LES LABORATOIRES SERVIER v. SERVIER CANADA INC., 2015 FC 108

Date: 20150216 Docket: T-222-13 Citation: 2015 FC 108 Ottawa, Ontario, February 16, 2015 PRESENT: The Honourable Mr. Justice Roy BETWEEN: LES LABORATOIRES SERVIER AND SERVIER CANADA INC. Applicants and THE MINISTER OF HEALTH AND APOTEX INC. Respondents PUBLIC JUDGMENT AND REASONS (Confidential Judgment and Reasons released January 28, 2015) I. Introduction ......................................................................................................................... 3 II.

The Parties ......................................................................................................................... 13 III. Witnesses ........................................................................................................................... 17 IV. The Notice of Allegation: What it says ............................................................................. 31 V. Burden ............................................................................................................................... 46 VI.

Person Skilled in the Art .................................................................................................... 52 VII. Construction of the Patent ................................................................................................. 60 A. How the patent is presented ....................................................................................... 60 B. Construction ............................................................................................................... 90 VIII.

Infringement .................................................................................................................... 123 A. Infringement: binder ................................................................................................. 125 B. Infringement: dissolution profiles ............................................................................ 138 IX. Invalidity ......................................................................................................................... 148 A.

Obviousness .............................................................................................................. 148 (1) (

a) The Skilled Person .............................................................................. 152 (1) (

b) The Common General Knowledge ..................................................... 153 i. Gliclazide used in the treatment of diabetes ......................... 153 ii. Modified release formulation and matrix alteration .............. 156 iii. Tablet Divisibility and Release Profiles ................................ 163

(2) The Inventive Concept ............................................................................. 171

(3) Differences between the Prior Art and the Inventive Concept ............... 176

(4) Were the Steps Obvious to Try? .............................................................. 177 (

a) The Actual Course of Conduct ...................................................... 194 B. Utility ....................................................................................................................... 204

(1) The Promise of the Patent ........................................................................ 207

(2) Demonstrated Utility ............................................................................... 211

(3) Sound Prediction ..................................................................................... 219 X. Conclusion ....................................................................................................................... 228 XI.

Post-script ........................................................................................................................ 232 [ 1 ] This is an application for judicial review, in the nature of a prohibition order, brought by Les Laboratoires Servier and Servier Canada Inc. [Servier] pursuant to the Patented Medicines (Notice of Compliance) Regulations , SOR/93-133, as amended [ NOC Regulations ]. Servier Canada sells a 60 mg modified release [MR] gliclazide tablet in Canada under the name DIAMICRON MR, which is used in the treatment of diabetes.

The respondent Apotex Inc. [Apotex] wishes to sell a generic version of a 60 mg MR gliclazide tablet. The applicants seek to restrain the Minister of Health from issuing a Notice of Compliance [NOC] to Apotex until after Canadian Patent No. 2,629,670 [the ‘670 Patent] expires. [ 2 ] For the reasons that follow, the Court concludes that the application must be dismissed, with costs to Apotex. I. Introduction [ 3 ] Gliclazide, the active ingredient in the product under review, was discovered by Servier. It is not a new product.

It is a hypoglycemic agent which helps maintain sugar levels in the blood of diabetic patients by releasing insulin. [ 4 ] Originally, Servier produced an 80 mg tablet with immediate release [IR], which produced a high concentration of gliclazide in the plasma in a short-term fashion. That tablet was breakable. [ 5 ] A second formulation was developed. It ended up being non-breakable, contrary to the 80 mg tablet, but it had a modified release. It is available in a 30 mg dosage. [ 6 ] The advantage of MR is that it is meant to avoid the high and short-lived concentration of an active ingredient in the blood.

Compared to IR, it reduces “peak effects”. The ‘670 Patent uses the terms “modified release” and “prolonged release”. (The ‘670 Patent under review was written in French. The parties referred to an English version produced on behalf of Apotex and used it throughout the proceedings. It has not been challenged. The original French version of the ‘670 Patent speaks of “libération modifiée du principe actif” and “libération prolongée”.) [ 7 ] The ‘670 Patent seeks to claim a new formulation that covers the 60 mg gliclazide MR divisible tablet.

Servier argues that its patent is limited to the 60 mg dosage, while Apotex counters that there is no such limitation. The tablet is breakable. [ 8 ] According to the patent, there are three components to the tablet: the active pharmaceutical ingredient (gliclazide), a cellulose derivative and a binder, which are all physical characteristics of the tablets. The patent claims that the whole tablet as well as a fraction of a whole tablet will have an “identical dissolution profile”.

Claim 1 speaks of an “identical dissolution profile” (“profil de dissolution identique”) while claim 15 speaks in terms of “similar dissolution profile” (“profil de dissolution similaire”). [ 9 ] Apotex argues that its tablets do not contain a binder. Furthermore, its tablets would not show an identical dissolution profile as defined by the patent where one compares the whole tablet to the fraction obtained once the tablet is broken.

Thus, the ‘670 Patent is not infringed according to Apotex because two of the essential elements are different. [ 10 ] The prohibition order sought in these proceedings will not issue if Apotex is successful on any of its allegations that it does not infringe the monopoly granted through the patent. If Apotex’s tablet and a fraction thereof do not have identical dissolution profiles, its product is not covered by the patent and, therefore, it does not infringe the ‘670 Patent. Similarly, if the Apotex product does not have a binder, as required by the patent, it could not be said that there is infringement.

In those circumstances, it does not matter that the ‘670 Patent would be valid or not since there would not be any infringement. [ 11 ] However, Apotex argues also that the patent, as framed, is invalid. If that is the case, it would evidently be impossible to infringe on an invalid patent. Either way, Servier cannot be successful because there is no infringement or the patent is invalid. [ 12 ] Thus Apotex alleges that the ‘670 Patent is not valid because the subject matter defined by a claim is obvious to the skilled person.

Similarly, the patent had to disclose an invention that is new and useful (definition of “invention”,

section 2 of the Patent Act , RSC, 1985, c P-4). It did not. For good measure, Apotex also argues that the patent is invalid because it lacks specificity ( subsections 27(3) and (4) of the Patent Act ) as well as being overbroad and ambiguous. These other arguments are largely presented in the alternative to arguing invalidity on the bases of obviousness and utility. II. The Parties [ 13 ] Servier is a “first person” as described in the NOC Regulations .

It received a NOC from the Minister of Health on September 9, 2010 to sell its 60 mg MR gliclazide tablets in Canada under the registered trade-mark DIAMICRON MR. In the course of obtaining regulatory approval, Servier submitted the ‘670 Patent to the Minister of Health for inclusion in the Patent Register maintained by the Minister pursuant to subsection 3(2) of the NOC Regulations . [ 14 ] Servier Canada is the Canadian affiliate of Les Laboratoires Servier, which is the owner of the ‘670 Patent. Les Laboratoires

Servier is a party to this application pursuant to subsection 6(4) of the NOC Regulations . [ 15 ] In these reasons, the applicants Servier Canada and Les Laboratoires Servier are collectively referred to as Servier. Servier filed its Notice of Application to launch these proceedings on January 31, 2013. [ 16 ] The respondent Apotex is a “second person” as referred to in the NOC Regulations . It manufactures and markets generic drugs and has filed an Abbreviated New Drug Submission [ANDS] with the Minister of Health to sell a 60 mg MR gliclazide tablet in Canada.

The ANDS compares Apotex’s product to Servier’s DIAMICRON MR tablet. In accordance with the NOC Regulations , Apotex served Servier Canada with a Notice of Allegation [NOA] dated December 19, 2012 in which it stated that the Apotex product would not infringe the ‘670 Patent and that the ‘670 Patent was invalid. III. Witnesses [ 17 ] The parties submitted the evidence in this proceeding, through affidavits, of several witnesses. [ 18 ] Servier’s history of how its invention came to be was presented by Dr. Patrick Wüthrich, a fact witness, its “directeur du centre de développement pharmaceutique”.

He is one of the named inventors and is located in Europe. Dounia Maizi is Servier’s Chief of Regulatory Affairs in Canada. This witness was offered as an expert with regard to the regulatory process that Servier and Apotex had to follow in order to get approval from the regulator, Health Canada. She also testified as to her understanding of the construction of the patent. Because Apotex’s product must be bioequivalent with that of Servier’s in order to get regulatory approval, Ms.

