PFIZER PRODUCTS INC. Applicant v. CANADIAN GENERIC PHARMACEUTICAL ASSOCIATION, 2015 FC 493

Date: 20150420 Docket: T-733-13 Citation: 2015 FC 493 Ottawa, Ontario, April 20, 2015 PRESENT: The Honourable Mr. Justice Russell BETWEEN: PFIZER PRODUCTS INC.Applicantand CANADIAN GENERIC PHARMACEUTICAL ASSOCIATIONRespondent JUDGMENT AND REASONS I. INTRODUCTION [1] This is an appeal under s. 56(1) of the Trade-marks Act, RSC 1985, c T-13 [Act] of the Trade-marks Opposition Board’s[Board] decision, dated January 23, 2013 [Decision], which refused Pfizer Products Inc.’s [Pfizer or Applicant] trade-mark application,No. 1, 244, 118, pursuant to s. 38(8) of the Act. II.

BACKGROUND [2] The Applicant applied to register the trade-mark, Viagra Tablet Design, on January 19, 2005. The registration was based onthe Applicant’s use of the trade-mark in Canada since at least as early as March 1999 in association with a pharmaceutical product usedfor the treatment of sexual dysfunction. [3] An official action was issued on April 29, 2005. The Examiner requested that the Applicant amend the drawing to show thetablet in a dotted outline and remove the statement “colour is claimed as a feature of the trade-mark.” The Applicant complied with therequest.

The amended trade-mark, Miscellaneous Three Dimensional Design [Mark], was advertised for opposition purposes in theTrade-marks Journal of October 5, 2005. An erratum was published on May 17, 2006. [4] The Canadian Generic Pharmaceutical Association [CGPA or Respondent] filed a statement of opposition to the applicationon March 6, 2006. The parties filed written submissions, and an oral hearing was held in May 2012. III. DECISION UNDER REVIEW [5] On January 23, 2013, the Board refused the Applicant’s trade-mark pursuant to s. 38(8) of the Act.

The Board concludedthat it was not satisfied, on a balance of probabilities, that the Mark was distinctive in accordance with s. 38(2)(

d) of the Act. Beforereaching its conclusion, the Board rejected each of the other grounds of opposition. Only the issues raised by the parties will bediscussed; these issues include the Board’s findings regarding the compliance of the application and the distinctiveness of the Mark. A. Compliance of the Application [6] At the opposition hearing, CGPA argued that the application did not comply with s. 30(

h) of the Act because the drawing didnot include the markings on the tablets, and it was impossible to tell whether the Mark was two or three dimensional and what variety ofshapes, sizes and colours the Mark included. [7] The Board said that there was no requirement that the markings of a tablet be included in the drawing: Novopharm Ltd v EliLilly and Co (2004), (CA TMOB), 45 CPR (4th) 254 at 282, [2004] TMOB no 173 (QL)(TMOB).

Notwithstandingthe lack of requirement, the Board found that the markings were only lightly scored on the tablets and were minor in nature. [8] The Board also said that it was not fatal to an application to have a drawing which includes both dotted and solid lines:Novopharm Ltd v Pfizer Products Inc, [2009] TMOB no 181 (QL) at para 27.

The Board found that there was no ambiguity in thedrawing: “the drawing and description clearly show that the claimed colour will be applied to the six sides of a three dimensionaldiamond shaped tablet with width, height and depth as opposed to a two dimensional figure lacking depth” (Decision at para 54).

TheBoard also noted that the application was in compliance with the Canadian Intellectual Property Office, Practice Notice: “Three-dimensional Marks” (December 6, 2000) because the description indicated that the Mark was to apply to the “whole of the visiblesurface of the tablet shown in the attached drawings” (Decision at para 54).

Further, the Board said that the Applicant was not required toattach a disclaimer to the drawing because “disclaimers often give rise to ambiguity” (Decision at para 56, citing Novopharm Ltd v PfizerProducts Inc, above, at para 30). [9] The Board concluded that the drawing and description complied with s. 30(

h) of the Act because the limits of the Mark were

clearly defined. B. Distinctiveness of the Mark [10] The Board said that the material date for assessing the distinctiveness of the Mark was March 6, 2006, the date that thestatement of opposition was filed. [11] At the opposition hearing, CGPA argued that the colour and shape of the Mark did not distinguish the wares. The Boardfound that CGPA had met its initial evidentiary burden because the evidence showed that there was a high number of blue and/or multi-sided pills in the marketplace in 2005 and 2006.

The Board found that this led to the conclusion that at least some of those pills had beenactively marketed in Canada at the material date.

As a result, the Applicant had the legal onus to establish, on a balance of probabilities,that the Mark distinguished the Applicant’s wares from the wares of others. [12] The Board said that three conditions must be satisfied to establish that a mark distinguishes wares (Philip Morris Inc vImperial Tobacco Ltd (1985), 7 CPR (3d) 254 at 270, [1985] FCJ no 1231 (QL)(FCTD) [Philip Morris], aff’d (1987) 17 CPR (3d) 289(FCA): “(1) that a mark and a product (or ware) be associated; (2) that the ‘owner’ uses this association between the mark and hisproduct and is manufacturing and selling his product; and, (3) that this association enables the owner of the mark to distinguish hisproduct from that of others.” To be distinctive, consumers must relate or associate the trade-mark with the source of the wares: GlaxoGroup Limited v Apotex Inc, 2010 FCA 313 at para 7 [Apotex FCA].

The Board said that this test required that the Applicant show thatphysicians, pharmacists and patients recognize the Mark as a trade-mark and not just as an ornamental or functional element of theproduct: Novopharm Ltd v Bayer Inc, (FC), [2000] 2 FC 553 at para 73, 179 FTR 260 [Novopharm], aff’d (2000) (FCA), 264 NR 384, 9 CPR (4th) 304 (FCA) [Novopharm FCA]; Novopharm Ltd v Astra Aktiebolag (2000), (CA TMOB), 6 CPR (4th) 101 at 112, [2000] TMOB no 35 (QL).

(1) Applicant’s Use of the Mark [13] At the opposition hearing, CGPA argued that there was no evidence to support the conclusion that use of the Mark by PfizerCanada Inc. enured to the Applicant. The Board said that it was satisfied by the evidence that there was both a 1986 and a 2006 licensingagreement in place such that the use of the Mark enured to the Applicant under s. 50 of the Act. The Board did not draw an adverseinference from the fact that the 2006 licensing agreement had not been produced because there is no requirement that a licensingagreement be in writing.

The Board also noted that CGPA could have confirmed further details about the licensing agreement on cross-examination if it believed that issues remained outstanding. [14] The Board also accepted the evidence that the total sales of Viagra in Canada had exceeded $470 million in 2006, with over850,000 prescriptions for Viagra having been filled in both 2005 and 2006.

The Board cautioned, though, that “impressive sales figuresalone do not satisfy the burden on an applicant for a trade-mark of proving distinctiveness” (Decision at para 85, quoting Novopharm Ltdv Astra Aktiebolag (2000), (FC), 187 FTR 119, 6 CPR (4th) 16 at 25 [Astra], aff’d 2001 FCA 296 [Astra FCA]). TheBoard was satisfied that the Applicant had used the Mark to create an association with its product.

(2) Distinctiveness among Patients [15] The Board said that while not determinative of use, advertising and reputation could result in a finding of distinctiveness:Bojangles’ International LLC v Bojangles Café Ltd, 2006 FC 657 at para 29. The Board noted that the only direct evidence from apatient who had taken Viagra came from Viagra’s brand manager, Marc Charbonneau. The Board said that Mr.

Charbonneau’s evidencecould not be representative of patients generally due to his position. [16] The Board considered the evidence regarding the marketing and sales of Viagra, as well as the evidence from physicians andpharmacists regarding patients’ perceptions of the Mark. The Board said that the evidence supported a finding that many patients hadbeen exposed to Viagra advertising and that some patients referred to Viagra as a “little blue pill.” This led the Board to conclude that theMark had a reputation among at least some consumers.

The Board concluded that the Mark was distinctive among patients because theevidence showed that patients associate the Mark with the wares.

(3) Distinctiveness among Pharmacists [17] The Board said that the Applicant was required to establish that the colour and shape were the “primary characteristics” bywhich pharmacists distinguished the wares from others: Apotex Inc v Registrar of Trade Marks, 2010 FC 291 at para 34 [Apotex], aff’dApotex FCA, above. The Board accepted the fact that no pharmacist would identify a medication solely by reference to colour, shape andsize, but said that this was not fatal to the application: Novopharm, above, at para 79.

The Board said that while three of the pharmacistswho provided evidence said that they were familiar with the appearance of Viagra and knew that it was manufactured by a single source,a unique and recognizable design is not sufficient for distinctiveness: Apotex, above, at para 13. The Federal Court and Federal Court ofAppeal’s jurisprudence has established that pharmacists must relate the trade-mark to their dispensing decisions: Apotex FCA, above, atpara 7.

