Federal Court Decisions

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Date: 20011030

Docket: T-810-00

                                                                                                Neutral Citation: 2001 FCT 1171

BETWEEN:                                                                                              

ASTRAZENECA AB

Applicant

- and -

NOVOPHARM LIMITED

- and -

THE REGISTRAR OF TRADE-MARKS

Respondents

                                                    REASONS FOR ORDER

KELEN J.

[1]                 This an appeal under section 56 of the Trade-marks Act, R.S.C. 1985, c.T-13, by Astrazeneca AB ("Astra") from a decision of the Registrar of Trade-marks dated March 9, 2000 which refused Astra's trade-mark application No. 783,267 for the trade-mark YELLOW TABLET DESIGN consisting of the colour yellow and the shape round for its tablets containing felodipine, a pharmaceutical typically used in the treatment of hypertension.


The Decision Relied on Non-Distinctiveness

[2]                 The respondent Novopharm Limited ("Novopharm") filed a statement of opposition to the trade-mark application. Among the several grounds for opposition under s.38 of the Trade-marks Act, the Registrar accepted one of the grounds of opposition, i.e. non-distinctiveness. The Registrar's decision said at page 9:

"In the present case, the opponent's evidence establishes that there are at least some other yellow tablets used for the treatment of hypertension that are available in the marketplace. [...] the existence of a fairly large number of yellow tablets for treating hypertension in the CPS [referring to the 1995 edition of The Compendium of Pharmaceuticals and Specialties] allows me, in the present case, to conclude that at least some of those tablets have been actively marketed in Canada. The evidence therefore suggests that the applicant's trade-mark is not capable of distinguishing its anti-hypertensive drug from those of others.

The applicant contends that the relevant market respecting the issue of distinctiveness in this case is not all anti-hypertensive tablets but only anti-hypertensive tablets that contain the active ingredient felodipine. I disagree. The applicant has defined the market too narrowly."

Evidence

[3]         The evidence shows that there are about twenty yellow, round tablets available in Canada for the treatment of hypertension. Astra is the only manufacturer of felodipine. Its product is sold under the trademark PLENDIL, in a box which contains a sleeve containing the tablets in "blister bubbles". Pharmacists do not rely solely on the colour and shape, i.e. yellow and round, but on the markings on the outer box and inner package.

[4]         There was no evidence from patients, i.e. the ultimate consumers, that patients associate the colour and shape of the tablets with felodipine or PLENDIL. The parties agreed that physicians "pay little or no attention" to the colour and shape of felodipine tablets.


Standard of Review

[5]         The Federal Court of Appeal in Molson Breweries v. John Labatt Limited, [2000] 3 F.C. 145 (Fed C.A.) set out the approach to standard of review with respect to appeals from the Registrar of Trade-marks. At page 168, paragraph 51, Mr. Justice Rothstein said:

"Having regard to the Registrar's expertise, in the absence of additional evidence adduced in the Trial Division, I am of the opinion that decisions of the Registrar whether of fact, law or discretion, within his area of expertise, are to be reviewed on a standard of reasonablenesssimpliciter. However, where additional evidence is adduced in the Trial Division that would have materially affected the Registrar's findings of fact or the exercise of his discretion, the Trial Judge must come to his or her own conclusion as to the correctness of the Registrar's decision."

Additional Evidence

[6]         The only additional evidence filed by Astra was the Affidavit of Adam Pignataro, a pharmacist, which addressed the perspective of pharmacists in relation to the colour and shape of Astra's PLENDIL 2.5 mg tablets. The witness deposed:

3.                    that pharmacists visually inspect the colour and shape of the tablets "to confirm that they are indeed PLENDIL brand tablets ...";

4.                    that the tablets are dispensed in a "compliance pack";

iii.          that the compliance pack is a box "which identifies Astra as the

supplier, felodipine as the active ingredient and PLENDIL as the brand name";

iv           that inside the compliance pack is a sleeve marked PLENDIL containing the       tablets in blister bubbles which permit the pharmacist

to observe the colour and shape of the tablets; and,

v.          that the pharmacist does not solely rely on the colour and shape.


[7]         The witness stated in the last paragraph of his Affidavit:

"Of course, the pharmacist will not rely solely on colour and shape, but will also ensure that other indicators of brand (such as the information on the PLENDIL compliance pack) are what they should be for the PLENDIL brand."

On cross-examination Mr. Pignataro admitted that he did not have actual knowledge whether other pharmacists in Ontario, or elsewhere in Canada, rely on the colour and shape of the tablets to ensure that the pills are Astra's felodipine tablets.

[8]         The additional evidence adduced in the Trial Division from Novopharm simply reinforced that there are several round, yellow tablets for hypertension on the market.

Evidence before the Registrar

[9]         The evidence before the Registrar included the affidavit of Roger Daher, a pharmacist from Toronto. On cross-examination, Mr. Daher stated that he checked the colour and shape of PLENDIL 2.5mg tablets before dispensing them. Accordingly, the additional evidence adduced before the Trial Division was not materially different in this respect. It was evidence that a pharmacist checks the colour and shape of Astra's felodipine tablets before dispensing them to a patient.

Additional Evidence would not have affected the Registrar's Decision


[10]       In my opinion, the additional evidence introduced by Astra before the Trial Division is not such that it would have materially affected the Registrar's conclusion on the issue of distinctiveness. Accordingly, the appropriate standard of review is reasonableness simpliciter.

