Download A bitter pill to swallow

Trademarks and
prescription drugs
A bitter pill
to swallow
Picture supplied by Claude Noel
Acquiring and asserting shape and colour
trademarks for prescription drugs remains a
challenge for the innovative pharmaceutical
industry – is there a way forward? Norton
Rose’s Patrick E Kierans and Kristin Wall
examine the issues
Many are familiar with drug advertisements for the “purple pill”
(Nexium®) or the little blue diamond-shaped tablet prominently
displayed in commercials for erectile dysfunction (Viagra®).
It may be surprising to learn that the shape and colour of these, and
many other uniquely coloured and shaped drugs, may not benefit from
traditional trademark protection.
In particular, the courts in Canada hold that because patients receive
their medication through professionals (ie, doctors and pharmacists)
they lose their inherent right as consumers to choose. As a result,
the courts appear to operate in the belief that shape and colour of
prescription drugs do not have traditional trademark significance
for patients.
In order to further explore whether or not patients regard the shape
and colour of prescription drugs as trademarks, the authors conducted
market research on this issue. The authors conducted a series of focus
groups in Canada to explore the trademark significance of Zovirax®
used in the treatment of various strains of herpes.
The Zovirax® study consisted of a series of four large mixed
medication patient groups, and eight smaller Zovirax® patient groups.
The four larger groups involved a total of 38 patients taking a variety of
prescription medications. Participation in the smaller groups was limited
to 28 patients actually taking Zovirax® 200 mg tablets.
The focus groups and a pilot survey questionnaire revealed
that shape and colour of prescription medicines do have traditional
trademark significance for patients. In particular:
• All patients want to make an informed decision about which brand of
their medication to accept;
• Drug appearance is important to patients in identifying their
medication and they do associate a particular shape and colour with a
particular manufacturer; and
• A majority of patients prefer that generic versions of the same
medication come in different shapes and colours so that a substitution
cannot be made without their knowledge.
This type of qualitative research, in combination with brand-focused
marketing strategies, suggests a viable approach for successfully
asserting legal rights in respect of shape and colour trademarks for
prescription medicines.
Generic position – patients play no role
Over the years, there has been an on-going debate in the courts in
many countries as to whether or not the shape and colour of innovative
medicines should be protected as trademarks. The challenge for
innovators seeking to assert these trademarks typically lies in proving
that drug appearance is not functional, and is distinctive of a single
source.
The generics industry argues that drug appearance cannot have
trademark significance for patients since patients have little, if any,
36 Intellectual Property magazine
role in selecting the drugs they take. Rather, doctors and pharmacists
dictate drug choices for patients. The role of the patient in establishing
evidence of distinctiveness in these cases is further complicated by issues
of confidentiality which can make the exercise of obtaining meaningful
evidence from representative patient samples both difficult and costly.
The end result is that courts have typically been presented with little
evidence on the patients’ point of view.
The authors suggest that relegating patient evidence to the sidelines
reflects an unwarranted and paternalistic view of the role of patients
in drug selection. When it comes to establishing the distinctiveness
of shape and colour trademarks, the drug industry at its core is not
unlike any other retail industry. Consumers rarely obtain products
directly from the manufacturer, but make product selections based
on the initial selections of store purchasers. As the “end” customer
who actually consumes the prescription drug, patients’ views on drug
appearance should be more, not less, important than those of doctors
and pharmacists.
The regulatory context should not override
In order to appreciate the framework in which decisions regarding
the protection afforded to shape and colour trademarks are made, it
is important to consider the regulatory context of the drug industry.
In Canada, as in many other jurisdictions, drug substitution laws
allow pharmacists to select the specific innovator or generic product
to be dispensed, provided the products have been designated as
interchangeable. For example, if a doctor writes a script for Prozac®
(brand name) or fluoxetine (chemical name), the pharmacist may
dispense Prozac® or any one of the available generic versions. In
certain circumstances, a different interchangeable product from the
product indicated on the script can be dispensed to a patient, without
notice.1 The patient, however, is entitled to request that a specific
interchangeable brand be dispensed, without a physician’s direction
of “no substitution” on the script. In addition to substitution laws,
government and private-funded drug insurance may also impact
product selection. Many insurance policies will only refund the cost of
the lowest-priced interchangeable product.
