IN THE MATTER OF AN OPPOSITION
by Novopharm Limited and Apotex Inc.
to application no. 1006334 for the trade-mark
XENICAL Capsule Design filed by Hoffman-
La Roche Limited/Hoffman-La Roche Limitée
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On February 24, 1999, the applicant Hoffman-La Roche Limited/Hoffman-La Roche Limitée filed an application to register the trade-mark XENICAL Capsule Design, illustrated below, based on proposed use of the mark in association with the following wares and services.
The drawing is lined for the colour blue. The trade‑mark consists of the colour blue applied to the whole of the visible surface of the capsule as shown in the specimen affixed to and forming part of this application. The capsule shown in dotted outline does not form part of the mark.
wares
pharmaceutical preparation, namely, an anti‑obesity and lipid lowering agent containing 120 mg. of orlistat.
services
provision of information, newsletters, pamphlets and leaflets, to health care professionals, relating to anti‑obesity and lipid lowering agents.
The subject application was advertised for opposition purposes in the Trade-marks Journal issue dated March 22, 2000 (erratum published May 3, 2000) and was opposed jointly by Novopharm Limited and Apotex Inc. on August 22, 2000. The Registrar forwarded a copy of the statement of opposition to the applicant on August 29, 2000.
On October 13, 2000, the applicant submitted an amended application "wherein the description of the mark has been amended in view of recent case law." The amended portion is shown in italics, below.
The trade-mark claimed is the colour blue applied to the whole of the visible surface of the particular capsule shown in the drawing. The outline of the shape of the pharmaceutical capsule in the drawing is shown in the dotted outline to signify that the application is not for the capsule itself. The drawing is lined for the colour blue.
By a ruling dated October 24, 2000, the Board refused the amendment because it was contrary to Section 32(a) of the Trade-marks Regulations. In this regard, Section 32(a) prohibits a change to the applied for trade-mark "in any manner whatsoever" after the application has been advertised in the Trade-marks Journal. On December 27, 2000, the applicant filed and served a counter statement generally denying the allegations in the statement of opposition. The opponents requested and were granted leave to file an amended statement of opposition dated August 2, 2001: see the Board ruling dated September 20, 2001.
The allegations in the statement of opposition, as amended, may be summarized as follows.
1. Section 38(2)(a) - non-compliance with Section 30
(a) The applied for "trade-mark" is not a trade-mark within the meaning of the Trade-marks Act. A common colour for a proposed trade-mark cannot distinguish a party's wares or services. Further, the applied for mark is merely ornamental or functional as indicative of the active ingredient.
(b) The applicant would not use the applied for mark as a mark within the meaning of the Trade-marks Act because
(i) when there is a transfer in the property or possession of the wares, the applied for mark is not "marked" on the ware, rather, it is the ware. The colour of the capsule would not even be visible when property or possession in the ware transfers since the capsules are sold in blister strips enclosed in outer packaging.
(ii) even if the capsule is visible, the consumer is familiar with blue capsules and will be unaware that any mark has been applied to the wares.
(iii) with respect to services, the applicant will by necessity use two-dimensional depictions of the applied for mark, not the subject three dimensional mark.
(c) The application does not include an accurate drawing and representation of the mark because
(i) the entire capsule including a particular shade of blue, markings, shape and size define the mark, all of which are not displayed by the drawings.
(ii) the application states that the dotted outline does not form part of the mark, thus, it is completely unclear what is being claimed. The applicant cannot claim a three-dimensional shape and at the same time not claim a distinguishing guise which would have the shape represented in solid outline. Further, it is not clear how a three dimensional mark can be intended for use in association with services, which usually requires a mark in two dimensions for print or other media advertising.
(iii) the colour blue has not been applied to the surface of a capsule. Rather, the capsules are gelatin shells containing a powder. The capsule is made of blue gelatin.
(iv) the lining on the drawings indicates that the capsules are striped blue with any colour in between.