The Board found that pharmacists used various characteristics to distinguish the wares including: Drug Identification Numbers;the name of the drug and the dosage; and, the Universal Product Code found on the packaging. [18] Earlier in its Decision, the Board addressed the admissibility of the expert evidence of Dr. Ruth Corbin. Dr.

Corbin is a surveyexpert who conducted a survey relating to pharmacists’ recognition of the Mark in 2002. [19] The Board considered the four criteria for the admissibility of expert evidence in R v Mohan, (SCC), [1994] 2SCR 9: relevance; necessity in assisting the trier of fact; absence of any exclusionary rule; and, from a properly qualified expert. TheBoard concluded that Dr. Corbin’s evidence was not relevant to the assessment of the distinctiveness of the design on March 6, 2006.The Board acknowledged that, on cross-examination, Dr.

Corbin said that the 2002 results were relevant to 2006 because the awarenessof a well-marketed product increases as the product becomes entrenched. Dr. Corbin said that even if another blue diamond-shaped pill

had been introduced between 2002 and 2006, the distinctiveness of the Mark would be the same or increased. However, the Board foundthat Dr. Corbin’s answers were inconsistent with the Board’s own understanding of the survey. The Board concluded that Dr. Corbin’sevidence was not relevant to the issue of distinctiveness and declined to address CGPA’s other objections to Dr. Corbin’s evidence. [20] The Board said that had it admitted Dr. Corbin’s survey, it would have supported the fact that pharmacists associated theMark with Viagra tablets manufactured by one company.

However, the Board concluded that it was not satisfied that the evidenceshowed that pharmacists primarily rely on colour and shape in making dispensing decisions. In fact, the evidence led to a finding thatpharmacists primarily use other means to distinguish the wares. The Board concluded that it was not satisfied that the Mark wasdistinctive among pharmacists.

(4) Distinctiveness among Physicians [21] The Board considered the evidence of three doctors in relation to the distinctiveness of the Mark among physicians. TheBoard found that Dr. Weiss’ evidence was not applicable to physicians generally given his role in developing and giving presentationsfunded by Pfizer. The Board also found that Dr. Perlin’s evidence was not applicable to physicians generally given her evidence that shedoes not watch television, does not look at advertising in medical journals, and has never seen a Viagra advertisement in a newspaper ormagazine. Dr.

Schiffman’s evidence was that he was aware of the appearance of Viagra and that Viagra is manufactured by Pfizer.However, his evidence was that he does not associate the Mark with a single source because he said that he would not identify a blue-diamond tablet as Viagra because “[i]t could be anything” (Decision at para 98). The Board concluded that it was not satisfied that theevidence established that the Mark was distinctive among physicians.

(5) Conclusion on Distinctiveness [22] The Board concluded that the Applicant had not established, on a balance of probabilities, that the Mark was distinctiveamong physicians and pharmacists as of March 6, 2006. The Board said that the Applicant had failed to establish that “a significantnumber of physicians and pharmacists relate the Mark to prescribing and dispensing of the Wares” (Decision at para 100). Theopposition succeeded because the Applicant had failed to establish distinctiveness in relation to patients and physicians and pharmacists. IV.

ISSUES [23] The Applicant raises two issues in this proceeding: 1. Whether the new evidence on appeal would have had a material effect on the Board’s Decision; and 2. Whether the Mark should have been held to be distinctive under s. 38(2)(

d) of the Act. V. STANDARD OF REVIEW [24] The Supreme Court of Canada in Dunsmuir v New Brunswick, 2008 SCC 9 [Dunsmuir] held that a standard of review analysisneed not be conducted in every instance. Instead, where the standard of review applicable to a particular question before the court issettled in a satisfactory manner by past jurisprudence, the reviewing court may adopt that standard of review.

Only where this searchproves fruitless, or where the relevant precedents appear to be inconsistent with new developments in the common law principles ofjudicial review, must the reviewing court undertake a consideration of the four factors comprising the standard of review analysis:Agraira v Canada (Public Safety and Emergency Preparedness), 2013 SCC 36 at para 48. [25] The Applicant submits that the Court is required to assess the new evidence to determine whether it would have materiallyaffected the Decision.

The Applicant says that material evidence is that which is “substantial and significant” when evaluated on thebasis of quality and not quantity.

The Decision is entitled to deference if the new evidence: adds nothing of probative significance; ismerely repetitive of existing evidence; is irrelevant; makes assumptions without specific support; or, was filed only to support theBoard’s Decision: JTI-Macdonald TM Corp v Imperial Tobacco Products Limited, 2013 FC 608 at paras 23-24; Scott Paper Limited vGeorgia-Pacific Consumer Products LP, 2010 FC 478 at paras 41-49 [Scott Paper]; Vivat Holdings Ltd v Levi Strauss & Co, 2005 FC707 at para 27 [Vivat Holdings].

The Applicant also submits that where the Board has noted an absence of information or a deficiency,new evidence that responds to the cited deficiency may be considered and may result in a review of the correctness of the decision:Mövenpick Holding AG v Exxon Mobil Corporation, 2011 FC 1397 at para 54; Advance Magazine Publishers Inc v Farleyco MarketingInc, 2009 FC 153 at paras 93-95, 98. [26] The Applicant submits that the standard of review for questions of law is correctness, no matter the materiality of newevidence: Engineers Canada v Rem Chemicals, Inc, 2014 FC 644 at paras 27, 58 [Engineers Canada]. [27] The Respondent submits that the Decision regarding distinctiveness should be reviewed on a standard of reasonableness:Mattel, Inc v 3894207 Canada Inc, 2006 SCC 22 at para 10 [Mattel]; John Labatt Ltd v Molson Companies Ltd (1990), (FC), 36 FTR 70, 30 CPR (3d) 293, aff’d (1992), 144 NR 318, 42 CPR (3d) 495 (FCA).

The Respondent submits that if theparties have submitted new, material evidence, the Court is required to consider the entire record and decide for itself whether theApplicant has demonstrated an entitlement to the registration: see Astrazeneca AB v Novopharm Ltd, 2003 FCA 57 [Astrazeneca];Mattel, above, at para 40; Novopharm FCA, above, at paras 4-6. [28] I will address the applicable standard of review in my analysis of the issues. VI. STATUTORY PROVISIONS

[ 29 ] The following provisions of the Act are applicable in this proceeding:

Definitions Définitions 2. In this Act , 2. Les définitions qui suivent s’appliquent à la présente loi. […] […] “distinctive” « distinctive » “distinctive”, in relation to a trade-mark, means a trade-mark that actually distinguishes the wares or services in association with which it is used by its owner from the wares or services of others or is adapted so to distinguish them; « distinctive »

Relativement à une marque de commerce, celle qui distingue véritablement les marchandises ou services en liaison avec lesquels elle est employée par son propriétaire, des marchandises ou services d’autres propriétaires, ou qui est adaptée à les distinguer ainsi. […] […] “trade-mark” « marque de commerce » “trade-mark” means « marque de commerce » Selon le cas : (

a) a mark that is used by a person for the purpose of distinguishing or so as to distinguish wares or services manufactured, sold, leased, hired or performed by him from those manufactured, sold, leased, hired or performed by others,

a) marque employée par une personne pour distinguer, ou de façon à distinguer, les marchandises fabriquées, vendues, données à bail ou louées ou les services loués ou exécutés, par elle, des marchandises fabriquées, vendues, données à bail ou louées ou des services loués ou exécutés, par d’autres; […] […] “use” « emploi » ou « usage » “use”, in relation to a trade-mark, means any use that by

section 4 is deemed to be a use in association with wares or services; « emploi » ou « usage » À l’égard d’une marque de commerce, tout emploi qui, selon l’article 4, est réputé un emploi en liaison avec des marchandises ou services. […] […] Statement of opposition Déclaration d’opposition 38.

(1) Within two months after the advertisement of an application for the registration of a trade-mark, any person may, on payment of the prescribed fee, file a statement of opposition with the Registrar. 38.

(1) Toute personne peut, dans le délai de deux mois à compter de l’annonce de la demande, et sur paiement du droit prescrit, produire au bureau du registraire une déclaration d’opposition. Grounds Motifs

(2) A statement of opposition may be based on any of the following grounds:

(2) Cette opposition peut être fondée sur l’un des motifs suivants : (

a) that the application does not conform to the requirements of

section 30;

a) la demande ne satisfait pas aux exigences de l’article 30; (

b) that the trade-mark is not registrable;

b) la marque de commerce n’est pas enregistrable; (

c) that the applicant is not the person entitled to registration of the trade-mark; or

c) le requérant n’est pas la personne ayant droit à l’enregistrement; (

d) that the trade-mark is not distinctive.

d) la marque de commerce n’est pas distinctive. […] […] Decision Décision

(8) After considering the evidence and representations of the opponent and the applicant, the Registrar shall refuse the application or reject the opposition and notify the parties of the decision and the reasons for the decision.

