2020 FC, 2020 FC 1189

Date: 20201224 Docket: T-2023-18 Citation: 2020 FC 1189 Ottawa, Ontario, December 24, 2020 PRESENT: THE CHIEF JUSTICE BETWEEN: ALLERGAN INC. Plaintiff and SANDOZ CANADA INC. Defendant and KISSEI PHARMACEUTICAL CO., LTD. Defendant/Patent Owner AND BETWEEN: SANDOZ CANADA INC. Plaintiff by Counterclaim and ALLERGAN INC. and KISSEI PHARMACEUTICAL CO., LTD. Defendants by Counterclaim JUDGMENT AND REASONS – PUBLIC VERSION (Identical to the Confidential Judgment and Reasons issued on December 23, 2020) Table of Contents I. Introduction 3 II. Background 4 A. The Parties 4 B.

Benign Prostatic Hyperplasia, Dysuria and Silodosin 6 III. The ‘002 Patent 7 IV. Issues 9 V. Witnesses 9 A. Allergan’s Witnesses 10

(1) Dr. Linda Felton 10

(2) Ms. Jenna Wilson 11

(3) Dr. MacGregor 11 B. Sandoz’s Witnesses 12

(1) Dr. Reza Fassihi 12

(2) Mr. Michael I. Stewart 13 VI. Analysis 14 A. Claim Construction 14

(1) Legal Principles 14

(2) The Skilled Person 17

(3) Common General Knowledge 20

(4) The Essential Elements of the ‘002 Patent 23 (

a) Claim 1 25 (

i) The First Prong of the Test: A Purposive Construction of the Wet Granulation Elements 26

(ii) The Second Prong of the Test: Would the Skilled Person Have Appreciated that a Dry Process Could be Substituted Without Affecting the Working of the Claimed Invention? 38 (iii) The Prosecution History of the ‘002 Patent 42 (iv)

Summary: The Essential Elements of Claim 1 49 (

b) Claims 2 and 3 50 (

c) Claim 6 51 B. Is the ‘002 Patent Invalid on the Ground of Obviousness? 53

(1) Introduction 53

(2) The Legal Test 54

(3) Assessment 57 (

a) Step One - The Skilled Person and the relevant common general knowledge 57 (

b) Step Two - The inventive concept 58 (

c) Step Three - The differences between the state-of-the-art and the inventive concept 62 (

d) Step Four - Were the differences between the inventive concept and the state of the art obvious? 63 (

i) Was it more or less self-evident that what is being tried ought to work? Were there a finite number of identified predictable solutions known to the Skilled Person? 64 (ii) What was the extent, nature and amount of effort required? Were routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine? 68 (iii) Was there a motive provided in the prior art to find a solution that the ‘002 Patent addresses? 78 (iv) Allergan’s experiment 80 (

v) Summary of “obvious to try” assessment 82 (

e) Conclusion regarding the allegation of obviousness 83 C. Infringement 83 D. The Gillette Defense 84 VII. Costs 84 APPENDIX 1 — Relevant Legislation 87 I. Introduction [ 1 ] There are three principal issues in this action. The first is whether the Defendant Sandoz Canada Inc. [ Sandoz ] will infringe a patent pertaining to the prescription drug RAPAFLO ® , for which the Plaintiff Allergan Inc. [ Allergan ] is the exclusive Canadian licensee. The second is whether representations that were made during the patent application process on behalf of the owner of the patent, the Defendant Kissei Pharmaceutical Co. Ltd. [ Kissei ], can be introduced as evidence in this proceeding pursuant to

section 53.1 of the Patent Act , R.S.C. 1985, c. P-4 [the Act ]. The third is whether the patent is invalid on the ground of obviousness. [ 2 ] For the reasons that follow, I have concluded that the generic alternative to RAPAFLO ® that Sandoz seeks approval to produce [the Sandoz Product ] will not infringe the patent at issue, namely, Canadian Patent No. 2,507,002 [the ‘002 Patent ]. This is because some of the essential elements of claims 1 to 3 and 6 of that patent are not infringed by the Sandoz Product.

Allergan’s suggestion to the contrary is based on a reading of the patent that, if upheld, would undermine the certainty and predictability of the patent system, and chill competition. [ 3 ] I have also determined that

section 53.1 of the Act cannot be invoked in this proceeding. This is because Allergan is not a " “patentee” " , within the meaning of the Act . Accordingly, the representations made to the Patent Office on behalf of Kissei and the amendments made to the proposed patent during the patent application process are inadmissible extrinsic evidence. [ 4 ] Finally, I have concluded that the ‘002 Patent in question is not invalid on the ground of obviousness. This is because (

i) it was not more or less self-evident that the claimed invention ought to work; (ii) the person skilled in the art of the ‘002 Patent would not likely have thought that the claimed invention could be achieved relatively quickly, through routine experimentation; (iii) the experimentation actually undertaken to achieve the claimed invention was prolonged and arduous; and (iv) the person skilled in the art would not have had any motivation to pursue the claimed invention.

II. Background A. The Parties [ 5 ] Allergan is a pharmaceutical company incorporated under the laws of Canada. Its principal address is located in Markham, Ontario. Allergan is a " “first person” " within the meaning of subsections 4(1) and 6(1) of the Patented Medicines (Notice of Compliance) Regulations , SOR/93-133 [the Regulations ]. [ 6 ] Allergan is authorized to manufacture, market, and sell RAPAFLO ® capsules in Canada pursuant to a series of Notices of Compliance [ NOC s] issued by Health Canada dated January 11, 2011, January 29, 2015, April 5, 2017 and March 12, 2018, respectively.

RAPAFLO ® capsules contain the active pharmaceutical ingredient [ API ] silodosin and are available in 4mg and 8mg silodosin strengths. RAPAFLO ® is indicated for the treatment of benign prostatic hyperplasia [ BPH ]. [ 7 ] Kissei is a pharmaceutical company based in Japan. It was joined to this action pursuant to subsection 6(2) the Regulations . Kissei takes no position on whether the Sandoz Product will infringe the ‘002 Patent. However, Kissei denies that any of the claims of the ‘002 Patent are invalid, void or of no force or effect.

It adopts and relies on Allergan's submissions in this regard and did not appear during the trial of this proceeding. [ 8 ] Sandoz is a pharmaceutical company incorporated under the laws of Canada. Its principal office is located in Boucherville, Quebec. It is a " “second person” " within the meaning of subsections 5(1) and 6(1) of the Regulations . [ 9 ] To obtain approval from Health Canada to market the Sandoz Product in Canada, Sandoz filed an Abbreviated New Drug Submission [ ANDS ] for a NOC for 4mg and 8mg silodosin capsules indicated for the treatment of the signs and symptoms of BPH.

Given that Sandoz's ANDS relied on Allergan's NOC for RAPAFLO ® , Sandoz served Allergan with a Notice of Allegation pursuant to subsection 5(3) of the Regulations on or about October 16, 2018. [ 10 ] Allergan commenced this action pursuant to subsection 6(1) of the Regulations shortly thereafter. B. Benign Prostatic Hyperplasia, Dysuria and Silodosin [ 11 ] BPH is an anatomical change that occurs to a man’s prostate. BPH is typically understood to refer to benign prostatic hyper trophy , a condition in which the cells of the prostate increase in size.

BPH is also sometimes used to connote benign prostatic hyper plasia , a condition in which the number of cells in the prostate increases. [ 12 ] BPH is the most common benign tumor in men. It is often age-related and occurs more frequently in men over the age of 50. The clinical symptoms associated with BPH include storage disturbances (e.g., the need to urinate more frequently or urgently), voiding disturbances (e.g., various difficulties associated with urinating), and pain during urination.

If left untreated, BPH can lead to other symptoms and infections. [ 13 ] Silodosin is a prescribed oral medication indicated for treatment of the signs and symptoms of BPH. Silodosin belongs to a class of drugs known as " “alpha-1 blockers” " . These drugs operate by blocking alpha-1 receptors located in the bladder and prostate that are responsible for the contraction of smooth muscles of the bladder and prostate.

By causing the muscles in the bladder and prostate to relax, alpha-1 blockers like silodosin can mitigate BPH symptoms and improve the ability to urinate. [ 14 ] Silodosin is manufactured, marketed and sold in Canada and the United States under the brand name RAPAFLO ® . The Drug Identification Numbers assigned by Health Canada to RAPAFLO ® are 02361663 (4 mg) and 02361671 (8 mg). III. The ‘002 Patent [ 15 ] The ‘002 Patent is titled " “Solid Drug for Oral Use” " .