(d) The applicant could not have been satisfied that it was entitled to use the applied for mark because
(i) many pharmaceutical pills of a similar colour, shape and size are available in the marketplace. In Schedule A attached to the statement of opposition, the opponents list 179 tablets and 97 capsules sourced from the Compendium of Pharmaceutical Specialties, 35th edition 2000 ("CPS").
(ii) the applicant does not use the colour blue to distinguish its wares from the wares of others. Rather, the applicant uses its packaging and the name XENICAL ROCHE 120 to distinguish its wares. In this regard, the applicant has a trade-mark registration (no. 742009) for XENICAL for the same wares and a second registration (no. 878096) for XENICAL & Design for the same wares and services,
(iii) it is not possible to use or display the colour of a three dimensional capsule in the performance or advertising of the applied for services as set out in 1.b(iii) above.
2. Section 38(2)(b) - the mark is not registrable
The applied for mark is not registrable because
(a) the mark is a distinguishing guise. If the ware is orlistat [a pharmaceutical that prevents the digestion of fat], then the blue capsule is a packaging of the contents. If the ware is a capsule, then the mark is the ware; the ware is a three dimensional entity for a specific shaping of orlistat, which is a distinguishing guise. It is inconsistent to describe the mark as a colour applied to a three dimensional shape and then claim that the mark is separate from the shape.
(b) the mark is a prohibited mark within the meaning of Section 10 of the Trade-marks Act. Having regard to Schedule A, the applied for mark at best designates a kind or type of medication, including its therapeutic effect but is not indicative of the source of the wares or services.
3. Section 38(2)(d) - the mark is not distinctive
The applied for mark is not adapted to distinguish the applicant's wares because
(a) blue tablets, capsules and caplets were at all material times common to the pharmaceutical trade and taken by patients in Canada. The applied for mark is calculated to appropriate familiar marketplace indicia having regard to the blue pills listed in Schedule A.
(b) if the wares are the applicant's patented pharmaceutical orlistat, Canadian Patent no. 1247547 (expiry date December 28, 2005), then the applicant has exclusive rights in respect of the wares. As no other person may manufacture or sell the wares, the applied for mark cannot distinguish the applicant's wares from the wares of others.
(c) in the alternative to (b) above, the applicant cannot rely on its patent monopoly to establish distinctiveness of the applied for mark nor can the applicant extend its monopoly by inferring distinctiveness of the colour of the capsules based on the patent monopoly.
(d) each capsule is marked with XENICAL ROCHE120. Therefore colour, shape and size do not distinguish the applicant's wares.
The remaining grounds of opposition are reproduced in full below.
(e) the Applicant has packaged its wares in blister strips which are placed inside boxes, so that the wares themselves are not visible at the time of purchase. Thus, at the time of the transfer of possession or property in the wares, the colour is not visible and cannot serve to identify any particular source. Therefore, colour cannot distinguish the Applicants wares or services for those of others;
(f) the Applicant has packaged its wares in blister strips which are placed inside boxes, which boxes are labeled with the Applicant's trade-mark XENICAL. Thus, not only is the mark not visible at the time of the transfer of possession or property in the wares, but another of the Applicant's mark is so visible. Therefore, the mark cannot distinguish the Applicant's wares or services for those of others; and
(g) The Mark cannot be distinctive of the Applicant, as the Mark is not limited by size or shade - it appears to include (i) all possible shades of blue, (ii) all possible sizes of capsules and (iii) both opaque and see-through capsules. However, the Applicant has only sold one blue capsule, having one shade and one size. All blue capsules, regardless of shade and all blue capsules, regardless of size, are not distinctive of the Applicant.