(8) Après avoir examiné la preuve et les observations des parties, le registraire repousse la demande ou rejette l’opposition et notifie aux parties sa décision ainsi que ses motifs. Appeal Appel 56.

(1) An appeal lies to the Federal Court from any decision of the Registrar under this Act within two months from the date on which notice of the decision was dispatched by the Registrar or within such further time as the Court may allow, either before or after the expiration of the two months. 56.

(1) Appel de toute décision rendue par le registraire, sous le régime de la présente loi, peut être interjeté à la Cour fédérale dans les deux mois qui suivent la date où le registraire a expédié l’avis de la décision ou dans tel délai supplémentaire accordé par le tribunal, soit avant, soit après l’expiration des deux mois. […] […] Additional evidence Preuve additionnelle

(5) On an appeal under subsection (1),evidence in addition to that adduced beforethe Registrar may be adduced and the FederalCourt may exercise any discretion vested inthe Registrar.

(5) Lors de l’appel, il peut être apporté unepreuve en plus de celle qui a été fourniedevant le registraire, et le tribunal peutexercer toute discrétion dont le registraire estinvesti. VII. ARGUMENT A. Applicant

(1) Proper Issues before the Court [30] As a preliminary issue, the Applicant argues that the only issue properly before the Court is the Board’s finding regarding thedistinctiveness of the Mark.

The Applicant says that if the Respondent wanted to argue that the Decision should be set aside on othergrounds, it was obligated to raise these issues in its notice of appearance or by commencing its own application: Minister of NationalRevenue v Larsson (1997), 216 NR 315 at paras 27-28 (FCA); Autodata Ltd v Autodata Solutions Co, 2004 FC 1361 at paras 23-27[Autodata]. [31] The Applicant says that the following issues are inappropriately raised in the Respondent’s evidence: the Board’s decisionregarding a motion for the recusal of the hearing officer; the merits of the Corbin survey; and the impact of Pfizer’s post-2006advertising.

The Applicant says that it is unable to respond to the evidence and the issues it raises without knowing how the Respondentintends to address the issues.

(2) Distinctiveness [32] The Applicant says that the Board erred in its application of the test for distinctiveness by requiring that distinctiveness beestablished among patients, physicians, and pharmacists. The Applicant says that establishing distinctiveness among patients should besufficient. The Board also erred in its application of the “consumer use” requirement in dealing with physicians and pharmacists.

Further,the new evidence establishes distinctiveness among physicians and pharmacists. [33] The Applicant submits that the test for distinctiveness is “whether a clear message has been given to the public that the wareswith which the trade-mark is associated and used are the wares of the trade-mark owner and not those of another party” (Applicant’sRecord at 12868).

The legal test for distinctiveness is not unique to the pharmaceutical context and is the same test that is used in allother industries: Ciba-Geigy Canada Ltd v Apotex Inc, (SCC), [1992] 3 SCR 120 at 152 [Ciba-Geigy]; Astrazeneca,above, at paras 18-20; Smith Kline & French Canada Ltd v Canada (Registrar of Trade Marks), (FC), [1987] 2 FC633 at 635-636, 9 FTR 129; Novopharm, above, at para 77, aff’d Novopharm FCA, above. Three conditions must be met to establishdistinctiveness: (

i) the mark and the ware must be associated; (ii) the owner of the mark must use the association between the mark andits product; and (iii) the association must enable the owner to distinguish its product from that of others: Oxford Pendaflex Canada Ltd vKorr Marketing Ltd, (SCC), [1982] 1 SCR 494 at 502 [Oxford Pendaflex]; Philip Morris, above, at 270; Havana HouseCigar & Tobacco Merchants Ltd v Skyway Cigar Store (1998), (FC), 147 FTR 54, 81 CPR (3d) 203 at 222-223[Havana House Cigar]; Act, s. 2.

Distinctiveness does not require evidence of exclusive use: Molson Breweries v John Labatt Ltd, (FCA), [2000] 3 FC 145, 252 NR 91 at para 48 (CA) [Molson Breweries]. [34] The Applicant acknowledges that it had the burden of establishing that consumers associated the appearance of the drug withthe manufacturer, or a single source of manufacture or supply, on a balance of probabilities, on March 6, 2006, the date the oppositionwas filed: Novopharm, above, at para 72.

The Applicant says it must show that the Mark is distinctive among pharmaceuticals used totreat erectile dysfunction despite the fact that CGPA displaced its evidentiary burden in relation to the relevant marketplace of allpharmaceutical products. The Applicant submits that the new evidence shows that the Mark is distinctive even if the marketplaceincludes all pharmaceuticals because there is no other blue, diamond-shaped tablet. [35] The Applicant submits that the new evidence would not have materially affected the Board’s Decision regardingdistinctiveness among patients.

The Respondent’s evidence is repetitive of the evidence that was before the Board. As the new evidencemerely confirms the previous findings, the Board’s findings regarding the distinctiveness among patients either should be entitled todeference and upheld as reasonable, or confirmed as correct. [36] The Applicant submits that a finding of distinctiveness among patients should have been sufficient to establish that the Markis distinctive. The Board erred in law in requiring the Applicant to show that the Mark was distinctive among patients, physicians, andpharmacists.

The legal test requires that a trade-mark be distinctive among ordinary consumers of the wares. In the context ofpharmaceutical products, these consumers may include patients, pharmacists or physicians. The Applicant also says that courts havephrased the distinctiveness test as requiring distinctiveness among patients, physicians, or pharmacists: Astra FCA, above, at paras 45-46; Novopharm Ltd v Ciba-Geigy Canada Ltd, [2000] FCJ No 508 (QL) at para 13 (TD). [37] The Applicant says that the Board’s reliance on Novopharm, above, is misplaced.

In Novopharm, the Court not only foundthat there was insufficient evidence to show distinctiveness in any of the three categories of consumers but also suggested thatdistinctiveness may have been established had there been strong enough evidence of distinctiveness among pharmacists alone. [38] Requiring that distinctiveness be established among every group in the supply chain of a pharmaceutical product isinconsistent with the application of the distinctiveness test in other contexts: Cross-Canada Auto Body Supply (Windsor) Limited vHyundai Motor America, 2007 FC 580 at para 31, aff’d 2008 FCA 98.

A finding of distinctiveness among patients should be sufficient toestablish distinctiveness because the Act seeks to protect end consumers.

[39] The Applicant submits that if the Court finds that distinctiveness must be established among all three categories of consumers,then the new evidence on this appeal would have materially affected the Board’s Decision. As a result, the Court must review theBoard’s findings on distinctiveness among physicians and pharmacists on a standard of correctness. The direct evidence from physiciansand pharmacists shows that they associated the blue, diamond-shaped tablet with Viagra and knew that it came from one source. [40] The Applicant also says that Dr.

Corbin’s survey should have been admitted to demonstrate the Mark’s distinctiveness amongpharmacists. The Board said that had the Corbin survey been admissible, it would have supported a finding that pharmacists recognizedthe Mark as being associated with Viagra and one manufacturing company. Even if the Board was not prepared to accept that the surveyshowed distinctiveness in 2006, the survey should still have been admitted as evidence of distinctiveness in 2002.

The Respondent’s newevidence regarding the merits of the survey is speculative and does not establish why the survey is inapplicable to market conditions in2006. [41] The Applicant further submits that the Board erred in applying a “consumer use” requirement in its analysis of whether theMark was distinctive among physicians and pharmacists. This test required the Applicant to establish that physicians use the Mark inmaking prescription decisions and that pharmacists use the Mark in making dispensing decisions. The Act only requires that an owneruse its Mark to distinguish its wares.

There is no requirement that a consumer also use the Mark. This test creates an impossible burden inthe pharmaceutical context because the decisions of physicians and pharmacists are heavily regulated. [42] The “consumer use” requirement comes from a misinterpretation and misapplication of previous case law.

In a number ofcases at the Federal Court in 2000, Justice Rouleau relied on Novopharm, above, as the foundation for the requirement that consumersmust “use” the shape and colour of a pharmaceutical product in making decisions: Apotex Inc v Monsanto Canada Inc (2000), (FC), 187 FTR 136 at para 14, 6 CPR (4th) 26; Novopharm Ltd v Ciba-Geigy Canada Ltd (2000), (FC), 6 CPR (4th) 224 at 232 (FCTD); Astra, above, at para 13; Apotex Inc v Ciba-Geigy Canada Ltd, above, at para 13.