Maizi states that “ce qui veut nécessairement dire que le comprimé entier de 60 mg du produit d’Apotex est un comprimé sécable à libération prolongée qui dans sa forme non subdivisée, possède un profil de dissolution in vivo identique à chacun des demis-comprimés de 30 mg de sorte qu’il existe une forte similarité entre la biodisponibilité du produit d’Apotex avec le produit DIAMICRON® MR 60 mg de Servier” (para 71 of the affidavit of Dounia Maizi of September 13, 2013). [ 19 ] Apotex took issue with Ms. Maizi’s testimony as she is an employee of the first person.

Relying on the Code of Conduct for Expert Witnesses (SOR/2010-176,

section 13 (Schedule)), Apotex argues that the expert must be independent and objective (

section 2 ). Ms. Maizi is not and declares that she wishes her employer prevail in these proceedings: indeed she is an officer of Servier. Pursuant to Rule 52.2(2) of the Federal Courts Rules , SOR/98-106, the failure to comply with the Code of Conduct may be sanctioned by the exclusion of some or all of the expert’s affidavit. [ 20 ] It seems to me that the Federal Court of Appeal’s statement in AB Hassle v Canada (Minister of National Health and Welfare) , 2002 FCA 421 , 298 NR 323 is apposite: [41] In fact, there is a further weakness in the evidence of the affiants: at the time of swearing her affidavit, Ms.

Murphy was a senior officer of Astra Pharma Inc., one of the Appellants to this action and, as a result her “opinion” evidence could be viewed as biassed or self-serving statements of an interested party. [ 21 ] However, I would not reject the evidence of Ms. Maizi altogether. Her evidence, on the regulatory process at Health Canada, to the extent it is relevant in these proceedings, may not in fact require any expertise other than that of someone familiar with the applicable regulations. I observe that Apotex has offered the testimony of Duane Terrill, an employee, for a similar purpose.

He did not testify as an expert. With respect to the evidence of Ms. Maizi concerning the construction that should be put on the ‘670 Patent, I would find her evidence much more suspicious.

Although it is true that my colleague Tremblay-Lamer J. found in Quadco Equipment Inc v Timberjack Inc , 2002 FCT 96 , 17 CPR (4th) 224, that, in the circumstances of that case, employees of the party could testify in an expert capacity, she was careful to note that they had “testified in a straightforward and competent manner, and I did not detect any bias in either experts’ testimony.” More caution is needed in our case, where the employee is in fact an officer at Servier and has readily conceded that she wishes to see Servier prevail in this proceeding (cross-examination of Ms. Maizi, question 38).

It follows that her testimony on the patent construction carries little weight. [ 22 ] Servier presented two other witnesses, Dr. Bodmeier and Dr. Marroum, whose expertise and ability to testify as experts I would not question. One, Dr. Roland Bodmeier, is a professor in the Department of Pharmaceutical Technology at the Freie Universität Berlin, in Germany. He declares to have focused his research on innovative drug delivery systems with special emphasis on controlled drug release and holds a Ph.D. in pharmaceutics. The other, Dr.

Patrick John Marroum, obtained his Ph.D. in pharmacy and spent a large portion of his career with the US Food and Drug Administration where he “worked to identify issues considered to be crucial to the determination of safety and efficacy of a drug product ” (para 3, affidavit of Dr. Marroum). His studies were in the area of pharmaceutics (the science of preparing dosage forms) and pharmacokinetics which studies the absorption, distribution, metabolism and elimination of drugs. [ 23 ] The Court was invited to accept with caution the evidence of experts Marroum and Bodmeier. It was said that Dr.

Bodmeier was not straightforward in cross-examination, perhaps to the point of truculence. As for Dr. Marroum, it was argued that his qualifications should not allow him to opine in matters of formulation design. [ 24 ] In my view, there is no reason to consider the opinions of these experts with caution on the basis of the arguments put forward by Apotex. I am satisfied that both are experts. These experts testified in cross-examination as is generally expected of experts: they do not change their view readily on cross-examination in spite of skilful attempts by adept counsel.

As was put tactfully in Phipson on Evidence (JH Buzzard, R May & MN Howard, eds, Phipson on Evidence , 13th ed (London, UK: Sweet & Maxwell Ltd, 1982)): It is proverbial that they [experts] are, perhaps unwillingly, biased in favour of the side which calls them, as well as over-ready to regard neutral facts as confirmation of preconceived theories: moreover support or opposition to given hypotheses can generally be multiplied at will. (Para 27-35.) [ 25 ] Furthermore, both these witnesses have sterling academic credentials and significant experience in their field. If there is a

distinction to be made between the experts presented by Apotex and those presented by Servier, it could be on the basis of the information provided to each set of experts, where the experts offered by Servier appear to have received more information about the issues in the proceedings than the experts offered by Apotex.

More than 30 years ago, Lord Wilberforce observed in Whitehouse v Jordan , [1981] 1 All ER 267 at 276b, HL): While some degree of consultation between experts and legal advisers is entirely proper, it is necessary that expert evidence presented to the court should be, and should be seen to be, the independent product of the expert, uninfluenced as to form or content by the exigencies of litigation. To the extent that it is not, the evidence is likely to be not only incorrect, but self-defeating. [ 26 ] Of course, experienced legal advisers will avoid that pitfall.

Where the evidence in-chief of a witness presents elements of tailoring, consciously or not, coming from an honest witness, to support the side that has hired him, the weight to be given to that evidence will be negatively affected. [ 27 ] As I will explain further later, the evidence of Dr. Marroum, however, must be discounted in some areas because he would have crossed the line between what can be expected of experts and an advocate for a product. Portions of his affidavit were more argumentative than informative.

In The Law of Evidence in Canada (Alan W Bryant, Sidney N Lederman & Michelle K Fuerst, Sopinka, Lederman & Bryant: The Law of Evidence in Canada , 3rd ed (Markham, ON: LexisNexis, 2009)), the authors remind us that experts are expected to provide independent assistance to the Court: §12.134 The expert witness should provide independent assistance to the court and should not assume the role of an advocate.

An expert should state the facts or assumptions upon which his or her opinion is based and should not omit to consider material facts which weaken his or her opinion. [ 28 ] In fact, the experts offered by Apotex were not challenged by Servier in that fashion. Dr. Reza Fassihi, who holds a Ph.D. in pharmaceutics, is a professor in that area of expertise at Temple University, in Philadelphia. As for Dr. Ping Lee, the second expert offered by Apotex, he holds a Ph.D. in pharmaceutics and teaches at the Faculty of Pharmacy of the University of Toronto. While Dr. Bodmeier and Dr.

Marroum were provided with the NOA, which would give them a good understanding of the issues that were to be litigated, Dr. Fassihi and Dr. Lee, according to their affidavits, were asked to consider the ‘670 Patent without the benefit of the NOA and the nature of the proceedings for which they were retained. A close examination of the affidavits of Dr. Lee and Dr. Fassihi confirms that they were not provided information concerning Apotex’s product, its composition or dissolution characteristics. That gave rise to Apotex’s argument that experts offered by Servier reached results-oriented constructions.

To put it in the words of counsel for Apotex, if a question is given “blind” to an expert, the suggestion is that his or her credibility is enhanced. [ 29 ] The only other Apotex affiant who was challenged on cross-examination was Duane Terrill, the Associate Director for Regulatory Affairs at Apotex. He oversaw the preparation of the ANDS filed by Apotex in order to seek approval for its tablet. For the purposes of this litigation, three elements of Mr.

Terrill’s affidavit have some importance: 1. [Redacted] 2. [Redacted] 3. [Redacted] [ 30 ] The respondent Minister of Health, responsible for approving drugs for sale in Canada and issuing NOCs, had notice of these proceedings, but took no active role. IV. The Notice of Allegation: What it says [ 31 ] The NOA is dated December 19, 2012. It constitutes the statement of allegations, both factual and legal, in accordance with subsections 5(1)(b)(iii) and (iv) of the NOC Regulations .

