Department of Law

Spring Term 2017

Master Programme in Intellectual Property Law

Master’s Thesis 30 ECTS

Pharmaceutical Trademarks
What should we know about them?

Author: Cristina Garbuz

Supervisor: Professor Sanna Wolk
 CONTENT:

ABREVIATIONS .................................................................................................................. 2
INTRODUCTION ................................................................................................................. 3
CHAPTER I. ENTRY ON THE MARKET........................................................................ 5
1.1.Freedom to choose a name………………………………………………………………6
1.1.1. Trademark’s double control ................................................................................................7
1.1.2. Intellectual Non-Property Names .....................................................................................11
1.1.3. Package/ Labelling and Leaflet ..........................................................................................14
1.2. Likelihood of confusion ............................................................................................... 17
CHAPTER II. MARKETING ............................................................................................ 21
2.1. Advertisement strategies and their limitations ............................................................. 21
2.2. Parallel importation ...................................................................................................... 26
2.2.1. Price control factor ............................................................................................................28
2.2.2. Repackaging factor ............................................................................................................30
CHAPTER III. TRADEMARK LAW AND PHARMACEUTICAL TRADEMARKS 33
3.1. Trademark cluttering .................................................................................................... 33
3.2. Genuine use .................................................................................................................. 35
CONCLUSION .................................................................................................................... 39
BIBLIOGRAPHY................................................................................................................ 41
Legislation ........................................................................................................................... 41
Case Law ............................................................................................................................. 42
Doctrine ............................................................................................................................... 43
Other Resources .................................................................................................................. 45

1
 ABREVIATIONS

WHO – World Health Organization

WTO – World Trade Organisation

EU – European Union

TFEU – Treaty on the Functioning of the EU

CJEU – The Court of Justice of the European Union

EUIPO – European Union Intellectual Property Office

TRIPS – Agreement on Trade-Related Aspects of Intellectual Property Rights

EMA - European Medicines Agency

NRG - Name Review Group

PTO – United States Patent and Trademark Office

FDA – United States Food and Drug Administration

Reg – Regulation

Dir – Directive

IPR – Intellectual Property Right

TM – Trademark

MA – Marketing Authorization

MAH – Marketing Authorization Holder

PI – Parallel Importation

Pharm – Pharmaceutical

ADR – Adverse Drug Reaction

2
 INTRODUCTION

Living in a century overcrowded with products and services trademarks allows us to

distinguish one undertaking from another and to understand for what we actually are paying and
what quality we will receive in a final step. Understanding the role and importance of TMs in
the European Union legislative organs adopted several acts which would help to provide a
uniform legislation between all member states.

In this work, we will focus on pharmaceutical trademarks. These trademarks come in

tangent with the health care system. Hence, pharm TM has a strong influence not only on the
market but on the public health system as well. Considering the importance of protection of
human's rights, in special the right for health we would like to figure out the specific
characteristic of the pharm TM. What makes pharm TM different from others, how they appear,
exist, develop and interact with each other. The most important question is how they influence
TM law in general and the case law precedents.

Our goal is to show to the reader how the existence of the fundamental right to health of
consumers influences the freedom of business of the owner of a pharm TM. We will not go into
details regarding procedural part of TMs (except the registration, which is a special one in case
of pharm TMs). Also, we will not put the accent on counterfeits which is relatable more for
pharm products in general and less to the TMs. The critical task is to try to emphasize the
influence of TM on the pharm product, delimitating this effect from patent rights which ensure
and realize other functions. Also, realizing the fact that the most pharm TMs represent pharm
names we will put the accent on them. We will mention other forms of pharm TMs only in
several moments as characteristic examples to the relevant topics.

In order to realize our goal, we will use several methods which will support us to find
and apply the relevant sources. The first steps will be realized through legal dogmatic methods
that will be applied with the aim to identify the legal provisions related to pharm TMs. We will
use EU’s legal framework because the work analyses characteristics of pharm TM from EU
community. It is decisive to understand what and how the EU's Dir and Reg reflect the
information regarding the pharm TM. In the process of interpretation of the legal norms, it would
be used international acts which will make it possible to see a more general picture about some

3
issues. The legal sources represent the basement of our work and give it a real value. To clarify
the law and understand how pharm TM works we will apply in addition the comparative law
method. Comparison of different legal systems always supports the development of law,
emphasizing the weak and strong parts of the legal norms. From the aspect of pharm TM, this
will assist in the understanding of how EU can improve the existing norms. In the case of
problems with international character (like parallel trade), this helps to create universal
instruments for cooperation between the parts and achieving a common consensus.