The Applicantsays that this is a misreading of Novopharm, above, in which the Court applied the usual distinctiveness test which only requires thatordinary consumers associate the mark with a single source. [43] The Applicant acknowledges that the Federal Court of Appeal has upheld cases where the consumer use requirement ismentioned, but it says that the Federal Court of Appeal has never expressly endorsed the consumer use requirement.

Rather, in upholdingthe cases, the Federal Court of Appeal has articulated the same distinctiveness test: whether “relevant consumers…distinguish thesource’s product from the wares of others, based on the source’s trade-mark”: Apotex FCA, above, at para 7. [44] The Applicant says that the evidence establishes that physicians and pharmacists use the Mark to the fullest extent possiblewithin the limits of their professional obligations. There is evidence that physicians understood references to patients’ requests for the“little blue pill” as references to Viagra, which could lead to prescribing decisions.

There is also evidence that pharmacists sometimesuse the Mark as part of their check that the proper medication is being dispensed. B. Respondent

(1) Issues before the Court [45] The Respondent submits that it was not required to file a cross-appeal of the Decision or to provide its grounds forchallenging the Decision in its notice of appearance. The Respondent says that the appeal is of the Decision, not the reasons for theDecision: Act, ss. 38(8), 56; Federal Courts Rules, SOR/98-106, r. 301; Ratiopharm Inc v Pfizer Canada Inc, 2007 FCA 261 at para 6.Further, the Federal Court Rules do not require a listing of grounds in a notice of appearance: see Form 38A.

The Respondent says that itis entitled to file evidence to address any issue that was before the Board: Société anonyme des bains de mer et du cercle des étrangers àMonaco, société anonyme v Monte Carlo Holdings Corp, 2012 FC 1528 at para 14; Autodata, above, at paras 24-27; Perka v The Queen, (SCC), [1984] 2 SCR 232 at 240.

(2) Compliance with the Act [46] The Respondent submits that Pfizer’s trade-mark application was not compliant with s. 30(

h) of the Act. The new evidenceestablishes that the markings on the Viagra tablets are not minor. The evidence of physicians and pharmacists confirmed that themarkings are used to identify Viagra when prescribing, dispensing, and educating patients. [47] The Respondent also submits that the Board erred in its determination of the sufficiency of the drawing. The drawing must beprecise enough to allow the public to accurately assess its limits: Astra, above, aff’d Astra FCA, above; Novopharm Ltd v Ciba-GeigyCanada Ltd, above, aff’d Astra FCA, above.

The drawing in Pfizer’s trade-mark application is ambiguous because it shows both dottedand solid lines. It is also not clear if the shape is part of the Mark. The Respondent submits that the Board erred by relying on decisionsin which the drawings were determined not to be ambiguous because, in those cases, the applications contained disclaimers whichresolved the ambiguity: Novopharm Ltd v Pfizer Products Inc, above; Astra, above.

(3) Distinctiveness [48] The Respondent submits that the test for distinctiveness is whether the appearance conveys to the consumer, in the ordinarycourse of trade, that the product emanates from one particular source.

Distinctiveness is not established if the consumer perceives theappearance to convey either the identity of the drug or erectile dysfunction medication generally. [49] The test for distinctiveness requires that the Applicant demonstrate that a significant proportion of “physicians, pharmacistsand patients understand the appearance of the drug to indicate the source of the drug when they select the brand of drug they areprescribing, dispensing or consuming”: see Eli Lilly and Company v Novopharm Ltd, 2006 FC 843 at paras 92-94; Apotex, above, atparas 5, 8-13, aff’d Apotex FCA, above; Novopharm, above, at paras 72-73; Eli Lilly and Co v Novopharm Ltd (2000), (FCA), [2001] 2 FC 502 at para 31, 195 DLR (4th) 547 (CA) [Eli Lilly FCA]; Ciba-Geigy, above, at 157.

The Applicant has failed

to establish distinctiveness among a significant proportion of patients, physicians and pharmacists because none of the physicians andpharmacists who provided evidence was speaking for anyone other than him or herself. [50] The Respondent also submits that the relevant marketplace is all pharmaceutical products in Canada: see Novopharm, above,at para 78; Astra, above, at para 14; Novopharm Ltd v AstraZeneca AB, 2003 FC 1212 at paras 8(4), 17, 20.

Novelty does not establishdistinctiveness and the Applicant was required to show more than that the tablet’s appearance is different from other drugs on themarket: Royal Doulton Tableware Limited v Cassidy’s Ltd (1984), (FC), [1986] 1 FC 357, 1 CPR (3d) 214 at 224-226(TD) [Royal Doulton]; Eli Lilly & Co v Novopharm Ltd (1997), (FC), 130 FTR 1, 147 DLR (4th) 673 [Eli Lilly], aff’dEli Lilly FCA, above; Novopharm, above. Distinctiveness is not established by showing that a drug has been widely promoted and hasappeared in advertising: Eli Lilly, above.

Showing that physicians, pharmacists and patients recognize, or can describe the appearance ofthe drug, does not establish that these consumers associate source significance to that appearance.

Distinctiveness is also not establishedby showing that customers associate the shape with the trade-name of the product. [51] The Respondent also says that the Applicant’s arguments regarding the “consumer use” requirement have already beenrejected by the Federal Court and the Federal Court of Appeal: Apotex, above, at paras 8-13, aff’d Apotex FCA, above, at paras 2-3, 6-7.The Mark must inform the consumer of the source of the product in order to function as a distinctive trade-mark.

A consumer “uses” theappearance to identify the source of a product by associating the appearance with a single source. [52] The Respondent submits that the new evidence makes clear that the Applicant has not established that use by Pfizer CanadaInc. enured to the Applicant. The new evidence establishes that the Applicant’s evidence regarding the licensing agreement before theBoard was inadmissible hearsay and not supported by the documentary evidence. The Applicant refused to produce any furtherdocuments regarding the licensing agreement.

This leads to the inference that there are no documents to support the Applicant’s claimthat the Mark was the subject of a 1986 licensing agreement. [53] The Respondent further submits that there is no evidence to establish that patients use the appearance of the drug todistinguish the wares. The evidence from physicians and pharmacists establishes that patients use “little blue pill” to refer to erectiledysfunction medication, not to a specific brand of medication. Further, patients do not associate the Mark with one source because theyknow that generics often resemble originating brands of a medicine.

Patients were also aware that there was a counterfeit tablet thatresembled the Viagra tablet. [54] The Respondent submits that there is no new material evidence to warrant re-opening the Board’s findings regardingdistinctiveness among physicians. The new evidence is merely repetitive of what was before the Board.

Further, the Respondent submitsthat the evidence is clear that no competent physician would consider the source of the drug in deciding whether to prescribe Viagra.Physicians prescribe solely on the basis of therapeutic concerns and would never identify a tablet by its appearance. [55] The Respondent also submits that the Applicant has failed to establish how its new evidence regarding distinctiveness amongpharmacists is materially different from the evidence that was before the Board. There is accordingly no reason to revisit the Board’sfindings on this issue.

The evidence is clear that no competent pharmacist would use the Mark as the basis for distinguishing amongproducts for dispensing purposes. The evidence from the pharmacists was that the appearance of a tablet is indicative of the medication,not the source, because all brands adopt the same appearance for the same medication. [56] The Respondent says that the new evidence supports the Board’s finding that the Corbin survey was not relevant to marketconditions in 2006.

The new evidence before the Court establishes even more clearly that there was a change in the marketplace from2002 to 2006: five new blue tablets were introduced between 2002 and 2006; look-alike counterfeit Viagra was available; Pfizer hadreduced its marketing efforts surrounding Viagra; and the demographics of pharmacists changed during this time period. In addition, theCorbin survey is so flawed that its conclusions are not supportable, even if it were admissible. VIII. ANALYSIS A. What is Before the Court?

(1) The Centrality of Distinctiveness [57] The parties disagree as to what is properly before the Court in this appeal under s. 56(1) of the Act. [58] There is considerable complexity in assessing whether some of the issues raised by the Respondent, and to which theApplicant objects, are stand-alone issues or simply part of a full response to the central issue of distinctiveness, or were raised in theApplicant’s own evidence. In addition, the relevant jurisprudence on this point is not entirely clear.

While the Court does not shy awayfrom these difficulties, they cannot be resolved – if they need to be resolved at all in this appeal – until the Court has addressed thecentral issue of distinctiveness. Both parties have made it clear in their materials and in their presentations before me at the oral hearingthat distinctiveness of the blue, diamond-shaped pill as of 2006 is at the heart of this appeal.

(2) The Dispute over Distinctiveness [59] Before I come to the Board Decision and the evidence before me in this appeal, I think it would help to set out as simply aspossible my understanding of the dispute between the parties as to how the jurisprudence requires distinctiveness to be assessed for theblue, diamond-shaped pill that the Applicant seeks to register as a trade-mark. [60] Reduced to basics, and I will come to subtleties later, the Applicant says that the test for distinctiveness is met for this Mark ifit can demonstrate, on a balance of probabilities and at the material time (2006), an association between the Mark and a single source ofmanufacture in the minds of either physicians, pharmacists or patients.