The named inventors are Tsuyoshi Naganuma and Mitsuo Muramatsu [the Inventors ]. [ 16 ] The ‘002 Patent issued from an application filed on December 11, 2003 claiming priority from Japanese Patent JP2002-364238, filed December 16, 2002 [the Claim Date ]. It was published ( " “laid open” " ) on July 1, 2004 [the Publication Date ] and issued on September 18, 2012. [ 17 ] As a preliminary observation, it is common ground between Allergan and Sandoz that the English translation of the ‘002 Patent is sub-optimal and that this may account for some of the ambiguities in the document.

In brief, the translation contains some unclear passages, uses some terms inconsistently and has some grammatical deficiencies. Nevertheless, as Allergan observed during the proceedings, the translation still provides " “enough … for us to understand what the patent is talking about” " : Public Transcript, at 636. [ 18 ] In a short

section entitled " “Background Art” " , the ‘002 Patent indicates that it was known that silodosin, as an API in a solid dosage form, is useful for treating dysuria without causing strong hypotensive activities or orthostatic hypotension. However, the prior literature identified in that patent did not disclose how to prepare a solid dosage form capsule by conventional formulation methods, or indeed by any other method. The patent notes that preparing such a capsule was extremely difficult to accomplish, due to the potent adhesive properties of silodosin that were disclosed by the patent.

Given those properties, the use of a lubricant is required to formulate silodosin in a capsule form. However, the addition of a lubricant " “causes the problem of delaying in [sic] dissolution time” " .

[ 19 ] Broadly speaking, the invention claimed in the ‘002 Patent is a solid oral dosage form capsule for the treatment of dysuria which comprises the API silodosin and specific excipients, manufactured in a manner that achieves a defined rapid dissolution profile. According to the patent disclosure, the invention also " “has a high precision for content uniformity, good stabilities, and excellent dissolution properties”. " It is further noted that an important objective of the Inventors was to achieve " “a high content uniformity among formulation batches” " . [ 20 ] The specific excipients identified in the patent are (

i) D-mannitol, (ii) partially pregelatinized starch, (iii) a lubricant selected from the group magnesium stearate, calcium stearate and talc, and (iv) sodium lauryl sulfate [ SLS ].

The rapid distribution profile is described in terms of 85% " “in not more than 15 minutes in a dissolution test according to method 2 (paddle method) of the Japanese pharmacopoeia in a condition using water as a test medium and a paddle speed of 50rpm [sic] ” " [ Method 2] . [ 21 ] Sandoz has admitted, for the purpose of this action, that the Sandoz Product contains silodosin, D-mannitol, partially pregelatinized starch, magnesium stearate and SLS, and that the capsules dissolve by 85% in no more than 15 minutes according to Method 2. [ 22 ] However, the Sandoz Product does not contain " “granules” " and does not involve " “granulating” " or a " “wet granulation process” " [collectively, the Wet Granulation Elements ], which are elements included in the independent claims that are in dispute in this proceeding, namely, claims 1 and 6 of the ‘002 Patent.

The Sandoz Product is made by a " “dry” " formulation method. [ 23 ] The disputed claims are reproduced and discussed in

Part VI.A.(4) of these reasons below. IV. Issues [ 24 ] There are three principal issues in this proceeding. They are as follows: 1) Are the Wet Granulation Elements in claims 1 – 3 and 6 essential? 2) Is the prosecution history of the ‘002 Patent admissible against Allergan, pursuant to

section 53.1 of the Act ? If so, what is the impact, if any, of amendments to the claims and corresponding representations that were made to the Patent Office by a representative of Kissei? 3) Is the ‘002 Patent invalid on the ground of obviousness? V. Witnesses [ 25 ] Allergan and Sandoz agreed on the qualifications of the four expert witnesses who testified in this case. A. Allergan’s Witnesses

(1) Dr. Linda Felton [ 26 ] Dr. Felton is a Professor of Pharmaceutics and Chair of the Department of Pharmaceutical Sciences at the University of New Mexico College of Pharmacy. She is an expert in pharmaceutical formulation, principally of solid oral dosage forms, qualified to opine on formulation methods (including wet granulation, dry granulation, and dry blending), the role of excipients used in formulation, evaluating and assessing dissolution, and the physical and chemical properties of excipients and pharmaceutical compositions. [ 27 ] Dr.

Felton testified with respect to the " “infringement” " and " “obviousness” " issues in this proceeding. More specifically, she testified with respect to the essential elements of claims 1, 2, 3 and 6 of the ‘002 Patent, and whether that patent is invalid on the ground of obviousness.

She also opined on related issues such as the person of skill in the art to whom the ‘002 Patent is addressed [the Skilled Person ], the common general knowledge of the Skilled Person, how the ‘002 Patent would have been understood by the Skilled Person, the prior art, certain Kissei internal documentation, and the invention contemplated by the patent. In addition, she commented upon experimental tests that were conducted by Dr. MacGregor. [ 28 ] Dr. Felton’s testimony was generally straightforward and frank. She readily made certain concessions on cross-examination.

Although counsel encountered some difficulty obtaining answers from her on other occasions, it appeared that this was because she was endeavouring to be precise or to identify potentially important nuances. Broadly speaking, her testimony was better supported and more helpful with respect to the issue of obviousness than it was with respect to the issue of the essential elements of the ‘002 Patent.

(2) Ms. Jenna Wilson [ 29 ] Ms. Wilson is a registered and practicing lawyer and Canadian and United States Patent agent with over 20 years of experience in patent practice. She has expertise in the drafting, filing and prosecution of patent applications before the Canadian Intellectual Property Office [ CIPO ] and the United States Patent and Trademark Office [ USPTO ], and in the analysis and

interpretation of communications between the Canadian Patent Office and patent applicant leading to the granting of a patent. [ 30 ] Ms. Wilson testified on behalf of Allergan with respect to the legislative history of

section 53.1 of the Act and the prosecution history of the ‘002 Patent. Her testimony in relation to the legislative history of

section 53.1 was generally direct, straightforward and helpful. However, given the conclusion that I have reached regarding the

interpretation of

section 53.1, her evidence concerning the prosecution history of the ‘002 Patent had no bearing on my decision.

(3) Dr. MacGregor [ 31 ] Dr. MacGregor is the President and Dean of Faculty at the Toronto Institute of Pharmaceutical Technology [ TIPT ], an institute for industrial pharmaceutical education. He has taught a variety of courses at TIPT for about 28 years, and has been performing dissolution testing for approximately 30 years. [ 32 ] Dr. MacGregor was a fact witness who testified with respect to dissolution testing experiments he conducted on behalf of Allergan. [ 33 ] Dr. MacGregor’s testimony was candid, very forthcoming and to the point. B. Sandoz’s Witnesses

(1) Dr. Reza Fassihi [ 34 ] Dr. Fassihi is a Professor of Biopharmaceutics and Industrial Pharmacy at Temple University. He is an expert in: the design of drug delivery systems; preformulation and formulation methodologies for drug delivery systems; excipients/non-medicinal ingredients used in drug delivery systems; the evaluation of drug delivery systems, including bioavailability and dissolution studies; and regulatory requirements relating to drug delivery systems. With respect to each of these five fields, Dr. Fassihi has particular expertise in relation to solid oral dosage forms. [ 35 ] Dr.

Fassihi testified with respect to essentially the same issues that were addressed by Dr. Felton. Broadly speaking, his testimony was less straightforward than Dr. Felton’s testimony, as he had several memory lapses (while being strikingly clear on other issues), he seemed reluctant to answer what appeared to be straightforward questions and his testimony was not entirely consistent on occasion. Moreover, his evidence with respect to the obviousness issue was not as well supported or persuasive as Dr. Felton’s evidence.

In addition, his testimony conveyed a sense of advocacy on a significant number of occasions, when he went beyond providing an answer by adding out-of-context commentary to convey his view that something was obvious. With the foregoing in mind, I generally found Dr. Felton’s testimony to merit greater weight, and to be more persuasive, than Dr. Fassihi’s on the issue of obviousness. [ 36 ] Nevertheless, I found Dr. Fassihi’s evidence to be very helpful and straightforward regarding the experiment conducted by Dr. MacGregor.

It was also forthcoming and helpful with respect to certain matters that had a bearing on the issue of the essentiality of the Wet Granulation Elements. I generally found his testimony to be more persuasive than Dr. Felton’s on these two matters.