The most relevant method for our work will be the hermeneutic one, which will be
realised using all the relevant legal articles and researchers. We will study the materials which
we will help us to interpret the actual situation of pharm TMs. The core for our judgments will
be the case law practice of CJEU because they show to us how the legal norms are applied and
how their interpretation differs when we have the patients’ rights implicated.

To highlight the economic impact of pharm TM we will use economical works made in
the base of EU's laws and experience. Through empirical methods, it will be possible to show
how the pharm TMs influence the incentives of the pharm firms, costs of the products and in the
end the parallel trade within the EU.

All the used methods will help to the formation of a coherent work which will present all
the essential moments regarding pharm TM through three chapters. The first chapter will explain
all the struggles connected to pharm TM through the perspective of pharm names and the
likelihood of their confusion. In the second chapter, it would be analysed the advertisement
strategies and the parallel importations. This will make possible to see what is the CJEU's
position regarding the parallel importation of pharm products. The last chapter will focus on
problems which appear in the actual practice of TM law when pharm TMs are involved. All the
presented information will contribute to the conclusion regarding pharm TMs, their role, existing
issues and future possible amendments.

4
 CHAPTER I. ENTRY ON THE MARKET

For a TM to be registered it must accomplish the requirements provided in art.26 of Reg.

207/20091. The article itself asks for such basic information like data about the applicant,
representation of his TM and for which goods or services it will be associated. If the TM doesn't
come against any absolute or relative grounds for refusal it will be registered for a period of 10
years with the possibility of renewing.2 In these conditions, the owner of the TM can put his
products or services on the marketing with the registered TM. On another hand, the owner of
pharm TM will have to take a longer way till he finally, will be able to sell his products. This is
due to the higher concern of society to the medicinal products.

According to Dir 2001/83/EC, no medicinal product can be placed on the market if it

didn't get an MA from a competent authority.3 This provision is directly affecting the interests
of a pharm TM owner who wants to start to sell his product under the TM concerning to recover
all the investments made and to obtain a profit. In the context of our research question, we will
miss the provisions related to the medicinal product itself such like how it is made and what
impact it has on consumers. On another hand, we will show the steps which an owner of a pharm
TM must do to get the MA.

Respectively, to obtain the authorization an application should be made in the manner

provided by art.8 of Dir 2001/83/EC. The points which are related to us are the provisions
regarding the necessity to offer: the name of the medicinal product, inclusively the international
non-proprietary name (INN) if it exists or the relevant chemical name4; a mock-up of the outer
packaging, immediate packaging, and package leaflet.5

In these circumstances, the first impediment for a person who wants to put on the market
a pharm TM will be the name of the pharm TM which should respect some characteristics in
order to be able to receive the MA.

1
Regulation No. 207/2009 of 26 February 2009 on the European Union trademark.
2
Ibidem. Art.46.
3
Directive 2001/83/EC … on the Community code relating to medicinal products for human use. Art.6.
4
Ibidem. Art.8 (b), (c).
5
Ibidem. Art.8 (j).
5
 1.1. Freedom to choose a name

From Reg 207/20096 and Dir.2015/24367 we can understand that a TM can consist of any
signs, such as words, colors, the shape of goods, sounds etc. as long as they are able to realize
the function of a TM. The freedom to choose a TM is limited by the absolute or relative grounds
for refusal or invalidity of a TM. These limitations are provided by the Reg 207/20098 with the
aim to protect the interests of other TM's holder but at the same time to protect the interest of
society in general and the fair application of TM's functions. Beyond the impossibility to register
a TM which comes in contradiction with above-mentioned cases the future owner of a TM can
choose whatever he wants.

When it comes to pharm TMs the freedom to choose a TM gets a different configuration.
In fact, the right to choose a TM is limited by such high concerns like safety and public health.

