Norway
Camilla Vislie, Andreas Nordby and Kirti Mahajan Thomassen
Advokatfirmaet Thommessen AS
Pharmaceutical
Trademarks
2015/2016
A Global Guide
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Advokatfirmaet Thommessen AS
Authors
Camilla Vislie, Andreas Nordby and Kirti Mahajan Thomassen
Selection, clearance and registration
In Norway, no separate rules apply to
pharmaceutical trademarks. The eligibility of
a pharmaceutical trademark for registration
depends on the rules set out in the Trademark
Act, which to a large extent is based on the EU
Trademarks Directive (2008/95/EC), and the
Norwegian courts generally interpret the act
in line with decisions of the European Court
of Justice (ECJ). A trademark may consist
of any sign, device, word or combination of
words, including slogans, letters, numerals,
moving images or the characteristic look of
goods or their packaging.
In order to be eligible for registration,
the mark must have distinctive character, be
non-descriptive and not conflict with public
interest (Sections 14 and 15 of the act). If the
trademark contains elements relating to, for
example, the characteristics or functions
of the pharmaceutical, this will generally
be considered to be descriptive and the
application may be rejected. For example,
trademarks containing the name of the active
pharmaceutical ingredient or elements similar
to the active pharmaceutical ingredient may
risk rejection as descriptive.
Trademark applications are handled by
the Norwegian Industrial Property Office
www.WorldTrademarkReview.com
(NIPO), which conducts a full examination
of whether the application meets the
registration requirements. Pursuant to Section
16 of the Trademark Act, the NIPO also
examines whether the applied-for trademark
conflicts with existing trademark rights. If
the applied-for trademark is confusingly
similar to another trademark registered
for pharmaceuticals or similar goods, the
application may be rejected.
Certain prefixes and suffixes are
considered to be ‘weak’ elements in a
pharmaceutical trademark – for example,
‘pharm’, ‘med’ and ‘anti’. Similarity with
respect to such weak elements will usually
not be decisive when assessing whether a
pharmaceutical trademark is confusingly
similar to another pharmaceutical trademark.
The assessment of whether one trademark
is confusingly similar to another is based on
the perception of the trademark in the relevant
course of trade. Generally, a higher degree
of similarity may be accepted when only
professionals constitute the relevant course
of trade, as opposed to end consumers also
forming part of the relevant course of trade.
In principle, the relevant course of trade for
pharmaceuticals could be said to vary for
over-the-counter (OTC) pharmaceuticals and
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ADVOKATFIRMAET THOMMESSEN AS
pharmaceuticals on prescription (see GULE
SIDER, Supreme Court Decision Rt 2005 p
1601, paragraph 56). However, this is not a
general rule under Norwegian trademark
law. Instead, end consumers are generally
considered to be part of the relevant course
of trade for prescription pharmaceuticals and
their perception will generally be part of the
assessment of whether one pharmaceutical
trademark is confusingly similar to another.
Therefore, the perception of end consumers
may have an impact on the specific assessment
and the accepted degree of similarity, even in
relation to prescription pharmaceuticals.
Pursuant to Section 2 of the Trademark
Act, it is possible to register three-dimensional
(3D) trademarks. 3D trademarks must fulfil
the general requirements of distinctiveness
– namely, that the shape be perceived as a
trademark. This assessment takes into account
that the public is generally not used to deriving
a product’s commercial origin on the basis of, for
example, the shape of a product. Even though
the requirements for distinctiveness are the
same for 3D trademarks as for other trademarks,
in practice it is more difficult to fulfil the
requirements for 3D trademarks. On this point,
Norwegian case law is also likely to follow
ECJ practice (see TRIPP TRAPP, ECJ Decision
C-205/13). Thus, such registrations are quite rare.
Similarly, it is also possible to register a
colour as a trademark (Section 14, cf Section
2, of the Trademark Act). However, the
distinctiveness test will again apply, and in
practice may be an obstacle to registration.
Under Section 37 of the Trademark Act,
a trademark registration may be deleted on
request if the rights holder has not used the
trademark within five years of registration or
has ceased to use the mark for five years. The
obligation to genuinely use the trademark
has a few exceptions. For example, there is an
exception to the obligation if the holder has
reasonable cause for not using the trademark.
This may be the case, for example, if the
trademark holder is awaiting marketing
authorisation for the pharmaceutical product.
Parallel imports and repackaging
Norwegian legislation and case law with
respect to parallel imports and repackaging
are generally based on EU legislation and
90 | Pharmaceutical Trademarks 2015/2016
ECJ case law, as described above. Pursuant
to Section 6 of the Trademark Act, a
registered trademark does not prevent
use of the trademark for goods put on the
market under the trademark within the
European Economic Area (EEA) by the rights
holder or with its consent, unless the rights
holder has legitimate reasons to oppose
commercialisation of the goods – for example,
if the condition of the goods has changed
or been impaired after they were put on the
market. Essentially, the issue is the extent
to which the exclusive rights conferred by a
valid trademark may be invoked as a means to
hinder parallel imports.