The ANDS presented by Apotex to the Minister of Health for a NOC is with respect to a 60 mg strength gliclazide MR tablet marketed by Apotex. The Apotex product is compared to DIAMICRON 60 mg MR tablets marketed by Servier Canada. [ 32 ] Servier has not argued that the NOA, as framed, is in itself not adequate. It would appear that the parties agree that the NOA must be complete in the sense that the first person must be given the information that will allow a sufficient understanding of the case: what is the case to answer?

It has not been alleged or argued that the NOA suffers from some infirmity. [ 33 ] Servier, on the other hand, suggests that Apotex raised for the first time late in the process, in its experts’ affidavits, its so- called manufacturing theory according to which its tablet holds together through direct compression, thus avoiding the need for a binder. This Court, in Bayer Inc v Cobalt Pharmaceuticals Company , 2013 FC 1061 , noted again that the second person must raise the facts and legal arguments it wishes to raise in the NOA. New arguments, facts, allegations not set out in the NOA cannot be raised later.

The goal posts cannot be moved.

Hughes J. put it succinctly: [36] As matters stand now, the Court must reject arguments based on facts or documents not set out in the Notice of Allegation nor can the Court address new allegations. [ 34 ] The Court is invited to disregard that theory. [ 35 ] Apotex counters that once an issue has been put into play by the second person, it must be allowed to respond to the patentee’s arguments, without having “to anticipate every theory of possible infringement, however speculative, in the detailed statement supporting its allegations” ( Astrazeneca AB v Apotex Inc , 2005 FCA 183 , at para 11 ).

In the case at hand, Apotex put in play the issue of the binder, which is one of the essential elements of the Servier invention claimed by Apotex to be absent in his product. As the Federal Court of Appeal put it in Novopharm Ltd v Pfizer Canada Inc , 2005 FCA 270 [ Novopharm ]:

[16] The Applications Judge erred in his formulation of the legal test to determine whether Novopharm’s NOA was deficient when he required Novopharm to ‘put into play’ all aspects of the non-infringement issue. Whether Novopharm’s NOA was adequate depends on whether it provided Pfizer with a sufficient understanding of the case it had to meet ( supra at paragraph 4). The legal test of adequacy does not require Novopharm to anticipate all possible grounds of infringement, including Pfizer’s speculative theory that the dihydrate could be used in the process of manufacturing Novopharm’s bulk monohydrate.

As noted by Evans J.A. in AstraZeneca AB v. Apotex Inc. 2005 FCA 183 , [2005] F.C.J. No. 842 (QL) at paragraph 11 : A second person [the generic] should not be required to anticipate every theory of possible infringement, however speculative, in the detailed statement supporting its allegations. [ 36 ] Accordingly, Apotex argues that it must be allowed to explain how its tablet holds together, its so-called manufacturing theory. [ 37 ] Whether or not Apotex can rely on its evidence with respect to how its tablet is manufactured appears to be the only significant difference between the parties about the NOA.

The parties appear to agree that claim 14, concerned with a method for producing the tablet of any of claims 1 to 13, is not relevant in these proceedings and need not be considered any further. [ 38 ] The parties have otherwise argued their case on the basis that the NOA puts the issues in play. Except for the issue of the existence of a binder, where Apotex has not indicated how its tablet holds together, there is no dispute that the NOA provided Servier with a sufficient understanding of the case it has to meet.

Paraphrasing the Federal Court of Appeal in Novopharm , supra , at para 4 , the statement in the NOA is sufficiently detailed to make Servier fully aware of the grounds put forward by Apotex that its patent is invalid or that it has not been infringed.

In my view, the NOA raised allegations of invalidity supported by evidence capable of establishing the invalidity of the patent: similarly, the allegations made by Apotex that it does not infringe the ‘670 Patent are in play. [ 39 ] The NOA constructs the claims of the ‘670 Patent as requiring that there be a cellulose derivative that is different from the binder: these are two separate ingredients. One can read at page 8 of the NOA: The claimed tablet comprises gliclazide as the active ingredient, between 50% and 60% of the total weight of the tablet of a cellulose derivative, and a binder.

The skilled person would understand what is meant by a cellulose derivative and a binder, and examples of these are provided in the 670 Patent. A skilled person would also understand from the context of the 670 Patent as a whole that the cellulose derivative is a separate and distinct component of the tablet from the binder so that two separate components of the tablet functions are the cellulose derivative and the binder.

Given that claim 1 requires both a cellulose derivative and a binder, the skilled person would understand that the use of the terms independently and separately means that two distinct functional agents, a binder and a cellulose derivative, must be present in the tablet. [ 40 ] Claims 1 and 10 require an identical dissolution profile (profil de dissolution identique) for the whole tablet and a fraction of it. Apotex complains that the conditions to use to conduct the dissolution test are not provided; similarly, how to assess the results in order to determine if there is a statistical difference is lacking.

The hardness, coating, size, shape of the tablet, as well as the score line (the tablet must be scored as the tablet is said to be “sécable”) receive no teaching in the patent. [ 41 ] As to non-infringement of the patent, Apotex points that its product does not infringe the ‘670 Patent for two reasons. First, it argues that the evidence will show that the dissolution profile of its product is not identical, as the notion is defined in the disclosure, when comparing the whole tablet and fractions of it. Indeed, Apotex alleges that the dissolution profile is not similar (claim 15) either.

Apotex goes on to state that if the method used to calculate the dissolution profiles of its product is challenged as inappropriate by Servier, it would allege that the patent is necessarily invalid because it would lack sufficiency, and thus would be in breach of subsection 27(3) of the Patent Act . “If a specific dissolution method and/or statistical test is required to be used in order to assess whether a given tablet is within or outside the scope of the claims of the 670 Patent, this essential information was required to be disclosed within the specification in order to provide a full and correct description of the invention” (pages 14-15 of the NOA).

Indeed, the patent does not place any limitation on the methods of comparison or analysis. [ 42 ] Second, Apotex argues that its product does not use a binder, contrary to the requirements of the ‘670 Patent with respect to claims 1 to 13 and 15. With respect more especially to claim 10, which is very precise as to the composition of the invention, the second person asserts that its tablet does not include some of the ingredients, which establishes non-infringement of claim 10, together with dependent claims 11 to 13.

Similarly, claim 4 cannot be infringed because the binder is said to be maltodextrin, polyvidone or a hydroxypropylmethylcellulose [HPMC] of very low viscosity. Apotex does not use any of these substances according to the NOA. The same is said of claim 9 which requires the binder to be between 2% and 15% of the total weight of the tablet. Apotex’s tablets not having a binder according to Apotex, that particular claim cannot be infringed. [ 43 ] Apotex raises a number of issues leading to its contention that the ‘670 Patent is invalid.

As already pointed out, it argued ambiguity if Servier were to counter that the method and analysis used by Apotex to establish that the dissolution profile of its product was not identical between their whole tablet and a fraction. Apotex also alleges obviousness. In essence, a person of skill in the art would have known that the purported invention is a scored, modified release tablet of gliclazide whose dissolution profile is identical to a subdivided fraction. Given the prior art, there was no inventiveness according to Apotex.

Any difference between the state of the art, and the inventive concept would have been obvious. [ 44 ] Apotex further argues that the patent lacked a demonstrated utility and that the promised utility was not soundly predicted. As an alternative argument, Apotex alleges that the specification of the ‘670 Patent was insufficient in that it did not provide the teaching needed to allow the person skilled in the art to put the invention into practice. (It is of course counterintuitive to argue obviousness and insufficiency.

If it was that obvious, how can the specification be also insufficient such that the person skilled in the art would be able, using only the disclosure, to produce the invention? However, I can think of no reason why such an argument could not be made. At any rate, Apotex made the argument solely in the alternative.) [ 45 ] Finally, Apotex asserts in its NOA that the ‘670 Patent is overbroad. It is said that the claims overreach if they are not already

invalid due to lack of utility. An inventor cannot claim more than what is disclosed or invented. Apotex dedicated three paragraphs of its 44-page NOA to the argument. Its Memorandum of Fact and Law presented the issue in two paragraphs and counsel for Apotex did not press the issue at the hearing; indeed he did not argue the point. I do not intend to address the issue. V. Burden [ 46 ] The validity of a patent is presumed (

section 43 of the Patent Act ). However, that early presumption can be rebutted once Apotex has made allegations supported by evidence that is capable of establishing invalidity. The issue is put in play. These passages of Pfizer Canada Inc v Apotex Inc , 2007 FC 26 , present the state of the law and were specifically approved by Hughes J. in GlaxoSmithKline Inc v Pharmascience Inc , 2011 FC 239 [ GlaxoSmithKline ]: [9] In my view, the burden on a respondent under the Regulations is an “evidential burden” – a burden merely to adduce evidence of invalidity.