We should remember that the TM can be not only a graphic representation but and a
shape as well. A pharm TM can be not only a name of the product or some graphic
representations but and the inner or outer package, the shape or color of the product. A good
example of the importance of a color or shape pharm TM can be Viagra's pills who had a blue,
diamond-shaped form. Besides the name, they registered as a TM the color and shape of the pill
which made it famous and in future gave to the initial owner a supplementary advantage against
generics who weren't allowed to use to their products the familiar look to which consumers were
used to.9

However, in this work, we will concentrate on the first thing which we see when we take
in hands a medicinal product – its name. Dir 2001/83/EC offers its own definition of what means
the name of the medicinal product: "The name, which may be either an invented name not liable
to confusion with the common name, or a common or scientific name accompanied by a
trademark or the name of the MAH".10 From this provision we can deduce two ways of
expression of a medicinal product’s name:

1. An invented name, not confused with the common name;

6
Ibidem. Art.4.
7
Directive (EU) 2015/2436 … to approximate the laws of the Member States relating to trade marks. Art.3.
8
Ibidem1. Art.7-8.
9
Driscoll B., Intellectual property rights: their implications … (2002), Vol.3 I.J.M. M., pag.74-79. Pag.77.
10
Ibidem3. Art.1 (20).
6
 2. Common or Scientific name plus a trade mark or name of the MAH.

1. An invented name, not confused with the common name – can be any word or word
combination which doesn't represent a medicinal common name. An invented name is, in fact,
a new TM which the TM holder choose to use for identification of his product. TM holder
can choose any name if it is not already registered as a TM or there doesn't exist any other
limitations provided by the Reg. 207/2009.

2. Common or Scientific name plus TM or name of the MAH:

- Common name (generic name) is an International Nonproprietary Name (INN) which

identifies a pharm substance or active pharm ingredient. These names are globally recognized
and put in the public domain by the WHO. They are called “Nonproprietary” because anyone
can use them without limitations.11 If an INN does not exist a usual common name will be
used.12 The last one is offered to a concrete pharm substance and accepted internationally
before the existence of INN system.
- Scientific name (chemical name) is the name when a new chemical entity is created. It is
based on the chemical compounds and as a rule is not used to identify the product at clinical
or marketing level.13

In present, the common name of medicinal products is premeditated to be the scientific

names gave by the WHO in accordance with the INN system. In the actual guideline of WHO
regarding INN, the creation of new trivial names for drugs (during laboratory trials) is not
encouraged because it can create confusion between the future, real INN and the trivial name of
the substance.14

1.1.1. Trademark’s double control

The name of a pharm TM is subject to a double control. First one is during the general
process of application for a TM (EUIPO level) and the second one is during the process of
application for MA (EMA level). Such a system is used because of the existence of high interests

11
Guidelines on the use of INNs for Pharmaceutical Substances ... WHO, 1997. Pag.1.
12
Ibidem3. Art.1 (20).
13
Kenagy J.W., Stein G., Naming, Labelling, and Packaging … 2001 Vol.58 A.J.H.-S.P., pag. 2033-2041. Pag.2035.
14
Ibidem11. Pag.10.
7
regarding pharm products and everything that is related to them. Hence, the same system exists
in USA where the first level will be represented by PTO and the second by FDA.15

When a pharm TM is registered at EUIPO it is supposed to the general requirements of

eligibility as any other TMs. Therefore, it can be supposed to absolute and relative grounds for
refusal. The TM should be non-descriptive, distinctive and not in conflict with public interest.
For example, the word Vektor-Lycopin was refused the registration because the Court
established that it had a lack of distinctiveness, having just a descriptive character for the
English-German speaking public.16 EUIPO will look at the possibility of the presence of
confusion between the TMs from the perspective of the relevant public. High similarities
between TMs could be tolerated if the pharm TM is aimed just for the circle of use for
professionals and not for the end consumers. Still, even in this case, it will be analyzed the risk
that the product can be accessed by consumers individually, which can bring to confusion.17

The process of application for obtaining a pharm TM can start at initial stages of
exploring and production of a medical product. To choose the most appropriate name it will be
made several surveys and researches regarding the availability of names.18 Though, the
pharmaceutical products referred to the Nice Class 5 is one of the most requested class, with over
67,000 EU’s TMs. This leads to the fact that up to 50% of proposed pharm TMs are rejected. 19
This shows that to obtain the registration of a pharm TM can be very taught.

If the person managed to get the TM he must put it in a genuine use, otherwise, the right
will be revoked.20 Taking into consideration that persons start the process for application for a
pharm TM before they have the real product done it can take some time till they will be able to
use the TM in the course of trade. The intention of using the TM and the preparatory actions are
not treated as examples of genuine use. The exception will be in the case of preparatory actions
with external character. According to the Court's decision, such an external character will have
the activities as an advertisement or get the price authorization.21

The process of analyzation of a name at EMA level is more specific than the normal
process of applying for a TM registration. For the name to be accepted it should not create
confusion in print, handwriting or speech with another medicinal product. But this confusion is