Parallel imports are generally allowed
under Norwegian trademark law. However, a
rights holder may object to marketing which
is capable of damaging the reputation or
standing of its trademark (Section 6 of the act).
As a starting point, any interference
with the product as such usually justifies an
Camilla Vislie
Partner
cav@thommessen.no
Camilla Vislie heads the firm’s IP and
technology practice. She works mainly
with patent, trademark and copyright
litigation, for clients within sectors such as
commerce, technology and media. She has
been involved in a number of well-known IP
cases, including before the Supreme Court.
Ms Vislie is top ranked by Chambers, Legal
500 and World Trademark Review. She has
many years’ experience on the Norwegian Bar
Association Expert Committee on IP Law and
frequently speaks on IP-related issues.
www.WorldTrademarkReview.com
ADVOKATFIRMAET THOMMESSEN AS
objection from the rights holder. The main
function of the trademark is to guarantee
the origin of the product and this function
cannot be fulfilled if the parallel importer
has interfered with the product. Further, the
rights holder generally has the right to object
to repackaging, which includes removing the
rights holder’s trademark and affixing the
rights holder’s trademark to new packaging.
However, the parallel importer can carry
out repackaging which involves removing
and re-affixing the trademark to the extent
necessary to avoid artificial market divisions
and ensure efficient access to the market.
For example, if it is necessary for the parallel
importer to repackage the goods due to
Norwegian statutory requirements concerning
the size or type of the packages, the rights
holder cannot prevent repackaging based
on its trademark rights. However, when
repackaging, the parallel importer must
ensure that the rights and interests of the
NORWAY
rights holder are properly safeguarded.
Certain EU requirements must be met
for repackaging to be permissible, based on
ECJ case law. The repackaged goods shall
include the names of both the repackaging
entity and the manufacturer. Further, the
rights holder must be given notice in advance
and, on request, be sent a sample of the
repackaged product. The repackaging shall
in no way harm the interests of the rights
holder; therefore, it cannot be defective, be
of poor quality or appear incomplete. If these
requirements are not met, the rights holder
may invoke the Trademark Act to prohibit
repackaging and parallel import.
Anti-counterfeiting and enforcement
Measures explicitly targeted at preventing the
marketing of counterfeited pharmaceuticals
were recently introduced into Norwegian
law for the purpose of implementing the
EU Counterfeit Pharmaceuticals Directive
Andreas Nordby
Managing associate
ann@thommessen.no
Kirti Mahajan Thomassen
Managing associate
kmt@thommessen.no
Andreas Nordby is a managing associate
at Thommessen. He has extensive
experience of matters concerning IP
rights, telecommunications, media and
technology, and dispute resolution. He is
considered a first-class litigator and has
extensive experience of handling noncontentious IP and technology-related
matters such as R&D projects, licensing and
trademark portfolios. Mr Nordby is also an
experienced negotiator.
Kirti Mahajan Thomassen is a managing
associate at Thommessen. She is an expert on
all aspects of health-related regulatory law,
including pharmaceuticals, medical devices
and food supplements. She advises on core
legal issues for life sciences clients, such as
marketing requirements, relevant codes of
conduct and product liability disputes. Ms
Thomassen was previously vice president of
the Norwegian Complaint Board for Health
Personnel. Her practice also includes public
procurement law and competition law.
www.WorldTrademarkReview.com
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(2011/62/EC). The measures in question have
primarily been implemented into national
regulations issued under the Medicinal
Products Act and the Pharmacies Act.
The relevant measures include:
• requirements for manufacturers to place
safety features on the outer packaging of
pharmaceuticals;
• pharmacies’ and OTC outlets’ control
of products’ authenticity based on such
safety features;
• introduction of the concept of brokers of
medicinal products and pre-registration
requirements for brokers;
• new compliance control and reporting
obligations for manufacturers, wholesale
distributors and brokers, including control
of good distribution practice compliance
and other necessary authorisations in
previous links of the distribution chain; and
• requirements for manufacturers to obtain
written confirmation of compliance
with good manufacturing practice from
relevant authorities when importing active
ingredients from countries outside the
European Union or EEA.
The anti-counterfeiting measures
introduced into Norwegian law also impose
further restrictions on private imports by
shipment of pharmaceuticals. Previously,
it was possible to import pharmaceutical
products from the EU/EEA area, but not from
outside this area. Under the new regime,
all imports of prescription pharmaceuticals
will be prohibited. However, imports of OTC
pharmaceuticals in quantities corresponding
to three months’ personal use from the EU/
EEA area will be permitted, provided that:
• the pharmaceuticals are imported for
personal medical use;
• they are legally acquired in the country of
purchase and this can be documented;
• the seller may legally sell and export the
relevant pharmaceuticals;
• the pharmaceuticals are covered by a valid
marketing authorisation in Norway; and
• the importer is at least 18 years old.
This amendment was announced on
November 7 2013, but has not yet entered
into force.
