Novugen Oncology Sdn Bhd v Novartis Ag (WA-22IP-36-06/2021)

The plaintiff sought to invalidate a patent granted to the defendant. The court dismissed , having found that the conditions for invalidation of the patent have not been met.

The defendant is the registered owner of the Malaysian Patent No. MY-148554- Patent , granted on 30 April 2013. It is not in dispute that the priority date of the 554 Patent is 20 July 2005 S/N fpM34FljWETbiwsg2bkfw **Note : Serial number will be used to verify the originality of this document via eFILING portal 2 , and the duration of the protection of the 554 Patent is until 18 July 2026.

The 554 Patent concerns is a Bcr-Abl tyrosine-kinase inhibitor which interferes with the signalling within the cancer cell. It is not in dispute that nilotinib is the active pharmaceutical ingredient of an oncology drug marketed by the defendant to treat chronic myelogenous leukemia.

The 554 Patent comprises 38 claims Claim 36 reads as follows: A substantially pure amorphous form of the hydrochloride salt of 4-methylN-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]- 3-(4-pyridin-3-ylpyrimidin-2 ylamino)-benzamide; where-methyl-N- [3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin- 3-yl-pyrimidin-2-ylamino)-

Claim 36 relates to a product, which is the substantially pure amorphous form of nilotinib hydrochloride

The plaintiff claimed it intended to be and had been actively involved in researching, developing and/or manufacturing ANH, active pharmaceutical ingredients and drug products containing ANH. In S/N fpM34FljWETbiwsg2bkfw **Note : Serial number will be used to verify the originality of this document via eFILING portal 3 particular, the plaintiff claimed it had expended substantial amounts of money for the research and development of nilotinib and on equipment to be put in the plaintiff's plants, to be used exclusively for the research and development of nilotinib.

following its extensive involvement in researching, developing and/or planning the use of ANH to manufacture and market drug products, its rights, interests, business trading and/or operations and ability to produce ANH and its products are adversely affected and/or prejudiced and/or wrongfully hindered by Claim 36.

The plaintiff sought to invalidate Claim 36 on two grounds, first, that it involves no inventive step and second, its description does not comply with C. Conditions for Invalidation

Th claim for invalidation of Claim 36 is made under , which provides that: Any aggrieved person may institute Court proceedings against the owner of the patent for the invalidation of the patent.

The Court shall invalidate the patent if the person requesting the invalidation proves S/N fpM34FljWETbiwsg2bkfw

that what is claimed as an invention in the patent is not an invention within the meaning of section 12 or is excluded from protection under section 13 or subsection 31(1) or is not patentable because it does not comply with the requirements of sections 11, 14, 15 and 16;

that the description or the claim does not comply with the requirements of section 23;

that any drawings which are necessary for the understanding of the claimed invention have not been furnished; or

that the right to the patent does not belong to the (emphasis added) [10] The plaintiff relied on section 56(2)(a) and (b) of the Patents Act to invalidate Claim 36, on the basis that: a. Claim 36 lacks inventive step, and is therefore not patentable; and b. The description of Claim 36 does not comply with the requirements of the Patents Regulations, as prescribed by section 23. S/N fpM34FljWETbiwsg2bkfw [11] Based on the provisions of section 56 of the Patents Act, the plaintiff must prove that the following conditions have been met, warranting the invalidation of Claim 36: a. The plaintiff of the Patents Act, which gives it the right to institute proceedings against the defendant for the invalidation of Claim 36; b. Claim 36 does not involve an inventive step; and c. Claim 36 does not comply with the requirements of the Patents Regulations. [12] The court examined all three conditions in reaching a determination of this matter. D. The law [13] The has been given a broad interpretation by the courts. [14] In IEV International Pty Ltd v Sadacharamani a/l Govindasamy [2008] 2 MLJ 754, Ramly Ali J (as His Lordship then was) held that: S/N fpM34FljWETbiwsg2bkfw [18] for invalidation order. special and technical meaning and should be liberally construed. The expression includes anyone who would be or in respect of whom there was a reasonable possibility of his being disadvantaged in a legal or practical sense by the Register being uncertified. [19] Anyone who can show he is in some way prejudiced by the wrongful entry qualifies as a person aggrieved. This can include, but is not limited to, a person who is carrying on trade in the same sort of goods as the articles for which the design is interpretation as including all persons who have a real practical interest in the issue. This does not necessarily equate with manufacturing rights so long as the plaintiff can show that it has a real practical or genuine interest beyond that of a mere busybody. (emphasis added) [15] More recently, in Iradar Sdn Bhd v Nutech Company Limited [2016] MLJU 1248, the High Court provided an example of who would qualify as under section 56(1) of the Patents Act. Wong Kian Kheong J (as His Lordship then was) held as follows: S/N fpM34FljWETbiwsg2bkfw [13] I am of the following view regarding the locus standi requirement of an in s 56(1) PA:

the term in s 56(1) PA refers to a person who has a genuine, real or actual grievance due to a registered patent (Patent A). A person, X has a genuine, real or actual grievance due to Patent A if right, interest, business, trading or operations is adversely affected or prejudiced by Patent A. X is a person aggrieved by Patent A if

X is an owner of a patent which is adversely affected or prejudiced by

X is a holder of a certificate for utility innovation which is adversely affected or prejudiced by Patent A; or

business, trading or operations may constitute an infringement of Patent A within the meaning of s 36(3)(a)(i), (ii), (b)(i) and/or

(ii) read with s 58 PA. S/N fpM34FljWETbiwsg2bkfw The above categories of are certainly not closed. If X does not have any grievance due to Patent A

X can lawfully continue his business, trading or operations without any restriction from the owner of Patent A; and