This association is the same for all trade-marks and there is no

heightened test just because the Mark happens to be the appearance of a pharmaceutical. The Applicant says that the Board erred by (a)requiring association in the minds of all three groups – physicians, pharmacists and patients – and (

b) applying a heightened test to theeffect that when considering physicians and pharmacists, the Applicant was required to demonstrate that the appearance of the blue,diamond-shaped pill was the “primary characteristic” used by these groups in their prescription and dispensing practices. [61] The Respondent’s position is that distinctiveness required the Applicant to demonstrate that its proposed Mark (the blue,diamond-shaped pill) was understood by physicians, pharmacists and patients (ie. all three groups) to identify that the pill came from asingle source of manufacture and that physicians, pharmacists and patients relied upon this appearance and its source connection whenthey prescribed, dispensed or requested the pill. [62] At this basic level, I see no dispute between the parties that, in order to establish distinctiveness for the proposed Mark, theonus was upon the Applicant to establish: (

a) that the Mark and the product are associated; (

b) that the owner of the Mark (Pfizer) mustuse the association between the Mark and the product; and (

c) that the association must enable the owner (Pfizer) to distinguish itsproduct from that of others. See Act, s. 2; Oxford Pendaflex, above; Philip Morris, above; Havana House Cigar, above. [63] I think that both sides also accept certain general propositions extant in the jurisprudence that:

a) Trade-marks seek to indicate the source of a particular product so that “consumers know what they are buying and from whom”and that “only a distinctive mark will allow the consumer to identify the source of the goods.” See Kirkbi AG v Ritvik Holdings Inc, 2005SCC 65 at para 39. However, it is sufficient for consumers to know that they are buying from a single source. It is sufficient that theappearance conveys to the consumer in the ordinary course of trade that the product (in this case the blue, diamond-shaped pill) emanatesfrom one particular source rather than another. See Novopharm, above, at paras 72, 78.

b) Distinctiveness is the quality that allows consumers to reference the trade-mark to distinguish the origin of the product and is “thevery essence and is the cardinal requirement of a trademark.” See Mattel, above, at para 75, quoting Western Clock Co v Oris Watch Co, (CA EXC), [1931] Ex CR 64 at 67;

c) The critical question is what the trade-mark actually conveys to the consumer. See Royal Doulton, above, at 225-226; Apotex Inc vMonsanto Canada, Inc, above, at para 12; Novopharm Ltd v Eli Lilly & Co, above, at para 81, aff’d Eli Lilly and Company v NovopharmLtd, above; Novopharm, above, at paras 70, 106-108, 120; Astrazeneca, above, at paras 22-24, 26;

d) For the appearance of the product itself (here, the blue, diamond-shaped pill) to be distinctive, it is the appearance that must conveythe information as to source. See Eli Lilly, above, aff’d Eli Lilly FCA; Royal Doulton, above, at 224-226; Astra, above, at para 11, aff’dAstra FCA, above; Novopharm Ltd v Ciba-Geigy Canada Ltd, above, at para 14, aff’d Astra FCA, above; Apotex Inc v MonsantoCanada Inc, above, at paras 12-13. [64] The cardinal points of conceptual disagreement between the parties on the issue of distinctiveness, as I understand them, arethat:

a) In order to demonstrate distinctiveness for the appearance of the pill, does the Applicant have to establish distinctiveness within allthree groups (physicians, pharmacists and patients) or will distinctiveness within one or two groups suffice?

b) Whether or not the requirement is for one, two or three groups, how extensive does the association have to be?

c) Does the Applicant have to show that physicians, pharmacists and patients rely upon the appearance of the proposed Mark and itssource connection when they prescribe, dispense and request the pill and, if so, to what extent? [65] In order to support their respective conceptual positions, the parties have referred me to an extensive body of complexjurisprudence. The Applicant says that a detailed examination of this jurisprudence will support its position and it asks the Court toclarify the law on the points of concern.

The Respondent says that the relevant jurisprudence supports its position on what the Applicantis required to do to establish distinctiveness in this case, and that the Court is bound by the rules of stare decisis and judicial comity toapply this jurisprudence and dismiss the appeal. [66] In order for me to examine the Decision of the Board under appeal, and the whole body of evidence before me, I think I mustfirst decide what the jurisprudence says the Applicant must establish to prove distinctiveness in this case, and, in particular, what thatjurisprudence teaches about the cardinal points of disagreement between the parties referred to above.

(3) Guidance in the Jurisprudence [67] I think the best place to begin is with an acknowledgement that my colleague, Justice Barnes, has already provided a detailedconsideration of many of the issues before me: see Apotex, above. Justice Barnes was affirmed by the Federal Court of Appeal: seeApotex FCA, above. [68] Every case involving distinctiveness depends upon its particular facts and the evidence adduced. However, many of thearguments based upon the principles that are before me were also before Justice Barnes in Apotex.

In addition, Justice Barnes’assessment of the evidence before him gives rise to significant parallels with the evidence before me, and to which I will later refer.Hence, I think it would be helpful at this stage to quote extensively from Apotex because it contains highly relevant summaries of therelevant jurisprudence in this area and a telling assessment of the difficulties that arise when the appearance of a product is claimed as atrade-mark in its own right. [69] Justice Barnes’ decision in Apotex reads, in relevant part, as follows: Applicable Legal Principles

[5] I accept GSK’s position that the GSK Mark is presumed to be valid and that the Applicants bear the burden of showingotherwise on a balance of probabilities as of the date of this application (December 21, 2007). A valid trade-mark is one which actuallydistinguishes the owner’s wares from those produced by others. Whether a mark is distinctive is a question of fact which is determinedby reference to the message it conveys to ordinary consumers: see Novopharm Ltd. v.

Bayer Inc. (1999), (FC), [2000]2 F.C. 553 at para. 70, 3 C.P.R. (4th) 305 (F.C.T.D.), affirmed (2000), (FCA), 9 C.P.R. (4th) 304, 264 N.R. 384(F.C.A.). The relevant constituency of consumers of a product like this one includes physicians, pharmacists and patients: see Ciba-Geigy Canada Ltd. v. Apotex Inc. (1993), (SCC), [1992] 3 S.C.R. 120 at para. 110, 44 C.P.R. (3d) 289 (S.C.C.).

For thepurposes of this case, the issue is whether on December 21, 2007 all of these consumers would, to any significant degree, recognize theGSK Mark by its appearance (excluding labels and packaging) and associate that get-up with a single source: see Novopharm Ltd. v.Bayer Inc., above, at paras. 78-79. […] What is the Legal Threshold for Distinctiveness? [8] GSK takes the position that all that is required to establish distinctiveness is that physicians, pharmacists and patients drawthe association between the appearance of the GSK Mark and a single trade source.

It says that it is unnecessary that the association bestrong enough to support dispensing or purchasing decisions. [9] In support of its position GSK contends that Justice Paul Rouleau went too far in the decisions he gave in Novopharm Ltd. v.Ciba-Geigy Canada Ltd. (2000), (FC), 6 C.P.R. (4th) 224 at para. 16, 97 A.C.W.S. (3d) 141 (F.C.T.D.), affirmed,Novopharm Ltd. v. AstraZeneca AB, 2001 FCA 296, [2002] F.C. 148 and in Novopharm Ltd. v. Astra Aktiebolag (2000), (FC), 187 F.T.R. 119, 6 C.P.R. (4th) 16 at para. 13 (F.C.T.D.), affirmed, Novopharm Ltd. v.

AstraZeneca AB, 2001 FCA 296,[2002] F.C. 148 where he held that a finding of distinctiveness required proof “that physicians, pharmacists or patients can and do usethe proposed trade-mark in choosing whether to prescribe, dispense or request [Ciba’s diclofenac or Astra’s omeprazole] product”. [10] For my purposes, it is enough to observe that the Federal Court of Appeal upheld Justice Rouleau’s decisions in NovopharmLtd. v. AstraZeneca AB, above, with specific reference to his approach to the issue of distinctiveness (see para. 46).

Furthermore, thelink between the get-up of a product and consumer choice was clearly recognized by the Supreme Court of Canada in Ciba-GeigyCanada Ltd. v.

Apotex Inc., above, where in language very close to that used by Justice Rouleau the concluding Order provided at para.111: THIS COURT ORDERS that with respect to the marketing of prescription drugs, a plaintiff in an action for the alleged passing-off of aprescription drug must establish that the conduct complained of is likely to result in the confusion of physicians, pharmacists orpatients/customers in choosing whether to prescribe, dispense or request either the plaintiff's or the defendant's product.