The opponents' evidence consists of the affidavits of Peter G. Bolland and George Photopolous, physicians; Barbara Cole, Andrew Yee Hon Hui, and Yin Han Siow, pharmacists; Lisa Pol Bodetto, market data analyst; Bernard Sherman, Chairman and CEO of the opponent Apotex; and Anna Hucman, law clerk. The applicant's evidence consists of the affidavit of James Draves, product manager for the applicant's orlistat product. The opponents' evidence in reply consists of the affidavits of Anna Hucman, referred to above, and Paula Rembach, research analyst. Each of the above named individuals were cross-examined on their written testimony. The transcripts of their cross-examinations, exhibits thereto and replies to undertakings form part of the evidence of record. Both the applicant and the opponents submitted written arguments and both parties were represented at an oral hearing.
I will first consider some of the "technical" grounds of opposition raised by the opponents. In this regard, the opponents take the position that the applied for mark is a distinguishing guise, within the meaning of Section 2 of the Trade-marks Act, shown below:
"distinguishing guise" means
(a) a shaping of wares or their containers, or
(b) a mode of wrapping or packaging wares
the appearance of which 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;
The term "package," which is germane to part (b) above, is defined in Section 2 as follows:
"package" includes any container or holder ordinarily associated with wares at the time of the transfer of the property in or possession of the wares in the course of trade.
Section 2 also includes a distinguishing guise as one of four types of trade-marks:
"trade‑mark" means
(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,
(b) a certification mark,
(c) a distinguishing guise, or
(d) a proposed trade‑mark.
Mr. Sherman in his written testimony explains the manufacturing process for pharmaceutical capsules and tablets. For capsules, the active ingredient is packaged in an outer shell, usually a rounded structure made of pliable gelatin. A capsule shell consists of a body and a cap that can be separated for filling and then re-closed. The capsule dissolves readily upon ingestion. In the case of a coloured capsule, the coloured gelatin material is first prepared and then formed into the two halves of the capsule. The colour is throughout the gelatin shell, i.e., throughout the cap and body. For various reasons, some patients are unable or unwilling to swallow capsules. These patients will open the capsule and pour the active ingredient onto a food such as apple sauce for ingestion: see also pp. 3 - 5 of Mr. Sherman's transcript of cross-examination.
There has been some judicial discussion concerning whether a pharmaceutical tablet or capsule may be considered to be a distinguishing guise. In Smith Kline & French Canada Ltd. v. Canada (Registrar of Trade-marks) [1987] 2 F.C. 628 (F.C.T.D.), the Court considered a trade-mark application for a tablet (compressed material) rather than a capsule (a shell filled with material). The tablet was described in the application as follows:
The distinguishing guise consists of a light green coloured coating applied to the outside of a circular bi-convex tablet as shown in the attached drawing lined for the colour green . . . . [the applicant] claims the right to the exclusive use of the distinguishing guise in the specific shape, colour and coating, limited to the wares described earlier in this paragraph.
(emphasis added)
The Court found, at p. 631, that the applied for mark did not fall within part (b) of the above definition of a distinguishing guise because the green film adhered to the outside of the tablet was inseparable from the tablet. The coating could therefore not be viewed as a "a mode of wrapping or packaging wares:"
There appears to be a dearth of authority on this point but in examining numerous dictionary definitions of "wrapping" and "packaging" the view is reinforced that these words ought to be given the meaning attached to them in ordinary usage. That is, they must be taken to refer to the use of a separate covering or container which is not part of the "wares" itself. The definition of "package" in section 2, while not directly relevant, and while not exhaustive, is at least consistent with this interpretation of "packaging".
The Court further stated, at p. 631, "it may well be that a capsule, which is a covering separate from its contents, can be viewed as a 'mode of wrapping or packaging wares' in the pharmaceutical context." In the instant case the evidence shows that the applicant's prescription medicine is generally packaged in blister packs and then placed in an outer paper box. Pharmacists dispensing the medicine place the applicant's wares in bags before transferring possession of the wares to the consumer. Considering the foregoing, I find that the capsule containing the active ingredient orlistat is not a "mode of wrapping or packaging wares" as contemplated by part (b) of the definition of a distinguishing guise.