15
B. Brett Heaver, Drug name headaches… (2007) Vol.2, No.9, J.I.P.L. & P., pag.589-592. Pag.589.
16
Case T-85/08, Exalation Ltd vs OHIM. Judgement of the General Court 9 July 2010.
17
Vislie C, Nordby A., Thomassen K.M., Norway, 2015/2016, P.T., A Global Guide, p.89-93. Pag.89–90.
18
Helen Mosback, Protection of pharm TM…, 2013, Vol. 8, No. 1, J.I.P.L. & P., p.69-77. Pag.71.
19
Ibidem.15
20
Ibidem1. Art.15(1).
21
Case R 878/2004-1, DINAXIL vs DINAXIL. Decision of the Board of Appeal (OHIM) of 16 September 2005.
8
not at a general level like usual TMs. In calculation are taken concrete specifications of the
compared products but what is even more important it will be compared not only with the actual
pharm products but also with ones which were withdrawn from the market in different member
states.22 Such a procedure emphasize the importance to avoid the confusion of consumers
between existing pharm TM names but also with one which existed or is possible to re-enter on
the market. In 2016 46,6% of proposed name were rejected because of the similarity with other
(invented) name.23
Besides the possibility of confusion in the calculation will be taken that the name doesn't
create some promotional messages or come in contradiction with the product's prescription and
its real effects. The name should not have any "bad" meanings in any of the EU's official
languages. A special look will be offered for the way how the name is written if it has separate
letter or numbers. Also, unique in this case is the fact that it will be taken in attention the label
and package of the product which can help the name to be more distinctive or vice versa to create
confusions.24
From a comparative point of view, we can mention that the USA have quite similar
general rules but they go a bit further. In the process of determination if the TM should be
approved they use the "sound-alike/ look-alike" test. This test is exciting from the aspect that it
analyzes the possibility of confusions and other risks from the doctor’s or pharmacist’s
perspective. They came with the idea that the biggest problem with the use of pharm names is
about how they are used by professionals. In this context, they examine how the professionals
will write, pronounce and read names. Using the presumption that people have not a perfect
writing they will mostly refuse TMs which have similar letters when they are written (by looking)
or even TMs with not similar letters but with similar sounds (by hearing).25 Such an approach is
even more drastic than the one used by EMA. It decreases substantially the possibility to get a
wanted pharm name.
Seeing the harsh system of selection of availability of a new pharm name, the candidate
may propose up to four different names. In fact, the person can propose two names to NRG
which he wants to use within the MA and to each of them, he is able to offer two alternatives.26
In the case when one proposed name is unacceptable the process can go further with the next one
without the necessity to apply again for MA.

22
Ibidem. Pag.5-6.
23
Overview of (invented) names reviewed ... Adopted at the CHMP meeting of 12-15 December 2016.
24
Ibidem. Pag.6–7.
25
Ibidem14. Pag.590–592.
26
Ibidem15. Pag.10–11.
9
 The USA have a similar provision with the difference that the person submits just two
TMs without alternatives. The applicant can indicate which TM he would prefer to register from
those proposed and only if it is not possible, FDA will start to check the availability of the second
one.27
Besides the general precautions which are made in relation to the proposed name we have
and some more specific rules connected to the fact if it is an invented name or a common name
plus TM or name of MAH. Respectively in the case of invented names if they represent a
composed vaccine with several antigens or serotypes it is mandatory to add to the invented name
the number of antigens (serotypes) present in the substance. In the same time if the product
contains radionuclides it must be represented as well in the name, in the form of superscription.28
When the person wants to represent in the name the essence of the product he should
avoid the use of active substance’s name or which is the target organ of the product (in the case
of radiopharmaceutical products). This comes in contradiction with the general practice of
registration of TMs where people are trying to give hints to the TM's names about what is the
product or service. In our case, this is discouraged in order to minimize the risk of confusion.
During the process of accepting an invented name, it will be taken in attention the fact if
it can be used with doctor’s prescription or without. In the second case, it has a higher importance
the level of identification or differentiation of the product from others. This moment is so critical
that if a pharm TM name was registered at the beginning for a product which should be used
only by prescription but then it changes to a non-prescribed as well then, the MAH must get a
confirmation that this name is still allowed to use in such a context.29 In 2016 EMA rejected 246
invented names and accepted 241 which demonstrates that a candidate has 50% chance of
success.30
When it comes to common names plus TM of MAH we also have some special rules like
the fact that the used INN should be represented in its official form without abbreviations or
omissions of some letters. As well, the name of MAH can be used in its complete form or just as
a part. A final fact to remember is that the connection between INN and MAH’s name or TM
could not be separated by any punctuation signs.31
Even though the MA applicant got the authorization with the pharm name which he
wanted this doesn’t mean that his right is from that moment forever in force. After obtaining the
MA it will be valid for 5 years after what it can be renewed for an unlimited period if there