Once it has discharged this burden, the presumption of validity dissolves and the Court must then determine whether the applicant has discharged its legal burden of proof. I believe this is what is meant in those cases where the Court has stated that the respondent must put its allegations “into play”. It must present sufficient evidence to give its allegations of invalidity an air of reality. … [12] To summarize, Pfizer bears the legal burden of proving on a balance of probabilities that Apotex’s allegations of invalidity are unjustified.

Apotex merely has an evidentiary burden to put its case “into play” by presenting sufficient evidence to give its allegations of invalidity an air of reality. If it meets that burden, then it has rebutted the presumption of validity. I must then determine whether Pfizer has established that Apotex’s allegations of invalidity are unjustified. If Apotex does not meet its evidential burden, then Pfizer can simply rely on the presumption of validity to obtain its prohibition order. [ 47 ] The burden then shifts onto the first person, Servier, that must establish that the allegations of invalidity are not justified.

It is the civil burden of proof, the balance of probabilities, which must be met by the first person (see Alcon Canada Inc v Apotex Inc , 2014 FC 791 ). [ 48 ] Evidence evenly balanced between the parties will favour the second person: the prohibition order would not issue (see Pfizer Canada Inc v Canada (Minister of Health) , 2008 FC 11 , at para 32 and GlaxoSmithKline , supra ). [ 49 ] It follows that it is Servier’s burden to satisfy the Court, on a balance of probabilities and not merely on a tied score, that none of the invalidity allegations are justified. [ 50 ] As for allegations of infringement of the patent, once again it is Servier that bears the burden of proof.

As early as 1994, the Federal Court of Appeal made the point clearly in Merck & Frosst Canada Inc v Canada (Minister of National Health and Welfare) , (1994) 55 CPR (3d) 302 . We can read at page 319: Furthermore, since the Regulations clearly allow the Minister, absent a timely application under

section 6, to issue a notice of compliance on the basis of the allegations in the notice of allegation, it would seem that on the hearing of such an application, at least where the notice has alleged non-infringement, the Court should start from the proposition that the allegations of fact in the notice of allegation are true except to the extent that the contrary has been shown by the applicant.

In determining whether or not the allegations are “justified” (subsection 6(2)) the Court must then decide whether, on the basis of such facts as have been assumed or proven, the allegations would give rise in law to the conclusion that the patent would not be infringed by the respondent. [ 51 ] More recently, the same point was made in Novopharm , supra at para 20 : [20] In my view, this statement remains good law. Where, as here, the NOA is found to be adequate, the legal burden remains squarely on Pfizer to prove, on a balance of probabilities, that the allegations in the NOA are unjustified.

Novopharm has no evidential burden to support the allegations in its NOA and detailed statement (see AB Hassle 2 at paragraph 35 ). Therefore, Novopharm need only file evidence supporting its detailed statement to counter evidence, if any, submitted by Pfizer in the course of the prohibition proceedings. VI. Person Skilled in the Art [ 52 ] Patent construction is undertaken through the lens of a notional person at whom the patent is said to be directed.

This person is often referred to as the “person skilled in the art,” the “person of ordinary skill in the art,” the “skilled worker,” and, in acronym form, as the POSITA or the POSA. The person is reasonably diligent in keeping up with advances and has an ordinary level of requisite competence and knowledge in the particular field. This person can be an individual or it can be a composite of multiple individuals working as a team, each bringing particular knowledge and skills to the reading of the patent as a whole.

See Whirlpool Corp v Camco , 2000 SCC 67 , [2000] 2 SCR 1067 [ Whirlpool ] at paragraphs 70 to 74 ; Merck & Co, Inc v Pharmascience Inc , 2010 FC 510 [ Merck & Co ] at paragraphs 32 to 42; AstraZeneca Canada Inc v Apotex inc , 2014 FC 638 at paragraph 51 . [ 53 ] In Merck & Co , supra , at paragraph 42, Justice Hughes described this person’s attributes and aptitudes: That person is to be unimaginative, but that does not mean that the person is slow-witted or graduated (if at all) at the bottom of the class. Nor is the person the gold medalist who graduated at the top of the class.

That person is the average person in the group. Just as a “reasonable man” is expected to be reasonable, the POSITA is expected to possess the ordinary skill in the art. [ 54 ] Servier and Apotex are substantially in agreement about the person of skill in the art at whom the ‘670 Patent is addressed. Where they vary is largely, in my view, a distinction without a difference and does not affect the construction of the patent.

[ 55 ] At the hearing, Servier contended that the POSITA can be made up of a number of people constituting a team. That team would be able to proceed to the evaluation of solid dosage forms. Indeed, individually experts would not have to be POSITAs and their evidence should not be rejected. [ 56 ] It would appear that Servier was concerned with an anticipated attack on the expertise of two of its witnesses, Ms. Maizi and Dr.

Marroum. [ 57 ] There is caselaw confirming that the person of ordinary skill in the art may be a team of persons ( Apotex Inc v Sanofi-Aventis , 2011 FC 1486 ; Pfizer Canada Inc v Pharmascience Inc , 2013 FC 120 ). It must be remembered that the POSITA is that notional person at whom the patent is directed and who, through their expertise, will understand that which may not be understood without those qualifications.

In this case, nothing rides on whether the POSITA is only one person or a team of persons as the qualifications required are present. [ 58 ] In the end, as already discussed, Apotex invited the Court to assess the evidence of Servier’s experts with caution, in particular Dr. Marroum because he is not an expert in formulation, and Ms. Maizi because she has a direct interest in the case and she would have limited expertise.

These considerations go to the weight of the evidence, not whether it is receivable. [ 59 ] The skilled person of the ‘670 Patent has a graduate degree in pharmacy, biopharmaceutics, pharmaceutical sciences, chemistry or chemical engineering, pharmacology, formulation engineering, or a related field. The person also has industrial experience in the design, formulation, and evaluation of solid dosage forms. Apotex and Servier agree that at least some of the team members could also have lesser degrees if they have more years of relevant, practical experience in this field.

The skilled person possesses the ability to formulate and then evaluate solid dosage forms to assess whether a particular form has the properties required of it by the claims of the ‘670 Patent. VII. Construction of the Patent A. How the patent is presented [ 60 ] The ‘670 Patent was filed with the Canadian Patent Office on April 24, 2008 and claims priority from an application filed in France on March 21, 2008 (FR08/01561).

The patent application was published on October 1, 2008 and the patent is set to expire on April 24, 2028, subject to being invalidated earlier. [ 61 ] By virtue of the patent application being filed after October 1, 1989, the so-called “new” Patent Act , RSC 1985, c P-4 governs the ‘670 Patent. [ 62 ] The ‘670 Patent, written in French as already indicated, is entitled “Forme galénique sécable permettant une libération modifiée du principe actif.” In its NOA, Apotex appended a document purporting to be a certified translation of the patent into English.

For ease of reference, these reasons will provide the English translation of the ‘670 Patent, which has been used by the parties, alongside the text of the patent, where applicable. [ 63 ] The ‘670 Patent was issued to Les Laboratoires Servier, FR. The patent lists four inventors, all of whom are from France: Gilles Fonknechten, Patrick Genty, Jean-Manuel Pean, and Patrick Wüthrich. As indicated earlier, Dr.

Wüthrich provided fact evidence in these proceedings and was cross-examined. [ 64 ] The specification of the ‘670 Patent, in its disclosure part, begins with a general description of the invention, at page 1: La présente invention s’inscrit dans le cadre de la recherche et de la mise au point de nouvelles formes galéniques de préparations pharmaceutiques. La présente invention concerne une forme galénique sécable permettant une libération modifiée du principe actif. The present invention falls within the context of the research and development of new dosage forms of pharmaceutical preparations.

