of reg. 12(1)(c) of the Patent Regulations 1986;

Independent Claim 1 is novel and has not been anticipated by “prior art” on Priority Date (Prior Art) within the meaning of s 11 read with s 14(1) and (2)(a) PA;

Independent Claim 1 does not comply with ss 11 and 15 PA because on Priority Date, Independent Claim 1 does not involve an “inventive step” and is “obvious” to a notional person ordinarily skilled in the art (POSITA) regarding Patent 194 [Invalidation (Independent Claim 1)];

premised on the Federal Court’s judgment in SKB Shutters, upon the Invalidation (Independent Claim 1), all the Dependent Claims are automatically invalid and cannot be amended under s 56(3) PA [Automatic Invalidation (All Dependent Claims)];

the Original Action was dismissed and the Counterclaim was allowed; and

as the Defendant was only successful on one issue regarding the Invalidation (Independent Claim 1) [please refer to the above sub-paragraph (4)], I only awarded 25% of the costs of the 1st Trial in favour of the Defendant [Costs (1st Trial)]. The grounds of the High Court’s Decision (1st Trial) are available at [2017] MLJU 77. A(5). Appeal to Court of Appeal 7 11. The Plaintiffs had appealed to the Court of Appeal against the Invalidation (Independent Claim 1) and Automatic Invalidation (All Dependent Claims) [Plaintiffs’ Appeal (Court of Appeal)].

A cross-appeal to the Court of Appeal against parts of the High Court’s Decision (1st Trial) as stated in the above sub-paragraphs 10(1) to (3), had been lodged by the Defendant [Defendant’s Cross-Appeal (Court of Appeal)].

In a judgment delivered by Abang Iskandar JCA (as he then was) in [2019] 4 MLJ 121, the Court of Appeal dismissed both the Plaintiffs’ Appeal (Court of Appeal) and Defendant’s Cross-Appeal (Court of Appeal) with no order as to costs [Court of Appeal’s Decision (1st Trial)]. The Court of Appeal’s Decision (1st Trial) was premised on, among others, SKB Shutters. A(6). Appeal to Federal Court 14. The Plaintiffs obtained leave of the Federal Court to appeal against the Court of Appeal’s Decision (1st Trial) on the following sole question of law: “Where an independent claim is adjudged to be invalid, whether claims which are dependent on the said independent claim would be automatically rendered invalid without the need for the Court to consider separately the validity of each and every dependent claim[s]?” (emphasis added).

There was a 3-2 majority decision of the Federal Court - please refer to [2019] 12 MLJ 66. The majority judgment was delivered by Nallini Pathmanathan FCJ (concurred by Tengku Maimun CJ and Mohd. Zawawi Salleh FCJ) [Majority Judgment (Federal Court)] while the dissenting judgment was given by Ramly Ali FCJ (agreed by Ahmad Maarop PCA). According to the Majority Judgment (Federal 8 Court), at [83]-[85], [87]-[92], [98]-[103], [105], [106], [109]-[111], [138], [140], [147], [153], [169], [174]-[176] and [179]-[186] - “[83] In drafting claims, an independent claim would typically be a broad, general claim that is an amalgamation of its dependent claims which are subsets of the independent claim. An example of this type of form of claim can be found in the case of Ultraframe (UK) Ltd v Eurocell Building Plastics Ltd [2005] RPC 36 at para 41: The argument is this: that the width of claim 1 must be wider than claim 3 and that it was only claim 3 which contained a limitation requiring some prior restraint. It is an example of the argument epitomised by the late Anthony Walton QC: ‘Claim 1 ‘A car’; Claim 2 ‘A car wherein the wheels are round’’ - forcing you to the conclusion that claim 1 covers cars with non-round wheels. [84] We will hereinafter refer to this type of form as a ‘Type 1’ for ease of reference. [85] Another form of claim is that which is described in the case of Generics in [24] above where the dependent claims include features that are added to the independent claim. We shall refer to this form of claim as ‘Type 2’ claims. … [87] Type 1 claims consist of one or more independent claims which are supersets of their dependent claims incorporating all features A to F, to have the broadest scope possible. Naturally, the dependent claims would be subsets of the independent claim, focusing on specific features and having a narrower scope. [88] Type 2 claims consist of one or more broad independent claims which do not necessarily include all of the features listed in 9 the specification. Their dependent claims however, include additional features over and above the independent claim(s), making them more specific, having a narrower scope, and thus harder to infringe. [89] It is also important to note that some of the drafting of claims might incorporate both Type 1 and Type 2 claims. The different forms of claims have different implications when determining their interdependency and by extension, their validity. INTERDEPENDENCY OF CLAIMS [90] Section 26 [PA] provides that ‘an application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept’ (unity of invention). This would suggest an automatic presumption of association between claims if a patent has been granted, be it by reason of construction or language. [91] Despite this presumption existing upon grant, it is not intrinsic during invalidity and infringement proceedings. [92] Determining the interdependency of claims is paramount for the purposes of deducing which dependent claims might fall when the claim(s) they are dependent upon fail(s). It is incumbent upon a trial court to not only read and construe the independent and dependent claims in full but to also hear evidence in respect of each of those claims or category of claims as may have been defined by counsel at the outset of trial. In this case and in SKB Shutters, there was no such consideration of oral evidence in respect of the dependent claims. … [98] A consideration of Malaysian case law prior to SKB Shutters discloses that a similar position conceptually was adopted (see for example Fukuyama Automation Sdn Bhd v Xin Xin Engineering Sdn 10 Bhd & Ors [2015] 9 MLJ 823 and Winthrop Pharmaceuticals (Malaysia) v Astrazeneca UK Limited [2015] MLJU 2014). After considering the positions in both the UK and the US, we are in agreement with the plaintiffs that independent and dependent claims should be treated separately. [99] In our opinion, the treatment of interdependent claims in other jurisdictions is relevant, especially to type 2 claims. This is because dependent claims incorporate additional features not included in the independent claim which could therefore have independent validity should the independent claim be invalidated, despite their dependence upon it. [100] A type 1 claim, although having its dependent claims intertwined with its independent claim(s), could still have its dependent claims found to be independently valid depending on the basis of challenge to the patent’s validity. [101] The determination of the form of claims will lay the foundation for the treatment of type 1 claims and type 2 claims. BASES OF CHALLENGES [102] The bases of challenges to validity include, but are not limited to:

lack of novelty/anticipation;

lack of inventive step/obviousness;

ambiguity;

insufficiency; and 11

lack of industrial applicability. We will pay particular attention to bases relating to prior art (lack of novelty/anticipation and lack of inventive step/obviousness) because these bases of challenge are relevant to the present appeal. [103] In cases where the validity of patents is challenged based on prior art, it is imperative to consider the type of the claim as it will have an effect on the validity of dependent claims. … [105] Since the dependent claim is a subset of the independent claim, and all its features are present in the independent claim, it stands to reason that, should the prior art have the same features of the independent claim, when the independent claim is found to be invalid, the dependent claim falls. [106] However, for the purposes of this appeal relating to the approach taken in SKB Shutters, it is crucial to note that in order to determine and hold that all the dependent claims fall if the independent claim fails, the trial court undertakes the exercise of hearing evidence to this effect. The trial court does not arrive at this conclusion without the benefit of such evidence. In short, a technical expert witness approximating the person ordinarily skilled in the art is expected to assist the court in confirming that there are no additional features that make the dependent claim independently valid. The court will then in a position to determine that all the dependent claims fall after the independent claim fails. … [109] The dependent claim contains all the features of the independent claim along with an additional Feature F. It cannot be the case that should the independent claim be invalid, then the whole 12 dependent claim necessarily lacks validity, as the dependent claim may have a feature or element that is not one disclosed by the Prior Art. [110] The hypothetical representation of circumstances in figures 4 and 5 coupled with Lefstin’s statements are in line with Laddie J’s discourse in [93] above, in that the opposing party must prove invalidity with regard to all claims that are opposed should the dependent claims have independent validity. [111] It is true that when the validity of a patent is challenged based on prior art and where the form of claims is of type 1, the dependent claims may be invalidated by virtue of the independent claim being invalid. However, the determination of the type or form employed requires careful consideration of: (a) the language; (b) the content of the claims themselves; and (d) the expert evidence in respect of each of the claims. … [138] Therefore, in cases where the challenge to validity is based on prior art (lack of novelty/anticipation or lack of inventive step/obviousness), the trial court is bound to hear evidence on each claim (whether independent or dependent) unless there is a concession and to then determine the type or form of claim (whether type 1 or type 2), before considering the validity of each of the independent and dependent claims. … [140] In light of the analysis above, we are unable to accept the defendant’s submission that the position adopted in SKB Shutters was similar to the approach adopted in other jurisdictions. … 13 [147] The legal position expounded in SKB Shutters namely that in the event an independent claim is invalidated, all the other claims fall, is, with great respect, not entirely accurate for the following reasons:

even though the independent claim is invalidated, the established practice of law is for a trial court to examine the dependent claims [2019] 12 MLJ 66 at 103 separately despite the invalidation of the independent claim (unless there is an express concession to that effect);

although in a type 1 claim, the invalidation of an independent claim due to prior art would result in the invalidation of the dependent claims, this position only reflects one of a myriad of possibilities that may arise in patent invalidation proceedings. Therefore, to apply that as a blanket rule would, with great respect, not be an accurate reflection of the law; and