27
Ibidem14. Pag.590.
28
Guideline on the acceptability of names for human medicinal … EMA/CHMP/ 287710/2014 – Rev.6. Pag.7–9.
29
Ibidem.
30
Ibidem26.
31
Ibidem. Pag.9.
10
doesn’t exist some precautions which will make it more reasonable to prolongate the term only
for five more years.32 Besides this, the right to use a pharm name can be limited at any moment.
The authorization will be invalidated in case of appearance of ADR caused by the misleading
name or if the name creates the risk of misuse, abuse or confusion with another pharma product.33
The highlighted moments show up how specific is the control of pharm name at the
EMA’s level. Here the accent is on pharm products, on their use and interaction with society. In
such conditions, even the fact that this name was already registered at EUIPO doesn't matter
anything if NRG thinks that it comes against the values which EMA protects. The process of
control of proposed TM name at EUIPO and EMA level are two parallel, independent processes
which have their own goals and doesn't have an influence on each other existence even if the
MAH needs to have the name registration in both places in order to be able to market and protect
the pharm product.
The court stated that the fact that a pharm name got an MA doesn’t mean that it should
have some advantages in the process of applying for general TM registration because this kind
of evidence doesn’t have any importance in the process of assessing of distinctiveness or lack of
likelihood of confusion of the TM.34 At the same time, it is not in EMA's authority to check the
validity of a TM name and if it creates a likelihood of confusion with other TMs. EMA is
checking if the name can create some public health issues or potential security risk while EUIPO
looks up at the standard characteristic which a TM should have. As a rule, EMA rejects three
times more the proposed name for pharm products than EUIPO does.
Anyway, all these requirements the show that in the case of pharm name which is used
for obtaining an MA the rules of acceptance of such a name is different from the general process
of registration of a TM. The interests of patients and their protection obtains a higher importance
than the applicants'. EMA will focus on public health and will not deal with the protection of
IPRs.

1.1.2. Intellectual Non-Property Names

We think that at this point of the work it is necessary to clarify a what INNs represent
and what is the correlation between them and pharm TM names.

32
Ibidem. Art.24.
33
Ibidem.21. Pag.13.
34
Case T-130/03, Alcon vs EUIPO. Judgment of the General Court 22 September 2005.
11
 The use of INNs is made with the porpoise to help the medical personnel from all other
the world with the use of medical substances. So, regardless the languages and countries the
same substance has the same name, that makes it easy to recognize and use the pharm product
by medical workers. The use of INN on the package of a medical product makes it clearly from
the beginning what active substance is inside, for what it can be used and what are the effects.

INNs have some similar features as TMs. They must be distinctive in aural and spelling
and at the same time to not be confused with other names in common use. INNs should not be
inconveniently long and use of isolated letters or numbers should be avoided as well as the
hyphenated form.35 INNs are made in such a way as to have a “stem” which will link the
substances with the same characteristics. Hence, being easy to classify the substances and
understand some of their basic features.36

How was stated at the beginning the use of INN on the package is proposed to take place
together with the TM or name of the MAH. While using of an INN and a name of the MAH
doesn’t represent a problem the correlation between invented pharm TM name and INN can be
very tricky. The biggest issue which exists at this point is the possibility of confusion between
the INN and TM. To avoid the confusion several steps have been made to ensure the distinctive
character for both. The first step towards this aim is the provision adopted by the WHO resolution
WHA 3.11 which specifies that when somebody makes an INN propose, before its registration,
during 4 months from its publication in WHO Drug Information anyone can make an opposition
if they can argue why this INN should not be allowed to be registered. 37 One of the reasons can
be the presence of a similar TM on the market.

A second step for preventing the confusion was made through the WHO resolution
WHA46.19 where was considered that it should be discouraged the registration of TMs derived
from INNs, especially TMs which contains INN stems. The same provision declared that it
should be provided more incentive for the use of INN together with the firm's name. 38 These
statements sound permissive and not binding to some concrete restriction regarding the use of
INN. In the resolution, WHA3.11 is mentioned that Member States should prevent the
acquisition of any rights above INN, including the interdiction to register them as TM or trade-
names.39 The last provision sounds more binding but here we should remember that WHO
doesn’t provide concrete methods of how this should be realized, it says that: members should

35
General principles for guidance in INNs for pharm substances. WHO T.R.S., No.581, 1975. Principle 1, 6.
36
Ibidem11. Pag.1.
37
Procedure for selection of INNs for pharm substances. WHO Assembly resolution WHA3.11, 1955. Point 5.
38
Nonproprietary Names for pharmaceutical substances. WHO Assembly resolution WHA46.19, 1993. Point 1.
39
Ibidem.15. Point 8 (B).
12
“take such steps as are necessary". In this way is kept the freedom of countries to decide how
they limit the possibility to use an INN as a TM.

