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PHARMACEUTICAL
TRADE-MARKS
The Canadian Experience
Warren SprigingsDirect Dial: +1-416-777-2273
Sun Life Financial Centre, East Tower
3250 Bloor Street West, Suite 715
Toronto, Ontario, M8X 2X9
Tel: +1-416-777-0888 Fax: +1-416-777-0881
www.sprigings.com
Introduction
• 2 typical forms of trade-mark protection for
pharmaceuticals:
- Word marks
- Trade-dress
Word Marks
• Word Marks –
- adoption of a coined word (Viagra)
- adoption of a generic word (taxol)
- adoption of a variation of both (Cipro)
Trade-Dress Marks
• Trade-dress can include:
- the packaging of the pharmaceutical (boxes,
blister packs, vials)
- the appearance of the product itself (tablets,
capsules, inhalers)
Generic Perspective
• Colour, Shape and Size of pharmaceutical identifies
medication “My yellow heart pill” or dosage (eg. 10 mg – red;
20 mg – green; ……)
• On genericization:
- pharmacists prefer pharmaceutical with similar colour,
shape and size – avoids customer concern wrong medication
dispenses.
- hospitals prefer similar colour, shape and size – avoids
administration errors
- patients taking multiple medications prefer appearance
of generics to be the same (drug plans – mandatory
substitution)
Brand Perspective
• Colour, Shape and Size of pharmaceutical
identifies source/manufacturer
• Retain brand market on genericization –
patients insist on product from the same
source
• Better opportunities for licenced generics
having same colour, shape and size.
Canadian Experience
Trade-Dress Protection
• Up until early 1990s, brand companies
unsuccessful in protecting the colour, shape
and size of their prescription pharmaceuticals.
• Consumers required a prescription
• Physician determined the drug to prescribe
• Pharmacist dispensed medication
• Courts only considered physicians and
pharmacists – no likelihood of confusion
Ciba-Geigy Decision
(Supreme Court of Canada, 1992)
TEST FOR CONFUSION
“… with respect to the marketing of prescription
drugs, a plaintiff in an action for the alleged
passing-off of a prescription drug must establish
that the conduct complained of is likely to result
in the confusion of physicians, pharmacists or
patients/customers in choosing whether to
prescribe, dispense or request either the
plaintiff's or the defendant's product.”
Ciba-Geigy Canada Ltd. v. Apotex
Inc. (Supreme Court, 1992)
The Ciba-Geigy Decision resulted in numerous
trade-mark applications being filed for the
appearance of pharmaceutical products.
Brand name companies relied on the Ciba-Geigy
decision – protection of consumers – in support
of claim of trade-dress protection.
Test for Distinctiveness
“Here, because the proposed trade-mark is the colour
and shape of the wares, Astra has the onus of proving
that the “get-up”… is recognized by the public as
distinctive of its wares. It is therefore incumbent upon
[Astra] to show that physicians, pharmacists or patients
can and do use the proposed trade-mark in choosing
whether to prescribe, dispense or request Astra’s
omeprazole product.”
Novopharm Ltd. v. Astra AB (Federal Court Trial Division, 2000)
Recent Canadian Case Law
• Prozac Trade-Dress
(Eli Lilly & Co. v. Novopharm Ltd., 2006 FC
843)
• Viagra Trade-Dress
(Novopharm Ltd. v. Pfizer Products Inc., Trade-
marks Opposition Board, 2009)
• Advair Diskus
(Apotex Inc. et al. v. Glaxo Group Limited,
2010 FC 291)
Prozac Trade-Dress
• Two generic companies
marketed generic versions
of Prozac having the same
colour, shape and size as
Eli-Lilly’s version
• Eli Lilly was unsuccessful in
an action for passing-off
• The Court did not find Eli-
Lilly had established
distinctiveness or likelihood
of confusion
Prozac Trade-Dress
• Notwithstanding dismissal of passing-off
action, Eli Lilly pursued trade-mark application
• The application was allowed for publication by
by the Trade-Marks Office
• Novopharm/Teva appealed the decision to
grant the trade-mark application to the Trade-
Marks Opposition Board
Prozac Trade-Dress
• Trade-mark claimed:
the colours pale green
and whitish yellow
applied to the whole of
the visible surface of
the capsule
• Wares: pharmaceutical
preparations, namely,
an antidepressant…
Prozac Trade-Dress
• The Trade-Marks Opposition Board found that
Eli Lilly had not met the test for
distinctiveness for the trade-dress to be
registered as a trade-mark
• The Trade-Marks Opposition Board allowed
the appeal and rejected the trade-mark
application.