the consequence of applying such an interpretation as stated in SKB Shutters would be to shut out the possibility of an inventor having his valid patent rightfully registered and protected. This is because the potentially valid patent would have been struck out simply by reason of the independent claim having been held to be invalid. … [153] The decision of SKB Shutters, with respect was premised upon an incomplete consideration of the law relating to the invalidation of claims. We are of the considered view that this court should depart from the ruling of the said case. … [169] For all these reasons, we are constrained to depart from the decision in SKB Shutters. We reiterate that it is essential that when a court is tasked with ascertaining the validity of a patent comprising 14 both independent and dependent claims, the trial court is bound to evidentially assess each of these claims separately. … [174] By virtue of s 56(3) [PA], [PA] envisages the grant of a declaration by the court to preserve the validity of some claims or parts of a claim, which would in turn necessarily require these claims or parts of claims to be reworded to reflect partial validity. To give effect to partially invalid claims, these claims must be amended. Section 56(3) requires that the invalid parts ‘be declared as a corresponding limitation of the claim in question’. This implicitly empowers the court to order amendments of the surviving claim(s). [175] Therefore this court in concluding in SKB Shutters that amendments per se were prohibited by the Act was less than accurate. [176] The fact that s 56(3) allows for partial validity supports the argument that a dependent claim may survive, even when an independent claim collapses. This allowance of partial invalidity is also reflected in s 63 of the UK Patents Act. … [179] Hence, by construing ss 56(3), 57(2), and 79A(3) together, in the event of partial invalidity, an application to amend a dependent claim may be permitted after court proceedings. This ensures that the invalidity of the independent claim would not affect all other dependent claims. The point we seek to make here is that the conclusion drawn in SKB Shutters, namely that amendments under the Act are prohibited is not entirely accurate, and this comprises a further reason we are constrained to depart from SKB Shutters. CONCLUSION 15 [180] For all the reasons that we have given above, our answer to the leave question is in the negative. When an independent claim is deemed to be invalid, it does not necessarily follow that all dependent claims which make reference to the said independent claim will automatically fail. [181] The validity of these dependent claims will ultimately depend on the form of claim used, whether type 1 or type 2, and the basis of challenge to their validity. A trial court can only ascertain the type of claim before it through undertaking the evidential process of examining each claim separately. If it fails to do so, the trial court may well overlook any additional features embedded within a dependent claim that could render such claim independently valid. The serious consequence of failing to undertake this examination is that a patentable invention would not be protected. [182] If the claims are of type 1 form and the basis of challenge relates to prior art (lack of inventive step/obviousness or lack of novelty/anticipation), then, when the independent claim is invalidated, the claims dependent on the said independent claim may also be declared to be invalid, but only after the trial court undertakes the evidential process described above (unless there is an express concession). [183] Where the claims are of type 2 form and the basis of opposition relates to prior art, the dependent claims, when the independent claim is invalidated, have to be addressed separately to determine their validity. This is because they may have additional features that have not been disclosed by prior art or prior publications. 16 [184] And if the basis of challenge does not relate to prior art, then the language and structure of all claims will have to be addressed separately to determine their scope, interdependency, and validity on a case by case basis. This also requires the court to undertake the evidential process. [185] We are of the opinion that the principle established in SKB Shutters that when an independent claim is invalid, all dependent claims dependent on the said independent claim also fall with it, fails to take into account the myriad of other claims and bases of challenge that routinely arise in patent adjudication. [186] Accordingly, we allow this appeal and remit the case to the High Court to determine whether each of the dependent claims (ie claims 2-22) possesses independent validity (notwithstanding the fact that this case may entail type 1 claims or unless there is an express concession).” (emphasis added). B. Trial of issue remitted by Majority Judgment (Federal Court)

In this judgment, I shall refer to the trial of the issue remitted by the Majority Judgment (Federal Court) as the “2nd Trial”. It has to be stressed that the 2nd Trial is not a trial de novo because the Majority Judgment (Federal Court) only remitted one question to be tried by this court, namely, whether all the Dependent Claims are valid or otherwise (Remitted Issue).

At the first case management for the 2nd Trial, I have informed learned counsel for the Plaintiffs and Defendant as follows:

all the parties have the right to -

call new witnesses in the 2nd Trial; 17

re-call any witness who had testified at the 1st Trial; and

tender new documents in the 2nd Trial;

all the documents filed in the 1st Trial [Documents (1st Trial)] are deemed to have been tendered as “Part B” documents for the purpose of the 2nd Trial. Both the Plaintiffs and Defendant may rely on the Documents (1st Trial);

the notes of proceedings of the 1st Trial shall be admissible as evidence in the 2nd Trial and may be relied on by all parties in the 2nd Trial; and

after the conclusion of the 2nd Trial, all parties have the right to submit, orally and in writing, regarding the Remitted Issue. This court then gave time for learned counsel for all the parties to consider the above matters.

At the next case management for the 2nd Trial -

learned counsel for the Plaintiffs informed the court as follows -

the 2nd Plaintiff wished to discontinue the Original Action against the Defendant regarding the Remitted Issue with no liberty to file afresh and with no order as to costs. Consequently, I struck out the 2nd Plaintiff’s Original Action against the Defendant in respect of the Remitted Issue with no liberty to file afresh and with no order as to costs;

the 1st Plaintiff would only proceed in the 2nd Trial in respect of Dependent Claims 14, 15 and 20. As such, the 2nd Trial only concerns Dependent Claims 14, 15 and 20. In this judgment -

the 1st Plaintiff’s claim in the 2nd Trial based on Dependent Claims 14, 15 and 20 shall be referred to as the “1st Plaintiff’s Claim (Dependent Claims 14, 15 and 20)”; and 18

(ii) I shall refer the Defendant’s counterclaim to invalidate Dependent Claims 14, 15 and 20 as the “Counterclaim (Dependent Claims 14, 15 and 20)”; and

the 1st Plaintiff would call Emeritus Professor Sokratis Papapoulos (Prof. Papapoulos) to give expert evidence as a POSITA in the 2nd Trial; and

the Defendant’s learned counsel stated that for the purpose of the 2nd Trial, the Defendant would call Prof. Seeman to testify.

The 2nd Trial proceeded solely on-line as follows:

the 1st Plaintiff called Prof. Papapoulos to provide his expert opinion in support of the 1st Plaintiff’s Claim (Dependent Claims 14, 15 and 20) and to oppose the Counterclaim (Dependent Claims 14, 15 and 20); and

Prof. Seeman gave expert testimony for the Defendant. C. Issues 20. As explained by Raus Sharif CJ in the Federal Court case of Spind Malaysia Sdn Bhd v Justrade Marketing Sdn Bhd & Ors [2018] 4 MLJ 34, at [144] and [145], I shall first decide the Counterclaim (Dependent Claims 14, 15 and 20). If Dependent Claims 14, 15 and 20 are invalid, the 1st Plaintiff’s Claim (Dependent Claims 14, 15 and 20) should be consequentially dismissed.

The following questions arise in the 2nd Trial:

whether Dependent Claims 14, 15 and 20 are -

“Type 1” claims falling within Independent Claim 1 [as explained in the Majority Judgment (Federal Court)]; or 19

“Type 2” claims which possess features which are not provided in Independent Claim 1 [as stated in the Majority Judgment (Federal Court)]; or

if Dependent Claims 14, 15 and 20 are Type 1 claims -

are Dependent Claims 14, 15 and 20 automatically invalid due to the

premised on the POSITA’s expert testimony and common general knowledge (CGK) possessed by the POSITA on Priority Date, whether Prior Art has the same features as the invalid Independent Claim 1;

by reason of the High Court’s Decision (1st Trial) and Court of Appeal’s Decision (1st Trial), whether the 1st Plaintiff is barred by an application of “issue estoppel” principle (the second limb of res judicata doctrine) from raising the following matters with regard to Dependent Claims 14, 15 and 20 -

should Prior Art concern only studies regarding patients who suffer osteoporosis (Osteoporosis Patients) and not patients of “Paget’s

what was CGK possessed by the POSITA on Priority Date?; and

whether Dependent Claims 14, 15 and 20 involve an inventive step (required by ss 11 and 15 PA) which was not obvious to the POSITA on

if issue estoppel principle does not bar the 1st Plaintiff in the 2nd Trial -

who is a POSITA regarding Dependent Claims 14, 15 and 20?;

whether Prior Art should only include studies in respect of Osteoporosis Patients and not Paget’s Disease Patients; 20

what was CGK possessed by the POSITA on Priority Date?; and

based on Prior Art, CGK and POSITA’s expert opinion -

does Prior Art have the same features as the invalid Independent

(ii) whether Dependent Claims 14, 15 and 20 involve an inventive step which was not obvious to the POSITA on Priority Date;

if Dependent Claims 14, 15 and 20 fulfill the inventiveness requirement and are therefore valid, whether the Defendant’s production, offers for sale, sales and stocking of Defendant’s Alendronate 70 mg Tablets [Defendant’s Commercial Dealings (Defendant’s Alendronate 70 mg Tablets)] have infringed Dependent Claims 14, 15 and 20 under ss 36(1)(a), (2), (3)(a)(i) and 58 PA (Patent Infringement); and

if the 1st Plaintiff’s Claim (Dependent Claims 14, 15 and 20) is successful and if the Counterclaim (Dependent Claims 14, 15 and 20) is dismissed -

whether the court has power under O 24 rr 3(1) and 7(1) of the Rules of Court 2012 (RC) to make an order (Post-Trial Discovery Order) for the Defendant to disclose to the 1st Plaintiff all contracts, purchase orders, delivery orders, invoices, receipts and other relevant documents (Defendant’s Documents) regarding the Defendant’s Commercial Dealings (Defendant’s Alendronate 70 mg Tablets) so as to enable the 1st Plaintiff to make an “informed decision” on the 1st Plaintiff’s election to -