A third step which will provide the minimization of the risk to confuse the INN and TM
we concluded by our self. We should use the INN with the company's name instead of a TM. If
we don't use any TM then there doesn't exist any risk of confusion. However, from the Dir
2001/83/EC, we can see that it was left at the disposal of persons to choose if they want to use a
TM or a company's name during the registration of the name of the medical product. This
freedom shouldn't provoke problems if people would respect the second step mentioned above
and would not register TM similar to the INN. But from practice, we know that people do it
because this is the easiest path to get the consumers confused between the INN and TM and to
make for them more difficult to differentiate the generic product and a patented one which has
the same basic outcomes as the first but a higher price.

The use of INN and pharm TM names in the sphere of medical products creates high risks
of confusion between those two. Therefore, it is important to emphasize the existing issues
coming from actual legislation which deals with INN and its protection from confusing with TM.
A first issue is the lack of the binding force of resolution WHA46.19 which in the same time
doesn't have any direct interpretation and no control bodies which could supervise how the
provisions are applied in practice. These facts in correlation with the lack of direct prohibition
of the use of INN as TM in most of the countries serves to the possibility of confusions and
necessity of the courts to prohibit such registration through other measures.40

The lack of proper international legislation brings to issues at the national level regarding
this topic. So, the Russian Federation does not recognize the regulations proposed by WHO as
part of its own legislation. So, theoretically, anyone can register an INN as a TM. In practice,
judges understand the importance of protection of INNs and try to prohibit registration of TMs
which represent an INN derivation or stem through the argumentation that it leads to confusion,
is against public interests or has a lack of distinctiveness as a TM.41 This way of solution is far
from perfect because in similar cases different argumentation would be used which will make
the practice inconsistent. Meanwhile, WHO doesn’t offer a definition for the INN’s derivates,
respectively from case to case the solutions can differ. In this context, we have the Karniton case
where the first instance and court of appeal said that TM Karniton doesn’t come in contradiction
with INN Karnitin. Only the Higher Arbitrage Court stated that such a registration of a TM is

40
Pilyugina V., Bakhtiozina A., Some Peculiarities of…, (2016) No. 2 Право. Ж. B. Ш. Е. at p. 135-142. Pag.139.
41
Ibidem. Pag.137-139.
13
against public interests and is too similar to INN Karnitin.42 This decision is significant through
the fact that it settles down the first precedent in Russian case law of prohibition to register a TM
which is too similar to an INN or its derivative form. Nonetheless, this still doesn’t resolve all
the issues regarding this topic.

Another way of solving the problem was tried by Russian’s legislators through the non-
mandatory Three Letters Rule. This rule mentions that a risk of confusion between TM and INN
can exist if the last one doesn’t have at least three consecutive letters (characters) or more
different from INN in any combination.43 Such a solution seems as a promising idea but in fact
can be useless in case of long words or words combination. Besides this, in the process of
comparison should be taken into account the way of how the words sound and not only how they
look. Even more, in the EU's courts practice regarding the confusion of TMs was already
established that a key factor plays the first part of a word because people read from the left to
the right.44 Respectively even if the last letters will be different the this will not help to avoid the
confusion between TMs. We think that the same analogy can be applied in the case of confusion
between INNs and TMs.

The necessity of states to find alternative methods to protect INNs makes it clear that
WHO should come with some new provisions in this sphere. A solution which could ensure the
protection of INNs could be the implementation of a convention regarding INNs where it will
be explained better what means an INN steam or its derivate, the rules of their use and the
prohibition of the existence of association with TM names.