(2) Mr. Michael I. Stewart [ 37 ] Mr. Stewart is a registered Canadian and United States Patent agent with over 40 years of expertise in: 1) the preparation, filing and prosecution of patent applications before the CIPO, the USPTO, and other foreign Patent Offices in areas such as chemistry and pharmacology; and 2) the analysis and

interpretation of communications between the Patent Office and the patent applicant leading to the grant of a patent. [ 38 ] Dr. Stewart testified on behalf of Sandoz with respect to the ‘002 Patent prosecution process, his

interpretation of the positions taken by the patent examiner and by Kissei (through its agent Kirby Eades Gayle Baker), and whether certain of Dr. Felton’s opinions are consistent with the ‘002 Patent prosecution history. His testimony was candid, straightforward and forthright. However, given the conclusion that I have reached regarding the

interpretation of

section 53.1 of the Act , his testimony did not have a bearing on my decision. VI. Analysis A. Claim Construction

(1) Legal Principles [ 39 ] The claims of a patent must be construed before conducting an assessment of the patent’s validity or infringement: Whirlpool Corp v Camco Inc , 2000 SCC 67 at para 43 [ Whirlpool ]. [ 40 ] In performing this exercise, the language of the claims must be read in an informed and purposive way, from the perspective of a skilled person: Free World Trust v Électro Santé Inc, 2000 SCC 66 at para 44 [ Free World ]. [ 41 ] The Skilled Person is presumed to have a mind willing to understand the claims, but to be unimaginative and uninventive.

This " “person” " is often a hypothetical individual or combination of individuals with different skills. It is on the basis of the Skilled Person’s " “common knowledge” " , sometimes referred to as " “common general knowledge” " , that the claims of the patent must be construed: Free World , above, at paras 20, 31(

e) and 44; Bell Helicopter Textron Canada Limitée v Eurocopter, société par actions simplifiée , 2013 FCA 219 at paras 64-65 [ Bell Helicopter ]; Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research , 2020 FCA 30 at para 79 [ Hospira Healthcare (FCA) ]; Teva Canada Limited v Janssen Inc , 2018 FC 754 at paras 64-66 , aff’d 2019 FCA 273 [ Teva- Janssen ]. [ 42 ] In construing the claims of a patent, the Court may require the assistance of expert evidence, for example, with respect to the technical meaning of the terms and concepts used in the claims, and how they would have been understood by the Skilled Person: Free World , above, at para 51.

However, at the end of the day, claims construction is a matter of law for the Court alone: Whirlpool , above, at para 61.

[ 43 ] Where the wording of the claims in a patent are clear and unambiguous, it is generally improper to have recourse to other parts of the patent in construing those claims: Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc , 2016 FCA 119 at paras 39 and 43 [ Mylan Pharmaceuticals ]. [ 44 ] However, to ensure a construction that is reasonable and fair to both the patentee and the public, the Court may have regard to the specification as a whole.

In brief, this can shed light upon the meaning of terms used in the claims or disclose an ambiguity that is not apparent from a reading of the claims alone: Whirlpool , above, at paras 48, 49(g), 52 and 53; Teva-Janssen , above, at paras 73-76. [ 45 ] Nevertheless, the focus of the assessment must remain on the language of the claims: Free World , above, at paras 39-40 and 66. The public is entitled to rely on that language, so long as is interpreted " “fairly and knowledgeably” " : Free World , above, at para 51.

Once the wording of the claims is so interpreted, language situated elsewhere in the patent cannot be relied upon to enlarge or contract the scope of the claims as written, or to achieve a desired result: Whirlpool , above, at para 52; Free World , above, at para 32. This is because " “it is the claims, not the rest of the specification, that define the monopoly” " : Whirlpool , above, at para 18.

In essence, those claims represent the " “fences” " and " “boundaries” " of the patent, which give the " “fields” " of the monopoly " “a comfortable pretence of bright line demarcation” " : Free World , above, at para 14. For this reason, it is impermissible to have recourse to indications of what may have been the underling " “spirit of the invention” " : Free World , above, at para 31(d). [ 46 ] In determining which elements in a claim are essential and which are non-essential, the Court begins with the presumption that all of the elements are essential.

The party alleging otherwise therefore bears the onus of establishing non-essentiality: Free World , above, at para 57; Teva-Janssen , above, at para 70. [ 47 ] That onus can be met by demonstrating either (

i) that on a purposive construction of the words of the claim it was clearly not intended that a particular element be essential, or (ii) that at the date of publication of the patent, the skilled person would have appreciated that the element in question could be substituted without affecting the working of the invention.

Another way of stating the latter part of the test is to ask whether the skilled person would have considered it to be obvious that the invention would " “work in the same way” " with the substituted variant, in the sense of " “performing essentially the same function in substantially the same way to obtain substantially the same result” " : Free World , above, at para 55. [ 48 ] I am aware that in Shire Canada Inc v Apotex Inc , 2016 FC 382 at para 137 , the Court suggested that the Supreme Court of Canada likely intended the disjunctive test described in (

i) and (ii) of the immediately preceding paragraph to be conjunctive. However, given the findings that I have made in

Part VI.A.(4) below with respect to the two prongs of the test for essentiality, nothing in this decision turns on the issue of whether that test is disjunctive or conjunctive. [ 49 ] In ascertaining the inventor’s intention, the Court must confine itself to objective manifestations of that intent in the claims of the patent, interpreted through the eyes of the skilled person at the relevant date and without resort to extrinsic evidence (except to the extent now permitted by

section 53.1 of the Act): Free World , above, at para 66. [ 50 ] In purposively construing the claims, it is incumbent upon the Court to keep in mind that the scope of patent protection must be reasonably predictable and uncertainty must be kept to a minimum. In turn, this requires " “that the subjective or discretionary element of claims

interpretation be kept to a minimum, consistent with giving ‘the inventor protection for that which he has actually in good faith invented’…” " : Free World , above, at para 43, citing Western Electric Co v Baldwin International Radio of Canada , [1943] SCR 750 at 574 . Among other things, this avoids chilling potential investment and competition: Free World , above, at paras 41-42 and 50. [ 51 ] For the purposes of construing the claims of the ‘002 Patent, the relevant date is the Publication Date, i.e., July 1, 2004. For greater certainty, the claims of a patent must be given the same

interpretation for all purposes, regardless as to whether there may be different relevant dates for such purposes: Whirlpool , above, at para 49(b).

(2) The Skilled Person [ 52 ] Allergan and Sandoz, together with and their experts (Dr. Felton and Dr. Fassihi, respectively), generally agree regarding the credentials of the Skilled Person in relation to the ‘002 Patent. However, Dr. Fassihi opined that the Skilled Person (to whom he referred as the " “skilled formulator” " ) would have somewhat more experience or relevant education. [ 53 ] For Dr. Felton, nothing turned on this minor disagreement.

She maintained that her opinions regarding the issues in dispute would remain unchanged even if the Skilled Person were considered to have the additional experience or education described by Dr. Fassihi. [ 54 ] Dr. Fassihi did not explain why he considered the Skilled Person to have at least two years more experience or additional education, relative to the Skilled Person described by Dr. Felton. By contrast, Dr.

Felton supported her description of the Skilled Person as follows: Each of the excipients and their general function in formulations is taught to undergraduate students in pharmaceutics or pharmacy programs. The excipient compatibility and dissolution tests described in the 002 Patent would be understood by and be of interest to undergraduate students in the same discipline. The function(

s) of different excipients and the desire to achieve a defined dissolution rate are each described in textbooks from which I have taught. [ 55 ] Given the foregoing explanation, I accept Dr. Felton’s position regarding the experience and education of the Skilled Person. In brief, that person would hold a Bachelor’s degree in pharmaceutical sciences, chemistry, or another related scientific discipline and would have one to three years of experience applying his or her education in a laboratory.

The laboratory experience would relate to the formulation of drugs and could have been gained through graduate studies or at a job in the pharmaceutical industry. [ 56 ] During the trial of this action, Dr. Felton testified that while the Skilled Person would know how to prepare formulations, he or she may not be responsible for selecting the excipients to be used in a drug, except in relation to " “simple drug products with easy formulation, you know, a stable chemical, very water soluble …” " : Public Transcript, at 62. Sandoz interpreted this as suggesting that the Skilled Person, as defined by Dr.