claim for damages (Assessment of Damages) or

(ii) take an account of profits (Account of Profits) from the Defendant regarding the Patent Infringement; 21

can the 1st Plaintiff recover Costs (1st Trial) from the Defendant?; and

what “reasonable amount” of costs had been “reasonably incurred” by the 1st Plaintiff in the 2nd Trial on the court’s assessment of costs on a “standard basis” within the meaning of O 59 r 16(3) RC? D. Elements of Dependent Claims 14, 15 and 20 D(1). Patent construction 22. As decided in Spind, at [123] and [125], I will give a purposive interpretation of Dependent Claims 14, 15 and 20. D(2). Purposive interpretation of Independent Claim 1 and Dependent Claims 14, 15 and 20 23. In the High Court’s Decision (1st Trial), at [66(3)], I have decided that Independent Claim 1 has the following four elements [4 Elements (Independent Claim 1)]:

use of Alendronate for the manufacture of a Medicament (Inhibition of Bone Resorption) [1st Element (Independent Claim 1)];

the Medicament (Inhibition of Bone Resorption) is adapted for oral administration [2nd Element (Independent Claim 1)];

the Medicament (Inhibition of Bone Resorption) is administered in a unit dosage form which comprises from about 8.75 mg to 140 mg of alendronate [3rd Element (Independent Claim 1)]; and

the Medicament (Inhibition of Bone Resorption) is administered in a continuous schedule having a periodicity from about once every 3 days to about once every 16 days [4th Element (Independent Claim 1)].

Adopting a purposive construction, I am of the following view: 22

Dependent Claim 14 has the following two elements [2 Elements (Dependent Claim 14)] -

use according to any one of Independent Claim 1 and Dependent Claims 2 to 9 [1st Element (Dependent Claim 14)]; and

use as provided in the 1st Element (Dependent Claim 14) is for the manufacture of a Medicament (Osteoporosis) [2nd Element (Dependent

there are two elements of Dependent Claim 15 [2 Elements (Dependent Claim 15)] as follows -

use according to Dependent Claim 14 [1st Element (Dependent Claim 15)]; and

the unit dosage of the use according to Dependent Claim 14 comprises about 70 mg of alendronic acid or a pharmaceutically acceptable salt thereof, on an alendronic acid active weight basis [2nd Element (Dependent Claim 15)]; and

Dependent Claim 20 has the following two elements [2 Elements (Dependent Claim 20)] -

use according to any one of Independent Claim 1 and Dependent Claims 2 to 9 [1st Element (Dependent Claim 20)]; and

the medicament for the use as provided in the 1st Element (Dependent Claim 20) is in the form of a tablet [2nd Element (Dependent Claim 20)]. E. Whether Dependent Claims 14, 15 and 20 are Type 1 or Type 2 claims 23 25. Premised on my construction of Dependent Claims 14, 15 and 20 in the above paragraph 24, it is clear that Dependent Claims 14, 15 and 20 are Type 1 claims because Dependent Claims 14, 15 and 20 are subsets of Independent Claim 1. F. Are Dependent Claims 14, 15 and 20 automatically invalid upon Invalidation (Independent Claim 1)?

The Defendant’s learned counsel, Ms. Cindy Goh Joo Seong, has invited me to invalidate Dependent Claims 14, 15 and 20 because -

Dependent Claims 14, 15 and 20 are subsets of Independent Claim 1; and

since Independent Claim 1 is invalid due to lack of an inventive step, Dependent Claims 14, 15 and 20 are automatically invalid for the same reason.

In an application to invalidate independent claim(s) and dependent claim(s) in a patent on the ground of lack of novelty and/or inventiveness, premised on the Majority Judgment (Federal Court), I am of the following view:

the court shall first decide on the validity of independent claim(s) regarding whether the independent claim(s) lacks novelty and/or inventiveness [1st Judicial Exercise (Independent Claim)]. In the 1st Judicial Exercise (Independent Claim), the court shall consider -

who is the POSITA with regard to the patent?;

what is the CGK possessed by the POSITA on the priority date of the patent?; and

what is prior art on the priority date of the patent?;

the burden to invalidate independent claim(s) under s 56(1) PA lies solely with the party applying to invalidate the independent claim(s) (Applicant) - please refer to the High Court’s Decision (1st Trial), at [40] and [41]; 24

if the court decides that independent claim(s) is invalid due to a want of novelty and/or inventiveness based on -

the expert opinion of the POSITA;

CGK; and

prior art, the court shall then consider separately whether the dependent claim(s) is invalid for want of novelty and/or inventiveness [2nd Judicial Exercise (Dependent Claim)];

in the 2nd Judicial Exercise (Dependent Claim) -

the court shall first decide whether the dependent claim(s) is a -

Type 1 claim; or

(ii) Type 2 claim;

if the dependent claim(s) is a Type 1 claim, the court has to consider the expert views of the POSITA and CGK on whether the prior art has the same features as the independent claim(s) which has been invalidated. There are two possible scenarios, namely -

if the prior art has the same features as the independent claim(s), the dependent claim(s) shall be consequently invalid on the same ground as the invalidation of the independent claim(s) (1st Scenario); or

(ii) if the prior art does not possess the same features as the independent claim(s), it is incumbent on the court to decide whether the dependent claim(s) is invalid due to want of novelty and/or inventiveness (2nd Scenario); and 25

if the dependent claim(s) is a Type 2 claim(s), even if the prior art possesses the same features as the independent claim(s), the dependent claim(s) cannot be automatically invalid by reason of the invalidation of the independent claim(s). This is because the dependent claim(s) has features which are not present in the independent claim(s); and

the Applicant bears the legal onus pursuant to s 56(1) PA to persuade the court to invalidate the dependent claim(s).

Even though Dependent Claims 14, 15 and 20 are Type 1 claims, I am not able to accede to the above contention by Ms. Goh. My reasons are as follows:

as explained in the above sub-paragraph 27(4)(b), notwithstanding the Invalidation (Independent Claim 1) and the fact that Dependent Claims 14, 15 and 20 are Type 1 claims, the court has to undertake a 2nd Judicial Exercise (Dependent Claim) based on the POSITA’s expert evidence and CGK to decide whether Prior Art has all the same features of Independent Claim 1; and

if I have accepted the above submission, this will indirectly resurrect SKB Shutters which is contrary to the Majority Judgment (Federal Court). G. Does issue estoppel principle apply in 2nd Trial?

Based on the High Court’s Decision (1st Trial) and Court of Appeal’s Decision (1st Trial), Ms. Goh has submitted that issue estoppel principle bars the 1st Plaintiff from revisiting the following matters in the 2nd Trial:

whether Prior Art should concern studies regarding Osteoporosis Patients and not Paget’s Disease Patients;

what constituted CGK which was known to the POSITA on Priority Date. In this regard - 26

whether POSITA would know that adverse gastrointestinal (GI) side effects, such as esophagitis [inflammation of esophagus (the tube that connects the throat to the stomach)], esophageal erosion or ulceration, abdominal pain, dyspepsia (indigestion), vomiting, nausea and gastritis, were associated with high doses of oral administration of Alendronate to

whether the POSITA would consider it safe to prescribe a 70 mg dose of Alendronate (a seven-fold higher dose than 10 mg approved dose) to

whether the POSITA could consider studies of the use of 40 mg or 80 mg Alendronate on Paget’s Disease Patients when the characteristics of Osteoporosis Patients are different from Paget’s Disease Patients; and

whether the POSITA would know that intermittent administration of “Bisphosphonates” (a class of drugs which includes Alendronate) was associated with a reduction in the risk of fractures (Anti-Fracture

Dependent Claims 14, 15 and 20 have no inventive step under ss 11 and 15 PA because on Priority Date -

the oral administration of 70 mg of Alendronate in a single weekly dose (70 mg Single Weekly Dose) was obvious to the POSITA; and

adverse GI side effects caused by oral administration of Alendronate were not known to the POSITA to be related to the dose of the Alendronate (Dose Related GI Side Effects).

I am of the view that with regard to Dependent Claims 14, 15 and 20, issue estoppel principle does not bar the 1st Plaintiff from revisiting the matters submitted by Ms. Goh in the above paragraph 29. The following reasons support this decision: 27

the High Court’s Decision (1st Trial) and Court of Appeal’s Decision (1st Trial) solely concern the Invalidation (Independent Claim 1). In other words, the 1st Plaintiff is only barred by issue estoppel principle in respect of all questions regarding the validity of Independent Claim 1. In paragraph 38 below, I have further explained why issue estoppel principle cannot apply to Dependent Claims 14 and 15 which apply to Medicament (Osteoporosis) and not to other kinds of Medication (Inhibition of Bone Resorption) (such as medicament for Paget’s Disease); and

if I have applied issue estoppel principle at the 2nd Trial, this will render nugatory the Majority Judgment (Federal Court). All the cases cited by Ms. Goh on the application of issue estoppel principle do not concern an appellate court’s order which remits a particular question for the trial court to try. H. Who is POSITA for Dependent Claims 14, 15 and 20?