The present invention relates to a scored dosage form allowing modified release of the active ingredient. [ 65 ] In other words, the disclosure announces an invention of limited scope. It says that the “forme galénique”, i.e. the form a medicine can take (syrup, capsule, suppository, etc.) is scored, thus allowing modified release of the active ingredient.

We are not concerned with a new medicine, the active ingredient being gliclazide which has been known for some time, but rather with the form in which it will be administered to and taken by patients. [ 66 ] The ‘670 Patent then describes certain benefits associated with modified release drugs, particularly that undesirable and perhaps harmful elevated concentrations of the active ingredient are avoided in a patient’s blood compared to immediate release. The specification also describes benefits associated with tablets that are, as written in the patent, “sécable”.

In the English translation of the patent provided by Apotex, the term “sécable” has been translated as “scored” although in the applicants’ materials the term “divisible” is used instead. There does not appear to be any difference intended in the use of different words. The benefit of a scored or divisible tablet lies in permitting the manufacturing of a single tablet which can be later subdivided into different dosages.

It is also said that there is a benefit for the patient by providing better treatment adherence as the 60 mg prolonged release scored tablet would limit the number of tablets a patient would have to take. [ 67 ] The ‘670 Patent disclosure describes the difficulty in combining modified release properties with a tablet shape that is scored or divisible. However, it only cites a warning, issued by the European Medicines Agency [EMA] in 1999, against this combination except in exceptional cases, at page 2:

C’est une mauvaise pratique de subdiviser les formes à libération prolongée mais cela pourrait être justifié dans des cas exceptionnels. It is bad practice to subdivide prolonged- release dosage forms but this may be justified in exceptional cases. [ 68 ] Essentially, the difficulty described by the ‘670 Patent is that when a modified release tablet is divided, the surface area increases as the broken face is now exposed. This change in surface area alters the rate of dissolution of the active ingredient in the tablet.

While tablets can be designed with deep scoring grooves to minimize the increase in surface area after division, the patent states that such tablets are prone to breaking too easily. [ 69 ] Accordingly, the ‘670 Patent presents the purported invention to overcome the alleged problems it identified with the subdivision of modified release tablets, at page 3: La présente invention a donc pour but de proposer une stratégie alternative permettant de contourner les problèmes inhérents au développement de comprimés sécables à libération modifiée déjà disponibles, en vue de remédier, au moins en

partie aux inconvénients liés à la subdivision des comprimés en dose fractionnaire. Cette stratégie alternative est fondée sur l’originalité de la composition pharmaceutique de la forme galénique. The objective of the present invention is therefore to propose an alternative strategy for bypassing the problems inherent in the development of modified-release scored tablets that are already available, with a view to remedying, at least in part, the drawbacks related to the subdivision of tablets into a fractional dose.

This alternative strategy is based on the originality of the pharmaceutical composition of the dosage form. La présente invention a pour objet une forme galénique sécable, par exemple un comprimé sécable, à libération modifiée comprenant un ou plusieurs principes actifs et les excipients suivants : un polymère dérivé de cellulose et un liant. Cette nouvelle forme galénique se caractérise par le fait qu’elle présente un profil de dissolution identique qu’elle ait été subdivisée ou non.

Par exemple, le comprimé sécable à libération prolongée dans sa forme non subdivisée et une fraction de ladite forme obtenue par subdivision ont un profil de dissolution identique. The subject of the present invention is a modified-release scored dosage form, for example scored tablet, comprising one or more active ingredients and the following excipients: a cellulose-derived polymer and a binder. This novel dosage form is characterized in that it has an identical dissolution profile whether or not it has been subdivided.

For example, the prolonged- released scored tablet in its non-subdivided form and a fraction of said form obtained by subdivision have an identical dissolution profile. [ 70 ] It is therefore announced that in order to bypass problems caused by the subdivision of tablets, it is the pharmaceutical composition of the dosage form that will address the issue. [ 71 ] The disclosure sets out what is meant by “profil de dissolution identique / identical dissolution profile” in the context of the claimed invention, at page 4: Dans le contexte de l’invention on entend par « profil de dissolution identique » des cinétiques de dissolution ayant des coefficients de variations sans différence statistiques entre eux.

Les cinétiques de dissolution in vitro identiques selon l’invention donnent des cinétiques plasmatiques identiques. In the context of the invention, the expression “identical dissolution profile” is intended to mean dissolution kinetics having variation coefficients with no statistic difference between them. The identical in vitro dissolution kinetics according to the invention give identical plasma kinetics. [ 72 ] I note that the disclosure uses language that can hardly be more precise. In the French version, the patentee speaks forcefully of “on entend”.

There is no ambiguity: “profil de dissolution identique / identical dissolution profile” has one meaning in the specification and it is spelled out in the disclosure. [ 73 ] While the disclosure notes that the expression “principe actif”, or “active ingredient”, relates in the invention to a variety of types of medicines, it notes that the preferred active ingredient for the invention is gliclazide. As previously mentioned, gliclazide is used in the treatment of diabetes. Indeed, claim 1, which defines the monopoly sought, speaks of gliclazide as being the active ingredient.

Claims 10 and 15 make the same limitation. The ‘670 Patent describes the two prior formulations of gliclazide: an 80 mg immediate-release tablet and a 30 mg prolonged- and controlled-release matrix tablet. The patent claims that the invention at issue compares advantageously with these prior formulations. [ 74 ] As noted, the claimed invention requires two excipients to be included in the formulation alongside gliclazide: a cellulose- derived polymer and a binder. [ 75 ] The patent describes the function of the cellulose-derived polymer, at pages 5 to 6:

Dans la formule, le polymère dérivé de cellulose a pour fonction de former la matrice assurant, entre autre, la libération modifiée du principe actif. La libération du principe actif se fait à la fois par diffusion et par érosion de la matrice et permet en particulier une libération prolongée du principe actif. In the formula, the function of the cellulose- derived polymer is to form the matrix providing, inter alia, the modified release of the active ingredient.

The release of the active ingredient is done both by diffusion and by erosion of the matrix and in particular allows prolonged release of the active ingredient. [ 76 ] The patent prefers the cellulose derivative to be a low-viscosity cellulose derivative and more preferably that the tablet comprise HPMC. The patent notes that HPMCs are sold under the brand names Methocel™ and Metolose™. The patent names certain high-viscosity, medium-viscosity, and low-viscosity HPMCs which can be selected in the formulation of tablets.

One of the named low- viscosity HPMCs is Methocel K100 LV™, which has a viscosity of 100 cP. [ 77 ] Similarly, the disclosure sets out the role of the binder in the invention as the following, at page 7: Dans la composition pharmaceutique selon l’invention le liant sert à agglutiner entre elles les particules qui ne peuvent l’être sous la seule action de la pression In the pharmaceutical composition according to the invention, the binding serves to agglutinate together the particles which cannot be agglutinated under the action of pressure alone. [ 78 ] Like with the cellulose-derived polymer, the patent sets out preferred binders for the invention, one of which is an HPMC of a very low molecular weight. [ 79 ] Thus, a pattern can be discerned in the presentation of the disclosure.

It advises that there are three essential elements, the active ingredient (gliclazide), a cellulose derivative and a binder. This novel dosage form (“nouvelle forme galénique”) has the further characteristic of having an identical dissolution profile, whether it is subdivided or not. For each of those elements, the disclosure gives a definition: the patent defines its own terms when dealing with its essential elements. [ 80 ] There are 15 claims in the patent. Servier asserts infringement of claims 1 to 6, 8, and 11 to 13.

Claim 7 is concerned with a particular binder, maltodextrin, which is not part of the composition of the Apotex tablet. Claim 9 requires a particular percentage of the weight of the tablet to consist of a binder. Claim 10 provides precise percentages of ingredients, including the essential ingredients including 6.9% of the total weight consisting of the binder maltodextrin. At the hearing, Servier announced that it was not asserting anymore infringement of claim 15 for a number of reasons that were not revealed. [ 81 ] That leaves us with the other claims being discussed in this case.