• Eli Lilly appealed to the Federal Court.
Prozac Trade-Dress
In the Federal Court, Eli Lilly argued that the
test for distinctiveness should be met by:
(a) establishing that the trade-mark is
distinctive in relation to one group:
physicians, pharmacists OR patients – not all 3
(b) establishing distinctiveness in relation to a
product category (i.e. antidepressants and not
pharmaceutical industry generally).
Prozac Trade-Dress
The Federal Court disagreed and found the
trade-mark to lack distinctivenss in view of:
(a)several other similar pharmaceutical products
on the market prescribed for conditions other
than depression.
(b)evidence of patients was not convincing and
physicians and pharmacists rely on markings
on the capsule, not only appearance, to
identify the product.
Viagra Trade-Dress
• Series of 3 trade-mark
applications relating to
the appearance of
Viagra tablets (25, 50
and 100 mg doses)
• Applications approved
for publication
• Novopharm/Teva
opposed the
Applications
• Trade-mark claimed:
the colour blue applied
to the whole of the
visible surface of the
tablet…. The tablet
shown in dotted outline
does not form part of
the trade-mark
• Wares: pharmaceutical
compound for treating
erectile dysfunction…
Viagra Trade-Dress
Viagra Trade-Dress
The Trade-Marks Opposition Board refused
the applications because the written
description of the trade-mark does not allow a
determination of the 3-dimensional limits of
the tablets:
“…it is unclear whether the Marks consist of
the colour blue alone or the colour blue
applied to the diamond-shaped tablets.”
Viagra Trade-Dress
Pfizer relied on the following evidence to
support distinctiveness of the trade-mark:
(a) 2000 - $45 million in sales
(b) Viagra had 95% share of ED market
(c) blue/diamond shape unique in
phamaceutical marketplace
(d) marketing in print, radio and media
(e) survey of pharmacists, direct evidence of
physicians
Viagra Trade-Dress
The Trade-Mark Opposition Board granted the
Opposition and refused the application:
- the relevant date for assessing
distinctiveness was the date of the opposition
May 2000
- Pfizer’s evidence did not address the
relevant date but rather 2001 and 2002.
• Application by Apotex
to expunge Glaxo’s
trade-mark registration
relating to the
appearance of the
Advair Diskus
• Application allowed;
Glaxo’s trade-mark
registration was struck
from the Register
Advair Diskus
Advair Diskus
• Trade-mark claimed:
the colours dark
purple… and light
purple… applied to the
visible surface of
portions of the
particular object…
• Wares: inhalers for
administration of
pharmaceuticals
GSK attempted to support the distinctivness
of its trade-mark with evidence of:
(a) millions of dollars promoting its inhaler in
advertsing
(b) appearance being one-of-a-kind
(c) affidavit evidence from patients,
physicians and pharmacists regarding use of
appearance to distinguish GSK inhaler from
others
Advair Diskus
The Court did not accept this evidence as establishing
distinctiveness.
(1) anectodotal evidence of 2 consumers not sufficient
(2) no notice given of the Trade-Dress on the product
package or on the inhaler
(3) trade-name Advair is the dominant mark
(4) no prudent physician or pharmacist would rely on colour
or shape of inhaler to exercise a professional judgment about
the product
(5) advertising does not depict Trade-Dress as self-standing
mark
Advair Diskus
Thank you
Warren SprigingsDirect Dial: +1-416-777-2273
Sun Life Financial Centre, East Tower
3250 Bloor Street West, Suite 715
Toronto, Ontario, M8X 2X9
Tel: +1-416-777-0888 Fax: +1-416-777-0881
www.sprigings.com