A POSITA has been explained in the High Court’s Decision (1st Trial), at [58] and [60], as follows: “[58]

the Court may be assisted by the evidence of a POSITA in respect of -

construction of a patent, especially its claims (Patent

whether a patent has made sufficient disclosure under regs. 12, 15 and 16 PR read with s 23 PA (Disclosure Requirement). The importance of a POSITA is provided in reg. 12(1)(c) PR; 28

whether an invention is novel and has not been anticipated by prior art under ss 11, 14(1) and (2)(a) PA (Novelty Requirement); and

whether a patent involves an inventive step which is not obvious to a POSITA within the meaning of ss 11 and 15 PA (Inventiveness Requirement). Section 15 PA has recognized the role of a POSITA regarding the inventive step embodied in a patent (4 Matters);

the Court is not bound to accept the evidence of a POSITA; and

the Court may sieve the evidence of a POSITA by accepting part and rejecting the rest of the POSITA’s evidence. … [60] I am of the following view regarding a POSITA:

a POSITA is a -

notional person; or

hypothetical group of persons (please see Rockwater) - who is or are ordinarily skilled in respect of the patented invention [please see Ramly Ali JCA’s (as he then was) judgment in the Court of Appeal case of Ranbaxy (M) Sdn Bhd v Ei Du Pont De Nemours & Co [2012] 4 MLJ 34, at paragraphs 29-36]. In the House of Lords case of Catnic Components Ltd & Anor v Hill & Smith Ltd [1982] RPC 183, at 242-243, Lord Diplock held that a POSITA should have a practical interest, knowledge and 29 experience in the invention in question. Catnic Components has been followed by Azahar Mohamed J (as he then was) in the High Court case of Kendek Industry Sdn Bhd v Ecotherm (TFT) Sdn Bhd [2010] 10 CLJ 210, at paragraph 36;

a POSITA has the common general knowledge which existed on the priority date of the patented invention (please see Ranbaxy and Rockwater);

a POSITA is generally unimaginative and does not have any inventive capacity (please see Rockwater);

a POSITA may possess common prejudices or conservatism regarding the patented invention which existed on the priority date of the patent (please see Rockwater);

a POSITA should be able to explain the 4 Matters to the Court with cogent reasons (please see Rockwater); and

for an expert to qualify as a POSITA, the expert need not necessarily resemble closely the POSITA provided that the expert is able to explain the 4 Matters to the Court with sufficient reasons (please see SKB Shutters Manufacturing and Rockwater). Under s 51 EA, the grounds of an expert’s opinion are relevant.” (emphasis added).

The following elements of Dependent Claims 14, 15 and 20 refer to the use of

the 2nd Element (Dependent Claim 14);

the 1st Element (Dependent Claim 15); and 30

the 1st Element (Dependent Claim 20).

As stated in paragraph 42 below, the oral administration of Alendronate [as provided in the 2nd Element (Dependent Claim 20)] according to the unit dosage as stated 2nd Element (Dependent Claim 15) has adverse GI side effects.

Based on the reasons as explained in the above paragraphs 32 and 33, I accept the submission by the 1st Plaintiff’s learned counsel, Mr. Indran Shanmuganathan, that a POSITA for Dependent Claims 14, 15 and 20 should be a notional team of gastroenterologist and endocrinologist (POSITA Team). The need for a gastroenterologist as a member of the POSITA Team is due to Dose Related GI Side Effects as result of oral administration of Alendronate - please refer to paragraph 42 below.

I have no hesitation to make a finding of fact that Prof. Papapoulos fulfils the notion of a POSITA Team for the purposes of Dependent Claims 14, 15 and 20. This is because Prof. Papapoulos’ resume clearly shows his expertise in both endocrinology and GI side effects due to oral administration of, among others, Alendronate.

Prof. Seeman has admitted during cross-examination that he is not a gastroenterologist. Consequently, Prof. Seeman could not answer certain questions posed by Mr. Indran regarding adverse side effects to the “upper GI tract” of patients who have orally consumed Alendronate.

In view of my decision regarding the POSITA Team (please refer to the above paragraphs 32 to 34) and the reasons stated in the above paragraphs 35 to 36, I prefer the expert view of Prof. Papapoulos to Prof. Seeman’s expert opinion. I. Whether Prior Art should only include studies regarding Osteoporosis Patients 38. I accept Prof. Papapoulos’ expert opinion that Prior Art for Dependent Claims 14, 15 and 20 should not include studies regarding the use of 40 mg or 80 mg Alendronate on Paget’s Disease Patients (which showed the tolerability of high doses of 31 Alendronate by Paget’s Disease Patients). This decision is due to the following reason:

Dependent Claims 14 and 15 concern the use of Alendronate as a Medicament (Osteoporosis)] and not the use of Alendronate as a medicament for Paget’s Disease. Osteoporosis and Paget’s Disease are two different diseases; and

the characteristics of Osteoporosis Patients are different from Paget’s Disease Patients. In the 1st Trial, I have relied on studies with regard to Paget’s Disease Patients because Independent Claim 1 concerns the use of Alendronate for the manufacture of a Medicament (Inhibition of Bone Resorption) (which includes a medicament for Paget’s Disease). In contradistinction to the wide Independent Claim 1, the scope of Dependent Claims 14 and 15 is solely confined to a Medicament (Osteoporosis). J. What was CGK possessed by POSITA Team on Priority Date?

The first question is whether the POSITA Team would have CGK on Priority Date that adverse GI side effects were associated with high doses of oral administration of Alendronate to Osteoporosis Patients. Ms. Goh contends that on the Priority Date, adverse GI side effects as a result of oral administration of Alendronate was not dose dependent because the major cause of adverse GI side effects was due to patients’ lack of compliance with the doctors’ dosing instruction (Patient’s Non-Compliance). According to Ms. Goh, as Prior Art had disclosed that a single dose of 80 mg of Alendronate was safe, a single dose of 70 mg of Alendronate could also be safely administered. Ms. Goh has relied on studies regarding the use of 40 mg or 80 mg Alendronate on Paget’s Disease Patients which showed their tolerability of high doses of Alendronate. Ms. Goh has further submitted that CGK on Priority Date would include the fact that intermittent administration of Bisphosphonates (which include Alendronate) was associated with Anti-Fracture Efficacy.

Firstly, as opined by Prof. Papapoulos, I am of the view that on Priority Date, the POSITA Team would possess CGK that Alendronate was an irritating substance to patients who had been orally administered Alendronate. Such a fact had also been admitted by Prof. Seeman during his cross-examination.

Prof. Seeman’s expert evidence had relied on studies in respect of Paget’s Disease. As explained in the above paragraph 38, the POSITA Team’s CGK on Priority Date should not include studies regarding the use of 40 mg or 80 mg Alendronate on Paget’s Disease Patients. This is another reason for rejecting Prof. Seeman’s expert opinion in the 2nd Trial.

Secondly, as explained by Prof. Papapoulos, this court agrees that CGK on Priority Date would include Dose Related GI Side Effects. The following reasons support this finding:

the following publications (before Priority Date) supported Dose Related GI Side Effects [Prior Art (Dose Related GI Side Effects)] -

Prof. Papapoulos’ own article, “Bisphosphonates, Pharmacology and Use in the Treatment of Osteoporosis”, published in “Osteoporosis” (1996), edited by R. Marcus et al, Academic Press, Chapter 64 (p. 1209-1234), at

Patient’s Non-Compliance may contribute to adverse GI side effects due to oral administration of alendronate to Osteoporosis Patients. Having said that, in view of the Prior Art (Dose Related GI Side Effects) and Prof. Papapoulos’ Clinical Experience (Before Priority Date) (as explained in the above paragraph 42), I am not persuaded that Patient’s Non-Compliance is the sole or major cause of adverse GI side effects when Osteoporosis Patients orally consume Alendronate. In other words, Patient’s Non-Compliance cannot displace Dose Related GI Side Effects as CGK which was known to the POSITA Team on Priority Date.

Thirdly, I decide that on Priority Date, the POSITA Team would have CGK that it would not be safe to give a 70 mg dose of Alendronate (a seven-fold higher dose than 10 mg approved dose) to Osteoporosis Patients. This decision is premised on the following reasons:

before Priority Date, the highest dose of Alendronate prescribed for Osteoporosis Patients was only 40 mg - please refer to Chestnut’s Article, at p. 144, 145, 147, 148, 149, 150 and 151;

there was no Prior Art which showed that -

70 mg dose of Alendronate had been administered to Osteoporosis

it was safe for doctors to prescribe 70 mg dose of Alendronate to Osteoporosis Patients; 35

the Prior Art (Dose Related GI Side Effects) clearly showed Dose Related GI Side Effects due to the use of high doses of Alendronate. Accordingly, on Priority Date, there was no CGK possessed by the POSITA Team that it would be safe for doctors to prescribe a 70 mg dose of Alendronate to Osteoporosis Patients; and

during Prof. Papapoulos’ Clinical Experience (Before Priority Date), he had never given a 70 mg dose of Alendronate to Osteoporosis Patients.

Lastly, I am of the view that Prof. Papapoulos was correct in his expert opinion that CGK on Priority Date would not include the fact that intermittent administration of Bisphosphonates (which include Alendronate) was associated with Anti-Fracture Efficacy. This is because there was no Prior Art which showed a nexus between Anti-Fracture Efficacy and intermittent administration of Bisphosphonates. K. Whether Prior Art had all features of Independent Claim 1 46. I accept Mr. Indran’s submission that Prior Art did not have all the features of Independent Claim 1. According to the 3rd Element (Independent Claim 1), the Medicament (Inhibition of Bone Resorption) is administered in doses from 8.75 mg to 140 mg Alendronate. There was no Prior Art which had satisfied the 3rd Element (Independent Claim 1) because -

as explained in the above paragraph 44, on Priority Date, there was no safe use of Alendronate for Osteoporosis Patients in excess of 10 mg Alendronate; and

Prior Art did not disclose any use of Alendronate for Osteoporosis Patients up to 140 mg.