Claim 1 deals with a prolonged release tablet which is scored. It is stated that it is comprised of gliclazide, a cellulose derivative that is 50% to 60% of the total weight and a binder. There is then the requirement that the tablet in its non-divided form have an identical dissolution profile (“profil de dissolution identique”) as would have a fraction produced by subdivision. Claims 2 and 3 depend on claim 1. Claim 2 identifies cellulose derivatives, including HPMC which is identified specifically at claim 3 in its low viscosity variety.

Such is the logic of the cascading claims: claim 1 identifies the four essential elements and claims 2 and 3 deal with one of these essential elements, the cellulose derivative. Having identified three cellulose derivatives in claim 2, the inventor identifies HPMC of low viscosity as the cellulose derivative in claim 3. The NOA notes that no definition of low viscosity is provided in the patent. However, I note that the disclosure identifies a number of HPMCs having high, medium and low viscosity. [ 82 ] The next cascading claim is claim 4 which addresses the binder needed in the patent.

It identifies three binders, before selecting in particular one of the three binders as maltodextrin at cascading claim 7. However, claim 4 also identifies as a binder HPMC of very low viscosity as a possible binder. As with HPMC of low viscosity, the patent does not define “very low viscosity”. While the disclosure identifies products of low viscosity, there is no such identification for what could be very low-viscosity HPMC.

The reader is left in the dark. [ 83 ] Claims 5 and 6 state that the tablet comprises a hydrophylizing agent, which is spelled out as being colloidal silica. [ 84 ] Claim 8 states that gliclazide comprises 12% to 40% of the total weight of the tablet, while claim 9 states that the binder weighs between 2% and 15% of the total weight of the tablet. [ 85 ] Claim 10 is much more precise than the cascading claims examined previously.

It states that the tablet is comprised of 18.7% of gliclazide, 22.3% of lactose monohydrate, 6.9% of maltodextrin, 0.5% of magnesium stearate, 1.6% of anhydrous colloidal silica and 50% of HPMC. The claim speaks of a scored tablet which produces a modified release with a dissolution profile said to be identical whether the tablet is subdivided or not.

Obviously, as with other claims dealing with a binder, Apotex’s product cannot infringe claim 10 because it does not contain 6.9% of its weight in maltodextrin. [ 86 ] Claim 11 simply requires that the tablet have one or more scores, or grooves, that will be perpendicular to its height and length.

The grooves are said to be breakable (“rainures de ruptures”). [ 87 ] Claim 12 addresses the dissolution profile of the tablet: within the first two hours, 13% to 27% of the active ingredient, gliclazide, will have been released; 32% to 52% of the total quantity of gliclazide will be released within four hours and 85% will have been released within 12 hours. [ 88 ] Claim 13 states that claims 1 to 12 are intended for a product that treats diabetes. Claim 14 speaks of methods for producing the tablet.

[89] Finally, claim 15 speaks again of a modified release tablet of gliclazide, including a cellulose derivative comprising 50% to60% of the tablet’s total weight and a binder. However, while claims 1 and 10 speak of identical dissolution profiles whether one has thewhole tablet or a fraction of it, claim 15 speaks in terms of a similar dissolution profile, in vitro, for a period of 12 hours following thestart of dissolution. This is the only claim that posits a time period. The second person notes in its NOA that there is no explanation as towhat is meant by “similar” (“similaire”).

It would appear reasonable to think that something different was meant. Being obviously anindependent claim, one is left with little or no information, on the size and shape, coating or not. As with claims 1 and 10, there is noindication concerning the conditions under which the dissolution tests are to be conducted. B. Construction [90] In this case, the construction of the patent will be important in that whether or not Apotex’s product infringes on the ‘670Patent will be largely a function of what the patent actually asserts.

However, the construction of the patent must be made without anyconsideration of allegations of infringement or validity. In Whirlpool, supra, Binnie J. for a unanimous Court states: [43] The first step in a patent suit is therefore to construe the claims. Claims construction is antecedent to consideration of bothvalidity and infringement issues. The appellants’ argument is that these two inquiries – validity and infringement – are distinct, and thatif the principles of “purposive construction” derived from Catnic are to be adopted at all, they should properly be confined toinfringement issues only.

The principle of “purposive construction”, they say, has no role to play in the determination of validity, and itsmisapplication is fatal to the judgment under appeal. [91] To be more specific, the Court goes on to say at paragraph 49 that “[a] patent must not of course be construed with an eye onthe allegedly infringing device in respect of infringement or with an eye to the prior art in respect of validity to avoid its effect” (see alsoFree World Trust v Électro Santé Inc, 2000 SCC 66, [2000] 2 SCR 1024 [Free World Trust], at para 19). [92] Claims construction is a question of law.

It is said that a purposive construction is to be performed, that is that theconstruction exercise seeks to elicit the inventor’s purpose.

In spite of being a question of law, POSITAs will be of assistance to a court.In Burton Parsons Chemicals, Inc v Hewlett-Packard (Canada) Ltd, (SCC), [1976] 1 SCR 555, the Court gives thefollowing explanation of the task at hand, at page 563: While the construction of a patent is for the Court like that of any other legal document, it is however to be done on the basis that theaddressee is a man skilled in the art and the knowledge such a man is expected to possess is to be taken into consideration. [93] Dickson J. referred with approval to this passage taken out of Fox, Canadian Patent Law and Practice (Harold G Fox,Canadian Patent Law and Practice, 4th ed (Toronto: Carswell, 1969)), at page 204, in Consolboard Inc v MacMillan Bloedel (Sask) Ltd, (SCC), [1981] 1 SCR 504 [Consolboard]: The persons to whom the specification is addressed are “ordinary workmen”, ordinarily skilled in the art to which the invention relatesand possessing the ordinary amount of knowledge incidental to that particular trade.

The true

interpretation of the patent is to be arrivedat by a consideration of what a competent workman reading the specification at its date would have understood it to have disclosed andclaimed. [94] Lord Diplock put it this way in Catnic Components Ltd v Hill & Smith Ltd, [1982] RPC 183: A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind ofmeticulous verbal analysis in which lawyers are too often tempted by their training to indulge.

The question in each case is: whetherpersons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understandthat strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essentialrequirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effectupon the way the invention worked. [Emphasis in original.] [95] However, purposive construction does not lead to a construction that would not be consistent with the language used by theinventor in the patent.

While it has long been true that a patent “must be read by a mind willing to understand, not by a mind desirous ofmisunderstanding” (Lister v Norton Brothers and Co (1886), 3 RPC 199, at page 203), that does not imply that the words used can beignored. In Free World Trust, supra, the Supreme Court describes in the following fashion the basic tension between a literal applicationof the text of the patent and an

interpretation that would be overly broad: [29] It is obviously an important public policy to control the scope of “substantive infringement”. A purely literal application of thetext of the claims would allow a person skilled in the art to make minor and inconsequential variations in the device and thereby toappropriate the substance of the invention with a copycat device while staying just outside the monopoly. A broader

interpretation, onthe other hand, risks conferring on the patentee the benefit of inventions that he had not in fact made but which could be deemed withhindsight to be “equivalent” to what in fact was invented. This would be unfair to the public and unfair to competitors. It is important thatthe patent system be fair as well as predictable in its operation. [96] That fundamental tension is resolved by the primacy of claims language which “was already rooted deeply in ourjurisprudence and should, I think, be affirmed again on this appeal” (Free World Trust, supra, para 40).

Thus the Supreme Court stated atparagraph 51 of the same case: The involvement in claims construction of the skilled addressee holds out to the patentee the comfort that the claims will be read in lightof the knowledge provided to the court by expert evidence on the technical meaning of the terms and concepts used in the claims. Thewords chosen by the inventor will be read in the sense the inventor is presumed to have intended, and in a way that is sympathetic toaccomplishment of the inventor’s purpose expressed or implicit in the text of the claims.

However, if the inventor has misspoken orotherwise created an unnecessary or troublesome limitation in the claims, it is a self-inflicted wound. The public is entitled to rely on thewords used provided the words used are interpreted fairly and knowledgeably. [Emphasis in original.]