1.1.3. Package/ Labelling and Leaflet

In the process of application for MA, the applicant must provide examples of the
product's package/labeling and leaflet. This step is not directly connected with the issues
regarding the pharm TMs but in the same time, they impose to the owner of the TM to adjust the
way how his product looks in order to respect all the mandatory rules associated with the
marketing of a pharm product. An example of why this point is essential for a pharm TM is that
if the person registered a TM regarding the shape of a product in a specific way he must write
on it the amount of active substance or use a concrete inner package if this is essential for the

42
Case No. A40-66999/10-26-563 - Karniton case. The Ruling of P. of the H.A.C. of 28 February 2012.
43
Ibidem18. Pag.140.
44
Case No. B2727512, Apogepha Arzneimittel vs Wellesley Pharmaceuticals. Dec. on Opposition 28 April 2017.
14
information and protection of patient's rights.45 Respectively the aspect of how the package will
look is not depending just on his own will. In the order of these ideas, it is important to know
and understand what are the provisions imposed by law regarding the package/ labeling or leaflet
of the pharm products.

Package of a medical product can be from carton, plastic or other durable material. For
us, package is significant from the perspective that it is the holder of ours pharm TM and we
want to use it in the best way to make our TM visible and recognizable. We should remember
that in fact, the size of the package should be relatable with the duration for which the product is
prescribed and with its specific characteristics. For example, for a short-term treatment it will be
a smaller pack and for a long term, accordingly, a bigger one.46

When it comes to pharmaceuticals their labels and packages must have some mandatory
details which are not present in the product. In this context, the Dir 2001/83/EC specify that
labeling represents the information on the immediate or outer packaging. Where the immediate
packaging is the container or another form of packaging immediately in contact with the medical
product and the outer packaging is where the immediate package is placed.47

Art.54 from the same Directive enumerates what information must be provided by the
labeling. It starts with such basic information like name of the product, manufacture's batch
number, authorization holder's name and the address. A sort of information which any owner of
a product will use in order to identify his product but and to make associations between the TM
and him. Further, there should be mandatory information as the way of use of the medicine,
dosage, precautions, date of expiry, special storage.

Marketing pharm products require providing a specific information not only on the outer
package but on the immediate package as well. On blisters or vials should be written the name
of the medicinal product, the name of the holder of the MA, expiration date and the batch
number.48

In all above-mentioned cases, the information should be easy to read, understand and
impossible to remove from the package. 49 More than this, clear indications are offered regarding
the size of the letters and their arrangements. The size of letters can differ in relation to the size

45
Ibidem3. Art.54.
46
Guideline on the Packaging Info of med products for a human use authorized by the Union. December 2016.
Pag.15.
47
Ibidem3. Art.1 (23-25).
48
Ibidem. Art.55.
49
Ibidem. Art.56-56a.
15
of the package but still should be as big as possible to avoid a medical error. 50 An additional
request exists for the name, which should be written on the package not only in the usual way
but also in the Braille format.51 The last specification comes as an outcome from UN Convention
on the rights of persons with disabilities to which the EU is a part.52

The goal of any owner of a product is to obtain profit. The owner of a pharm TM would
like to have an attractive package which will increase the consumers’ attention. However, the
form of how the package is looking will be highly influenced by the mandatory labeling imposed
by EU's legislation but more than this even the Member States may ask some more specific
details which should be presented on the package. For example, the member state can ask that
on the package to be mentioned the price of the product. In some cases, this can make the product
less attractive, respective it will be against the interests of the pharm TM holder.53 In the eyes of
the legislator, MAH's will to make the product attractive will be always less important than
patients' rights and interests. Such provisions impose the MAH to think carefully about how he
will make the labeling.

The way how the package looks is influenced by the importance to have an accurate label.
This is why the owner of pharm TM should remember that on the package should be primary
highlighted the obligatory information. This is realized by using white boxes, good contrast
between the colors of the text and background, avoidance of glossy, metallic or reflective
package or of too many colors on the package which can confuse the consumer.54 All these
suggestions don't have an obligatory character but if a person will register a package as a TM
which later will not ensure the legibility of the labeling then the product will not get the MA, so
as an outcome the person should look even at the provisions with recommended character.

The leaflet contains the information which is mandatory for the consumer to know.55
Everyone saw at least once a package leaflet from a pharm product. As a consumer, we should
know that all that information is provided in accordance with the legal provisions.56 From the
viewpoint of the owner of a pharm TM or of whom wants to apply for it is relevant to remember
that the TM which he wants to use should not give indications or expectations which are against
the leaflet provisions.57 The applicant should read carefully the leaflet before choosing a TM

50
Guideline on the readability of the labeling and package leaflet for ... Revision 1, 12 January 2009. Pag.12.
51
Ibidem3. Art.56 (a).
52
UN Convention on the rights of persons with disabilities. 13 December 2006. Art.9.
53
Ibidem. Art.57.
54
Ibidem41. Pag.13-14.
55
Ibidem. Art.1.
56
Ibidem. Art.59-63.
57
Ibidem15. Pag.6–7.
16
name. The TM should represent the reality, to give some hints but no direct indications because
otherwise, it can create confusion between its name and real proprieties which it has. The fact
what the TM represents is very important and couldn't be neglected. The essence of the
medication which is specified by the leaflet is the base from where the TM name can be created
but still, TM should not reflect just the effect or active substance of the product.