In view of the reasons stated in the above paragraph 46, I have no hesitation to decide that notwithstanding the fact that Dependent Claims 14, 15 and 20 are Type 1 Claims, Prior Art did not fulfil the 3rd Element (Independent Claim 1). Accordingly, 36 premised on the Majority Judgment (Federal Court), this court cannot automatically invalidate Dependent Claims 14, 15 and 20. L. Do Dependent Claims 14, 15 and 20 involve an inventive step which was not obvious to POSITA Team?

Sections 11 and 15 PA provide as follows: “Patentable inventions.

An invention is patentable if it is new, involves an inventive step and is industrially applicable. Inventive step 15. An invention shall be considered as involving an inventive step if, having regard to any matter which forms part of the prior art under paragraph 14(2)(a), such inventive step would not have been obvious to a person having ordinary skill in the art.” (emphasis added).

In Kingtime International Ltd & Anor v Petrofac E&C Sdn Bhd [2018] MLJU 1840, I have followed the Federal Court’s judgment in Spind regarding the inventiveness requirement for a valid patent as provided in ss 11 and 15 PA. It is decided in Kingtime, at [68], as follows: “[68]

the Inventiveness Requirement is distinct from the Novelty Requirement - Spind, at paragraph 57. The question of inventiveness only arises when an invention is novel - Spind, at paragraph 57; …

the Federal Court has decided in Spind as follows - 37

the four-step test laid down by Oliver LJ (as he then was) in UK’s Court of Appeal in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59, at 73-74 (Windsurfing’s Test), is a “helpful guide”. The Windsurfing’s Test is as follows -

the Court shall identify the inventive concept embodied in the patent (1st Step);

(ii) the Court shall assume the mantle of the POSITA in question and impute to the POSITA the CGK on the Priority Date (2nd Step);

(iii) the third step (3rd Step) is that the Court shall identify the differences between the Prior Art and the alleged invention (Differences); and

(iv) whether, viewed without any knowledge of the alleged invention, the Differences constitute steps which would have been obvious to the POSITA or whether the Differences require any degree of invention (4th Step);

regarding the 4th Step -

its application is an objective one and a question of fact. Hence, reliance on previous cases is “not helpful”;

(ii) the POSITA cannot have the benefit of hindsight; and

(iii) the Court may consider primary and secondary evidence. Primary evidence consists of a POSITA’s expert testimony and the reasons for such a 38 testimony. Secondary evidence includes contemporary events and commercial success of the alleged invention. Secondary evidence in itself is not conclusive of the 4th Step;

the application of Windsurfing’s Test is not set in stone and should not be mechanically applied. The Court must always bear in mind that the ultimate question as expressed in s 15 PA is the 4th Step; and

it is “unnecessary” to apply the reformulated Windsurfing’s Test as explained by Jacob LJ in UK’s Court of Appeal in Pozzoli Spa v BDMO SA & Anor [2007] FSR 37, at paragraphs 14-23.” (emphasis added). The above judgment in Kingtime has been affirmed on appeal to the Court of Appeal. The Federal Court has refused leave to appeal against the Court of Appeal’s decision in Kingtime.

As Lord Reid has explained in United Kingdom’s (UK) House of Lords’ judgment in Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [1972] RPC 346 at 355, in ascertaining whether a patent possesses an inventive step or otherwise, the POSITA Team may make a “mosaic” out of Prior Art but “it must be a mosaic which can be put together by an unimaginative man with no inventive capacity”.

Premised on Windsurfing’s Test as explained by the Federal Court in Spind, this court is persuaded that Dependent Claims 14, 15 and 20 have an inventive step as understood in ss 11 and 15 PA. My reasons are as follows:

according to Prof. Papapoulos, the inventive step introduced by Dependent Claims 14, 15 and 20 on Priority Date was the 70 mg Single Weekly Dose of 39 Alendronate for Osteoporosis Patients [Inventive Step (Dependent Claims 14, 15 and 20)]. The Inventive Step (Dependent Claims 14, 15 and 20) overcame adverse GI side effects which would be caused if Osteoporosis Patients were administered with daily doses of 10 mg Alendronate;

there was a difference between Prior Art and the Inventive Step (Dependent Claims 14, 15 and 20) because Prior Art only referred to daily dose of 10 mg Alendronate for Osteoporosis Patients (Difference); and

without any knowledge of the Inventive Step (Dependent Claims 14, 15 and 20) and without the benefit of hindsight, on Priority Date -

the Difference would not have been obvious to the POSITA Team with CGK as stated in the above Part J - please refer to Prof. Papapoulos’ expert view; and

the Difference would require a certain degree of invention by the POSITA Team.

I have not overlooked the following two publications in “Lunar News” (2 Lunar News Publications) which have been relied on by this court in the Invalidation (Independent Claim 1):

Lunar News (April, 1996); and

Lunar News (July, 1996).

I reproduce below the relevant part of Lunar News (April, 1996), at p. 31: “One of the difficulties with alendronate is its low oral bioavailability. When taken with water in a fasting state, only about 0.8% of the oral dose is bioavailable [13]. Even coffee or juice reduces this by 60%, and a meal reduces it by >85%. Alendronate must be taken, either an overnight fast, 30-60 minutes before breakfast. Subjects should remain seated or 40 standing; a very small group of patients have reported some upper [GI] distress if this is not done. This regime may be difficult for the elderly to maintain chronically. An intermittent treatment program (for example, once per week or one week every three months) with higher oral dosing, needs to be tested.” (emphasis added). Based on Prior Art [including Lunar News (April, 1996)] and CGK on Priority Date, I accept Prof. Papapoulos’ expert opinion that the Difference would not be obvious to the POSITA Team.

It was published in Lunar News (July, 1996), at p. 23, among others, as follows: “The difficulties with oral bisphosphonates may favor their episodic (once/week), or cyclical (one week each month) administration. Even oral alendronate potentially could be given in a 40 or 80 mg dose once/week to avoid dosing problems and reduce costs.” (emphasis added). I am not able to accept Ms. Goh’s contention that the Difference would have been obvious to the POSITA Team on Priority Date based on Lunar News (July, 1996). In this regard, I accept Prof. Papapoulos’ expert view that the publication in Lunar News (July, 1996) regarding the proposal to administer 40 or 80 mg Alendronate dose once a week, was subsequently proven to be wrong. Furthermore, no 80 mg Alendronate tablet had been marketed for Osteoporosis Patients.

In any event, reading together the 2 Lunar News Publications with Prior Art in a mosaic manner, the Difference would not have been obvious to the POSITA Team on Priority Date.

It is to be noted that - 41

the 2 Lunar News Publications had not been “peer-reviewed” in the sense that the accuracy and quality of their contents had been reviewed by experts in endocrinology and gastroenterologists; and

no study, research or reference had been cited in the 2 Lunar News Publications to support their contents. M. Has Defendant discharged burden to invalidate Dependent Claims 14, 15 and 20?

As explained in the above Parts H to L, the Defendant has failed to discharge the burden under s 56(1) and (2)(a) PA to prove that Dependent Claims 14, 15 and 20 lack an inventive step within the meaning of ss 11 and 15 PA. As such, Dependent Claims 14, 15 and 20 are valid and the Counterclaim (Dependent Claims 14, 15 and 20) must be dismissed. N. Patent Infringement N(1). Whether Defendant’s Alendronate 70 mg Tablets have infringed Dependent Claims 14, 15 and 20 58. The relevant parts of ss 36(1)(a), (2), (3)(a)(i) and 58 PA are reproduced below: “36. Rights of owner of patent.

Subject and without prejudice to the other provisions of this Part, the owner of a patent shall have the following exclusive rights in relation to the patent:

to exploit the patented invention; …

No person shall do any of the acts referred to in subsection

without the consent of the owner of the patent. 42

For the purposes of this Part, “exploitation” of a patented invention means any of the following acts in relation to a patent:

when the patent has been granted in respect of a product:

making, importing, offering for sale, selling or using the product; …

Acts deemed to be infringement. Subject to subsections 37(1), (2) and (3) and section 38, an infringement of a patent shall consist of the performance of any act referred to in subsection 36(3) in Malaysia by a person other than the owner of the patent and without the agreement of the latter in relation to a product or a process falling within the scope of protection of the patent.” (emphasis added).

