Laboratoires Servier v. Canada (Health)

Laboratoires Servier v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2015-02-16
Neutral citation
2015 FC 108
File numbers
T-222-13
Decision Content
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 im