However, in view of Mr. Sherman's evidence, it appears to me that the applied for mark comes within part (a) of the above definition of a distinguishing guise, that is, a container for the applicant's wares orlistat, albeit an ingestible container. In this regard, I see no reason in principle why a small ingestible capsule cannot be considered a "container" as contemplated in part (a) of the above definition of a distinguishing guise. Small ingestible capsules (and tablets) are the norm in the pharmaceutical industry. "The prescription pharmaceutical products business is not so fundamentally different from other areas of commercial activity that special [trade-mark] rules should apply to it.": see Ciba-geigy Canada Ltd. v. Apotex Inc.(1 992), 44 C.P.R.(3d) 289 (S.C.C.) p. 312 at a. Just as a shaping of wares for confectionary items may in principle qualify as a distinguishing guise, I see no reason why an ingestible pharmaceutical capsule may not qualify as a distinguishing guise.
Presumably, in appropriate circumstances where an applicant claims a distinguishing guise which consists of a tablet without a coating, then a tablet of a specific colour and size may also fall within part (a) of the above definition as a shaping of wares. In this regard, see Glaxo Wellcome Inc. v. Novopharm Ltd. 8 C.P.R. (4th) 448 (F.C.T.D.) where a tablet in the shape of a
six sided shield was accepted as a distinguishing guise, although the Court ultimately held that the applied for trade-mark had not become distinctive under Section 13(1)(a) of the Trade-marks Act and was therefore not registrable.
In Smith Kline & French Canada Ltd. v. Canada (Registrar of Trade-marks) [1987] 2 F.C. 633 (F.C.T.D.) ("Smith Kline & French (2)"), the Court was considering an appeal from a decision of the Registrar wherein the Register refused a trade-mark application for a pharmaceutical tablet described as
. . . the colour green applied to the whole of the visible surface of the tablet, as shown in the specimen tablet affixed to the form of the application, the precise shade of green being shown in the attached colour patch.
The Court inferred that the Registrar refused the application because the Registrar believed that colour alone could not function as a trade-mark. The Court noted that the application in issue did not reside in colour alone but in size and shape as well:
. . . the trade mark whose registration as sought is a particular colour of green applied to a particular size and shape of tablet. I would not preclude registration simply on the basis that the colour is applied to the whole of the exterior of the tablet and not to some part of it alone.
(emphasis added)
As mentioned earlier, a distinguishing guise is a genre of a trade-mark referred to in Section 2 of the Trade-marks Act.
Smith Kline & French (2), above, has implicitly given approval for a colour patch to be considered as part of a trade-mark application to specify the exact shade of colour claimed by the applicant. However, a specimen included in a trade-mark application does not form part of the trade-mark: see Novopharm Ltd. v. Astra Aktiebolag 6 C.P.R. (4th) 16 (F.C.T.D.) at p.22, para. 8, affirmed 15 C.P.R. (4th) 327 (F.C.A.), wherein the Court noted that "a specimen, whether submitted to clarify colour or shape, does not replace, nor can it cure a deficiency in, a written description." Thus, size would have to be specified in the written description. Presumably, reference in the written description to generally accepted colour standards might serve the same purpose as a colour patch.
In view of the foregoing, the opponents succeed on the ground of opposition alleging that the proper subject of the application is a distinguishing guise.
Another "technical" objection raised by the opponents is that the application does not include an accurate drawing and representation of the mark. In this regard, the subject application describes the mark as "the colour blue applied to the whole of the visible surface of the capsule" but then goes on to disclaim the capsule shape by stating that " The capsule shown in dotted outline does not form part of the mark." (emphasis added)
The opponents argue that the language used to describe the applied for mark is unclear whether the mark consists of a shape together with the colour blue or the colour blue alone. Similar language was used to describe a BROWN-PINK capsule in Novopharm Ltd. v. Astra Aktiebolag (2000), 6 C.P.R.(4th) 16 (F.C.T.D.), affirmed (2001), 15 C.P.R.(4th) 327 (F.C.A.); leave to appeal dismissed, [2001] S.C.C.A No.646 (S.C.C.), as shown, in part, below:
The design consists of the colour pink applied to the whole of the visible surface of the opaque capsule as shown in the drawings, and the colour reddish‑brown applied to the cap portion of the capsule as also shown in the drawings, and in the specimens filed with this application. The drawing is lined for the colour pink and brown and is claimed as a feature. The capsule shown in dotted outline does not form part of the trade‑mark. (emphasis added).