It is decided in Kingtime, at [81], that there are three tests to decide whether a patent has been infringed or not (3 Tests): “[81] My understanding of case law is that there are three tests to decide Patent Infringement Issue (3 Tests) as follows:

the Essential Integers Test is explained by Lord Upjohn in the 3- 2 majority judgment in the House of Lords’ case of Rodi & Wienenberger AG v Henry Showell Ltd [1969] RPC 367, at 391 (Rodi’s Case), as follows - “To constitute infringement, the article must take each and every one of the essential integers of the claim. Non-essential integers may be omitted or replaced by mechanical equivalents.” 43 (emphasis added). Rodi’s Case has been followed by the Court of Appeal’s judgment delivered by Vernon Ong JCA in Yeohata Machineries Sdn Bhd & Anor v Coil Master Sdn Bhd & Ors [2015] 6 MLJ 810, at paragraph 15;

according to the Improver’s Test [1990] FSR 181, at 189 - “If the issue was whether a feature embodied in an alleged infringement which fell outside the primary, literal or a contextual meaning of a descriptive word or phrase in the claim (“a variant”) was nevertheless within its language as properly interpreted, the court should ask itself the following three questions:

Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no -

Would this (i.e. that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art. If no, the variant is outside the claim. If yes -

Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention. If yes, the variant is outside the claim. 44 On the other hand, a negative answer to the last question would lead to the conclusion that the patentee was intending the word or phrase to have not a literal but a figurative meaning (the figure being a form of synecdoche or metonymy) denoting a class of things which included the variant and the literal meaning, the latter being perhaps the most perfect, best-known or striking example of the class.” (emphasis added). In Cadware Sdn Bhd v Ronic Corp [2013] 6 MLJ 19, at paragraph 24, our Court of Appeal in a judgment given by Mohd. Hishamudin JCA, has applied Improver’s Test; and

Actavis’ Test [2018] 1 All ER 171, at paragraph 66, is as follows - “[66] In these circumstances, given the weight that has been given by courts in this jurisdiction (and indeed in some other jurisdictions) to the three 'Improver questions', I think it must be right for this court to express in our own words our reformulated version of those questions. In doing so, it is right to emphasise, as Lord Hoffmann did in Kirin-Amgen [2005] 1 All ER 667, [2005] RPC 169 (at [52]), that these questions are guidelines, not strict rules (as indeed the Oberlandesgericht indicated in Eli Lilly & Co v ratiopharm GmbH Case No 6U 3039/16, when saying that it was 'generally' true that 'three requirements must be met'). While the language of some or all of the questions may sometimes have to be adapted to apply 45 more aptly to the specific facts of a particular case, the three reformulated questions are as follows:

Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, ie the inventive concept revealed by the patent?

(ii) Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?

(iii) Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention? In order to establish infringement in a case where there is no literal infringement, a patentee would have to establish that the answer to the first two questions was 'yes' and that the answer to the third question was 'no'.” ” (emphasis added).

As opined by Prof. Fennerty, the Defendant’s Alendronate 70 mg Tablets have infringed Dependent Claims 14 and 15. I am also of the view that Dependent Claim 46 20 has been infringed by the Defendant’s Alendronate 70 mg Tablets. This decision is due to the fact that the 3 Tests have been satisfied as follows:

based on the “Essential Integers Test” as applied by Vernon Ong JCA (as he then was) in the Court of Appeal case of Yeohata Machineries Sdn Bhd & Anor v Coil Master Sdn Bhd & Ors [2015] 6 MLJ 810, at [15], the Defendant’s Alendronate 70 mg Tablets have all the elements of Dependent Claims 14, 15 and 20 - please refer to the above Part D(2) for the elements of Dependent Claims 14, 15 and 20;

applying “Improver’s Test” as laid down by Hoffmann J (as he then was) in UK’s High Court case of Improver Corp & Ors v Remington Consumer Products Ltd & Ors [1990] FSR 181, at 189, this court decides as follows -

the ingredients of the Defendant’s Alendronate 70 mg Tablets do not have a material effect on the way the Dependent Claims 14, 15 and 20 are used (Immaterial Variant);

the Immaterial Variant would have been obvious to the POSITA Team on

the POSITA Team would not have understood from the language of Dependent Claims 14, 15 and 20 that the 1st Plaintiff intended that strict compliance with the primary meaning of Dependent Claims 14, 15 and 20 was an essential requirement of the invention in Dependent Claims 14, 15 and 20; and

Improver’s Test has been “reformulated” by Lord Neuberger P in UK’s Supreme Court in Actavis UK Ltd & Ors v Eli Lilly and Co, and other appeals [2018] 1 All ER 171, at [66] (Actavis’ Test). An application of Actavis’ Test in this case clearly shows an infringement of the Dependent Claims 14, 15 and 20 as follows - 47

the Defendant’s Alendronate 70 mg Tablets achieve substantially the same result in substantially the same way as the invention in Dependent Claims 14, 15 and 20;

it is obvious to the POSITA Team reading Dependent Claims 14, 15 and 20 on the Priority Date that the Defendant’s Alendronate 70 mg Tablets achieve substantially the same result as the invention in Dependent Claims 14, 15 and 20 in substantially the same way as the invention in Dependent Claims 14, 15 and 20; and

the POSITA Team would not have concluded that the 1st Plaintiff intended that strict compliance with the literal meaning of Dependent Claims 14, 15 and 20 was an essential requirement of the invention in Dependent Claims 14, 15 and 20.

In view of the fulfilment of the 3 Tests as explained in the above paragraph 60, I find as a fact that the Defendant’s Commercial Dealings (Defendant’s Alendronate 70 mg Tablets) have infringed Dependent Claims 14, 15 and 20 as understood in ss 36(1)(a), (2), (3)(a)(i) and 58 PA. N(2). Remedies available to 1st Plaintiff for Defendant’s Patent Infringement 62. Patent 194 has expired on 30.9.2019. Hence, the court cannot grant any injunctive relief for the Patent Infringement in favour of the 1st Plaintiff against the Defendant with regard to the Defendant’s Commercial Dealings (Defendant’s Alendronate 70 mg Tablets).

As a result of the Patent Infringement, the 1st Plaintiff is entitled to elect either one of the two monetary remedies against the Defendant (1st Plaintiff’s Election):

Assessment of Damages; or

Account of Profits 48 - please refer to Kingtime International Ltd & Anor v Petrofac E&C Sdn Bhd (No. 2) [2020] 11 MLJ 141 [Kingtime (No. 2)], at [6].

To enable the 1st Plaintiff’s Election to be carried out in the interest of justice, the court has a discretionary power under O 24 rr 3(1) and/or 7(1) RC to grant a Post-Trial Discovery Order in respect of the Defendant’s Documents.

The relevant parts of O 24 rr 3, 4, 7 and 8 RC provide as follows: “Order for discovery O 24 r 3(1) Subject to the provisions of this rule and of rules 4 and 8, the Court may at any time order any party to a cause or matter (whether begun by writ, originating summons or otherwise) to give discovery by making and serving on any other party a list of the documents which are or have been in his possession, custody or power and may at the same time or subsequently also order him to make and file an affidavit verifying such a list and to serve a copy thereof on the other party. …

The documents which a party to a cause or matter may be ordered to discover under paragraph (1) are as follows:

the documents on which the party relies or will rely; and

the documents which could -

adversely affect his own case;

(ii) adversely affect another party’s case; or

(iii) support another party’s case. Order for determination of issues before discovery 49 O 24 r 4 Where on an application for an order under rule 3, it appears to the Court that any issue or question in the cause or matter should be determined before any discovery of documents is made by the parties, the Court may order for that issue or question to be determined first and give such other directions as may be necessary. Order for discovery of particular documents O 24 r 7(1) Subject to rule 8, the Court may at any time, on the application of any party to a cause or matter, make an order requiring any other party to make an affidavit stating whether any document specified or described in the application or any class of document so specified or described is, or has at any time been, in his possession, custody or power, and if not then in his possession, custody or power when he parted with it and what has become of it.

An order may be made against a party under this rule notwithstanding that he may already have made or been required to make a list of documents or affidavit under rule 3.

An application for an order under this rule shall be supported by an affidavit stating the belief of the deponent that the party from whom discovery is sought under this rule has, or at some time had, in his possession, custody or power the document, or class of document, specified or described in the application, and that it falls within one of the following descriptions:

a document on which the party relies or will rely;

a document which could -

adversely affect his own case;

(ii) adversely affect another party’s case; or 50

(iii) support another party’s case; and

a document which may lead the party seeking discovery of it to a series of inquiry resulting in his obtaining information which may -

adversely affect his own case;

(ii) adversely affect another party’s case; or

(iii) support another party’s case.

An order under this rule shall not be made in any cause or matter in respect of any party before an order under rule 3 has first been obtained in respect of that party, unless, in the opinion of the Court, the order is necessary or desirable. Discovery to be ordered only if necessary O 24 r 8 On the hearing of an application for an order under rule 3, 7 or 7A, the Court, if satisfied that discovery is not necessary, or not necessary at that stage of the cause or matter, may dismiss or adjourn the application and shall in any case refuse to make such an order if and so far as it is of the opinion that discovery is not necessary either for disposing fairly of the cause or matter or for saving costs. ” (emphasis added).

It is decided in Kingtime (No. 2), at [9], as follows: “[9] I am of the view that the court has a discretion under O 24 rr 3(1) and/or 7(1) RC to grant a Post-Trial Discovery Order to - 51

assist the execution of a judgment or order - please see the judgment of UK’s Court of Appeal delivered by Kerr LJ (as he then was) in Maclaine Watson & Co Ltd v International Tin Council (No. 2) [1989] 1 Ch 286, at 301, 302 and 303;

enable a plaintiff to make an informed election regarding an Assessment of Damages or Account of Profits - please see Island Records, Brugger and LED Builders; and

to aid an Assessment of Damages or Account of Profits (as in this case). The discretionary power of the court to grant a Post-Trial Discovery Order is clear from the words “may at any time” in O 24 rr 3(1) and/or 7(1) RC. It is to be noted that the words “at any time” in O 24 r 3(1) RC are not found in the repealed O 24 r 3(1) of the Rules of High Court 1980 (RHC).” (emphasis added).

As explained in Kingtime (No. 2), this court grants a Post-Trial Discovery Order to enable the 1st Plaintiff’s Election to be made. If otherwise, there will be an injustice to the 1st Plaintiff because without a Post-Trial Discovery Order, the 1st Plaintiff’s Election is meaningless.