Although this was a passing-off case, I do not believe that the question of whether the get-up of a product had acquired a secondarymeaning would be any different than determining whether a trade-mark based on product appearance was distinctive. [11] In Kirkbi AG v.

Ritvik Holdings Inc., 2005 SCC 65, [2005] 3 S.C.R. 302, the Supreme Court of Canada again recognized thata mark is a symbol of a connection between source and the product “so that, ideally, consumers know what they are buying and fromwhom” (para. 39). [12] I would add to this that s. 2 of the Act defines trade-mark as a mark that is used by a person to distinguish wares.

Thisconnotes something more than a passive or indecisive observation of potential provenance. [13] In my view it is insufficient to show that the appearance of a product may represent a secondary check of product identity orthat it may cause a person to wonder whether the expected product was correctly dispensed. What is required is that physicians,pharmacists and patients relate the trade-mark to a single source and thereby use the mark to make their prescribing, dispensing andpurchasing choices.

An educated guess about source is not enough to constitute distinctiveness and neither is a design that is simplyunique in the marketplace and recognized as such: see Royal Doulton Tableware Ltd. v. Cassidy’s Ltée (1985), (FC),[1986] 1 F.C. 357 at 370-371, 1 C.P.R. (3d) 214 (F.C.T.D.). The fact that a physician or pharmacist might make an informal assumptionabout the provenance of a purple disc-shaped inhaler in the context of a therapeutic discussion with a patient is also insufficient toestablish distinctiveness.

Product Colour and Shape as Aspects of Distinctiveness [14] There is no question that colour and shape can help to distinguish the products of one manufacturer from another. Shape andcolour can also be powerful influences on consumer behaviour. Nevertheless, a trade-mark which is based on product colour and shapeis likely to be weak: see Novopharm v. Bayer Inc., above, at para. 77. Demonstrating that product appearance or get-up has becomedistinctive is also not easy to satisfy: see AstraZeneca AB v. Novopharm Ltd. (2003), 2003 FCA 57 at para. 26, 24 C.P.R. (4th) 326.

Unlike trade-marks in the nature of corporate symbols, there are sound public policy concerns that arise from an expansive recognition ofdistinctiveness in the area of non-functional product design: see Wal-Mart Stores, Inc. v. Samara Brothers, Inc. (2000), 529 U.S. 205 (S.Ct. U.S.). [15] In the realm of prescription medications the significance of colour and shape to purchasing choices and brand identification isless obvious because, as the evidence shows, the initial choices are made on an informed basis by physicians and pharmacists.

Thatprofessional intermediation is also an influential but not an exhaustive component of consumer decision-making. Prescriptionmedications are, after all, not purchased on impulse. [16] I agree with GSK that there is nothing inherently objectionable about a trade-mark which applies to a unique combination ofproduct shape and colour. There are, of course, well-known marks that are based on shape and colour combinations.

However, in thecontext of a market where purchasing decisions are usually made by professionals or on the advice of professionals, the commercialdistinctiveness of such a mark will be inherently more difficult to establish. That is so because, as the weight of the evidence before me

establishes, physicians and pharmacists are not strongly influenced by these attributes and have no obvious reason to associate them witha single trade source or provenance.

To the extent that the ultimate consumer enjoys a purchasing choice, they will also be significantlyinfluenced by the prescribing and dispensing advice received (including labelling) and, undoubtedly, by associating products with certainwell-known trade-names. [17] It is also important to remember that the consumer would only ever see the GSK Mark with a label affixed and would bepresumed to rely heavily upon the printed information to draw conclusions about source. This was a point expressed by Justice Heery inCadbury Schweppes Ltd. v. Darrell Lea Chocolate Shops, [2008] FCA 470 (Fed. Ct.

Australia) at paras. 64-65: 64. Use of purple seen to be bound up with the “Cadbury” script – purple never used in isolation [100]. The fact that purple wasnever used without the “Cadbury” script does not seem to be disputed; see earlier judgment [82]-[87]. 65. The Cadbury experts said that this was irrelevant. I do not agree. Cadbury’s expert called at the earlier trial, ProfessorRoger Layton, Emeritus Professor of Marketing at the University of New South Wales, clearly regarded the association of brand withcolour as relevant to consumer perceptions; see earlier judgment at [77]-[78].

For obvious enough reasons, consumers are neverpresented at the point of sale with a Cadbury product, in purple or not, without the Cadbury name prominently displayed. The ordinaryreasonable consumer is to be credited with awareness of this when confronted with the allegedly misleading Darrell Lea product.

If the consumer of chocolate confectionaries is presumed to have sufficient intelligence to make a product identity decision informed bya label, the consumer of pharmaceutical products must be afforded nothing less. [18] The attribution of a modest level of consumer intelligence was also recognized by Justice Barbara Reed in Eli Lilly and Co. v.Novopharm Ltd. (1997), (FC), 130 F.T.R. 1 at paras. 151-152, 73 C.P.R. (3d) 371 (F.C.T.D.), affirmed (2001), (FCA), [2001] 2 F.C. 502, 10 C.P.R. (4th) 10 (F.C.A.) when, in examining the issue of confusion in the context of apassing-off proceeding, she stated: 151 Customers who do not request a particular brand but nevertheless expect to receive one can be alerted to the identity of theparticular brand they have received by the receipt given at the time of purchase, the labelling on the vial, the markings on each capsule,or by the price differential when the change is from an innovator's brand to a generic.

While some of these indicia, the designation ofmanufacturer on the receipt and on the vial label, would only be effective notice if the customer had been schooled to look for them, it ishighly probable that when a customer has been receiving the plaintiff's Prozac and a pharmacist is going to dispense a different brand,the pharmacist will inform the customer of the dispensing change. 152 I cannot conclude that the plaintiffs have proven, on the balance of probabilities, that the defendants' sale of fluoxetine incapsules having a similar appearance to those of the plaintiff would result in any significant likelihood of confusion. [19] The distinctiveness of a mark based on colour and shape may also be diminished by its association with a registered trade-name.

Where a pharmaceutical product is always used in direct association with a well-known word-mark, the risk of customerconfusion will be diminished, if not entirely absent, where a look-alike product is presented for purchase with a different brand name. The problem of association of marks was addressed in the case of General Motors of Canada v.

Décarie Motors Inc. (2001), (FCA), [2001] 1 F.C. 665 at para. 34, 9 C.P.R. (4th) 368 (F.C.A.) where the consistent use of the claimed word-mark“Décarie” in association with the words “Motors” and “Moteurs” was said to indicate that “Décarie” appearing in isolation represented a“weak, if not absent” use which had not acquired a secondary meaning. [20] I accept the point made by Justice John Evans in Novopharm Ltd. v. Bayer Inc. above, at para. 79 that it is not fatal to a trade-mark registration that consumers may use other means than the mark for identifying the product with a sole source.

Nevertheless,Justice Evans qualified this with the statement that there still had to be sufficient evidence that the trade-mark was capable of being sorecognized on its own. In other words, a trade-mark based on get-up cannot acquire its distinctiveness by virtue of its use in combinationwith a distinctive word-mark. [21] In Novopharm Ltd. v. AstraZeneca AB (2004), 2003 FC 1212 at para. 22, 28 C.P.R. (4th) 129, Justice Eleanor Dawson foundthat colour and shape represented only a secondary check for the identification of a pharmaceutical tablet.

She posited the question: What does a red-brown pill mean to a pharmacist? The answer she found was that pharmacists do not dispense medications to asignificant degree on the basis of colour and/or shape. The Evidence of Distinctiveness – Physicians, Pharmacists and Patients [22] The essential problem with much of the GSK evidence about the supposed distinctiveness of the GSK Mark is that the inhaleris never marketed without a label so that the witnesses were opining on a hypothetical situation that almost never presented itself. Agood example of this arose in the evidence of Dr. Robert Dales.

He deposed that the Advair Diskus inhaler “looks very different fromother inhalers” and this permitted him “to distinguish [it] from inhalers made by other companies”. Nevertheless, under cross-examination, he acknowledged that he relied upon the labels to identify the product and when asked what he would do if he was given anunlabelled inhaler, he replied as follows: Q. And if it did happen, you would have to look at the label. Isn’t that right? A. I don’t know, I’ve never been in this situation. It’s just kind of - - I’m trying to imagine, but I’m not sure.

For example, I don’tknow if there are purple inhalers on the Internet. I’ve never seen a - - like a diskus - - a purple inhaler that looked like the Advair diskus,that wasn’t the Advair diskus, to my knowledge, so. Q. Have you ever done a search on the Internet to see if they’re available? A. No.