In view of this regulatory context, proponents of shape and colour
trademarks for prescription drugs argue that protecting distinct drug
appearances is especially important to patients as it allows them to
more readily determine the source manufacturer of their prescription
drug. For example, although generic products are required to be
bioequivalent to the original brand, this does not mean that they must
contain the same non-active ingredients. For this reason, some patients
may experience adverse effects amongst different interchangeable
products. Drug appearance can play an important role in a patient’s
ability to determine that he has been given the product from the source
he has come to depend on.
April 2012
www.intellectualpropertymagazine.com
Trademarks and
prescription drugs
“For one brief shining moment…”
Twenty years ago, this logic resonated with Canada’s highest court in
Ciba-Geigy Canada Ltd v Apotex Inc (“Ciba-Geigy).2 Ciba-Geigy was
decided in the context of a trademark/passing-off case involving the
drug Lopresor®, used to treat hypertension. In finding that the relevant
consumer pool for determining distinctiveness includes physicians,
pharmacists, dentists and patients, the Supreme Court of Canada held
that: “As the patient has no direct access to the product, it is all the
more necessary for him to be able to exercise some kind of control
over what he is being given. In the field of prescription drugs the first
information the patient receives when the product is given to him
comes from its appearance”.3
Despite the direction in Ciba-Geigy, lower courts have nevertheless
generally failed to recognise the value of drug shape and/or colour
trademarks for patients.
A global problem
US, UK, Australia and South Africa
It is just as difficult to register the shape and colour of a drug as a
trademark in other jurisdictions. Although these marks are generally
www.intellectualpropertymagazine.com
Adopting a patient-centric approach to proving
trademark significance
The fact that the shape and colour of prescription drugs are prima facie
eligible for registration, but are failing to establish proof of acquired
distinctiveness raises many questions concerning the type of evidence
required to establish the trademark significance of a drug’s appearance.
In the Canadian Advair case discussed earlier, the court found that
doctors and pharmacists do not identify drugs by shape and colour alone
April 2012
Intellectual Property magazine 37
Picture supplied by Claude Noel
Canada
In Canada, the shape of a prescription drug can be registered as a
trademark as a distinguishing guise if there is evidence that the guise has
acquired distinctiveness as of the date of filing the trademark. In order to
avoid this evidentiary hurdle, the more common approach adopted by
pharmaceutical companies has been to seek trademark protection for a
combination of the product shape and colour. A trademark for the shape
and colour of a prescription drug is registrable. However, if the trademark
is challenged or enforced, the evidentiary burden is on the owner to
demonstrate the distinctiveness of the mark.
Canadian courts have held that the distinctiveness
of shape and colour trademarks for prescription
drugs will not be presumed. Rather, there must
be evidence that the mark has acquired a
“secondary meaning” in the minds of the
relevant consumer population. This was
demonstrated by the recent decision in
Apotex Inc et al v Registrar of Trade-Marks
et al involving a challenge to the trademark
registration for a purple-shaded circular
Advair® diskus inhaler (right) (“Advair”)4.
This evidentiary burden is high such
that distinctiveness is rarely found. In order
to establish distinctiveness, Canadian courts
require evidence that doctors, pharmacists and
consumers/patients associate the drug’s shape
and colour with a single trade source such that they
use the mark to make their prescribing, dispensing
and purchasing choices. Arguably, this test has imposed an
unnecessarily high standard of distinctiveness. For example, trademark
law does not require that the public be able to name the source of the
wares. It is enough to be able to associate the wares as emanating from
a single source. Moreover, a mark does not cease to be a mark simply
because it conveys something more than the source of the goods to the
relevant consumer population. It is not uncommon for a trademark to
indicate the quality of the wares in addition to the source. Proof that
a significant number of patients associate the shape and colour of a
prescription drug as emanating from a single manufacturer should be
sufficient to support a finding of distinctiveness. The fact that a patient
may also associate drug trade dress with the quality of the drug or its
therapeutic effect should not undermine its trademark significance.
prima facie eligible for registration provided the get-up is nonfunctional, most jurisdictions take the view that such trademarks lack
inherent distinctiveness. As a result, proof of distinctiveness acquired
through use of the mark is required in order to support or maintain
a registration. Similar to the situation in Canada, few pharmaceutical
products have been able to satisfy the evidentiary requirements of
establishing distinctiveness.