(ii) there is no lawful basis for X to apply to Court to invalidate Patent A under s 56(1) PA (Invalidation of Patent Procedure); (emphasis added) [16] In Iradar (supra), the court referred to section 103 of the Evidence Act 1950 and held that the party alleging a particular fact, namely that it is aggrieved by the patent, has the legal burden of proving such a fact. Thus, in the present case, the onus is on the plaintiff to prove that it is an [17] Relying on IEV International (supra) and Iradar (supra), the plaintiff in the present case must show that: a. It has a real practical or genuine interest in Claim 36; S/N fpM34FljWETbiwsg2bkfw b. There was a reasonable possibility of it being disadvantaged in a legal or practical sense by Claim 36; and c. Its rights, interests, business, trading and/or operations are adversely affected or prejudiced by Claim 36. [18] The plaintiff claimed it has a real practical or genuine interest in ANH which is covered under Claim 36, as it had carried out the following: a. It had developed nilotinib hydrochloride as a product to treat chronic myelogenous leukemia for over four years, since 2018. b. It had expended substantial investments in the development of ANH as a drug. The plaintiff claimed it had incurred costs to purchase equipment, labour costs and research and development costs, to generate a stable ANH as a product. It had also conducted numerous research and development trials to formulate and manufacture ANH in an oral dosage form that is therapeutically equivalent to the available nilotinib hydrochloride product in the market, namely Tasigna. [19] With these claims, the plaintiff contended that it has a genuine, real or actual grievance due to Claim 36, as there is a real risk that the S/N fpM34FljWETbiwsg2bkfw p and/or operations in relation to the development of its product may constitute an infringement of Claim 36. It the Patents Act. [20] claims, I considered whether the evidence before the court is sufficient to prove that the plaintiff had created ANH that would infringe Claim 36 or developed a product containing ANH as an active ingredient that would infringe Claim 36. [21] The plaintiff had relied on two key documents in support of its claim. These are the ustification Report testing and analysis performed by the plaintiff . [22] The defendant challenged the admission of the Documents, arguing that these documents were classified as Part C of the common bundle of documents, and their maker was not called as a witness. [23] The plaintiff s position is that Documents is , who gave evidence . However, the defendant contended that PW2 did not type out the ocuments, and had testified during cross-examination that the person who created the document was a colleague, one Dr. Praveen. S/N fpM34FljWETbiwsg2bkfw [24] I Documents as evidence. although he did not type out the P was involved in their preparation, together with his team. [25] In Public Prosecutor v Abdul Rahim bin Abdul Satar [1990] 3 MLJ 188, the High Court held at page 190B that: The mere deed of composing, framing, ascribing, or preparing a document or reducing certain details into writing, does not ipso facto turn the writer into the maker of a document within the contemplation of the hearsay rule. In my opinion, the affirming person for whose purpose or on whose behalf the averments contained in the documents are made is the actual maker of the document. The petition writer, typist or even a lawyer who prepares a document for his client is not himself a maker but is the person who assists in the preparation of the document. The maker is the person who authenticates the document. (emphasis added) [26] In this case, Documents. However, he testified during re-examination that he was personally involved in the preparation of the documents, alongside his colleagues: S/N fpM34FljWETbiwsg2bkfw GJS Yes. Ok, you were referred to this document from 113 to 117, and it was asked to you, are you the mentioned Praveen. My question to you, Mr Sandheep, is, then why are you testifying on this document, and not Praveen? Can you please answer the question? SANDHEEP Yes, Cindy. Thank you for asking that question. Because my friend Raymond repeatedly kept on typed this repor have not prepared this report. So, when these reports were being prepared, so me and my colleagues, both Irfan and Dr Praveen were sitting in the same room, and we were discussing how to put this into place, and obviously when you are making a report, you need to go through all these lab notebooks and testing reports and batch data and things on like that before you actually make this report. So, I was personally involved in all those aspects. (emphasis added) S/N fpM34FljWETbiwsg2bkfw [27] of his personal involvement in the preparation of the I am therefore of the view that he was in the position to confirm the authenticity of the Documents, which qualifies him as the maker of the documents. It is on this basis that [28] However, I did not give any weight to these documents, due to the admission by PW2 that the documents were created for the purpose of this suit. PW2 justified this admission during re-examination, by explaining was data generated in 2020 during product development: Ok, and then if I could just rotate it. Remember in anticipation asked that question? SANDHEEP Yes, it was asked to me. GJS So, can you please explain why this is stated here? SANDHEEP characterisation of reference listed, point No.1, is one of the data which we have generated, you know, to understand the reference product, reference listed product. And this data was generated in 2020 during the product S/N fpM34FljWETbiwsg2bkfw development, while this document was created sometime in 2021. Because by that time we were sure that the amorphous form of nilotinib is, it is possible to develop a therapeutic equivalent product. And hence the Claim No.36 of Patent 554 has no novelty or inventiveness and should stand invalid. So, to create that case, so when we submit this document to the Court, we put this confidential work product tag there. That is our standard practice recommended by IPT (emphasis added) [29] Documents was Documents were created in 2021, and they were created in preparation and for the purpose of litigation. Thus, I find the documents to be self-serving, without any probative value. The content of the [30] Further, information or data that could lead to the conclusion that the plaintiff had created ANH. [31] From my assessment of the , I note they only contain a summary of developments and trials the plaintiff claimed it had S/N fpM34FljWETbiwsg2bkfw carried out. This was acknowledged by PW2 during cross-examination. It is important to note that the : a. the results of the developments and trials, or any testing and analysis the plaintiff claimed it had carried out; or b. a description of the composition of the product that the plaintiff claimed contained ANH. [32] In my view, the results of the developments and trials, and analysis carried out, together with a description of the composition of the product that the plaintiff claimed contained ANH would conclusively prove that the plaintiff had created ANH. The documents before the court are not sufficient to prove that the plaintiff had created ANH. [33] The plaintiff however argued that: a. T the research carried out in developing its own nilotinib product, as well as the test results obtained from a comparison between the p nilotinib product and the d . If the p improbable for the plaintiff to be able to produce such a comprehensive report and documents to show the comparison. b. The inclusion of all documents behind the data recorded, namely the results of the research and development trials, S/N fpM34FljWETbiwsg2bkfw tests and analysis conducted by the plaintiff, would not be practical, as the documents are voluminous, and span over five years since 2018. Further, some documents contain confidential information that should not be made public. c. The defendant had failed to offer compelling evidence to establish a motive for the plaintiff to fabricate the existence of its nilotinib product. [34] s, I considered section 103 of the Evidence Act 1950, which provides that: The burden of proof as to any particular fact lies on that person who wishes the court to believe in its existence, unless it is provided by any law that the proof of that fact shall lie on any particular person. (emphasis added) [35] The plaintiff wished the court to believe that it had created ANH that would infringe Claim 36, and further developed a product containing ANH as an active ingredient that would infringe Claim 36. Based on section 103 of the Evidence Act 1950, the burden is on the plaintiff to prove this fact. [36] However, I find the plaintiff had failed to discharge the burden of proof, as the fall short of proving this fact. It is not S/N fpM34FljWETbiwsg2bkfw open to the plaintiff to shift the burden of proof to the defendant, by arguing that the defendant must show evidence that the plaintiff had a motive to fabricate the existence of its product. [37] plaintiff had created ANH that would infringe Claim 36 or developed a product containing ANH as an active ingredient that would infringe Claim [38] Without evidence of the creation of ANH by the plaintiff, the plaintiff does not have a real practical or genuine interest in Claim 36. There is also no reasonable possibility of it being disadvantaged in a legal or practical sense by Claim 36, and its rights, interests, business, trading and/or operations would not be adversely affected or prejudiced by Claim 36. E. Does Claim 36 involve an inventive step? The law [39] While my finding on the first condition is sufficient to dispose of this claim, for completeness, I assessed whether the plaintiff had met the two remaining conditions for invalidation of Claim 36. S/N fpM34FljWETbiwsg2bkfw [40] On the lacks inventive step and is therefore not patentable. [41] I first considered the relevant provisions of the Patents Act. [42] ection 12(1), which provides that: An invention means an idea of an inventor which permits in practice the solution to a specific problem in the field of technology. [43] Not all inventions are patentable. Section 11 provides that an invention is patentable: if it is new, involves an inventive step and is industrially applicable. [44] Thus, a patentable invention must involve an inventive step. Section 15 sets out what an inventive step entails: 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) S/N fpM34FljWETbiwsg2bkfw [45] Prior art under section 14(2)(a) consists of: everything disclosed to the public, anywhere in the world, by written publication by oral disclosure, by use or in any other way, prior to the priority date of the patent application claiming the invention (emphasis added) [46] Based on these provisions, to determine whether Claim 36 involves an inventive step, the question that must be considered is whether having regard to any matter which forms part of the prior art as at the 554 Patent Priority Date (prior art being everything disclosed to the public anywhere in the world), Claim 36 would have been obvious to a person having ordinary skill in the art. [47] The case of Spind Malaysia Sdn Bhd v Justrade Marketing Sdn Bhd & Anor [2018] 4 MLJ 34 is of guidance on this issue. In Spind (supra), the four-step test set out in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd v Tabur Marine (Great Britain) Ltd [1985] RPC 59 to assess whether an invention involves an inventive step was adopted. The Federal Court held as follows on the test of inventiveness under Malaysian patent law: [76] We find merit in the Windsurfing test as a good starting point for analysing the issue of inventive step. The structured test offers a useful framework for considering the various factors involved in the assessment, and provides some clarity of S/N fpM34FljWETbiwsg2bkfw reasoning and consistency of approach. That said, we agree with the caution noted in First Currency Choice against over-elaborating the statutory requirement. While the four-step test will be a helpful guide in most cases, the individual steps should not be taken as set in stone and mechanically applied, especially where the evaluation of a straightforward factual scenario may be derailed by ancillary debates on niceties. The court must always bear in mind that the ultimate question, expressed in s 15 of the Patents Act 1983 and contained in the fourth and final step, is simply whether the invention is obvious to a person having ordinary skill in the art, having regard to the prior art. [77] The reformulation in Pozzoli does not purport to alter the basic principles in the Windsurfing test. Properly understood, we consider the relative simplicity of the original Windsurfing test sufficient and advantageous, and thus find it unnecessary to adopt the restated version of the test in Pozzoli. With only changes in terminology to mirror s 15 of the Patents Act 1983, the Windsurfing test for determining inventiveness in the Malaysian context is set out as follows: identify the inventive concept embodied in the patent; assume the mantle of person having ordinary skill in the art, and impute to him the common general knowledge at that date; S/N fpM34FljWETbiwsg2bkfw identify the differences between the prior art and the alleged invention; and determine whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the person having ordinary skill in the art. (emphasis added) Step 1: Identify the inventive concept embodied in the patent [48] Following Spind (supra), the first step is to identify the inventive concept in Claim 36. [49] The Federal Court in Spind (supra) clarified that the inventive concept of a patent must be distilled from the claims, and not generally from the patent specification as a whole: [99] It follows that the inventive concept of a patent must necessarily be identified by reference to its claims. Referring to the Windsurfing test on inventiveness, Laddie J rightly observed in Brugger and others v Medic-Aid Ltd [1996] RPC 635 at p 637: Windsurfing was only putting forward a convenient way of approaching the statutory question; S/N fpM34FljWETbiwsg2bkfw [100] It is the inventive concept that the patentee has put forward as underpinning his monopoly that must be identified (at p 636): The important issue as far as this case is concerned is to identify correctly the inventive concept which the patentee must be taken to have put forward as underpinning his monopoly. For this purpose it is necessary to bear in mind that the relevant inventive step must apply to all embodiments falling within the claims which are said to have independent validity. It is not legitimate to define the inventive step as something narrower than the scope of the relevant claims. In particular it is not legitimate to identify a narrow sub-group of embodiments falling within the claim and which have certain technical advantages and then to define the inventive step in terms which apply to that sub-group but not the rest of the claim. (Emphasis added.) [101] It is well-established that the inventive concept is to be distilled from the claims, not generally from the patent specification as a whole. As was held in Unilever Plc v Chefaro Proprietaries Ltd [1994] RPC 567 at p 580 (quoted in Pozzoli at para [17]): So when the Act says, in section 3: S/N fpM34FljWETbiwsg2bkfw An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part it means that which is in the claim under consideration. It is the of the claim in question which must be considered, not some generalised concept to be derived from the specification as a whole. (Emphasis added.) (emphasis added) [50] In the present case, I found a divergence between the views of the two expert witnesses Dr. Arvind Kumar on the identification of the inventive concept. [51] In his , PW3 stated that: The inventive concept of Patent 554 is providing crystalline forms of nilotinib free base and salts thereof, prepared by various processes. It additionally relates to pharmaceutical composition comprising crystalline forms and methods of treatment using the same. Patent 554 deals with crystalline forms of free base, hydrochloride and sulphate salt of nilotinib. S/N fpM34FljWETbiwsg2bkfw Patent 554 further deals with pharmaceutical composition comprising substantially pure crystalline form of free base or salts, pharmaceutically acceptable excipients and a method of treatment of disease. The specifications provide crystalline forms of free base, hydrochloride and sulphate. It also mentions amorphous form of hydrochloride and sulphate salts. The only claim that relates to amorphous form is Claim 36. All the other (emphasis added) [52] Based on the above, PW3 had identified the inventive concept in this case to be based on the 554 Patent. Although he referred to Claim 36 being related to ANH, essentially the stand taken as set out in the first part of paragraph 4, appears to be that the inventive concept is based on the 554 Patent, namely the crystalline forms of nilotinib free base and salts thereof, prepared by various processes . [53] PW3 adopted the same approach in his Afidavit Pakar 2 :