Ms. Goh has attempted to persuade me not to issue a Post-Trial Discovery Order because according to her, the Defendant’s Documents contain the Defendant’s confidential information regarding, among others, the identity of the Defendant’s clients (Defendant’s Confidential Information). To ensure the confidentiality of the Defendant’s Confidential Information - 52

the Defendant may apply for leave of court to redact the Defendant’s Documents in respect of the Defendant’s Confidential Information - please refer to Tokai Corporation v DKSH Malaysia Sdn Bhd [2016] MLJU 621, at [26(1) and (2)]; and/or

as decided in Kingtime (No. 2), at [20], the court may, on the Defendant’s application, grant a Protective Order pursuant to the court’s inherent jurisdiction, court’s inherent power and/or O 92 r 4 RC.

If the Defendant has complied with the Post-Trial Discovery Order and upon the 1st Plaintiff’s Election, I will conduct an Assessment of Damages or Account of Profit (as elected by the 1st Plaintiff).

At the conclusion of the Assessment of Damages or Account of Profit, as the case may be, the 1st Plaintiff is entitled to apply to court under s 11 of the Civil Law Act 1956 for “pre-2nd Trial” interest (to be paid by the Defendant to the 1st Plaintiff) on the amount damages or profit as decided by the court. O. Costs 71. O 59 rr 2(2), 3(2), 16(1), (2), (3), 19(1) and (2) RC provide as follows: “O 59 r 2(2) Subject to the express provisions of any written law and of these Rules, the costs of and incidental to proceedings in the Court, shall be in the discretion of the Court, and the Court shall have full power to determine by whom and to what extent the costs are to be paid. O 59 r 3(2) If the Court in the exercise of its discretion sees fit to make any order as to the costs of or incidental to any proceedings, the Court shall, subject to this Order, order the costs to follow the event, except when it appears to the Court that in the circumstances 53 of the case some other order should be made as to the whole or any part of the costs. Basis of assessment O 59 r 16(1) In assessing the costs payable in relation to any item, the Court shall have regard to all relevant circumstances, and in particular to -

the complexity of the item or of the cause or matter in which it arises and the difficulty or novelty of the questions involved;

the skill, specialized knowledge and responsibility required of, and the time and labour expended by, the solicitor or counsel;

the number and importance of the documents, however brief, prepared or perused;

the place and circumstances in which the business involved is transacted;

the importance of the cause or matter to the client;

where money or property is involved, its amount or value;

any other fees and allowances payable to the solicitor or counsel in respect of other items in the same cause or matter, but only where work done in relation to those items has reduced the work which would otherwise have been necessary in relation to the item in question.

Subject to the other provisions of these Rules, the amount of costs which any party are entitled to recover is the amount allowed after determination of costs on the standard basis where - 54

an order is made that the costs of one party to proceedings be paid by another party to those proceedings;

an order is made for the payment of costs out of any fund; or

no order for costs is required, unless it appears to the Court to be appropriate to order costs to be determined on the indemnity basis.

On an assessment of costs on the standard basis, there shall be allowed a reasonable amount in respect of all costs reasonably incurred and any doubts which the Court may have as to whether the costs were reasonably incurred or were reasonable in amount shall be resolved in favour of the paying party; and in these Rules, the term “the standard basis”, in relation to the determination of costs, shall be construed accordingly. O 59 r 19(1) The amount of costs (excluding disbursement) that are payable shall be at the discretion of the Court and shall be determined upon the conclusion of the trial.

In fixing the costs payable, the Court shall have regard to the relevant circumstances including but not limited to the factors set out in the rule 16.” (emphasis added).

Firstly, the court has a wide discretion under O 59 rr 2(2), 3(2) and 19(1) RC to award costs after a trial.

Secondly, as the 1st Plaintiff’s Claim (Dependent Claims 14, 15 and 20) and Counterclaim (Dependent Claims 14, 15 and 20) are tried together, only one set of costs for both the 1st Plaintiff’s Claim (Dependent Claims 14, 15 and 20) and 55 Counterclaim (Dependent Claims 14, 15 and 20) [Costs (2nd Trial)] shall be awarded by the court.

Thirdly, in accordance with the rule that “costs to follow the event” [as embodied in O 59 r 3(2) RC], I order the Defendant to pay Costs (2nd Trial) to the 1st Plaintiff.

Fourthly, I exercise my discretion to award costs on a standard basis pursuant to O 59 rr 16(2) and (3) read with O 59 r 19(2) RC because there is no exceptional circumstance in the 2nd Trial which warrants the imposition of costs on an indemnity basis under O 59 r 16(2) and (4) read with O 59 r 19(2) RC. O(1). Can 1st Plaintiff recover Costs (1st Trial) at 2nd Trial?

Mr. Indran has sought to persuade me to order the Defendant to “refund” Costs (1st Trial) to the 1st Plaintiff. I am not able to accede to this plea because at the time of the 1st Trial, the prevailing legal position had been authoritatively laid down in SKB Shutters. In other words, the Defendant was entitled to Costs (1st Trial) by virtue of SKB Shutters. Furthermore, the 1st Trial concerned solely the Invalidation (Independent Claim 1) while the 2nd Trial focused on Dependent Claims 14, 15 and

For these reasons, I decline to exercise my discretion under O 59 rr 2(2), 3(2) and 19(1) RC to order the Defendant to reimburse the 1st Plaintiff with regard to the Costs (1st Trial). O(2). How should court assess Costs (2nd Trial) on a standard basis?

The 1st Plaintiff’s “Bill of Costs” (BC) claimed for the following sums as Costs (2nd

a sum of RM900,000.00 for “getting up” (GU); and

“out of pocket expenses” (OPE) amounting to RM571,572.67. This sum includes expert’s fees of RM557,281.19 for all legal work done in respect of experts (Expert’s Fees). 56 78. In support of the BC, Mr. Indran has relied on, among others, a judgment of Sachs J (as he then was) in UK’s High Court case of Francis v Francis & Dickerson [1955] 3 All ER 836. It is decided in Francis, at p. 840, as follows: “When considering whether or not an item in a bill is “proper” the correct viewpoint to be adopted by a taxing officer is that of a sensible solicitor sitting in his chair and considering what in the light of his then knowledge is reasonable in the interests of his lay client.” (emphasis added).

In deciding the quantum of costs after a trial on a standard basis (not on an indemnity basis), I adopt the following approach:

costs is not a remedy, let alone a monetary relief. Costs are imposed by the court on a standard basis to reimburse partly (not in full unless the court orders costs to be borne on an indemnity basis) a party who has incurred expenses in litigation (Cost of Litigation). It is decided in Singham Sulaiman Sdn Bhd v Appraisal Property Management Sdn Bhd & Anor and another case [2018] 10 MLJ 187, at [115(3)] as follows - “[115] Regarding the court’s power to certify fees for 2 counsel under O 59 r 14(1) RC, I am of the following view: …

the court should be wary in certifying fees for more than one counsel because as explained by Vincent Ng Kim Khoay J (as he then was) in the High Court in Pen Apparel Sdn Bhd v Leow Chooi Khon & Ors [1995] 4 CLJ 606, at 616-617, “the process of litigation is solely to enable a litigant to have his rights litigated, rather than to permit him to acquire monetary gains”. Costs is not a remedy in itself. Excessive costs amounts to an unjustifiable windfall and impedes a party’s fundamental right of access to justice as 57 provided in Article 5(1) Constitution - please see the Federal Court’s judgment in Sivarasa Rasiah v Badan Peguam Malaysia [2010] 3 CLJ 507, at 514-515.” (emphasis added). As explained in Singham Sulaiman, excessive Cost of Litigation (awarded on a standard basis) may -

impede a party’s (X) fundamental right of access to justice as enshrined in Article 5(1) of the Federal Constitution (Fundamental Access To Justice); and

constitute an unjustifiable windfall for the party (Y) who has been awarded costs (Unjustifiable Windfall);

O 59 r 16(3) RC has the following two limbs [2 Limbs (Standard Basis)] -

“a reasonable amount in respect of all costs reasonably incurred” by Y “shall be allowed” [1st Limb (Standard Basis)]; and

if there is any doubt as to -

whether the costs had been reasonably incurred by Y; or

(ii) whether the costs claimed by Y was reasonable in amount - the doubt “shall” be resolved in favour of X [2nd Limb (Standard Basis)]. The 2nd Limb (Standard Basis) ensures Fundamental Access To Justice (for X) and prevents any Unjustifiable Windfall (for Y);

cases on costs which had been taxed, assessed or reviewed under O 59 of the Rules of High Court 1980 (RHC) do not apply in the construction of the 2 Limbs 58 (Standard Basis) because RHC has no provision which is equivalent to the 2 Limbs (Standard Basis);

with regard to the 1st Limb (Standard Basis) -

Y bears the burden to persuade the court that the amounts of GU and OPE as stated in Y’s BC are “reasonable …in respect of all costs reasonably incurred” by Y; and

Y cannot claim for “time costs” paid by Y to Y’s solicitors and counsel (Time Costs). In Allan Lee Mason & Anor v Jeremy Keith Smeeton & Ors [2016] 1 LNS 1593, at [81] and [82], I have not allowed Time Costs to be awarded to the successful parties after a trial;

if there is any doubt on whether costs were reasonably incurred by Y or were reasonable in amount, the 2nd Limb (Standard Basis) requires such a doubt to be resolved in favour of X;

in view of the 2 Limbs (Standard Basis), I am not able to accept the judgment in Francis. Furthermore, Francis concerned a taxation of costs pursuant to UK’s Legal Aid and Advice Act 1949 [LAAA (UK)]. The LAAA (UK) does not provide for the 2 Limbs (Standard Basis); and

the exercise of the court’s discretion under the 2 Limbs (Standard Basis) depends solely on the particular facts of the case in question. Accordingly, from the view point of the stare decisis doctrine, cases on costs should not be cited as binding legal precedents.