Q. I take it you would never give a patient an inhaler such as the one that’s pictured in Exhibit “A”, if you didn’t know what was in it? A. If I didn’t know what was in an inhaler, I wouldn’t give it to the patient. Q. And I take it if you saw an inhaler like Exhibit “A”, you could make an educated guess that it looks like an Advair inhaler, but you would never jeopardize the safety of your patient by giving it to a patient if it had no labelling on it? A. If I saw an inhaler like that, I agree.

I mean, it looks like Advair diskus, but if it didn’t have the label on it, to me that would say, well, it’s not the way I’m used to seeing these things. So, I would certainly be worried and have to sort of, sort out what’s going on. [23] The evidence of Dr. John Axler was much firmer in support of colour and shape being the primary distinguishing features of the Advair Diskus inhaler in his practice. There is, however, a troubling dogmatism to that evidence including a surprising statement under cross-examination that he relied mostly on colour and shape and that “[t]he label plays a minor role.

I must admit I don’t - - I don’t read the label”. This evidence is inconsistent with the weight of the other professional evidence and I do not accept it. [24] The evidence of Dr. Richard Kennedy is no stronger than the recognition that because the appearance of the various inhalers on the market is different their source is likely to be different. This inference provides a very weak foundation to support a claim to commercial distinctiveness because as the Court noted in Wal-Mart Stores Inc. , above, at 1344, “product design almost invariably serves purposes other than source identification”. Dr.

Kennedy also candidly acknowledged that he used the trade-name Advair to properly identify product samples and, in the absence of a label, he would be suspicious about what he had in front of him. [25] The evidence of Ayman Eltookhy does not support GSK’s claim to distinctiveness. As a dispensing pharmacist, Dr. Eltookhy only uses colour and shape as secondary indicia of product identity and he would never dispense an inhaler without a label. This evidence is also consistent with that of James Snowdon and Janine Matte. When Mr.

Snowdon was asked about his ability as a pharmacist to distinguish an unlabelled Advair Diskus inhaler, he answered as follows: Q. I take it if you saw something like your exhibit “A” you would know something was wrong? A. Yeah. At first recognition it would seem like Advair but the clarification would not be there with the label, through the label. Q. And I take it as a careful pharmacist you would not be able to dispense something like exhibit “A”? A. Until I further identified what it was. Ms.

Matte, also a pharmacist, was asked what she would make of an identical inhaler bearing the name Apo-Fluticasone Salmeterol and answered: “It’s going to be Apotex”. [26] Gordon Hood provided evidence about the significance of colour and shape and similarly acknowledged the primary importance of labelling in his pharmacy practice. He conceded that a look-alike inhaler bearing an Apotex label would support an assumption that it came from Apotex and not GSK.

When asked what his reaction was likely to be if presented with an inhaler bearing an unexpected colour, he said that he “would follow up with the manufacturer to see if there had been a change in the product appearance”.

This was a common sense response but it also recognized that appearance provides an uncertain basis for drawing conclusions about product identity or source and that, for a professional, the brand name and label will almost always trump product appearance for identifying its source. [27] I do not accept the anecdotal evidence from GSK’s two consumer witnesses as being sufficient to establish that a significant number of consumers would associate the appearance of the Advair Diskus inhaler with a single source.

Their evidence to that effect was based on a hypothetical situation they did not encounter (i.e. an unlabelled inhaler). In the case of Ms. McGee she did not care or know where the inhaler she used was sourced. She also did not know if Ventolin was a trade-name for one company and she did not know if other purple inhalers were available in Canada. In other words, the appearance of the product was not particularly important to her. [28] Mr.

Owens testified that he would be concerned if he received a look-alike inhaler that did not have the label for Advair affixed to it and he clearly identified that word-mark with the distinctiveness of the product.

This evidence is essentially consistent with that of the doctors and pharmacists who acknowledged that, in the context of prescribing and dispensing, product identity is associated with the information contained on the labels including the trade-name Advair and not on the basis of the appearance of the inhaler. [29] It seems to me that this very limited anecdotal evidence is insufficient to displace the evidence of the Applicants’ professional witnesses to the effect that patients, as a general rule, do not attribute much significance to the appearance of pharmaceutical products including inhalers.

What they are concerned about is functionality, dosage and effectiveness. The affidavit evidence of Pharmacist Heather Parker seems to me to reflect a more accurate view of patient perception: 66. Patients are most concerned about whether the drug, including inhalers, they have been prescribed and/or purchased will work, whether there will be any side effects, and how much it will cost. Most patients are not concerned about what a drug or an inhaler looks like. 67. Patients are rarely concerned about the manufacturer of their medications (including inhalers).

In fact in my experience, most patients do not think about and are not aware of the manufacturer of their medications. Patients are also not aware that there may only be a single manufacturer or several manufacturers of a pharmaceutical product. 68. In the normal course of my practice, I do not mention the manufacturer when counseling patients. In general, most patients are solely focused on what a drug does and how to take it.

69. When patients refer to the appearance of their drugs, I have found through experience that patients will refer to the colour, shape and/or size of drugs as being an indicator of the use of their medication. For example, they may make reference to “my blue sleeping pill”, “my pink water pill” or “my blue inhaler”. In my opinion, patients generally consider appearance to mean therapeutic effect. 70. When patients use more than one inhaler concurrently, they often use the general colour of their inhalers to differentiate between the inhalers that they use for various reasons.

For example, they may state that they use their “blue” rescue inhaler when they experience an asthma attack, or their “purple” inhaler is used twice a day to control their asthma. Similarly, while patients frequently do not remember the name of the active ingredient in their inhalers, they often remember that an inhaler is “blue” and is used for rescue from asthmatic symptoms, for instance. 71. Patients are generally aware that inhalers may come in a variety of colours, shapes and sizes, and that several inhalers may be the same colour, shape and/or size.

They do not generally associate colour or shape with the manufacturer or source of the inhaler. [30] To similar effect was the evidence of Dr. Robert McIvor, Dr. Neil Marshall and Pharmacist Joseph Lum: Dr. McIvor stated: 62. It is my experience and opinion that patients do not associate the shape and colour of their inhaler with a particular manufacturer or even a single source of their inhaler. Patients associate the colours of their inhalers with their therapeutic use. They frequently refer to their inhalers by their colour and, more rarely, by their brand or generic name.

Furthermore, when they use these names, I believe they are using them to describe what the medicine is (i.e. its therapeutic use), not where it comes from (e.g., “Advair” means their controller medication). Dr. Marshall stated: 59 When patients refer to the appearances of their drugs (i.e., the colour, shape and/or size), they associate appearance with the therapeutic use of the drug. For example, patients will refer to their “blue” sleeping pills.

In particular, for my patients who take fluticasone propionate/salmeterol xinafoate (e.g., Advair) and another inhaler (often salbutamol sulfate (e.g., Ventolin)), they will often make reference to their “blue” rescue inhaler that they use when they have an asthma attack and their “purple” inhaler that they take regularly for maintenance. In fact, for my patients who take multiple inhalers, most of them differentiate or refer to inhalers is [ sic ] by their colour. 60 The above association between the colour of an inhaler and its therapeutic effect is not unique to my regular patients.

In my emergency room duties, I often deal with patients who use inhalers, and they speak to me in the same way – they refer to their inhalers by colour and therapeutic effect. In dealing with these emergency room patients, most of whom have their own regular family physicians, I do not have to change my language. This means that (

a) many other physicians counsel their patients regarding their inhalers with reference to the inhalers’ colour and therapeutic effects, and (

b) patients commonly associate the appearance (i.e., colour, shape and/or size) of their inhalers with their therapeutic uses. Mr. Lum stated: 63 I understand that many of my patients have come to recognize their medication and inhalers by their general appearance, particularly where customers are taking several medications or inhalers on a regular basis.

For example, many patients who regularly use the fluticasone propionate/salmeterol xinafoate DPI (e.g., Advair Diskus) inhaler also use the salbutamol sulphate (e.g., Ventolin) inhaler for asthma attacks. 64 If the colour of the patient’s medication or inhaler were changed, the patient would ask me if there has been a mistake. In these circumstances, it is my experience that patients are concerned that a mistake has been made and the prescription has not been filled properly (i.e., medication for the wrong therapeutic area has been dispensed).

Patients usually seek assurance that they have received the correct medicine (i.e., correct active ingredient for the proper therapeutic area) their doctors have prescribed for their conditions. Patients are not normally concerned that they have received a different brand when the appearance (i.e., colour, shape and/or size) of their pharmaceuticals have changed. Accordingly, it is apparent that if patients attach any meaning to the appearance of their medications or inhalers, this appearance indicates the therapeutic effect or use of the medicine or inhaler.

For example, patients refer to their “blue” rescue or emergency inhaler or their “purple” everyday inhaler. [31] In some measure this evidence was confirmed by GSK’s witnesses including an acknowledgment by Dr. Dales that colour was “clinically helpful for patients and physicians to identify what’s inside…”. [32] I would add that unlike the word-marks Advair and Diskus , there is no notice given of the GSK Mark on the product packaging or on the inhaler itself to reinforce the claimed commercial association in the mind of the purchaser at the point of sale.