At the outset, I wish to emphasize that the inventive concept of Patent 554 is providing crystalline forms of nilotinib free base and salts thereof, prepared by various processes. It additionally relates to pharmaceutical composition comprising crystalline forms S/N fpM34FljWETbiwsg2bkfw and methods of treatment using the same (see pages 1 to 4 of the patent specification).

Report which claimed that the inventive concept of Claim 36 of Patent 554 relates to discovery of specific conditions and processes in which one may convert substantially pure amorphous form of nilotinib hydrochloride to specified crystalline forms of nilotinib or vice versa as well as utilise these characteristics to use substantially pure amorphous form of nilotinib hydrochloride as an intermediate to prepare other solid forms of nilotinib hydrochloride. I state that these statements are not true as it is contrary to the wordings of the patent specification of Patent 554 and has distorted the inventive concept set out in the patent specification. (emphasis added) [54] After considering both reports, it is clear to me that PW3 had identified the inventive concept in this case to be based on the 554 Patent. This approach is not in line with the decision of the Federal Court in Spind (supra), which held that the inventive concept of the claim in question (in this case Claim 36) must the considered, and not the generalised concept from the specification as a whole. The inventive concept relied on by PW3, which is based on the 554 Patent, would have the effect of reading additional features into the language of Claim 36. S/N fpM34FljWETbiwsg2bkfw [55] Thus, I preferred and adopted the approach taken by DW2 in the identification of the inventive concept. This is set out in his expert report The principal characteristic of Claim 36 of the '554 Patent is the discovery of the claimed substantially pure amorphous form of nilotinib hydrochloride, which was not known until the disclosure in the '554 Patent [56] As such, for step 1, I found the inventive concept in Claim 36 to be the discovery of the substantially pure ANH. Step 2: Assume the mantle of a person having ordinary skill in the art, and impute to him the common general knowledge at the priority date [57] The court is then required to assume the mantle of a person having ordinary skill in the art, and impute to him the common general knowledge as at the 554 Patent Priority Date. [58] The concept of the person having ordinary skill in the art was elaborated in Merck Sharp & Dohme Corp & Anor v Hovid Bhd [2017] MLJU 77, where the High Court held as follows: [60] I am of the following view regarding a POSITA:

a POSITA is a S/N fpM34FljWETbiwsg2bkfw

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 (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 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; (emphasis added) [59] In the present case, a person with ordinary skill in the art would be a person with qualification, knowledge, experience and practical interest in pharmaceuticals and drug development, and specifically in S/N fpM34FljWETbiwsg2bkfw researching, generating and/or discovering the polymorphic forms, which includes the amorphous form, of a drug. [60] I am of the view that the qualifications, expertise and experience of the two expert witnesses, PW3 and DW2, would qualify them to be persons with ordinary skill in the art for the purpose of the current case. Further and in any event, their qualifications, expertise and experience have not been questioned or challenged. [61] Next, the court is required to impute the common general knowledge as at the 554 Patent Priority Date, on the person skilled in the art. [62] The definition of the term common general knowledge is set out by the Court of Appeal in See Hau Global Sdn Bhd v Mah Sing Plastics Industries Sdn Bhd [2018] 1 MLJ 213: [62] Common general knowledge is defined in Terrell on the Law of Patents (17th Ed), at p 211 as follows: The common general knowledge of the persons skilled in the art has been defined by the Board of Appeal as being normally represented by the content of encyclopedias, handbooks and dictionaries on the And at p 207: S/N fpM34FljWETbiwsg2bkfw which, at the date of the patent in question, is common knowledge in the art or science to which the alleged invention relates, so as to be known to duly qualified persons engaged in that art or sciences. [63] The foregoing definition was taken from the case of British Thomson-Houston Co Ltd v Stonebridge Electrical Co Ltd (1916) 33 RPC 166. [64] In the more recent case of Raychem Patent, Re [1998] RPC 31 Laddie J explained common general knowledge as follows: The common general knowledge is the technical background of the notional man in the art against which the prior art must be considered. This is not limited to material he has memorised and has at the front of his mind. It includes all that material in the field he is working in which he knows exists, which he would refer to as a matter of course if he cannot remember it and which he understands is generally regarded as sufficiently reliable to use as a foundation for further work or to help understand the pleaded prior art. This does not mean that everything on the shelf which is capable of being referred to without difficulty is common general knowledge nor does it mean that every word in a common text book is either. In the case of standard S/N fpM34FljWETbiwsg2bkfw textbooks it is likely that all or most of the main text will be common general knowledge. In many cases common general knowledge will include or be reflected in readily available trade literature which a man in the art would be expected to have at his elbow and regard as basic reliable information. (emphasis added) [63] See Hau (supra) also referred to General Tire and Rubber Co v Firestone Tyre and Rubber Co Ltd [1972] RPC 457, the locus classicus on what constitutes common general knowledge, where it was held that: The common general knowledge imputed to such an addressee must, of course, be carefully distinguished from what in patent law is regarded as public knowledge. This distinction is well explained in Halsbury's Laws of England, Vol. 29, para. 63. As regards patent specifications it is the somewhat artificial (see per Lord Reid in the Technograph case [1971] FSR 188 at 193) concept of patent law that each and every specification, of the last 50 years, however unlikely to be looked at and in whatever language written, is part of the relevant public knowledge if it is resting anywhere in the shelves of the Patent Office. On the other hand, common general knowledge is a different concept derived from a commonsense approach to the practical question of what would in fact be known to an appropriately skilled addressee the sort of man, good at his job, that could be found in real life. S/N fpM34FljWETbiwsg2bkfw (emphasis added) [64] Based on the cited cases, the common general knowledge in this case is the common knowledge to which Claim 36 relates, that would be known to PW3 and DW2 from readily available information and materials they are expected to have knowledge of, as persons with ordinary skill in pharmaceuticals, drug development and research, generation and discovery of the polymorphic forms of a drug. [65] The plaintiff devised their version of what they claim the parties agree would constitute the common general knowledge, by relying on the However, I note that the defe they did not agree for the content of the discussions between the experts to be referred to at trial. As order 40A rule 3(4) and (5) of the Rules of Court 2012 disallows discussions and agreements between experts from being referred to at trial and from binding the parties unless agreed, the plaintiff is not entitled to rely on the convergence and divergence report as a basis of the common general knowledge claimed to have been agreed by the parties. [66] Essentially, Claim 36 reveals a product, which is the substantially pure ANH. Before the Patent 554 Priority Date, ANH is not known. [67] Thus, the common general knowledge a person with ordinary skill in pharmaceuticals, drug development and research, generation and S/N fpM34FljWETbiwsg2bkfw discovery of the polymorphic forms of a drug would have prior to the 554 Patent Priority Date can only be the following: a. The general physicochemical properties of the amorphous form, e.g. with a higher dissolution rate than the crystalline form and more chemically and/or physically unstable as compared to the crystalline form; b. The methods to generate the amorphous form, for example through quench cooling, spray drying and precipitation. These methods do not include the specific conditions to generate the amorphous form of a particular chemical compound, for example, the solvent, temperature and duration of the process, all of which are unique to a particular chemical compound and essential to successfully carry out the method; and c. The characterisation of the various polymorphic forms using tools such as FT-IR, FT-RAMAN and XRPD. Step 3: Identify the differences between the prior art and the alleged invention [68] Following Spind (supra), the next step in assessing the inventiveness of Claim 36 is to identify all relevant prior art as at the 554 Patent Priority Date, and then to compare the differences between the prior art and the invention disclosed in Claim 36. S/N fpM34FljWETbiwsg2bkfw [69] Referring back to the provisions of the law, section 15 of the Patents Act provides that an invention involves an inventive step if, having regard to any matter which forms part of the prior art under section 14(2)(a), such inventive step would not have been obvious to a person having ordinary skill in the art. [70] Prior art under section 14(2)(a) of the Patents Act consists of: disclosed to the public, anywhere in the world, by written publication by oral disclosure, by use or in any other way, prior to the priority date of the patent application claiming the [71] It is also important to note that section 14(3) provides that a disclosure made under section 14(2)(a) shall be disregarded:

if such disclosure occurred within one year preceding the date of the patent application and if such disclosure was by reason or in consequence of acts committed by the applicant or his predecessor in title (emphasis added) [72] From these provisions, the term prior art refers to anything that has been disclosed to the public anywhere in the world, regardless of whether the disclosure was made in writing, orally, by use or any other way, before the priority date of a patent. However, a disclosure occurring within one year preceding the date of the patent application by reason or S/N fpM34FljWETbiwsg2bkfw in consequence of acts committed by the applicant or his predecessor in title, would not constitute prior art. I note that in this case, by virtue of section 27A of the Patents Act, the 554 Patent Priority Date, i.e. 20 July 2005 is also the filing date of the patent application. [73] In the present case, the plaintiff adduced D1 to D29 as prior art in support of its challenge against the validity of Claim 36. However, having considered D1 to D29, I found that D3 to D29 do not constitute prior art for the present purpose. My reasons for the finding are as follows: a. The data and samples relied on by the researchers to prepare D3 to D7, all published between November 2004 to July 2005, were provided by the defendant. In this regard, D3 to D7 fall within the exception under section 14(3) of the Patents Act, as they were disclosed less than one year from the 554 Patent Priority Date, by reason or in consequence of acts committed by the defendant. b. D8 to 29 do not qualify as relevant prior art for the purpose of this case, due to the following: i. These documents do not mention or discuss nilotinib, nilotinib hydrochloride or ANH; ii. The chemical structure of the compounds referred to and/or discussed in these documents are different from and do not pertain to nilotinib and/or nilotinib hydrochloride; S/N fpM34FljWETbiwsg2bkfw iii. These documents do not mention or teach the techniques, methods or conditions for the synthesis and/or manufacture of ANH; and iv. There is no evidence that the techniques, methods or conditions taught in these documents are interchangeable with the processes disclosed in the 554 Patent. [74] D2 was not relied on by the plaintiff. Thus, the only prior art adduced by the plaintiff that can be relied on by this court is D1. D1 is a patent document for the free-base form of nilotinib. During cross-examination, after being referred to D1, PW3 confirmed that D1 does not provide any teaching on the generation of nilotinib hydrochloride, and therefore cannot be said to have anticipated the generation of ANH: Much obliged, Yang Arif. Now, Dr Bansal, the reason why I'm referring to this page is because during our discussion on the 13th and 14th February when I asked where in D1 shows the process, this was where you pointed us to. And that process is set up in the paragraph starting - So, to you this is the process set out in 281 which enables the synthesis of nilotinib hydrochloride, agree? S/N fpM34FljWETbiwsg2bkfw Yes. Now, can you tell me whether based on this procedure here, how much nilotinib free base is required and how much equivalent of HDL molecule is required? Slightly take more. Sorry? Slightly take more of both of them would be general knowledge that to make a salt, you need one more of the base and one more of the acid. RYK that you're putting to us? Of course. That's even high school chemistry, I would say. RYK stated here. S/N fpM34FljWETbiwsg2bkfw Now, sorry, what solvent did you mention just now? I did not mention any solvent. But based on this method here in 281, do you know what solvent would be the one that's required? Again I mean, solvent which dissolves it can be very easy thing to do. Ok. Now, just agree or disagree that the solvent required for hydrochloride salt is not stated here. BANSAL ed here, correct. The same can be said about the temperature stated here in the 281. (emphasis added) S/N fpM34FljWETbiwsg2bkfw [75] As such, based on the evidence before this court, the relevant prior art: a. Only discloses the existence of the free-base form of nilotinib; b. Does not disclose ANH; and c. Does not disclose the specific conditions required to generate the substantially pure ANH. Step 4: Determine whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the person having ordinary skill in the art [76] Based on the prior art adduced and accepted by this court, prior to the disclosure in Claim 36, the following were unknown: a. The existence of nilotinib hydrochloride; b. The physicochemical properties of nilotinib hydrochloride; c. The methods to generate nilotinib hydrochloride; d. The existence of ANH; e. The physicochemical properties of ANH; and S/N fpM34FljWETbiwsg2bkfw f. The specific conditions to generate ANH. [77] Adopting the fourth and final test in Spind (supra), the court must now determine, whether without any knowledge of Claim 36, the difference between the prior art and the invention disclosed in Claim 36 would have been obvious to a person having ordinary skill in the art. [78] In Seng Kong Shutter Industries Sdn Bhd & Anor v SKB Shutters Manufacturing Sdn Bhd [2014] 5 MLJ 98, the Court of Appeal held that this question must be determined from the point of view of the ordinary but unimaginative person skilled in the art: [29] In considering whether the invention claimed is obvious and hence did not involve any inventive step to devise a product or process falling within the scope of the claim, the relevant comparison is not between the preferred embodiment of the invention claimed and the prior art. Rather the question to be As to this question Lord Reid in Technograph Printed Circuits Limited v Mills & Rockley (Electronics) Limited said as follows (p 355): It is not disputed that the hypothetical addressee is a skilled technician who is well acquainted with the workshop technique and who has carefully read the the relevant documents, but it must be a mosaic which S/N fpM34FljWETbiwsg2bkfw can be put together by an unimaginative man with no inventive capacity. Whether or not it was obvious to take a particular step is But the question is not whether it is now obvious to the court but whether at the relevant date it would have been obvious to the unimaginative skilled technician. A thing which may now seems obvious to anyone may at that date have (emphasis added) [79] The plaintiff argued that Claim 36 is obvious as the process of screening for polymorphic forms including amorphous form is a routine step. In PW3 Afidavit Pakar 1, PW3 stated as follows:

There are essentially two (2) reasons as to why it is a routine step in drug development process to screen for amorphous forms. The reasons are:

18.1 Due to higher solubility and bioavailability of amorphous form as compared to crystalline forms; and

18.2 Regulatory requirements. S/N fpM34FljWETbiwsg2bkfw

It is also evident that screening for amorphous form of chemical compounds is routine as there are many examples where screening for amorphous form of chemical compounds which share the same physico-chemical/structural properties as nilotinib hydrochloride have been done in the past. (emphasis added) [80] for the amorphous form of chemical compounds is routine is inconsistent with his statement in paragraph 76 of the same report, PW3 Afidavit Pakar 1, when he considered D9 and D10: D9 and D10 teach that it is generally known in the art that it is necessary to mitigate the inherent physical and chemical instability of amorphous forms by applying certain process conditions or adding stabilizing agents in order to produce a usable amorphous form i.e., an amorphous form that will remain stable over a meaningful pharmaceutical time-scale. D9 and D10 teach this in theory but each chemical compound would need specific conditions and compositions applied to achieve a usable amorphous form. However, no such technical teaching is provided in the description of Patent (emphasis added) S/N fpM34FljWETbiwsg2bkfw [81] amorphous form of chemical compounds is routine downplays the complexities of the process of arriving at a stable amorphous form of a compound, which he acknowledged in paragraph 76 of his report. [82] I also considered the decision by the Board of Appeal of the European Patent Office, Warner-Lambert Company LLC v Teva Pharmaceutical Industries Ltd. T 0777/08 (Atorvastatin polymorphs/WARNER-LAMBERT), which the plaintiff claimed contained facts similar to the instant case, and in which it was held that the provision of the crystalline form of a known pharmaceutically active compound cannot be regarded as involving an inventive step. [83] However, a more thorough consideration of the case reveals that of the similarities between Warner-Lambert (supra) and this case is erroneous. This is clear in headnote 2 of the case report, which states: When starting from the amorphous form of a pharmaceutically active compound as closest prior art, the skilled person would have a clear expectation that a crystalline form thereof would provide a solution to the problem of providing a product having improved filterability and drying characteristics. The arbitrary selection of a specific polymorph from a group of equally suitable candidates cannot be viewed as involving an inventive step (emphasis added) S/N fpM34FljWETbiwsg2bkfw [84] Thus, in Warner-Lambert (supra), the starting point was the amorphous form of a compound, and the invention was the crystalline form of the same compound. In the case before this court, the starting point is the free-base of a pharmaceutically active compound, while the invention in Claim 36 is the amorphous form of a specific salt of the compound, namely, the hydrochloride salt. This is a crucial distinction as it means that t invention is clearly much larger than that in Warner-Lambert (supra). In the present case, the [85] The defendant provided two decisions of the European Technical Board of Appeal, T 0478/17 08-09-2020 and T 1684/16 03-03-2020 which distinguished Warner-Lambert (supra) on the basis that the cases are not about the selection of any crystalline form, but about the selection of one specific crystalline form. [86] I also accepted DW2 testimony that a person skilled in the art will only look to the amorphous form as a last resort. There is no motivation to look to the amorphous form, due to the generally known shortcomings of the amorphous form, including poor chemical and physical stability. This was explained by DW2 during re-examination: Alright, ok. Now the other suggestion that was made to you is that the benefit of being able to generate amorphous nilotinib hydrochloride 20 would outweigh any time and effort for the screening, and you had disagreed with that S/N fpM34FljWETbiwsg2bkfw statement. Could you please explain to us why did you disagree? ABATO Because of that stage in the development, the more stable, so amorphic forms are generally unstable. They do have potential benefits as being more bioavailable because they are more soluble and they get into the body easier. But the crystalline forms are more stable, and you want to make a stable drug. You don't want to make an unstable drug, because for obvious reasons, it will convert and change and degrade, and then you won't get the therapeutic value. You won't hit safety. So the first thing that, at that stage in development is to generate a form, in this case, a crystalline form that is stable and examine it. And if it has shortcomings like for you then look for other forms of it, for example, the free base of nilotinib is not as soluble as we now know the hydrochloride salt is, due to the publication of the 554 Patent. So the first thing you would do is you make a stable form, in this case, a crystalline form, and then you examine it. And if it has shortcomings like solubility for example, you then do other things, like you will look to other crystalline S/N fpM34FljWETbiwsg2bkfw forms, try to generate other crystalline forms first, see if they are more soluble, see if they overcome the liabilities. compound is able to be converted to a salt form, that is the next step you would take, because salt forms are generally more soluble, because they are charged. So the salt form would be the next stage that you would go to, and then you would examine different salts. So you would then go to the salt form, you would then look at different salts, the HCl salt, the measly. Again go through, is this stable, is it soluble, does it give us the profile we want? And if all that failed, you then would be forced to look at the amorphic form and go into that area of research and examine alright, one can be generated. If we can't generate it, can we generate different salt forms that will make it, you can generate a salt form and then you generate the amorphic form of that salt form, and then test it, is it stable, is it able to overcome our previous liabilities? But that is the only, that is the time not something that they will do prior to the 554 Patent. This is the process that happens. (emphasis added) S/N fpM34FljWETbiwsg2bkfw [87] DW2 also explained in DW2 Afidavit Pakar 1 that the production of the amorphous form of a chemical compound is not guaranteed:

6.7 As a starting point, I am of the view that the discovery process of understanding what polymorphs are possible for a specific molecule and determining under what conditions they form is a significant challenge and is not something that is trivial. For example, consider the following quote from a 2021 article: "Control and prediction of polymorphic formation is considered the greatest challenge in physical chemistry." (Ala Salim, 2021).

6.8 Furthermore, the production of the amorphous form is not guaranteed, as the ability for a particular substance to be produced as a stable amorphous form is ultimately due to the intrinsic properties inherent to the molecule itself, specifically the chemical structure of the molecule (Yu. L, 2001). For example, molecules that are naturally more rigid tend to crystalize much more easily due to the fewer number of configurations that are available. Specifically, for these molecules the amorphic form is particularly unstable and easily converts to a crystalline polymorph. Conversely, some molecules have many rotatable bonds which enable many different configurations. As the number of potential conformations increase, the less probable that S/N fpM34FljWETbiwsg2bkfw proper alignment is, making them more difficult to crystalize on the one hand but easier to generate the disordered solid state requirement to be classified as (emphasis added) [88] I found further guidance in the case of Leo Pharma A/S and another v Sandoz Ltd, [2009] EWHC 996 (Pat), where the court recognised the difficulty in the generation of the amorphous form of a specific chemical compound: [29] In general, crystallisation is an empirical process. It is not possible to predict in advance whether a particular compound will crystallise, or whether it will form an amorphous solid. A given compound may fail to crystallise even where similar compounds are known to crystallise. If a given compound crystallises in one way, it is not possible to predict what if any other forms it might exist in, or whether it will form solvates. Inducing a compound to crystallise for the first time, or into a new crystalline form, involves choosing the correct conditions which themselves cannot be predicted in advance. Seemingly trivial matters such as impurities, may influence the result. (emphasis added) [89] What is also important to highlight is that the discovery of the amorphous form of a chemical compound is recognised as inventive and S/N fpM34FljWETbiwsg2bkfw is patentable in Malaysia when its existence was previously unknown. The defendant provided two examples of such patents: a. Claim 1 of Malaysian Patent No. MY136394-A, which reads: Amorphous beta-L-2'- b. Claim 1 of Malaysian Patent No. 170086-A, which reads: Amorphous (S)-2-(4-chlorophenyl)-1-(4- ((SR,7R)-7-hydroxy-5-methyl-6,7- dihydro-5H-cyclopenta[d]pyrimidin-4- yl)piperazin-1-yl)-3- isopropylamino)propan-1-one [90] Thus, from the evidence before this court, I find that the discovery of the amorphous form of a chemical compound is not trivial or routine, as there are difficulties in foreseeing the specific conditions required to generate the amorphous form of a specific compound. Further, the discovery of the amorphous form is not guaranteed. [91] Following this, upon donning the mantle of the unimaginative ordinary person skilled in the art who is imputed with the common general knowledge, the court finds that as at the 554 Patent Priority Date, the differences between the prior art and the invention disclosed in Claim 36 S/N fpM34FljWETbiwsg2bkfw do not constitute steps which would have been obvious to an unimaginative ordinary person skilled in the art. [92] With such finding, the court holds that Claim 36 is inventive. F. Did Claim 36 comply with the requirements of the Patents Regulations? Requirements in the Patents Regulations [93] The third condition raised by the plaintiff which it claimed warranted the invalidation of Claim 36 is that Claim 36 does not comply with the requirements of the Patents Regulations. [94] Section 23 of the Patents Act requires every application for the grant of a patent to comply with prescribed regulations, namely the Patents Regulations. [95] Regulation 12 of the Patents Regulations contains requirements on the description of a patent: The description shall first state the title of the invention as appearing in the request and shall