I decide the quantum of Costs (2nd Trial) to be RM714,291.48 [Costs Sum (2nd Trial)]. The Costs Sum (2nd Trial) has been determined by the court as follows:

the sum of RM557,281.19 for Expert’s Fees is -

not reasonable; and/or 59

not reasonably incurred by the 1st Plaintiff - as required by the 1st Limb (Standard Basis);

if there is any doubt regarding whether the Expert’s Fees had been reasonably incurred by the 1st Plaintiff or were reasonable in amount, such a doubt “shall” be resolved in favour of the Defendant - please refer to the 2nd Limb (Standard Basis);

this court awards a sum of RM200,000.00 as Expert’s Fees because this amount is reasonable and would have been reasonably incurred by the 1st Plaintiff within the meaning of the 1st Limb (Standard Basis);

other than the Expert’s Fees, I allow the 1st Plaintiff to claim all other items of OPE in the 1st Plaintiff’s BC because such items of OPE fall within the 1st Limb (Standard Basis);

the amount of RM900,000.00 as GU is neither reasonable nor reasonably incurred by the 1st Plaintiff as understood in the 1st Limb (Standard Basis); and

I assess GU to be a sum of RM500,000.00 pursuant to the 1st Limb (Standard Basis). My reasons are as follows -

the 2nd Trial concerns complicated and highly technical issues of patent law regarding Dependent Claims 14, 15 and 20 - please refer to O 59 r 16(1)(a) RC;

Mr. Indran is a senior and experienced counsel who specializes in, among others, patent law as understood in O 59 r 16(1)(b) RC;

there are many volumes of documents which have been filed for the purpose of the 2nd Trial - O 59 r 16(1)(c) RC;

the 2nd Trial is very important to the 1st Plaintiff - O 59 r 16(1)(e) RC; and 60

intellectual property rights conferred by Dependent Claims 14, 15 and 20 have a high value - O 59 r 16(1)(f) RC.

By reason of O 59 r 24 RC, I order interest at 5% per annum on the Costs Sum (2nd Trial) from 25.8.2021 [date of assessment of Costs Sum (2nd Trial)] until full payment of the Costs Sum (2nd Trial) by the Defendant to the 1st Plaintiff. P. Court’s decision 82. Premised on the above evidence and reasons -

the 1st Plaintiff’s Claim (Dependent Claims 14, 15 and 20) is allowed;

the Counterclaim (Dependent Claims 14, 15 and 20) is dismissed;

a Post-Trial Discovery Order of the Defendant’s Documents is granted with the Defendant’s right to apply to court for -

a redaction of the Defendant’s Documents; and/or

a Protective Order;

after 3 months from the Defendant’s compliance with the Post-Trial Discovery Order and upon the 1st Plaintiff’s Election -

the Judge shall conduct an Assessment of Damages or Account of Profit (as elected by the 1st Plaintiff); and

the 1st Plaintiff is entitled to apply to the Judge for “pre-2nd Trial” interest (to be paid by the Defendant to the 1st Plaintiff) on the amount damages or profit as decided by the Judge (as elected by the 1st Plaintiff); and

the Defendant shall pay one set of Costs (2nd Trial) to the 1st Plaintiff based on a standard basis. 61 83. A summary of the above decision is as follows:

Dependent Claims 14, 15 and 20 are Type 1 claims but notwithstanding such a fact, the court has to undertake a 2nd Judicial Exercise (Dependent Claim) in accordance with the Majority Judgment (Federal Court) to decide whether Prior Art has all the features of Independent Claim 1 (based on the POSITA Team’s expert testimony and CGK). As Prior Art did not fulfil the 3rd Element (Independent Claim 1), the court cannot automatically invalidate Dependent Claims 14, 15 and 20;

the High Court’s Decision (1st Trial) and Court of Appeal’s Decision (1st Trial) do not attract the application of issue estoppel principle which bars the 1st Plaintiff at the 2nd Trial because -

the High Court’s Decision (1st Trial) and Court of Appeal’s Decision (1st Trial) concern solely the Invalidation (Independent Claim 1); and

an application of issue estoppel principle at the 2nd Trial will be contrary to the Majority Judgment (Federal Court);

the POSITA Team for Dependent Claims 14, 15 and 20 consists of endocrinologist and gastroenterologist;

Prior Art for Dependent Claims 14, 15 and 20 should only include studies regarding Osteoporosis Patients (not Paget’s Disease Patients);

CGK possessed by the POSITA Team on Priority Date regarding Dependent Claims 14, 15 and 20 was stated by Prof. Papapoulos;

Dependent Claims 14, 15 and 20 involve an inventive step which was not obvious to the POSITA Team on Priority Date; 62

by reason of the application of the 3 Tests, the Defendant’s Alendronate 70 mg Tablets have infringed Dependent Claims 14, 15 and 20;

to enable the 1st Plaintiff’s Election to be carried out in the interest of justice, the court grants a Post-Trial Discovery Order pursuant to under O 24 rr 3(1) and/or 7(1) RC with the Defendant’s right to apply to court for -

an order to redact the Defendant’s Documents; and/or

a Protective Order - so as to safeguard the confidentiality of the Defendant’s Confidential

with regard to Costs (2nd Trial) -

the 1st Plaintiff cannot recover Costs (1st Trial) from the Defendant because at the time of the 1st Trial, the Defendant was entitled to Costs (1st Trial) according to the prevailing legal position as decided in SKB

Costs Sum (2nd Trial) in an amount of RM714,291.48 has been assessed by the court in accordance with the 2 Limbs (Standard Basis).

I must end this judgment by expressing my gratitude to all learned counsel who have ably assisted me in the 2nd Trial (as in the 1st Trial). WONG KIAN KHEONG Judge High Court (Commercial Division) Kuala Lumpur 63 DATE: 4 JANUARY 2022 Counsel for 1st Plaintiff: Mr. Indran Shanmuganathan, Ms. Michelle Loi Choi Yoke, Puan Zaraihan Bt. Shaari, Mr. Yap Khai Jian & Ms. Elisia Engku Kangon (Messrs Shearn Delamore & Co.) Counsel for Defendant: Ms. Cindy Goh Joo Seong, Ms. Heidi Lim Ai Yuen, Ms. Samantha Siow San San & Mr. Nigel William Kraal (Messrs Chooi & Company + Cheng & Ariff)

“Rationale for the Use of Alendronate in Osteoporosis”, JA Kanis et al, Osteoporosis International Journal (1995) 5:1-13, at p. 10-11;

“Bisphosphonates in Bone Disease - from the Laboratory to the Patient”, H. Fleisch, (2nd Edition, 1995), at paragraph 3.8.2;

“Alendronate Treatment of the Postmenopausal Osteoporotic Woman: Effect of Multiple Dosages on Bone Mass and Bone Remodeling”, C.H. Chestnut et al, American Journal of Medicine (1995) Vol. 99, 144, at p. 150 (Chestnut’s Article); 33

“Esophaghitis associated with the Use of Alendronate”, P.C. De Groen et al, New England Journal of Medicine (1996) Vol. 335, 1016, at p. 1016 and 1018-1020;

“Incidence of gastrointestinal side effects due to alendronate is high in clinical practice”, R. Kelly et al, British Medicine Journal (1997) Vol. 315, 1235, at p. 1235;

“Alendronate Use Among 812 Women: Prevalence of Gastrointestinal Complaints, Noncompliance with Patient Instructions, and Discontinuation”, B. Ettinger et al, Journal of Managed Care Pharmacy, (1998) Vol. 4, 488, at p. 488 and 490-492;

“Multiple Ulcerative Esophagitis Caused By Alendronate”, C. Maconi et al, American Journal of Gastroenterology and Hepatology (1995) Vol. 90, 1889, at p. 1889;

“A New Probable Increasing Cause of Esophageal Ulceration: Alendronate”, R. E. Colina et al, American Journal of Gastroenterology and Hepatology (1997) Vol. 92, 704, at p. 704-705;

“Primary Amino-Bisphosphonates: A New Class of Gastrotoxic Drugs - Comparison of Alendronate and Aspirin”, D. Y. Graham et al, American Journal of Gastroenterology and Hepatology (1997) Vol. 92, 1322, at p. 1322 and 1323-1324;

“Excess Gastric Ulcers Are Associated With Alendronate Therapy”, D. Y. Graham, American Journal of Gastroenterology and Hepatology (1998) Vol. 93, 1395, at p. 1395-1396;

“Alendronate gastric ulcers”, D. Y. Graham et al, Alimentary Pharmacology & Therapeutics (1999) Vol 13, 515, at p. 515 and 517-518; and 34

“Esophageal Stricture Associated with Alendronate Therapy”, J. Levine et al, American Journal of Medicine (1997) Vol. 102, 489, at p. 489-491; and

Prof. Papapoulos’ own clinical experience before Priority Date with oral administration of Alendronate to Osteoporosis Patients, showed that the POSITA Team would have CGK regarding Dose Related GI Side Effects [Prof. Papapoulos’ Clinical Experience (Before Priority Date)].