Felton and Allergan, " “is incapable of formulating a low-solubility drug without assistance – the

very problem that the ‘002 Patent purportedly addresses”". I do not interpret Dr. Felton’s testimony in this manner. In my view, Dr.Felton was simply stating that the Skilled Person would not necessarily be responsible for selecting the excipients ultimately used in adrug, before it is finalized for use.

Her confirmation that the Skilled Person knows how to formulate drugs implies that the SkilledPerson as she defined him/her would have been "“sufficiently versed in art to which the patent relates to enable such person on atechnical level to appreciate the nature and description of the invention and to put it into practice”": Donald H.

MacOdrum, Fox on theCanadian Law of Patents, 5th ed (Toronto: Thomson Reuters, 2019) (loose-leaf updated 2020-6) at §4.13. [57] In any event, keeping in mind that "“[t]he Court must take a fair and generous view as to what sort of person comprises a personskilled in the art”" (Janssen-Ortho v Novopharm, 2006 FC 1234 at para 90, aff’d 2007 FCA 217), I consider that the Skilled Person issomeone who is familiar with the excipients identified in the ‘002 Patent, as well as with their functions and the alternative excipientsavailable to perform those functions.

For greater certainty, the Skilled Person is also someone who has "“the ability to pursue reasonableand logical inquiries”": Apotex Inc v Syntex Pharmaceuticals International Ltd (1999 (FC), CarswellNat 4895, 1 CPR(4th) 22 at para 39 (FCTD), quoting John Bochnovic, "Invention/Inventive Step/Obviousness" in G.F. Henderson, ed., Patent Law ofCanada (Scarborough, Ontario: Carswell, 1994) at 47-48.

(3) Common General Knowledge [58] Common general knowledge [CGK] refers to the knowledge generally known by the Skilled Person at the relevant time: Apotex Incv Sanofi-Synthelabo Canada, 2008 SCC 61 [Sanofi] at para 37. This includes the subset of patents, journal articles and technicalinformation that are generally acknowledged to form part of the CGK in the field to which the patent relates. However, it does notinclude knowledge of all journal articles or other technical information: Bell Helicopter, above, at paras 64-65; Janssen Inc v TevaCanada Ltd, 2020 FC 593 at para 109.

For the purposes of patent construction, the relevant time is the patent publication date, in thiscase, July 1, 2004. [59] Allergan and Sandoz, generally agree regarding the CGK of the Skilled Person. In particular, it is common ground between themand their respective experts (Dr. Felton and Dr. Fassihi) that the CGK of the Skilled Person would have included a general understandingof: solid oral dosage forms and the general requirements of dosage forms.

This includes tablets, capsules, powders and granules, aswell as the fact that powders and granules are often incorporated into capsules for convenience; common excipients (inactive ingredients) used in pharmaceutical tablets and capsules, and the reasons why particular excipientsmay be used, including to aid in manufacturing/processing or product performance, and to improve the drug dissolution rate and/ordrug stability – common excipients include diluents/fillers/bulking agents (including lactose and mannitol), binders (includingstarches and pre-treated starches), lubricants (including magnesium stearate), surfactants (including SLS) and disintegrants(including pre-treated starches); the fact that some common excipients can fill multiple roles within a formulation; the fact that excipients and the length of mixing time can affect dissolution times; the importance of drug dissolution rates, dissolution studies and the methodologies to measure the dissolution profile of a drug; common handbooks and guidelines regarding pharmaceutical formulations, such as: Alfonso R.

Gennaro, ed, Remington: TheScience and Practice of Pharmacy, 20th ed (Baltimore: Lippincott Williams & Wilkins, 2000) [Remington]; Arthur H.

Kibbe, ed,Handbook of Pharmaceutical Excipients, 3rd ed (Washington: American Pharmaceutical Association Press, 2000); ThePharmacopeia of the United States, 25th ed (Rockville, MD: United States Pharmacopeial Convention, 2011); the InternationalCouncil for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines; and the Food and DrugAdministration’s Guidelines regarding active ingredients and finished dosage forms; tests performed to assess drug potency and content uniformity, and be able to interpret the results from such tests; and various manufacturing methods, including (

i) wet granulation – including powder granulation, flued-bed wet granulation andspray-dry granulation; (ii) dry granulation; and (iii) dry blending (which can be used entirely separately, or as simply the first stepin both wet and dry granulation). [60] Allergan and Sandoz, supported by Dr. Felton and Dr.

Fassihi, respectively, also appear to agree that the CGK of the Skilled Personwould have included: the knowledge that, in a wet granulation process, a lubricant is typically added near the end of the formulation process, beforetableting or the filling of capsules, an understanding of common pre-formulation steps, including optimization procedures, statistical design, the design orexperiments or factorial design and tests/processes to determine how an API would interact with common excipients and behaveunder formulation conditions, such as dry blending and wet granulation; an understanding of the potential impact of subjecting an API to compression forces (which are part of the tableting process); and an understanding that if there were other products on the market from the same family of drugs (similar chemical structure), thoseproducts should be researched to determine what excipients were used with those formulations. [61] However, despite the representation in the Joint List of Issues that their respective "“experts generally agree regarding the [CGK] ofthe Skilled Person”", Allergan and Sandoz disagreed about whether 13 articles addressed in the First Fassihi Report formed part of therelevant CGK or the broader "“state of the art”".

Four of those articles focus on matters relating to light and discolouration that are no

longer relevant in this proceeding. The remaining nine articles deal with issues addressed in the immediately preceding paragraphs above. Dr. Felton opined that those articles do not form part of the relevant CGK, as they relate to different therapeutic classes, different biological targets and different chemical structures. For this reason, she added that they would not likely have been found by the Skilled Person on a reasonably diligent search. I do not consider this disagreement between Dr. Felton and Dr.

Fassihi in relation to those articles to have a material bearing on the claim construction issue in this proceeding. However, pursuant to the recent decision in Hospira Health (FCA) , above, at para 86, those articles must be considered in the obviousness analysis, regardless of whether they may not have been found by the Skilled Person in the course of a reasonably diligent search. This is because they form part of the body of information " “available to the public in Canada or elsewhere” " , within the meaning of

section 28.3 of the Act . The issue of whether the Skilled Person would have found those articles on a reasonably diligent search and then thought to combine their collective teachings with the other CGK and with the other prior art discussed later in these reasons is something that is relevant to the fourth step in the obviousness analysis: Hospira Health (FCA) , above at para 86; Biogen Canada Inc v Taro Pharmaceuticals , 2020 FC 621 at para 153 [ Biogen ] . [ 62 ] Allergan and Sandoz, also disagree on certain other aspects of the CGK of the Skilled Person.

The principal disagreements in this regard are based on disagreements between Dr. Felton and Dr. Fassihi that will be addressed in Parts VI.A.(4) and VI.B of these reasons, dealing with the essential elements of the ‘002 Patent and obviousness, respectively.

(4) The Essential Elements of the ‘002 Patent [ 63 ] The ‘002 Patent contains six claims. Only four of them are in dispute. Those are claims 1-3 and 6, which state as follows: 1. A capsule which comprises: (1) a granule prepared by wet granulation of a mixture of

a) as the active ingredient, an indoline compound represented by the formula:

b) D-mannitol and

c) partially pregelatinized starch; and

(2) d) a lubricant selected from the group consisting of magnesium stearate, calcium stearate and talc, and

e) sodium lauryl sulfate, wherein 85% dissolution time of the capsule is not more than 15 minutes in a dissolution test according to method 2 (paddle method) of the Japanese pharmacopoeia in a condition using water as a test medium and a paddle speed of 50rpm. 2. The capsule according to claim 1, wherein the lubricant is magnesium stearate. 3. The capsule according to claim 2, which further comprises 0.1 to 2 parts of sodium lauryl sulfate based on 1 part of magnesium stearate. … 6. A method for preparing a capsule, comprising the steps of (1) granulating a compound represented by the formula:

b) D-mannitol and

c) partially pregelatinized starch by a wet granulation process; and (2) mixing the granule obtained in step (1),

d) a lubricant selected from magnesium stearate, calcium stearate and talc, and

e) sodium lauryl sulfate. [ 64 ] There is no significant dispute in this proceeding regarding the meaning of the words in the foregoing claims. Instead, Allergan and Sandoz disagree on whether the Wet Granulation Elements are essential. For greater certainty, it is common ground between them that the " “compound” " described in claims 1 and 6, is silodosin. [ 65 ] For the reasons that follow, I consider that the Wet Granulation Elements are essential in each of Claims 1-3 and 6. (

a) Claim 1 [ 66 ] Among other things, claim 1 claims a capsule formulation comprising " “a granule prepared by wet granulation of a mixture of” " silodosin and certain identified excipients. As mentioned above, there is no dispute in this proceeding with respect to the identified excipients and there is no dispute with respect to the words " “wherein 85% dissolution time of the capsule is not more than 15 minutes in a dissolution test according to [Method 2]” " . The sole claims construction dispute is with respect to whether the Wet Granulation