specify the technical field to which the invention relates; S/N fpM34FljWETbiwsg2bkfw

indicate the background art which, as far as is known to the applicant, can be regarded as useful for the understanding, searching and examination of the invention, and, wherever possible, cite the documents reflecting such art;

disclose the invention in such terms that it can be understood and in a manner sufficiently clear and complete for the invention to be evaluated and to be carried out by a person having ordinary skill in the art, and state any advantageous effects of the invention with reference to the background art;

briefly describe figures in the drawings, if any;

describe the best mode contemplated by the applicant for carrying out the invention, using examples where appropriate and referring to the drawings, if any; and

indicate explicitly, when it is not obvious from the description or nature of the invention, the way in which the invention is industrially applicable and the way in which it can be made and used or, if it can only be used, the way in which it can be used. S/N fpM34FljWETbiwsg2bkfw (emphasis added) [96] Regulation 13 sets out the requirements of a patent claim: 13(1) The claims shall be clear and concise and fully supported by the description; and the number of the claims shall be reasonable taking into consideration (emphasis added) [97] In the present case, the plaintiff claimed that: a. Claim 36 lacks sufficiency, as its description does not disclose the invention in such terms that it can be understood and in a manner sufficiently clear and complete for the invention to be evaluated and to be carried out by an ordinary person skilled in the art. This resulted in non-compliance with regulations 12(1)(c) and 13(1). b. . This resulted in non-compliance with regulation 12(1)(e). S/N fpM34FljWETbiwsg2bkfw Is the disclosure in Claim 36 sufficient? [98] The issue of sufficiency of disclosure was examined by the Court of Appeal in Ranbaxy (M) Sdn Bhd v EI Du Pont Nemours and Co [2012] 4 MLJ 34, where it was held that: The disclosure in Example 316 Part D in respect of claim 7 of the 414 patent specifications is sufficient to enable a person of ordinary skill in the art to produce crystalline losartan potassium even though the example does not expressly state that the crystalline form of losartan potassium would be produced. The example gives unmistakable indication as to the predictability of success. The method disclosed by Example 316 Part D inherently produces the crystalline form of losartan potassium. [44] specification would be sufficient for the purpose of the description. The disclosure is sufficient to show that the natural result following from the operation as taught would result in the performance of the questioned function. It is well settled that the disclosure of this nature should be regarded as sufficient for its purpose (see Re Oelrich, 666 F 2d 578, 581 (CCPA 1981); Synthon BV v Smithkline Beecham plc [2006] 1 All ER 685 and Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd [1996] RPC 76 (emphasis added) S/N fpM34FljWETbiwsg2bkfw [99] The court finds the present case to be in line with the extent of disclosure in Ranbaxy (supra). The defendant highlighted four parts in the 554 Patent which provide a set of operations that would naturally lead an ordinary person skilled in the art to arrive at ANH: a. Page 12, lines 5 to 13 of the 554 Patent: monohydrate which has a theoretical moisture content of 3.1% and shows superior crystallinity and physical stability with respect to form A of the hydrochloride salt. In the presence of ethanol, form B converts to form A. A DSC scan of form B shows a first endotherm at about 100°C-120°C which corresponds to dehydration, i.e., transition to an anhydrous crystalline form B'; DSC also shows a second endotherm at about 190°C which corresponds to melting. XRPD at various temperatures shows anhydrous form B' between about 145°C-195°C; after melting at about 195°C, form B' becomes amorphous upon holding at about 40°C for about 30 minutes. Form B' converts within a few minutes under room condition (emphasis added) S/N fpM34FljWETbiwsg2bkfw b. Page 14, lines 17 to 24 of the 554 Patent: monohydrate. In the presence of methanol vapor, form C converts to form B. A DSC scan of form C shows a first endotherm at about 100°C-120°C which corresponds to dehydration, i.e., transition to an anhydrous crystalline form C'; DSC also shows a second endotherm at about 180°C which corresponds to melting. XRPD at various temperatures shows anhydrous form C' between about 155-195°C; after melting at about 195°C, form C' becomes amorphous upon holding at about 40°C for about 30 minutes. (emphasis added) c. Example 4 of the 554 Patent: The residue (hydrochloride salt of 4-methyl-N-[3- (4-methyl-imidazol-1-yl)-S-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)- benzamide) from Example 2 can be examined for its crystalline form upon evaporation at room temperature. The results are shown in Table 6 below. S/N fpM34FljWETbiwsg2bkfw Table 6. Evaporation at Room Temperature Solvent Form Acetone Amorphous Acetonitrile Amorphous Ethanol (96%) A & B Ethyl Acetate Methanol Propan-2-ol Toluene Tetrahydrofuran Amorphous Tetrahydrofuran-water (50:50) Acetonitrile-water (50:50) Ethanol-water (50:50) Methanol-water (50:50) (emphasis added) d. Example 22 of the 554 Patent: -methyl-N-[3-(4-methyl-imidazol-I-yl)-5- trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide hydrochloride (14 g) is dissolved in 1,000 g of methanol in a hot water bath. The solution is spray dried in a Buchi Mini spray at about 65°C to form the amorphous hydrochloride salt of 4-methyl-N- [3-(4-methyl-imidazol-1-yl)-S-trifluoromethyl-S/N fpM34FljWETbiwsg2bkfw phenyl]-3-(4-pyridin-3-yl-pyrimidin-2- ylamino)-benzamide. (emphasis added) [100] In relation to Example 22, PW3 contended that it is incomplete as there are no details regarding the spray drying conditions, including the spray rate and the atomisation pressure. [101] However, regulation 12(1)(c) only requires the disclosure of the invention in such terms that it can be understood and in a manner sufficiently clear and complete for the invention to be evaluated and to be carried out by a person having ordinary skill in the art. As such, as long as a person with ordinary skill in the art is able to implement routine steps and carry out the invention, the disclosure would be sufficient. The experts concur that details on the spray drying process are accepted as common practices that can be applied by a person skilled in the art. [102] From the evidence before this court, I am satisfied that the specification in the 554 Patent, and specifically the sets of operations as highlighted, would naturally lead a person skilled in the art to arrive at a substantially pure ANH. The patent specification in the 554 Patent also reveals the physical stability of ANH. [103] Thus, I find the specification of the 554 Patent to be sufficiently clear and complete so as to enable an ordinary person skilled in the art to perform the invention in Claim 36 without undue burden. S/N fpM34FljWETbiwsg2bkfw [104] Finally, an ordinary person skilled in the art would be able to determine whether a particular product falls within or outside the scope of Claim 36. Both experts, PW3 and DW2, agreed that the tools used to determine whether a product is in the amorphous form which they confirmed to be FT-IR, FT-RAMAN and XRPD are well-known, and can be utilised for such determination. Is the designation of a specific method as the carrying out an invention required? [105] Regulation 12(1)(e) of the Patents Regulations provides that the description of a patent shall: describe the best mode contemplated by the applicant for carrying out the invention, using examples where appropriate and referring to the drawings, if any (emphasis added) [106] The plaintiff argued that the specification in the 554 Patent did not disclose which would be