[97] Indeed, the Supreme Court cited with approval this passage written by Pratte J.A. in Eli Lilly & Co v O’Hara ManufacturingLtd (1989), 26 CPR (3d) 1 [O’Hara], at page 7: A court must interpret the claims; it cannot redraft them. When an inventor has clearly stated in the claims that he considered arequirement as essential to his invention, a court cannot decide otherwise for the sole reason that he was mistaken. [98] Accordingly, the dictionary approach to claims construction is rejected (Whirlpool, supra, para 52), but the purposive claimsconstruction would take into account the primacy of the language used.

It is also clear that the construction must consider the disclosureand the claim. In Consolboard, supra, Dickson J. writes at pages 520-521: We must look to the whole of the disclosure and the claims to ascertain the nature of the invention and methods of its performance,(Noranda Mines Limited v. Minerals Separation North American Corporation), being neither benevolent nor harsh, but rather seeking aconstruction which is reasonable and fair to both patentee and public.

There is no occasion for being too astute or technical in the matterof objections to either title or specification for, as Duff C.J.C. said, giving the judgment of the Court in Western Electric Company,Incorporated, and Northern Electric Company v. Baldwin International Radio of Canada, at p. 574, “where the language of thespecification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faithinvented, the court, as a rule, will endeavour to give effect to that construction”.

Sir George Jessel spoke to like effect at a much earlierdate in Hinks & Son v. Safety Lighting Company. He said the patent should be approached “with a judicial anxiety to support a reallyuseful invention”. [99] It follows that the task at hand is to conduct a purposive construction of the patent, relying on the particular words and phrasesin the claims as defined or further described in the disclosure, with a view to ascertaining the essential elements of the invention.

TheSupreme Court reasserted in Whirlpool, supra, its view expressed in Metalliflex Ltd v Rodi & Wienenberger Aktiengesellschaft, (SCC), [1961] SCR 117, at page 122: The claims, of course, must be construed with reference to the entire specifications, and the latter may therefore be considered in order toassist in apprehending and construing a claim, but the patentee may not be allowed to expand his monopoly specifically expressed in theclaims “by borrowing this or that gloss from other parts of the specifications”. [100] However, there is a clear limitation to the use that can be appropriately made of the specification.

In Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61, [2008] 3 SCR 265 [Sanofi], Rothstein J., for a unanimous Court offers this reminder: [77] The inventive concept of the claims is not readily discernable from the claims themselves. A bare chemical formula in a patentclaim may not be sufficient to determine its inventiveness. In such cases, I think it must be acceptable to read the specification in thepatent to determine the inventive concept of the claims.

Of course, it is not permissible to read the specification in order to construe theclaims more narrowly or widely than the text will allow. [101] In the case at bar, the parties do not disagree on what claim 1 identifies as the essential elements of the invention.

They are theactive ingredient, identified in claim 1 as gliclazide, a cellulose derivative which provides the modified release of the active ingredient, abinder and, once subdivided, that the gliclazide tablet has an identical dissolution profile to that of the whole tablet. [102] There is not any dispute in the construction of the asserted claims around the active ingredient and the cellulose derivative.

Onthe other hand, there is much debate around the other two. [103] Servier contends that, with respect to the “profile de dissolution identique” (identical dissolution profile), the POSITA wouldunderstand that “[a] divided tablet exhibits similar in vivo plasma kinetics (bioequivalence) as a whole tablet, which may be predicted byin vitro dissolution” (Applicant’s Memorandum of Fact and Law, para 30). The Memorandum of Fact and Law states that the identicaldissolution profile “is defined to mean in vivo similarity or bioequivalence” (para 32). [104] In order to make that case, Servier relies on its expert Dr.

Bodmeier who states that the POSITA would understand “identicaldissolution profile” to mean statistically similar in vivo dissolution profile. [105] With respect, this is less than convincing. For starters, the words “in vivo” are nowhere to be found in the specification.Furthermore the expression “identical dissolution profile” is defined in the disclosure: Dans le contexte de l’invention on entend par« profile de dissolution identique » descinétiques de dissolution ayant descoefficients de variations sans différencestatistiques entre eux.

Les cinétiques dedissolution in vitro identiques selonl’invention donnent des cinétiquesplasmatiques identiques. In the context of the invention, the expression“identical dissolution profile” is intended tomean dissolution kinetics having variationcoefficients with no statistical differencebetween them.

The identical in vitrodissolution kinetics according to theinvention give identical plasma kinetics. [106] The applicant would want to read in the words “in vivo” in the first sentence (which would then read “is intended to mean invivo dissolution kinetics having variation coefficients with no statistical difference between them”). There was never a justification givenby Servier for how there would be two types of dissolution kinetics in consecutive sentences, in the same definition. The second sentencecarefully states that the “identical in vitro dissolution kinetics” are “according to the invention”.

The first sentence makes the same point:“In the context of the invention…” A fair reading of the paragraph suggests that the “dissolutions kinetics” in the first sentence are thesame dissolution kinetics in the second sentence, i.e. in vitro kinetics. [107] Servier has argued at the hearing that its

interpretation is supported by paragraphs 2 and 3 of the disclosure. It is said that thereference to variations in plasma levels of the active ingredient signals that the reader would have to look for in vivo dissolution kinetics.There are many difficulties with this argument. First, the reference to “in vivo dissolution kinetics” does not appear anywhere in the two

paragraphs; the same is true of “ in vivo ” alone. Second, this very early part of the specification is at best descriptive: it merely states the obvious, in that the active ingredient will find its way into the bloodstream. Hence, the inventor refers to “variations in the plasma levels of the active ingredient” and “the production of high and short-lived blood concentrations of active ingredient” in the context of presenting the advantages of the modified release of the active ingredient. [ 108 ] I was less than convinced by the Servier experts. No doubt they are skilled readers.

But in order to reach their conclusions, they need to put a strained construction on the definition and “read in” words that are not present. They do not account either for the only example that can be found in the specification.

Under the heading “Example 1: Dissolution kinetics” the patentee asserts that “[t]his example compares the in vitro release kinetics of non-subdivided tablets and of fractional doses according to the invention.” The example goes on to show that the in vitro dissolution profiles satisfy the so-called f2 similarity factor, which is a mathematical equation, that measures the variation between release profiles. As pointed out by Dr. Bodmeier, “[a] similarity factor, or f2 value, of 50 or higher denotes similarity between the two profiles being compared” (para 79, affidavit of Dr. Bodmeier). [ 109 ] Dr.

Fassihi, who was measured in his testimony, appears to me to express adequately what the skilled person would understand: 203. At various places in their affidavits, both Dr. Marroum (see, for example paragraphs 21, 84-85, 87, 105 and 111) and Dr. Bodmeier (see, for example, paragraphs 17, 86-88, 109 and 123) provide the opinion that the identical dissolution profile in claims 1 and 10 relates to an in vivo dissolution profile or bioequivalency. This

interpretation of the claims is surprising given that there is no in vivo testing described in the 670 Patent. Rather, the single dissolution study that is reported in the 670 Patent was conducted in vitro . It is also stated in the 670 Patent (see page 5) that the identical in vitro dissolution kinetics according to the invention give identical plasma kinetics. In the 670 Patent (see pages 4-5), “identical dissolution profile” is defined as meaning dissolution kinetics with no statistical difference between them, and the only dissolution kinetics provided in the 670 Patent are found in Example 1 (and Figure 1).

These dissolution kinetics relate to the in vitro dissolution of a whole and half tablet of batch L0014022. Based on the information provided in the 670 Patent, it is my opinion that the skilled person would understand the 670 Patent to be referring to in vitro dissolution rather than in vivo dissolution or bioequivalency. To put it bluntly, there is nothing in this patent that would signal in vivo dissolution. [ 110 ] Similarly, Dr. Lee did not try to give a strained

interpretation of the patent. Furthermore, the

interpretation conforms with the plain words used by the patentee: 77. This issue is complicated by the fact that claim 15 refers to a “similar dissolution profile”. While the meaning of a “similar” dissolution profile is not described in the remainder of the 670 Patent, this is a term that the skilled person would understand in the context of dissolution profiles.

One of the common statistical tests for comparing two dissolution profiles is the similarity factor test, or f 2 , which compares the amount of material dissolved between a test sample (for example, the subdivided tablet) and a reference sample (for example, the whole tablet) at different time points. If the value calculated for f 2 is between 50 and 100, the dissolution profiles are considered to be similar. This allows for an approximate 10% variance in dissolution between two sets of dissolution data at each time point (f 2 = 50).