Elements are essential. [ 67 ] On a plain reading of claim 1, the terms " “granule” " and " “prepared by wet granulation” " are unambiguous. There is nothing in the language of claim 1 itself to suggest that these elements, which have the effect of limiting the scope of the claim, were not intended to be essential. Accordingly, those elements are presumed to be essential. This presumption will hold unless it is established either (

i) that on a purposive construction of the patent disclosure and claims as a whole, those elements were not intended to be essential ( Whirlpool , above at paras 48, at 49(g)), or (ii) that at the Publication Date the Skilled Person would have appreciated that those elements could be substituted without affecting the working of the invention: Free World , above, at para 55. (See discussion at paras 46 - 48 above.) I will now address each of those two prongs of this test separately below. (

i) The First Prong of the Test: A Purposive Construction of the Wet Granulation Elements [ 68 ] Allergan and Dr. Felton maintain that there are a number of indicators in the ‘002 Patent that reveal that the Wet Granulation Elements were not intended to be essential. I disagree. [ 69 ] Allergan and Dr. Felton insist that the Skilled Person would have understood that the claims of the ‘002 Patent focus upon, and are directed to, a specific combination of excipients and silodosin in capsule formulations that achieve a well-defined dissolution profile.

That profile is 85% dissolution in not more than 15 minutes in a test according to Method 2. Stated differently, the achievement of 85% silodosin dissolution within 15 minutes, as described above, was the purported essence of the invention. This achievement was important because a drug’s dissolution profile and batch-to-batch uniformity can be critical for both efficacy and safety.

In addition, the rapid dissolution profile permitted the claimed solid-dose formulation to be expected to behave like a solution, and therefore to generally have no bioavailability problems, e.g., of the type that can sometimes be associated with solid formulations. Allergan maintains that when the ‘002 Patent is understood in this manner, it becomes readily apparent that the Wet Granulation Elements in claim 1 are not essential. [ 70 ] Dr. Felton opined that a Skilled Person would understand that the Wet Granulation Elements in claim 1 are not essential for five reasons. [ 71 ] First, Dr.

Felton noted that on page 3 of the Technical Field

section of the ‘002 Patent, a capsule comprising " “a granule prepared by wet granulation of a mixture of” " silodosin and the identified excipients is described as simply " “a particular embodiment of the invention” " . This was the first reference to the Wet Granulation Elements, and occurred after " “the present invention” " was described over the course of the preceding two pages. Dr. Felton stated that the Skilled Person would understand from this that the Inventors made a distinction between " “the present invention” " and " “a particular embodiment” " of the invention.

I agree that this provides some indication that the Inventors may not have intended the Wet Granulation Elements to be essential. However, as discussed below, a reading of the patent as a whole clearly suggests otherwise. [ 72 ] Second, Dr. Felton opined that the Skilled Person would expect that other manufacturing methods (such as dry granulation and dry mixing) could be substituted without affecting the working of the invention. This will be discussed in the next

section below. [ 73 ] Third, Dr. Felton opined that the Skilled Person would understand that the lubricants identified in claim 1 would overcome the disclosed difficulties associated with dry production processes. Once again, this will be addressed in the next

section below. For the present purposes, it will suffice to note that this is not something that reflects any intention whatsoever, explicit or implicit, that the Wet Granulation Elements are not essential. In any event, relative to the other indicators of intent discussed below, the presence of lubricants in claim 1 would constitute a weak indicator of the Inventors’ intentions in relation to this issue. [ 74 ] Fourth, Dr. Felton observed that the ‘002 Patent does not set out any details as to how to conduct wet granulation, even though different methods of wet granulation were known.

She opined that " “[i]f wet granulation were important, the Skilled Person would expect to see details explaining (

i) which binder to select, (ii) how much of the binder to use, (iii) how to select the granulating fluid (solvent), and (iv) desired residual water” " : Felton First Report, at para 131. Allergan added that the claims in the ‘002 Patent also do not address the drying conditions that are apparently necessary to make granules by wet granulation, even though those conditions were described whenever wet granulation was clearly used in the tests discussed in the ‘002 Patent (e.g., Test Example 4 and Examples 1-3). However, as Dr.

Felton conceded, the patent also does not set out details with respect to mannitol and pregelatinized starch, which she considers to be essential elements: Public Transcript, at 157-160. (For example, there are different types of mannitol that can be used, and pregelatinized starch can be used as a filler, a binder and sometimes a disintegrant: Public Transcript, at 48.) Moreover, elsewhere in her first report, Dr. Felton explicitly stated that instructions regarding wet granulation were not required for the Skilled Person to know how to formulate using wet granulation.

The full import of her view in this regard is captured in the following passage: 73. The Skilled Person would have been familiar with wet granulation as it was a well-known formulation approach that had been used in the pharmaceutical industry for decades. No details are provided on the 002 Patent about how to carry out the wet granulation process, although details for drying the granules in the fluid bed apparatus were provided. Regardless, multiple wet granulation techniques were known to the Skilled Person and could have been selected and utilized without difficulty.

Instructions from the 002 Patent were not required for the Skilled person to known [sic] how to formulate using wet granulation. [ 75 ] Having regard to all of the foregoing, I consider that the absence of details pertaining to wet granulation is at best a weak indication that the Inventors may not have intended the Wet Granulation Elements to be essential. [ 76 ] Fifth, Dr. Felton noted that there are no studies reported in the ‘002 Patent to indicate to the Skilled Person that wet granulation is a necessary manufacturing process.

Although the patent notes that " “processes for preparing formulations according to conventional procedures” " were investigated, no comparison was made between wet granulation and the other conventional processes, i.e., dry granulation and dry blending. Dr. Felton suggested that the Skilled Person would infer from this that wet granulation was not the only method that could be used to produce the claimed formulation. Instead, the Skilled Person would understand that other methods could be used.

[ 77 ] I consider the absence of any discussion of the above-described studies in the ‘002 Patent to be a relatively weak indicator of an intention that the Wet Granulation Elements may not have been intended to be essential. As discussed below, there are other, stronger, indications of a contrary intention. [ 78 ] In addition to all of the foregoing, Allergan submitted that that the ‘002 Patent includes other important indications that the Wet Granulation Elements were not intended to be essential.

In particular, in its written submissions, Allergan states that the ‘002 Patent only discloses the use of wet granulation in place of a dry process once (‘002 Patent, at page 14), and that discussion pertained to a formulation attempt [the First Formulation ] which involved a tablet and did not result in a suitable capsule formulation, due to an unexpected fill problem. [ 79 ] I do not read that particular reference to the use of wet granulation in place of a dry process as pertaining solely to the purported First Formulation for two independent reasons.

First, the sentence in question specifically refers to the wet granulation process being used to achieve a " “high precision for filling” " . [1] This implicitly refers to capsules. As Allergan recognized elsewhere, tablets are pressed, rather than filled: Public Transcript, at 640. [ 80 ] Second, it is readily apparent that the discussion of the purported First Formulation is part of a broader disclosure that teaches away from the use of dry processes in connection with the claimed invention.

This is so despite the sub-optimal quality of the translation from the original Japanese language. [ 81 ] The teaching away from the use of dry processes begins at page 8 of the patent, in the following passage: KMD-3213 [i.e., silodosin] contained as an active ingredient in a solid oral dosage form pharmaceutical of the present invention has potent adhesive and electrostatic properties.

Particularly, in cases where formulations are prepared by a dry process , electrostatic charges are generated by physical irritations caused through processes such as pulverization, agitation, blending, granulation and the like, which in turn cause a decrease in fluidity of pulverized, blended or granulated materials, worsen handling properties and decrease precision for content uniformity of an active ingredient. (Emphasis added.) [ 82 ] After then discussing the findings that were made in respect of various additives that were investigated (including binders, lubricants and surfactants), the patent turns to a discussion of the processes for preparing formulations according to conventional procedures that were investigated.