the best mode or best method to perform Claim 36. [107] There are no decided cases in Malaysia on the requirement in regulation 12(1)(e), and as such, in reaching a determination of this issue, I am guided by authorities and cases in other jurisdictions that were highlighted by the defendant. S/N fpM34FljWETbiwsg2bkfw [108] section 112 of United States Code Title 35 Patents. The provision reads as follows: a. For patent applications filed before 16 September 2012: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. (emphasis added) b. For patent applications filed on or after 16 September 2012: IN GENERAL. The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall S/N fpM34FljWETbiwsg2bkfw set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. (emphasis added) [109] The United States Patent and Trademarks Office Manual of Patent Examining Procedure (ninth edition, revision 07.2022, published February 2023), states as follows in section 2165.01: III. DESIGNATION AS BEST MODE IS NOT REQUIRED There is no requirement in the statute that inventors point out which of their embodiments they consider to be their best; that the disclosure includes the best mode contemplated by the inventor is enough to satisfy the statute. Ernsthausen v. (emphasis added) [110] not [111] Decisions by the courts in the United States are consistent with these provisions. In the decision of the United States Court of Customs and Patent Appeals in Application of George BOSY 149 USPQ 789, 360 F.2d 972 (1966) at 360 F.2d 976, it was observed that: S/N fpM34FljWETbiwsg2bkfw n advance any convincing reason for finding that the invention is so dependent on the amounts of pulp and pectinase that a best mode of the claimed process is not disclosed by the general teachings of the specification. It does not follow that there is a proper basis for a best mode rejection under 35 U.S.C. § 112 merely because appellant does not pinpoint within the specification some portion that represents a best mode. (emphasis added) [112] In Randomex, Inc v Scopus Corp and Dennis Haskamp 7 U.S.P.Q.2d 1050, 849 F.2d 585, the United States Court of Appeals, Federal Circuit, held at 849 F.2d 589 that: the best mode requirement complied with when an inventor discloses his preferred embodiment indiscriminately with other possible 2 D. Chisum, Patents Sec. 7.05 at 7-68 (1987). The Board of Patent Appeals and Interferences has stated: [t]here is no requirement in 35 USC 112 that an applicant point out which of his embodiments he considers his best S/N fpM34FljWETbiwsg2bkfw mode; that the disclosure includes the best mode contemplated by the applicant is enough to satisfy the statute. There is no concealment of best mode here since one of ordinary skill in the art could readily determine the best operating mode.... Ernsthausen v. Nakayama, 1 USPQ2d 1539 , 1549 (Bd.Pat.App.Int.1985), aff'd, Nos. 86-736, 86-923 (Fed.Cir. Nov. 24, 1986) [809 F.2d 787, 788 (tables) ]. As applicable to the facts of this case, we agree with this statement of the Board. The disclosure of the 91% alcohol solution is suspect in light of evidence that one who used it might have had to contend with an explosion. Although the motive for including the 91% alcohol solution in the disclosure is not apparent, Randomex, 2 USPQ2d at 1623 & n. 1, the solution was part of the prior art and suggested an easily procurable inferior substitute for the Randomex Cleaner No. 50281. But if the words "Randomex Cleaner No. 50281" satisfy the best mode requirement, we will not invent a rule that would result in the forfeiture of a patent due to the district court's novel combination of patent misuse and best mode notions. The indiscriminate disclosure in this instance of the preferred cleaning fluid along with one other possible cleaning fluid satisfies the best mode requirement. (emphasis added) S/N fpM34FljWETbiwsg2bkfw [113] The position in Australia is in line with that of the United States. Section 40(2) of the Australian Patents Act 1990 provides that: A complete specification must: (aa) disclose the best method known to the applicant [114] I also note that it is provided in Patent Manual of Practice and Procedure, in sub-chapter 5.6.7.5 (published 21 February 2024) that: to s40(2)(aa), clear enough and complete enough disclosure. that differs in any way from that which is otherwise provided when disclosing the invention in a clear enough and complete enough manner. Note that the specification does not need to use the words the (emphasis added) S/N fpM34FljWETbiwsg2bkfw [115] From the authorities in the United States and Australia, the positions taken in both countries are aligned, namely that there is no strict requirement for an applicant to point out which method in the patent specification the applicant considers to be the mode . I find these authorities to be persuasive, given the similarities in the provisions of regulation 12(1)(e) of the Patents Regulations, section 112 of United States Code Title 35 Patents and section 40(2)(aa) of the Australian Patents Act 1990. [116] I also considered the wordings in regulation 12(1)(e) of the Patents Regulations, which state that the description of a patent shall: describe the best mode contemplated by the applicant for carrying out the invention, using examples where appropriate and referring to the drawings, if any (emphasis added) [117] In my view, the wordings of regulation 12(1)(e) do not require the designation of a for carrying out an invention. What is required is simply that the best mode contemplated by the applicant is described, with examples where appropriate. The invention to be specifically designated, or that imposition of additional requirements not contained in the regulation. S/N fpM34FljWETbiwsg2bkfw [118] Essentially, the purpose of regulation 12(1)(e) is that the specification must be sufficient to allow an ordinary person skilled in the art to readily carry out the invention without undue burden. This is also explained in Part B (4.8) of the Intellectual Property Corporation of Malaysia s (MyIPO) Patent Examination Guidelines 2023: A detailed description of the best mode contemplated by the applicant for carrying out the invention, using examples and referring to the drawings, if any, must be given. Since the application is addressed to the person skilled in the art it is neither necessary nor desirable that details of well known ancillary features should be given, but the description must disclose any feature essential for carrying out the invention in sufficient detail to render it obvious to another person skilled in the art how to put the invention into practice. (emphasis added) [119] It is clear from the above that the purpose of requirement is for there to be sufficient teaching in the patent document which would enable an ordinary person skilled in the art to readily carry out the invention without undue burden. [120] The defendant had disclosed four different methods in the 554 Patent to achieve a substantially pure ANH, which would be sufficient to put Claim 36 into practice. Thus, I find that these disclosures comply with regulation 12(1)(e) of the Patents Regulations. S/N fpM34FljWETbiwsg2bkfw [121] With these findings, the court holds that the requirements in the Patents Regulations have been met. G.

[122] Based on the considerations as set out, the court finds that the dismissed. [123] After hearing brief submissions from counsel on costs, and taking into account the complexity of this claim which involves the evidence of experts, the court ordered costs of 800,000 to be paid by the plaintiff to the defendant. Dated 30 July 2024 ADLIN ABDUL MAJID Judge High Court of Malaya Commercial Division (NCC6) Kuala Lumpur S/N fpM34FljWETbiwsg2bkfw Counsel: Plaintiff: Cindy Goh Joo Seong (together with Jessye Ng, Loh Heng Yeong and Chong Xin Xian) of Messrs. Cheang & Ariff Defendant: Chew Kherk Ying (together with Raymond Tan and Mak Ming Jie) of Messrs. Wong & Partners S/N fpM34FljWETbiwsg2bkfw