92 | Pharmaceutical Trademarks 2015/2016
Moreover, the Medicinal Products Act
has been amended to empower Customs to
immediately withhold, seize and destroy
illegally imported pharmaceuticals. Before
Customs destroys suspected illegally
imported pharmaceuticals, the recipient shall
be notified and given the opportunity to file a
statement within a certain deadline.
The trademark legislation may be used
to remove counterfeit products from the
market. Norwegian trademark legislation
encompasses both civil and criminal penalties,
with civil penalties being most practical. Civil
penalties include compensation and damages,
but also other remedies such as prohibition
against future infringements and withdrawal
or destruction of goods. Goods suspected of
infringing trademark rights may be seized by
Customs. The owner may obtain a customs
seizure pursuant to an interim injunction from
a court.
Advertising
The advertising of pharmaceuticals with
Norwegian marketing authorisation is
primarily governed by Chapter 7 of the
Medicinal Products Act and Chapter 13 of
the Medicinal Products Regulation. The
main requirement is that any advertising
for pharmaceuticals be sober and unbiased,
and not give a misleading or exaggerated
impression of the pharmaceutical’s
characteristics and medicinal benefits.
The definition of ‘advertising’ is quite wide
under Norwegian law. Pursuant to Section 13(2)
of the Medicinal Products Regulation, any kind
of written or oral statement, picture or sample
which is designed to promote the sale or use of
pharmaceuticals is considered to be advertising.
Only OTC pharmaceuticals may be
advertised to the public. A significant number
of negative requirements in relation to the
content apply to such advertising. Among
other things, the advertising may not:
• contain recommendations from doctors or
similar;
• mention serious diseases such as
tuberculosis, AIDS, cancer or diabetes;
• contain statements to the effect that the
pharmaceutical has no possible side effects
or is equivalent to or better than other
treatments or pharmaceuticals; or
www.WorldTrademarkReview.com
ADVOKATFIRMAET THOMMESSEN AS
•
indicate that a person’s health condition
may be worsened by not taking the
pharmaceutical.
It is further prohibited to direct any
advertisement towards children and to
indicate that the pharmaceutical is a
nutriment or a cosmetic product. Certain
positive requirements in relation to the
content also apply to such advertising. Among
other things, the advertisement shall always
contain the name of the pharmaceutical and
the active ingredient, as well as information
regarding correct use. Advertising on
television is not allowed under any
circumstances and there are also restrictions
with respect to the use of illustrations.
Prescription pharmaceuticals may be
advertised to healthcare professionals.
Section 13(7) of the Medicinal Products
Regulation explicitly lists a number of positive
requirements that the content of advertisements
directed at healthcare professionals must meet
and prohibit advertisements with gifts, favours
or other contributions attached. Samples of
pharmaceuticals may be handed out only to
medical professionals and only pursuant to a
written requisition.
Generic substitution
Generic substitution of an original
pharmaceutical product is permissible under
Norwegian law and is encouraged by the
Norwegian authorities. Pursuant to Section
6(6) of the Pharmacies Act, pharmacies may
substitute an original pharmaceutical product
with a cheaper generic product (or parallel
imported product) when the latter has been
approved for substitution by the Medicines
Agency. The provision is worded as a right for
pharmacies to offer generic substitution, thus
suggesting that pharmacies may freely choose
not to offer such substitution. However, in
practice, substitution may be avoided only if
the prescribing physician has made an explicit
and medically justifiable reservation against
substitution on the specific prescription, or if
the patient opposes substitution. In the latter
case, the patient will be required to pay the
difference between the price of the original
product and the price of the generic substitute.
Approved generic substitutions are listed
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on the Medicines Agency’s website and
the list is updated twice a month. Before
a pharmaceutical is approved for generic
substitution, the Medicines Agency conducts
an assessment of whether the generic product
is equivalent to the original product.
Online issues
Pursuant to Section 42 of the Pharmacy
Regulation, pharmacies can sell OTC
pharmaceuticals online. However, prescription
pharmaceuticals cannot be sold online.
There are certain reporting requirements
for pharmacies selling pharmaceuticals online.
Further, there are certain requirements regarding
the content on websites offering pharmaceuticals
for sale. For example, pharmacies are obliged to
include a link to the Medicines Agency’s website,
on which a list of authorised online sellers is
published. Further, the general requirements in
the Electronic Commerce Act (eg, in respect of
information to be included on the pharmacy’s
website) must also be met.
Any marketing of pharmaceuticals online
must also conform with the general rules
on advertising and the special advertising
rules for pharmaceuticals (in particular, the
Marketing Control Act and Chapter 13A of the
Medicines Act).
Under Norwegian law, general guidance
on a website is considered as potential
advertising, since such guidance is not
individualised. Therefore, general guidance
on websites will be subject to the rules on
advertising. Individualised guidance is
normally not considered to be advertising.
Such guidance is subject to the rules in the
Healthcare Personnel Act.
Advokatfirmaet Thommessen AS
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Norway
Tel+47 23 11 11 11
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