The Registrar applied the Correct Principle that Colour and shape are a Weak Basis for a Drug Trademark

[11]       The Registrar relied upon Novopharm Ltd. v. Bayer Inc. (1999), 3 C.P.R. (4th) 305 per Evans J. (as he then was) at page 322:

" ... while I accept that the colour, shape and size of a product may together be capable in law of constituting a trade-mark, the resulting mark is, a general rule, likely to be inherently weak ..."

Mr. Justice Evans continued:

"In this case, pink, round, small tablets are commonplace in the pharmaceutical market. This means that Bayer has a heavy burden to discharge in proving on the balance of probabilities that in 1992 those properties had a secondary meaning, so that ordinary consumers associated the tablets with a single source ..."

This case held that pink, round tablets are so commonplace that the applicant for a trade mark has a "heavy burden" to discharge in proving on the balance of probabilities that the colour and shape associated with the tablets are distinctive and entitled to a trade-mark. Astra has a similar burden in this case. The fact that Astra has used this colour and shape in association with its felodipine tablets, and that pharmacists recognize the colour and shape of the tablets inside their packaging is not enough. The Registrar's decision is reasonable in this regard.


[12]       Several other cases have rejected colour and shape as distinctive. In Eli Lilly Co. v. Novopharm Ltd. (1997), 73 C.P.R. (3d) 371 Reid J. held at page 397:

"It is clear that a large percentage of the general population of Canada know the name Prozac and associate that name with a mood altering drug. Despite the publicity the product has received, however, the evidence does not show that any significant number associate the size, shape, and colour of the capsule, or colour alone, with Lilly or with one trade source or provenance."

[13]       On appeal, the Federal Court of Appeal (see (2000), 10 C.P.R. (4th) 10)held at page 26:

" [...] I cannot conclude, as the appellants suggest, that the Supreme Court of Canada is of the view that the appearance of a prescription drug constitutes in every case a trade-mark right. Each case must be demonstrated by relevant evidence."

[14]       In Novopharm Limited v. Astra, [2000] F.C.J. No. 496 (F.C.T.O), per Rouleau J. held at paragraph 14:

"Applying these principles to the evidence now before me, I am unable to conclude that the colour and shape of Astra's omeprazole capsules are distinctive of the product. The evidence is clear that, both prior to and at the date of opposition, there were a number of well-known, two-toned capsules sold and distributed in the pharmaceutical industry, including a number of pink/brown capsules. The respondent has not adduced any evidence which clearly establishes, on a balance of probabilities, that a significant number of consumers associate the appearance of its product with a single source. Accordingly, it has failed to establish the distinctiveness for a valid trade-mark."


[15]       In the case at bar, Astra has not adduced evidence from consumers or physicians. Astra has adduced evidence that pharmacists check the colour and shape of the tablets inside the compliance box before dispensing the product. With the number of yellow, round tablets on the market, it is necessary for Astra to establish clearly on the balance of probabilities that the colour and shape have been used with felodipine to the extent that pharmacists associate the colour and shape with a single source. The Registrar's Decision is reasonable in finding that the proposed trade-mark is not distinctive.

[16]       Astra relies on Ciba-Geigy Canada Ltd. v. Apotex Inc. (1992), 44 C.P.R. (3d) 289 (SCC) where the Supreme Court of Canada considered the "get up" of a pharmaceutical product in a passing-off action. That case dealt with a pharmaceutical product purchased by pharmacists in bulk and dispensed to the public in transparent and anonymous containers so that the only way of drawing the attention of the patients to the origin of the product would be the tablet itself. In the case at bar, Astra has distinctive markings on the outer cardboard box and on the plastic sleeve which contains the tablets in blister bubbles. The Supreme Court of Canada referred to an English Court of Appeal Decision, Hoffman-Laroche and Company v. D.D.S.A Pharmaceuticals Ltd., [1972] R.P.C. 1, which found that:

"On the whole, I conclude that the evidence does not sufficiently establish that the very ordinary appearance of the plaintiff's white and yellow DZP tablets has led consuming patients to attribute them to one manufacturing trade source or provenance."

[17]       I would follow the reasoning of the English Court of Appeal and conclude that the ordinary appearance of Astra's yellow round tablets are not so distinctive as to attribute them to one manufacturing trade source or provenance but for the packaging. Pharmacists will, first and foremost, check the markings on the outer packaging and the inner packaging sleeve containing the tablets in blister bubbles. It is the packaging which makes the drug distinctive, not the colour and shape. Accordingly, the Registrar's decision is reasonable.


Correctness

[18]       In the event that correctness was the appropriate standard of review, based upon all of the evidence, I am satisfied that the colour and shape of the felodipine tablets are not "distinctive" in accordance with the meaning of the term in sections 2 and 12 of theTrade-mark Act because the colour and shape do not distinguish the tablets from other yellow, round tablets. It is the packaging which distinguishes the wares.

Conclusion

[19]       Subsection 38(2)(d) of the Trade-marks Act provides that an opposition may be based on the ground that the mark is not distinctive. In the case at bar, it is my opinion that the colour yellow and the shape round does not distinguish Astra's felodipine tablets so that the Registrar's decision is reasonable.

[20]       For these reasons, the appeal is denied with costs.

                                                                                                                          "Michael A. Kelen"         

                                                                                                                                              JUDGE                      

OTTAWA, ONTARIO

OCTOBER 30, 2001

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