Once again, the patent teaches away from the use of a dry process. Specifically, the patent states the following (beginning at the bottom of page 12): Firstly, in cases where formulations are prepared by dry processes , pulverized, blended or granulated materials, which are prepared at pulverization, blending or granulation processes, generate electrostatic charges and decrease in fluidities of the materials.

As a result, particularly in the case of preparing capsules, handling properties are worsened at the filling processes, and uniformity of the fill volume and precision for filling are worsened . (Emphasis added.) [ 83 ] In the next paragraph (on page 13), the disclosure turns to a discussion of lubricants and once again teaches away from the use of dry processes.

In addressing the importance of lubricants and the additional complexity that they introduce (in formulating capsule and tablet dosage forms), the disclosure states as follows: KMD-3213 has inherently potent adhesive properties, and particularly in the case of dry processes , electrostatic charges are generated and fluidities of blended or granulated materials are worsened as described above, which result in the use of much more amount of lubricants.

However, lubricants have generally water repellant properties and the use of lubricants causes delaying in a dissolution time. (Emphasis added.) [ 84 ] In addition to explicitly teaching away from dry processes, the disclosure of the patent explicitly teaches towards a wet granulation process. It does so in two places, the second of which is the passage on page 14 (discussed at paragraphs 78-79 above).

On the first occasion (at page 10), the disclosure states as follows: Moreover, the present inventors have studied a variety of processes for preparing formulations, and have found out that formulations, which has [sic] satisfactory content uniformity without influenced [sic] by electrostatic charges and has [sic] good stabilities an excellent dissolution properties, are prepared through granulating by a wet process and regulating the amount of lubricant and a mixing time. (Emphasis added.) [ 85 ] As with the passage on page 14 of the ‘002 Patent, Allergan suggests that this passage refers solely to the purported First Formulation, which was a tablet formulation, because there is no reference to a capsule or to SLS. [ 86 ] I disagree.

Read in its context, it is readily apparent that the passage quoted immediately above pertains to the claimed invention, which does not involve tablets. After addressing (in that passage) the issue of the manufacturing process, the paragraph proceeds to disclose two additional findings and then states: " “Based on these findings, the present invention has been accomplished.” " (Emphasis added.) [ 87 ] The two additional findings were (

i) that " “in the cases [sic] of capsules, formulations with excellent dissolution profiles are prepared by admixing a lubricant in a specific ratio with another additive which is a solid with hydrophilic or surface-active properties” " , and (ii) " “the photo-degradations of KMD-3213 are well prevented by titanium oxide and photostable formulations can be prepared by using a capsule containing titanium oxide or a coating agent containing titanium oxide” " . (Emphasis added.) [ 88 ] In brief, well before the passage on page 14 of the patent that Allergan states is confined to the purported First Formulation (which involved tablets), the ‘002 Patent explicitly teaches away from the use of dry processes and towards a wet granulation process (for capsules).

I agree with Dr. Fassihi that in view of this teaching, the Skilled Person would not have read the reference on page 14 to " “granulating through a wet process in place of a dry process” " as being confined to the purported First Formulation and tablets. [ 89 ] My conclusion in this regard is reinforced by the fact that the disclosure of the ‘002 Patent also teaches towards wet granulation in

the following passage (that appears on page 19), which Dr. Felton conceded describes a wet granulation process: Public Transcript, at 136. Solid oral dosage form pharmaceuticals of the present invention such as capsules can be prepared as follows. KMD-3213, acceptable salt or pharmaceutically acceptable solvate thereof is admixed with a filler, preferably D-mannitol, if required, an appropriate binder and disintegrator. Then, the mixture is kneaded with the addition of an aqueous solution of binder in an appropriate concentration, and if required, sieved to prepare a granule.

Thereafter, a lubricant, preferably magnesium stearate and a solid additive with hydrophilic or surface-active properties, preferably sodium lauryl sulfate are added to the granule, in that case the lubricant being used in an amount of 0.5-2.0%, and the solid additive being used in a ratio of l:10 to 20:10, more preferably 5:10 to l0:l0, evermore preferably 5:10 relatively to magnesium stearate.

Then, mixing and filling into an appropriate capsule, preferably a capsule containing titanium oxide in a blending amount of not less than about 3%, more preferably about 3.4 to 3.6% provide capsules. [ 90 ] Moreover, with one exception, the test formulations discussed in the patent all used the wet granulation process. This was acknowledged by Dr. Felton, who also conceded that the one exception was a dry blended formulation that did not include all of the essential excipients – it was missing SLS: Public Transcript, at 176 and 195.

She further conceded that there are no examples in the ‘002 Patent of a dry granulation process used to make a capsule: Public Transcript, at 137. Likewise, the only embodiment of the invention discussed in the Technical Field

section of the patent was prepared by wet granulation. [ 91 ] In my view, all of the foregoing, taken together, demonstrates a clear indication that the Inventors intended the Wet Granulation Elements to be essential.

For greater certainty, this clear indication overcomes the relatively weak indications of a contrary that are discussed at paragraphs 71 , 73 , 75 and 77 above. [ 92 ] Allergan also maintains that the discussion of what it characterizes as " “the second formulation attempt” " [the Second Formulation ], which begins at line 13 on page 14 of the ‘002 Patent, reflects that the Inventors did not intend the Wet Granulation Elements in claim 1 to be essential.

In this regard, Allergan asserts that the disclosure of the purported Second Formulation, which it says resulted in the claimed invention, teaches a solution that not only works for wet granulation but also works for dry blending and dry granulation. Allergan maintains that it does so by disclosing the possibility of using " “atypically high amounts of lubricant” " , together with the surfactant SLS to offset the waterproofing effect of the lubricant.

Allergan observes that a Skilled Person would have understood that by permitting the use of an atypically high amount of lubricant, the patent is not requiring the claimed formulation to be produced by a wet granulation process. Allergan explains that this is because an atypical amount of lubricant is not required in a wet granulation process, even for capsules. Allergan insists that there would have been no need to investigate and solve for the use of atypically high amounts of lubricant, if the Inventors had intended the Wet Granulation Elements to be essential.

Allergan adds that the absence of any discussion of wet granulation in connection with the Second Formulation would have provided a further reason for the Skilled Person to understand that this formulation was " “entirely agnostic” " to the manufacturing process. [ 93 ] I disagree with this

interpretation of the disclosure in relation to the purported Second Formulation. [ 94 ] Even if one accepts the sequence of events as advanced by Allergan, the reason given for the decision of the Inventors to continue their investigations beyond the purported First Formulation is that there continued to be a high risk for " “a filling problem such as sticking” " .

Accordingly, they investigated the use of lubricants in an amount of " “not less than 1%” " to solve that problem (which relates to capsules), while also achieving the desired dissolution profile. [2] [ 95 ] In my view, the mere fact that the Inventors pursued this investigation does not, as Allergan suggests, necessarily imply that they were " “agnostic” " to the process by which the capsules were produced: Public Transcript, at 637.

Although it was a matter of common general knowledge that increased lubricant is more often used in a dry formulation process, a Skilled Person reading the disclosure would have understood that it was entirely possible that the Inventors wished to solve the filling/sticking problem using the wet granulation process, particularly given the problems that they had discovered with respect to dry processes.

The Skilled Person would also have understood that the adverse impact on dissolution caused by an increase in the amount of lubricant could potentially be offset by the use of a surfactant, such as SLS, whether in a wet granulation process or a dry process: Public Transcript, at 471-73; Remington , above, at 861. [ 96 ] It follows that the Skilled Person would not necessarily infer from fact that the Inventors decided to investigate the use of a lubricant in amounts of " “not less than 1%” " that the Inventors had clearly intended to convey that the Wet Granulation Elements in claim 1 were not essential. [ 97 ] Indeed, the Skilled Person would have understood from a reading of the tests that pertained to the investigation of what Allergan characterizes as the Second Formulation that several of those tests, as well as Test Example 3, involved the use of the wet granulation process in testing capsule formulations.

This was acknowledged by Dr. Felton: Public Transcript, at 155 and 195. The Skilled Person would also have understood that the description of the wet granulation process in several of those examples (which involved an amount of lubricant in excess of 1%) was not matched by any similar description of a dry process anywhere in the patent. [ 98 ] In addition, although it was common general knowledge that " “[m]ost lubricants … are used in concentrations below 1%” " , it was also known that " “[t]he quantity of lubricant varies, being as low as 0.1% and, in some cases, as high as 5%” " : Remington , above, at 861.