In the US, the non-functionality requirement has proven difficult for
many prescription drugs to overcome. For example, registration was
refused on the grounds of functionality where the colour and shape
of the drug were indicative of different drug dosages associated with
patient compliance, where colour/shape was indicative of the drug’s
therapeutic effect, and where colour/shape enabled those taking
multiple medications to differentiate amongst them or better identify a
drug in an emergency situation.5
In the UK, the House of Lords in Smith Kline and French Laboratories
Ltd v Sterling-Winthrop Group Ltd (“Smith Kline”)6 determined that the
external appearance of a partially coloured capsule was a “mark” within
the definition of the Trade Marks Act 1938. In light of overwhelming
evidence that the market recognised the distinctive colour combinations
of the capsule and associated them with the manufacturer, the
trademark was held to be distinctive in fact and sufficiently inherently
distinctive to justify registration. However, pharmaceutical get-ups
in subsequent cases under the Trade Marks Act 1994 have failed to
establish sufficient distinctiveness to obtain registration without proof
of distinctiveness acquired through use.7
Unlike the UK, the Australian court refused to register the equivalent
Smith Kline coloured capsule on the basis that a description
of goods by shape, size or colour does not constitute
a trademark. The court held that a mark “must
be capable of being described and depicted as
something apart from the goods to which it is
to be applied” in order to be registrable.8 The
Trade Marks Act has since been amended to
permit the registration of shape and colour
trademarks. Pharmaceutical trade dress
registrations are now possible in Australia
provided that the mark is non-functional
and capable of distinguishing the wares and
services of the applicant. There have been no
court cases specifically on pharmaceuticals,
but there are many registrations of colour and
shape marks including Glaxo Group Limited’s
registration of “the colours dark and light green
applied to a medicament dispensing device”.9
Finally, although shape and colour trademarks can be
registered in South Africa, the shape of a prescription drug has been
held to lack distinctiveness where the shape is necessary to obtain a
specific technical result or function, such as for ease of swallowing or to
prevent the drug from crumbling.10 Shape and colour registrations have
also been denied on the basis that a trademark registration would limit
competition in a market where only a limited number of get-ups are
available for use in certain kinds of medications.
Trademarks and
prescription drugs
and would not dispense a product without a label. Relying mainly on a
pharmacist’s testimony on patient perception, the court also held that
patients do not typically attribute much significance to the appearance
of pharmaceutical products, and are more concerned about a product’s
functionality, dosage and effectiveness.
The need for qualitative evidence on patient
opinion
Picture supplied by Claude Noel
In order to determine whether patients associate the shape and
colour of prescription drugs with a source manufacturer, the authors
conducted a series of focus groups in Canada to explore the trademark
significance of Zovirax® 200 mg, a light blue, shield-shaped tablet used
in the treatment of various strains of herpes.
The use of focus groups is a qualitative research technique to collect
data through a moderated group discussion.
The Zovirax® study consisted of a series of four large mixed
medication patient groups, and eight smaller Zovirax® patient groups.
The four larger groups involved a total of 38 patients taking a variety of
prescription medications. Participants were identified with the assistance
of dispensing pharmacists who were asked to distribute a letter of
request to patients obtaining a refill of any one of nine specified brand
drugs representing a broad spectrum of innovative pharmaceutical
companies. Participation in the smaller groups was limited to 28 patients
actually taking Zovirax® 200 mg tablets. The Zovirax® patients were also
recruited via pharmacists, as well as through patient groups, treating
physicians and STD clinics. All participants were paid an honorarium for
attending the focus group session.
original product; and (iv) it seemed “unfair” that a generic product
could copy all of the same detail of the brand product.