Rouleau J. of the Federal Court, Trial Division ruled as follows, at p. 22, para. 8:
In the present case, I agree with Novopharm that the respondent's trade‑mark application is confusing and ambiguous and that this is the result of an inconsistency between the description and the disclaimer. It is unclear whether the application relates to a shape along with the colours or simply the colours alone. Although the application disclaims the capsule shape, the appellant maintains that its trade‑mark is inherently distinctive in its "colour and shape combination". While the application will therefore result in a trade‑mark not limited to the capsule shape, Astra has admitted that its trade‑mark is a colour and shape combination.
Applying the above reasoning to the description of the mark appearing in the instant application, I find that the opponents succeed on the ground of opposition alleging that applicant has not complied with Section 30(h).
The opponents also argue that the description of the mark is erroneous because it is incorrect to state that colour is "applied" to the surface of the capsule when, in fact, the blue colour arises from the material comprising the capsule shell. Further, the applicant in a product information monograph describes its product as "a dark-blue [rather than blue], hard gelatin capsule containing pellets of powder." In another case involving a trade-mark for a pharmaceutical capsule, Apotex Inc. v. Monsanto Canada, Inc. (2000), 6 C.P.R. (4th) 26 (F.C.T.D.), Rouleau J. discusses the requirement for precision in a trade-mark application, at pp. 31-2:
First, paragraph 30(h) of the Trade‑marks Act provides that a trade‑mark application must contain a drawing of the trade‑mark and such number of accurate representations of the mark as may be prescribed. The onus is on the applicant for a mark to show its compliance with this requirement of the legislation. The drawing submitted must be a meaningful representation of the applicant's mark in the context of the written description appearing in the application and must enable the determination of the three‑dimension limits of the tablet to which the colour is applied. The rationale behind these statutory requirements is that a trade‑mark registration is a monopoly and must therefore, be precise in terms of its scope.
Applying the above rationale to the description of the mark appearing in the instant application, I find that the applicant has not complied with Section 30(h), particularly as no colour patch was attached to the application to indicate the exact shade of blue claimed by the applicant. Although a specimen of the capsule was attached to the application, the specimen does not form part of the application: see Novopharm Ltd. v. Astra Aktiebolag, above.
Having already found in favour of the opponents, it is not necessary for me to consider the remaining grounds of opposition. However, the opponents would likely have succeeded on the substantive ground of opposition alleging that the applied for mark is not distinctive of the applicant's wares (at the material date August 22, 2000) based on the test for distinctiveness set out in Philip Morris v. Inperial Tobacco Ltd. (1985) 7 C.P.R.(3d) 254 (F.C.T.D.) at p. 270. In this regard, the opponents have provided comprehensive evidence that (i) there are many like coloured pills available to consumers for a variety of medical conditions, (ii) pharmacists and physicians do not associate the applied for mark (without additional indicia) with the wares orlistat, (iii) the evidence from pharmacists and physicians is that patients associate the colour of a drug with its therapeutic effect rather than with a particular source. The applicant, on the other hand, has not provided direct evidence to show that patients associate the applied for mark with a single source. In these circumstances, the absence of such evidence from the applicant is damaging to the applicant's case: see Novopharm ltd. v. Bayer Inc. (1999) 3 C.P.R.(4th) 305 at p. 331, affirmed (2000), 9 C.P.R.(4th) 304 (F.C.A.).
In view of the above, the subject application is rejected.
DATED AT VILLE DE GATINEAU, QUEBEC, THIS 5th DAY OF MAY, 2006.
Myer Herzig,
Member,
Trade‑marks Opposition Board