If the value calculated for f 2 is less than 50, the dissolution profiles are considered not to be similar. 78. Absent a different explanation in the 670 Patent, it is my opinion that the skilled person would adopt this understanding of the term “similar dissolution profile” in claim 15. While an f 2 value of 100 would represent “identical” dissolution values, the skilled person would understand that this is an impractical standard and could not be what the inventors had intended when they refer to an “identical dissolution profile”.

Therefore, the skilled person would understand that “identical dissolution profile” in claim 1 must be referring to something that is more than “similar” (an f 2 value of greater than 50) but less than absolutely “identical” (and f 2 of less than 100). However, the skilled person would not know exactly what this difference was intended to be. [ 111 ] Both Dr. Lee and Dr. Fassihi gave

interpretations that sought to account for the written words, as defined in the disclosure, and for claim 15. Their

interpretation is in my view more persuasive than adding words in the definition the patentee chose to give and ignore the sole example given which refers to in vitro dissolution profiles. Dr. Fassihi gave an opinion which has the merit of acknowledging the difficulties inherent in the language used by the patentee: 85. However, this understanding of the phrase “identical dissolution profile” in independent claims 1 and 10 of the 670 Patent is complicated by the fact that there is a reference to a “similar dissolution profile” in claim 15.

There is no doubt that the skilled person would understand a “similar dissolution profile” as used in claim 15 to refer to an f 2 similarity factor of greater than 50.

What is not clear is whether the inventors intended the phrase “identical dissolution profile” to mean the same as the phrase “similar dissolution profile”, or whether the phrase “identical dissolution profile” is meant to refer to a dissolution profile that is more similar than a “similar dissolution profile” (that is, an f 2 value that is somewhat greater than 50), or whether the inventors intended the phrase “identical dissolution profile” to mean that some other statistical test was to be used. 86.

Therefore, while it is not clear exactly what the inventors intended to mean with their use of the term “identical dissolution profile” in independent claims 1 and 10, it is my opinion that the skilled person would understand that the inventors likely intended that this would refer to dissolution profiles where the f 2 value was at least 50, but most likely something closer to the upper end of 50-100.

As noted above, the skilled person would understand a “similar dissolution profile” to refer to dissolution profiles having an f 2 value of 50 or greater. [ 112 ] Thus, the applicant has not discharged its burden that the identical dissolution profile requires in vivo dissolution kinetics in the eyes of the POSITA.

The specification provides clearly, in my view, that the essential element requires that there be identical in vitro dissolution kinetics. [ 113 ] Apotex also argues that the patent requires that there be a binder other than the cellulose derivative that is used in providing the modified release of the active ingredient. Servier argues that the cellulose derivative can serve both purposes once the specification is purposively constructed.

[ 114 ] Once again, the disclosure is of assistance in describing what the binder is for: Dans la composition pharmaceutique selon l’invention le liant sert à agglutiner entre elles les particules qui ne peuvent l’être sous la seule action de la pression. In the pharmaceutical composition according to the invention, the binder serves to agglutinate together the particles which cannot be agglutinated under the action of pressure alone. [ 115 ] Hence, in order to qualify as a binder, an excipient will have to serve to agglutinate (in Dr.

Marroum’s affidavit, he gives at paragraph 90 the explanation that the word comes from the Latin “to glue”) and that the particles cannot be agglutinated under the action of pressure alone. [ 116 ] Servier asserts that out of the list of binders found in the specification, the inventor specifies that HPMC can be a binder. In essence, Servier contends that HPMC can be both a cellulose derivative and a binder. It must be noted, however, that the cellulose derivative would preferably be of low viscosity (‘670 Patent, page 8 and claim 3).

Indeed, the Servier product uses HPMC 100 cP, which is described in the specification as a low-viscosity HPMC. Conversely, the binder is presented as being preferably a number of substances ( inter alia glucose, sucrose, maltodextrin, polyvidone and HPMC of very low viscosity). We know that Servier uses maltodextrin for its product.

When, as part of the disclosure at page 9, the inventor offers a further preference, it is for “maltodextrin, polyvidone or an HPMC of very low molecular weight.” [ 117 ] Claim 4, which deals with the binder, speaks of three possible excipients: maltodextrin, polyvidone and HPMC of very low viscosity. In the disclosure, HPMC is referenced as a possible binder, but it would have to be either of very low viscosity or very low molecular weight. In spite of that Servier argues that the binder can be the HPMC of low viscosity. [ 118 ] Servier relies on the testimonies of its two experts, Dr. Bodmeier and Dr.

Marroum, for its view that the POSITA would accept that the binder may be HPMC of low to very low viscosity (Memorandum of Fact and Law, para 34). In so doing, Servier appears to seek support in one of the three preferred combinations found after the paragraphs on page 9 that speak of “an HPMC of very low viscosity” and “an HPMC of very low molecular weight”. That paragraph evidently deals with the third essential element. It reads: La présente invention concerne donc de préférence un comprimé sécable à libération prolongée comprenant:

a) du gliclazide, un dérivé de cellulose, de la maltodextrine ou

b) du gliclazide, un dérivé de cellulose, de la polyvidone ou

c) du gliclazide, un dérivé de cellulose, une HPMC de faible à très faible poids moléculaire. The present invention therefore preferably relates to a prolonged-release scored tablet comprising:

a) gliclazide, a cellulose derivative, maltodextrin or

b) gliclazide, a cellulose derivative, polyvidone or

c) gliclazide, a cellulose derivative, an HPMC of low to very low molecular weight. [ 119 ] I would not hold against the applicant that it speaks in its factum of low to very low viscosity, instead of low to very low molecular weight. Rather, the issue is that the specification speaks in terms that forcefully suggest that the binder will be a different excipient than the cellulose derivative which forms “the matrix providing, inter alia, the modified release of the active ingredient.” The patent is careful to speak of an HPMC of very low molecular weight.

It also states that the HPMC, in order to be a binder, will be of very low viscosity both in the disclosure and claim 4. This helps confirm that if the binder is to be HPMC, it has to be a different HPMC than that forming the cellulose derivative. [ 120 ] I am comforted in this conclusion by the fact that nothing in the specification teaches that the cellulose derivative and the binder can be one and the same. Indeed, the applicant does not explain how the same HPMC would be capable “to agglutinate together the particles which cannot be agglutinated under the action of pressure alone”.

What part of HPMC of low viscosity (as opposed to very low viscosity) can serve to agglutinate the particles without being under the action of pressure alone was never explained? Servier tries to take advantage of three words (“low to very”) in a paragraph in the disclosure after having stated clearly that the binder could be HPMC if it is either of very low viscosity or very low molecular weight.

It seems to me that the balance of probabilities favours that the POSITA would understand that the patent requires that the binder be a different excipient that, if it is to be HPMC, would have to be an HPMC of very low viscosity (or of very low molecular weight). To paraphrase Pratte J.A. in O’Hara , supra , it is not for the Court to redraft claims.

When claims are written to state four essential elements, and the specification is written to identify a binder as a different element, it will not be possible to construct the claims as allowing two of the essential elements to be the same, but with different properties unless, somehow, the party seeking that construction convinces the Court that the patent teaches that much. Here the applicant has failed to meet that burden.

Its reliance on three words, in the face of other statements in the specification and the gist of it will be not sufficient to reverse the tide. [ 121 ] It follows that the ‘670 Patent must be constructed as having the following essential elements:

a) an active ingredient: gliclazide;

b) a cellulose derivative (50% to 60% of the total weight of the tablet);

c) a binder which will be an excipient other than the cellulose derivative, but could be an HPMC of very low viscosity (or very low molecular weight);

d) the subdivided tablet will have an identical in vitro dissolution profile to that of the undivided tablet. [ 122 ] It is understood that the prolonged-release tablet is scored, or grooved. VIII. Infringement

[ 123 ] Apotex alleges that it does not infringe the ‘670 Patent because its tablet does not contain a binder and its testing has not shown in vitro dissolution profiles that would be identical for undivided and subd

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