A way forward
The research collected from the focus groups and international experience
to date, suggest that a more patient-centric approach is necessary for
successfully establishing shape and colour trademark distinctiveness
for prescription drugs. Qualitative market research may provide a more
sensitive mechanism for accessing the complexity of consumer opinions
concerning the trademark significance of drug appearance.
In addition, innovative companies should continue to undertake
proactive marketing strategies to better develop, protect and enforce
shape and colour drug branding, including: (i) by selecting a unique
shape and colour trade dress; (ii) where possible, by making these
selections arbitrary to avoid allegations of functionality; and (iii) by using
drug shape and colour like a trademark when advertising to doctors,
pharmacists and patients, and incorporating trademark notifications on
packaging and advertising.
Footnotes
1.See for example Ontario’s Drug Interchangeability and Dispensing Fee Act,
RSO 1990, Chapter P. 23, s 4.
2. Ciba-Geigy Canada Ltd v Apotex Inc [1992] 3 SCR 120 [Ciba-Geigy].
3. Ciba-Geigy, supra.
4.Apotex Inc et al v Registrar of Trade-Marks et al, 2010 FC 291, aff’d 2010
FCA 313.
5.Shire US Inc v Barr Labs, Inc, 329 F3d 348 (3d Cir 2003) re: ADDERALL
for treating ADHD; Inwood Labs, Inc v Ives Labs, Inc, 456 US 844 (1982)
re: CYCLOSPASMOL for treating vascular diseases. But see, Boehringer
Ingelheim GmbH v Pharmadyne Labs, 532 F Supp 1040 (DNJ 1980) re:
DIPRIDAMOLE.
6.Smith Kline and French Laboratories Ltd v Sterling-Winthrop Group Ltd,
[1975] 2 All ER 578.
7.In the Matter of Application Nos 2209936 and 2209937 by GD Searle &
Company to Register Two Three Dimensional Trade Marks In Class 5 (appeal
by the Applicant dated January 30, 2002).
8.Smith Kline & French Laboratories (Australia) Ltd v Registrar of Trade Marks,
[1967] HCA 42 at para. 21.
9. Registration No 924285.
10. Beecham Group PLC Smithkline Beecham Pharmaceuticals v Triomed (Pty)
Limited [2002] 2 All SA 126.
Authors
Trademark significance for patients
Contrary to the court’s findings for Advair®, the focus groups determined
that a majority of patients do in fact associate the shape and colour of
a prescription drug with a single source manufacturer.
The consumer evidence collected by the focus groups also revealed
that patients prefer that generic versions of the same medication have
a different appearance so that a substitution cannot be made without
their knowledge. Overall, drug appearance plays an important role in
drug selection for patients who want to make an informed decision
about which brand of their medication to accept.
Most of the patients interviewed believe that a particular
combination of colour, size and shape belonged to that particular
medication, and to the company that produced it. Patients feel that
a particular drug get-up should remain the property of the drug name
and drug company. This was desirable to patients for several reasons,
including: (i) the public might otherwise be given a generic product
without the doctor’s authorisation and without being informed; (ii)
receiving the generic product might prove problematic where the nonactive ingredients might be slightly different; (iii) the generic product
was falsely encouraging people to assume that its product was the
38 Intellectual Property magazine
Patrick E Kierans is global head of pharmaceuticals and life
sciences at Norton Rose Group. Kristin Wall is an associate in the
Toronto office of Norton Rose Canada LLP. Mr Kierans and
Ms Wall act in a wide range of IP matters involving the
innovative pharmaceutical industry.
The authors wish to acknowledge the contribution of their
colleagues on the state of the law in their respective jurisdictions,
including George Cameron of Norton Rose LLP (London), Frances
Drummond of Norton Rose Australia and Brian Wimpey of
Norton Rose South Africa.
April 2012
www.intellectualpropertymagazine.com