It was not suggested during this proceeding that this particular CGK was confined to dry processes. [ 99 ] In brief, having regard to the foregoing, I do not consider that the disclosure with respect to the purported Second Formulation reflects any intention, clear or otherwise, that the Inventors decided to revisit the possibility of using a dry process, which they had already discovered worsened the fluidities of blended or granulated materials.

Stated differently, this disclosure, including in respect of the investigations that were conducted in relation thereto, does not reflect any intention that the Inventors considered the Wet Granulation Elements to be non-essential. I reach the same conclusion with respect to Allergan’s suggestion that the absence of any explicit specification regarding content uniformity, flowability and stabilities, in connection with the purported Second Formulation, reflects an intention that the Wet Granulation Elements were not considered essential: Plaintiff’s (Allergan) Outline of Oral Argument, at

paras 20(

g) and (h). [ 100 ] In any event, Allergan’s

interpretation of this disclosure requires such a subtle reading of the patent that it does not rise to the level of conveying a clear intention that the Wet Granulation Elements are not essential elements of claim 1 : Free World , above, at para 55. Indeed, permitting such a subtle and unclear indication of intention to displace the unambiguous language in claim 1, as well as the much clearer teachings in the ‘002 Patent away from dry processes, towards wet granulation, would undermine the important objectives of promoting predictability and reducing uncertainty: Free World , above, at paras 41-42.

Rather than clearly disclosing an ambiguity in the language of claim 1, it would introduce an ambiguity by suggesting an intention that is not readily apparent on a purposive reading of the claim 1, having regard to the specification as a whole. [ 101 ] For greater certainty, the fact that the Inventors (and the Skilled Person) might have understood that the claimed dissolution profile could also potentially be achieved through dry mixing or dry granulation, as Allergan suggests, does not suffice to provide a clear indication that the Inventors did not intend the Wet Granulation Elements to be essential: Free World , above, at para 55.

In this regard, I do not agree with Allergan’s suggestion that Dr. Fassihi acknowledged that the discussion of the Second Formulation contemplated the possibility of using a dry process. My

interpretation of his evidence is that he simply acknowledged that the purported First Formulation, which did not include SLS, had a high risk of a filling problem, as stated at page 14 of the patent.

Elsewhere, he was very clear that he read the disclosure pertaining to the purported Second Formulation as contemplating a wet granulation process: see for example, Public Transcript, at 493-494. [ 102 ] I also agree with Sandoz’s submission that the use of the limiting terms " “granule” " and " “prepared by wet granulation” " in claim 1, when the options of dry mixing and dry granulation were known, suggests that the Inventors intended those terms to be essential elements: Teva v Janssen , above, at para 312. [ 103 ] In

summary, insofar as the Inventors’ intention is concerned, a purposive reading of claim 1 and the patent specification as a whole reflects that the Wet Granulation Elements were intended to be essential. Allergan’s assertions to the contrary constitute an attempt to stretch the language of claim 1 to encompass anything that achieves the same desired result as what was actually claimed.

This is not permissible: Free World , above, at para 32. (ii) The Second Prong of the Test: Would the Skilled Person Have Appreciated that a Dry Process Could be Substituted Without Affecting the Working of the Claimed Invention? [ 104 ] Allergan and Dr. Felton maintain that at the Publication Date, the Skilled Person reading the ‘002 Patent would have understood that the method of manufacture would not impact and was not critical to the working of the invention claimed therein.

In this regard, they assert that the Skilled Person would have understood that the lubricants identified in claim 1 would overcome the disclosed difficulties associated with dry production processes. They insist that it would have been obvious to the Skilled Person that a dry process could be substituted for the wet granulation process described in the patent, with routine experimentation.

Allergan adds that the fact that Sandoz’s capsules, which contain the same API and excipients as that invention but were not made using a wet granulation process , nonetheless achieve a similar rapid dissolution as the invention, serves to affirm the Skilled Person’s understanding that the Wet Granulation Elements are not essential to achieve the claimed dissolution rate. [ 105 ] I disagree. [ 106 ] As discussed at paragraphs 80 - 91 above, the patent specification both teaches away from the use of a dry manufacturing process and towards the wet granulation process.

In the course of doing so, it makes specific references to the problems associated with dry processes.

For the present purposes, the most noteworthy of these passages are as follows: Particularly, in cases where formulations are prepared by a dry process , electrostatic charges are generated by physical irritations caused through processes such as pulverization, agitation, blending, granulation and the like, which in turn cause a decrease in fluidity of pulverized, blended or granulated materials, worsen handling properties and decrease precision for content uniformity of an active ingredient. (Page 8, emphasis added.) Firstly, in cases where formulations are prepared by dry processes , pulverized, blended or granulated materials, which are prepared at pulverization, blending or granulation processes, generate electrostatic charges and decrease in fluidities of the materials.

As a result, particularly in the case of preparing capsules, handling properties are worsened at the filling processes, and uniformity of the fill volume and precision for filling are worsened . (Pages 12-13, emphasis added.) KMD-3213 has inherently potent adhesive properties, and particularly in the case of dry processes , electrostatic charges are generated and fluidities of blended or granulated materials are worsened as described above, which result in the use of much more amount of lubricants .

However, lubricants have generally water repellant properties and the use of lubricants causes delaying in a dissolution time . (Page 13, emphasis added.) [ 107 ] After describing the abovementioned problems, the disclosure specifically explains that " “formulations with good fluidities of blended materials, satisfactory handling properties and high precision for filling can be prepared by granulating through a wet process in place of a dry process, using lubricants in an amount of not more than 1% and mixing for a period of about 3 minutes” " : ‘002 Patent, at page 14 (emphasis added). [ 108 ] Given the foregoing, I consider that it would not have been obvious to the Skilled Person that a dry process could be substituted for the wet granulation process described in the patent, with routine experimentation.

Indeed, to the extent that a dry process would likely require a greater amount of lubricant, as well as a change in the amount of SLS or other surfactant that might be used, Dr.

Felton’s position on this is somewhat inconsistent with her position that " “the selection of excipients and their ratios to achieve a specific dissolution profile was not routine or predictable” " , and that the Skilled Person would know that " “[d]ifferent formulations can impair or enhance the dissolution rate and efficacy of the drug, particularly poor water soluble drugs” " , such as silodosin: Felton Second Report, at paras 86 and 99(4).

[ 109 ] Considering Dr. Felton’s caution regarding the potential impact of changes to a formulation, and having regard to the problems with dry processes that were identified in the ‘002 Patent disclosure, I accept Dr. Fassihi’s opinion that the Skilled Person would have understood that the adhesive and electrostatic properties of silodosin " “could be problematic in a dry process and decrease the precision for content uniformity” " : Fassihi First Report, at para 62. I also accept Dr.

Fassihi’s related statement that those properties were such that " “it would likely be difficult to prepare [a capsule formulation using a method other than wet granulation] with acceptable content uniformity for regulatory approval” " : Fassihi Second Report, at para 22. [ 110 ] In addition, I accept Dr. Fassihi’s testimony regarding another property of silodosin that is problematic when attempting to use the dry granulation process.

This is the property that results in silodosin undergoing polymorphic transformation when subjected to the compression used in the dry granulation process: Public Transcript, at 479-481.

I note in passing that this testimony is corroborated by Kissei’s internal records, which explain that because it was known that the bulk form of silodosin undergoes " “polymorphism conversion under strong pressure … dry method granulation examination was not done, and wet granulation (wet method) was adopted” " : Kissei Production No. 229, at para 5.2.4. [ 111 ] Given the manner in which the ‘002 Patent taught away from the use of dry processes, and given Dr.

Fassihi’s evidence regarding the Skilled Person’s understanding of silodosin’s properties and their implications for a dry process, I consider that the Skilled Person would not have understood that a dry process could be substituted for the wet granulation process without materially affecting the working of the invention. Put differently, the Skilled Person would not have appreciated that the invention " “would obviously work in the same way” " : Free World , above, at para 55.

The disclosure in the patent suggested otherwise. [ 112 ] For completeness, I will simply add in passing that I do not accept Allergan’s submission (at paragraph 104 above) regarding the significance of the Sandoz Product for the purposes of construing claim 1.

In brief, the fact that a third party such as Sandoz might have been able to achieve a similar rapid dissolution as the invention , with the same API and excipients, is not particularly relevant if the allegedly infringing product does not infringe each of the essential elements of the invention: Free World , above, at para 32. (iii) The Prosecution History of the ‘002 Patent [ 113 ] Sandoz submits that its position that the Wet Granulation Elements are not essential elements in claim 1 is supported by the file prosecution history of the ‘002 Patent.