The reasoning from the authorities cited above applies to the GSK Mark because GSK never uses it as a self-standing mark but always in combination with Advair and Diskus . The trade-name Advair is clearly the dominant mark and is sometimes used by physicians as a prescribing reference. [33] The evidence also conclusively establishes that no prudent physician or pharmacist would rely upon the colour or shape of an inhaler to exercise a professional judgment about the product and few patients would make a choice based solely on the appearance of an unlabelled inhaler.

With a label, patients are sufficiently equipped to distinguish one product from another and to make informed purchasing choices. [34] I am satisfied from this evidence that colour and shape are not the primary characteristics by which GSK distinguishes the Advair Diskus inhaler from the wares of its competitors or, more significantly, by which its purchasers make their choices. [35] I have concluded on a balance of probabilities that, although a few patients may make an association between the appearance of the GSK Mark and a single source, the evidence is insufficient to support GSK’s contention that a substantial body of patients would

do so. With respect to physicians and pharmacists, I do not believe that any of them would draw such an association in the exercise oftheir professional judgment. Sales and Marketing Evidence [36] There is no question that GSK has developed a marketing strategy around its Advair Diskus inhaler which uses a consistentdesign theme. That is evident from its advertising and its packaging. I accept, as well, that GSK has spent millions of dollars inpromoting its Advair Diskus inhaler in advertising and promotional campaigns.

At the same time, the promotion of the GSK Mark as anaspect of that branding strategy is not as universal or as prominent as that which GSK employs for its word-marks Advair and Diskus. Inaddition, in its advertising the GSK Mark is not depicted as a self-standing mark (i.e. unlabelled) such that it would serve to reinforce itsdistinctiveness in the minds of the purchasers. [37] GSK also emphasizes the point that in terms of appearance, the Advair Diskus inhaler is one-of-a-kind in Canada and widelyused.

This evidence of uniqueness and market exposure, it argues, is what has led to a distinct brand identity and the public recognitionof the GSK Mark. [38] All of this is relevant evidence but it is not of itself persuasive. In Molson Breweries v. John Labatt Ltd. (2000), (FCA), [2000] 3 F.C. 145, 5 C.P.R. (4th) 180 (F.C.A.), Justice Marshall Rothstein writing for the majority, discounted evidence ofextensive sales and advertising expenditures in proving distinctiveness where the claimed word-mark “Export” was never used inisolation (see para. 79). In Ciba-Geigy Canada Ltd. v.

Novopharm Ltd. (1994), 56 C.P.R. (3d) 289 at 313, 83 F.T.R. 161 (F.C.T.D.),Justice Rothstein also held that the existence of a monopoly did not of itself imply that the appearance of a product had given it asecondary meaning. This decision was varied for other reasons at (1994), 83 F.T.R. 161, 56 C.P.R. (3d) 289 and at (1994), 83 F.T.R.233, 56 C.P.R. (3d) 344. Similarly, in Canadian Council of Professional Engineers v.

Lubrication Engineers, Inc. (1992), (FCA), 41 C.P.R. (3d) 243 at 245, [1992] 2 F.C. 329 (F.C.A.), Justice James Hugessen held that the use of a mark in associationwith the wares in advertising was insufficient to establish its distinctive character without anything more. Colour as a Functional Attribute [39] GSK’s claim to a secondary meaning from its use of the colour purple is further weakened by the recognition in themarketplace of colour as a functional attribute for bronchial inhalers.

The evidence before me indicates that the colour of inhalers hasacquired a partial therapeutic association which is used by manufacturers and by public interest groups to counsel patients. For example,in a publication by the Asthma Society of Canada directed to children with asthma, inhalers containing a reliever medication are said tocommonly come in blue and inhalers containing a maintenance medication are said to come in many colours.

This distinction betweenthe colour of reliever inhalers and maintenance inhalers is reflected in several other examples contained in the record including materialsassociated with GSK and with the Lung Association. This therapeutic association with colour is further described in the followingpassages from the affidavit of Mr. Lum at paras. 34-35: 34. For all types of inhalers, colour plays an important role in indicating to patients the therapeutic use of the inhaler. Oftentimes,patients take (

a) a maintenance medication like fluticasone propionate/salmeterol xinafoate (e.g., Advair), fluticasone propionate (e.g.,Flovent), or salmeterol xinafoate (e.g., Serevent), and (

b) a rescue medication, such as salbutamol sulfate (e.g., Ventolin), concurrently. As such, the colour of the inhaler, in association with the labels affixed on it, becomes functional in providing another safeguard for theproper administration of medications. It is also common for patients to have used either the fluticasone propionate DPI (e.g., FloventDiskus) and/or the salmeterol xinafoate DPI (e.g., Serevent Diskus), switch to the fluticasone propionate/salmeterol xinafoate DPI (e.g.,Advair Diskus), or vice versa.

Patients generally notice the colour change, and attribute it to a difference in therapeutic use and purpose. Some patients may also attribute colour change to the difference in active ingredients in the inhaler. 35. It is my experience that patients generally associate the colours of their inhalers with their therapeutic use. Colours are often usedby patients to differentiate between the inhaler they use for immediate relief (i.e., the rescue medication) and the inhaler they use forpreventative therapy (i.e., maintenance or prophylactic use).

For example, the majority of my patients who use inhalers to [sic] refer totheir “blue” inhalers to mean their rescue medications. Therefore, patients become generally conscious that the colours of their inhalersfunction as an indicator of the inhalers’ therapeutic effects. [40] I accept GSK’s position that, at least with respect to maintenance or controller inhalers, this functional association with colouris not a conclusive bar to the registration of a unique colour-based mark.

However, in a market that has created certain therapeuticassociations with product colour, it becomes more difficult to establish commercial distinctiveness on the partial basis of colour and itweakens the argument for a secondary meaning. [emphasis in original, footnotes omitted] [70] The Federal Court of Appeal decision in Apotex reads, in relevant part, as follows: [6] I am also not persuaded that the judge applied the wrong test for distinctiveness. A trade-mark is actually distinctive if theevidence demonstrates that it distinguishes the product from others in the marketplace: Astrazeneca AB v.

Novopharm Ltd., 2003 FCA57, 24 C.P.R. (4th) 326 at para.16. A critical factor is the message given to the public: Philip Morris Inc. v. Imperial Tobacco Ltd.(1985), 7 C.P.R. (3d) 254 (F.C.T.D.), aff’d (1987), 17 C.P.R. (3d) 289 (F.C.A.). Distinctiveness is to be determined from the point ofview of an everyday user of the wares in question and the trade-mark must be considered in its entirety and as a matter of firstimpression: Molson Breweries v.

John Labatt Ltd., (FCA), [2000] 3 F.C. 145, 5 C.P.R. (4th) 180 at para. 83(F.C.A.). [7] Glaxo characterizes the judge’s reference to the “use” consumers make of the GSK Mark as a flawed application of thedistinctiveness test. I disagree with that

interpretation of the judge’s reasons. The judge neither devised nor applied a new test. Glaxo’ssuggestion to the contrary constitutes a misinterpretation of the manner in which the judge utilized the word “use”. The judge’s statementmust be read in the context in which it was written, that is, examining the process of connecting a product to its source. To be distinctive,the relevant consumers must distinguish the source’s product from the wares of others, based on the source’s trade-mark. Taken in

context, the judge’s comments demonstrate that it is the act of relating a trade-mark to its source that establishes the requisite consumer “use”. If one substitutes the word “associate” for the word “use” – which is equally consistent with the judge’s reasoning – Glaxo’s argument evaporates. Accordingly, this argument fails. [8] The judge’s application of the test to the facts turns on his appreciation and assessment of the evidence and his resulting factual determinations. The judge’s reasons contain a detailed and comprehensive review and analysis of the evidence.

Glaxo has not demonstrated any palpable and overriding error in this respect. Rather, it effectively seeks to reargue its case without pointing to any specific instance where the judge’s appreciation or assessment of the evidence is palpably wrong. Absent palpable and overriding error, which has not been established, this argument must also fail. [emphasis in original] [ 71 ] As regards the significant points of contention before me, I make the following observations about Apotex :

a) Neither Justice Barnes nor the Federal Court of Appeal deals directly with the issue of whether an applicant must establish distinctiveness in all three groups (physicians, pharmacists and patients), or whether distinctiveness within one group will suffice, although both sides in the present dispute point to wording and inference in Apotex that they feel support their respective positions;

b) The wording in paragraph 35 of Justice Barnes’ decision – “a substantial body of patients” – suggests that it is not sufficient to establish that “a few patients,” or, indeed, physicians and pharmacists, mak

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