It makes a similar argument with respect to the other claims in dispute in this proceeding. [ 114 ] Evidence with respect to the prosecution history of a patent is also known as " “file wrapper” " evidence. This is because in the United States representations to the Patent Office were historically noted on the file cover or " “wrapper” " .

Pursuant to the doctrine of " “file wrapper estoppel” " , sometimes called " “prosecution history estoppel”, " patentees may be precluded from recapturing ground conceded during negotiations with the Patent Office: Free World , above, at para 63. [ 115 ] However, in Free World , above, at paragraph 66, the Supreme Court of Canada confirmed that there is no doctrine of file wrapper estoppel in Canada and that the prosecution history pertaining to a patent is extrinsic evidence that cannot be considered in construing the patent. [ 116 ] Notwithstanding the foregoing, Sandoz maintains that the representations made by a patent applicant constitute objective facts that can be considered by the Court.

In support of this position, Sandoz relies on Distrimedic Inc v Dispill Inc , 2013 FC 1043 at para 210 [ Distrimedic ].

There, the Court stated that a " “change in the wording of a claim as a result of an objection from the Patent Office is an objective fact from which an inference may be drawn, and is not the same as representations made to the Patent Office” " . [ 117 ] In Distrimedic , the change and the objection in question occurred after a Notice of Allowance that had been granted in respect of a prior version of the Defendant’s patent was withdrawn, subsequent to another patent having been brought to the attention of the Patent Office.

To overcome the Patent Office’s objection and distinguish its invention from the invention covered by the other patent, the Defendant amended the patent. [ 118 ] Distrimedic would appear to have been overcome by the enactment of

section 53.1 of the Act , which now codifies the limited circumstances in which Parliament intended the prosecution history of a patent to be admissible in an action or proceeding respecting a patent. In any event, the Court made it very clear in Distrimedic that " “statements or admissions made in the course of patent prosecution should not be used for the purpose of interpreting a claim…” " : Distrimedic , above, at para 210. This is precisely what Sandoz is seeking to do in the present proceeding. Moreover, the facts in Distrimedic are distinguishable from the facts in the current proceeding.

This is because the representations and amendments upon which Sandoz wishes to rely in the present proceeding were made in the course of prosecuting the ‘002 Patent, as opposed to in the type of situation that was at issue in Distrimedic . [ 119 ] Subsequent to Free World and Distrimedic , Parliament enacted

section 53.1 of the Act . That provision states as follows: 53.1

(1) In any action or proceeding respecting a patent, a written communication, or any part of such a communication, may be admitted into evidence to rebut any representation made by the patentee in the action or proceeding as to the construction of a claim in the patent if (

a) it is prepared in respect of (

i) the prosecution of the application for the patent, (ii) a disclaimer made in respect of the patent, or (iii) a request for re-examination, or a re-examination proceeding, in respect of the patent; and (

b) it is between (

i) the applicant for the patent or the patentee; and

(ii) the Commissioner, an officer or employee of the Patent Office or a ember of a re-examination board. [120] The Legislative

Summary pertaining to this provision, which appeared in Bill C-86, states as follows: Clauses 187, 191, 197 and 201 make written communications between the Patent Office and an individual that occurredduring the patent application process admissible as evidence in patent litigation. Previously, any communications between apatent owner and the Patent Office made during a patent application could not be considered as evidence in any laterlitigation involving that patent.

As a result, patent owners were not bound, when enforcing their patent, to what they had saidto the Patent Office about its scope, allowing them to assert a larger reach for their patent in court than they had initiallyasserted in their application. (Emphasis added.) [3] [121] Sandoz asserts that the words "“an individual”" in the second line of the above-quoted

summary suggests that Parliament intendedsection 53.1 to be applicable to permit file prosecution history evidence to be admitted, not just to rebut representations made by apatentee in an action or proceeding, but also by other people who make representations in the course of prosecuting a patent. Sandozmaintains that such an

interpretation would be consistent with the following language from the Budget Implementation Act, 2018, No. 2,SC 2018, c 27, which states: Subdivision A of Division 7 of

Part 4 amends the Patent Act in order to […] (

d) ensure that patent prosecution histories may be admissible into evidence for certain purposes; […] [122] Sandoz adds that permitting

section 53.1 to be applied to representations made by a licensee in the course of prosecuting a patentwould be consistent with the definition of "“patentee”" in s.2 of the Act, which states: "“patentee means the person for the time beingentitled to the benefit of a patent; (brevet/ ou titulaire d’un brevet)”".

Given that Allergan is the exclusive licensee of the ‘002 Patent,Sandoz submits that it is the only company entitled to the benefit of that patent in Canada. [123] Finally, Sandoz states that it can be inferred from certain representations that were made to the Senate Banking, Trade andCommerce Committee [BTCC] that Parliament was "“alerted to the prospect that "section 53.1 of the Act would introduce ‘American-style’ estoppel doctrine and chose not to amend the legislation, thereby accepting that the

section would be applicable to licensees” [4].The representations in question were made in a written submission by the Intellectual Property Institute of Canada [IPIC] to the BTCC.In this regard, IPIC stated that

section 53.1 "“introduces the American-style estoppel doctrine into Canadian Law”": Intellectual PropertyInstitute of Canada (IPIC) Recommendations on Possible Amendments to Bill C-86, Subdivisions A, B, C, E & H, Submission to theSenate Standing Committee on Banking, Trade and Commerce, November 27, 2018, at 4 [IPIC Submission]. [124] In my view, none of the arguments advanced by Sandoz can overcome the plain wording of subsection 53.1(1), a contextualreading of the Act or the jurisprudence in respect of the definition of the word "“patentee”" in

section 2 of that legislation. [125] It is trite law that "“the words of a statute must be read ‘in their entire context and in their grammatical and ordinary senseharmoniously with the scheme of the Act, the object of the Act, and the intention of Parliament’”": Canada (Minister of Citizenship andImmigration) v Vavilov, 2019 SCC 65 at para 117, quoting Rizzo & Rizzo Shoes Ltd (Re), (SCC), [1998] 1 SCR 27 atpara 21; and Bell ExpressVu Limited Partnership v Rex, 2002 SCC 42 at para 26, both quoting E.

Driedger, Construction of Statutes, 2nded. (Toronto: Butterworths, 1983) at 87. [126] The "“chapeau”" in subsection 53.1(1) plainly limits the scope of that provision to permitting certain written communications to beadmitted into evidence to rebut any representation made by the patentee in an action or proceeding, in respect of the construction of aclaim in a patent that is at issue in the action or proceeding. In the present proceeding, it is admitted that the patentee is the defendantKissei, which has not made any representation to the Court with respect to the construction of the ‘002 Patent.

Accordingly, in theabsence of any clear indication elsewhere within the scheme or object of the Act that Parliament intended to word "“patentee”" to includea licensee of a patent, subsection 53.1(1) cannot be invoked in this proceeding. [127] I do not agree with Sandoz’s position that a licensee falls within the meaning of the word "“patentee”", as defined in

section 2 ofthe Act, namely, "“the person for the time being entitled to the benefit of a patent”". This position was specifically considered andrejected in Electric Chain Co of Canadas Ltd v Art Metal Works Inc, (SCC), [1933] SCR 581 at 586-587 [ElectricChain]. The effect of that decision was that a licensee had no right to be a party to an infringement action in Canada. As a result, what issubsection 55(1) was added to the Act: American Cyanamid Co v Novopharm, [1972] FC 739 at paras 23-24 (FCA) [AmericanCyanamid].

That provision, which has undergone some minor amendments that are not germane for the present purposes, states: “A person who infringes a patent is liable to the patentee and to all persons claiming under the patentee for all damagesustained by the patentee or by any such person, after the grant of the patent, by reason of the infringement.” [128] It has since been confirmed that a person who is a licensee under a patent is a "“person claiming under”" the patentee within themeaning of subsection 55(1): Armstrong Cork Canada v Domco Industries Ltd, (SCC), [1982] 1 SCR 907 at 914;American Cyanamid, above, at paras 31-32. [129] What is instructive for the present purposes is that while the Act was amended to permit a licensee to sue for infringement, thedefinition of "“patentee”" was not amended following the

interpretation that it was given in Electric Chain, above. [130] Moreover, given that Parliament included the words "“the ap

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