1.2. Likelihood of confusion

Likelihood of confusion of trademarks creates the risk that the average consumer will
think that two TMs comes from the same undertaking or that it represents two undertakings
which have a relationship (economic or legal).58 With the aim to avoid appearance of the
likelihood of confusion we have the art.8(1)(b) of the Reg 207/2009 which mentions that to
establish the presence of confusion we should determine the:59

- Relevant public;

- Similarity of the goods or services;

- The similarity of the TMs.

All these three moments must be taken into consideration but at the same time, they
should have some interdependence. It was confirmed by the case law that the high similarity of
the TMs can be ignored if the degree of similitude between products or services is very low or
vice versa.60

Starting with the condition to determine the relevant public we should look at the degree
of the attention of the public. As a rule, the consumer will have an average degree of attention.61
Nonetheless, this can vary from dependence to who is the TM addressed or what class of goods
the TM represents.62 In the case of pharm TM if they are addressed only to the medical workers
it is presumed that the professionals will have a higher degree of attention, in special because of
the role which they have - prescription of medical products.

58
Case C-251/95, Sabel BV vs Puma AG, Rudolf Dassler Sport. Judgement of the Court of 11 November 1997.
59
Ibidem1.
60
Case C-39/97, Canon Kabushiki Kaisha vs Metro-Goldwyn-Mayer Inc., The Jud.C. of 29 September 1998.
61
Case C-342/97, Lloyd Schuhfabrik Meyer & Co. GmbH vs Klijsen Handel BV. The Jud.C of 22 June 1999.
62
Case T-256/04 Mundipharma vs OHIM – Altana Pharma. Judgment of the General Court of 13 February 2007.
17
 Respectively, determination of the average consumer in case of pharm TM depends on
the category products which it represents. If the product is offered over-the-counter than as
average consumer is considered to be both the medical worker and the end consumer.63 In the
case of only prescription products, the average consumer is considered to be the professional
worker.64 Regarding the second affirmation, we have same concerns because of the new case
law practice. In the Teva case65 the Court stated that the relevant public in connection to the only
prescription products is both the patients and professional workers. They argued that even in the
case when patients buy the product through intermediaries they have the chance to get face to
face with the product. This is a totally innovative approach taken by the Court because in
previous decisions they allowed the existence of TMs with high similitude because they were
only by prescription, so in that case, the medical worker was sufficiently attentive to not confuse
them (Ribomunyl and Ribomustin66).

The change of the Court practice is explained by the fact that EUIPO (OHIM) started to
determine the degree of attention of the average consumer by a new method. In this way, they
establish it by the category of the pharm product. Assuming that for more serious drugs both
attention of the professional worker and of the patient will be higher in comparison with simple,
easy drugs. Such a practice comes against the case law of the CJEU who communicated that if
the product is addressed both to the healthcare worker and the patient then the average consumer
should be determinate from the degree of how well-informed and observant is the consumer and
not in the dependence if the products treat a serious disease or not.67

Even though we remain to the general practice at determining the average consumer the
new case law created by EUIPO couldn't be ignored. As an outcome, when it comes to the only
prescription products the focus will be on the professional worker (in special if it will be used
only in hospitals) but in the same time, the examiner should bear in mind the existence of the
end consumer - patient.

EUIPO Guideline mentions that both professionals and non-professionals have a high
degree of attention when it comes to pharm TMs.68 Theoretical, this means that a higher degree
of similarity between pharm TMs will be accepted in comparison with other TMs because the

63
Ibidem.
64
Case R 304/2003-1, RIBOMUNYL vs RIBOMUSTIN. Dec of the Board of Appeal (OHIM) of 12 May 2004.
65
Case T-222/09, Ineos Healthcase Ltd vs Teva Pharmaceutical Industries Ltd. The Jud.C of 9 February 2011.
66
Ibidem64.
67
Ibidem.
68
Guide for exam EUIPO Part C, Section 2, Chapter 3 Relevant Public and Degree of Attention. 01.02.17. Pag.11.
18
average consumer will be very attentive. In practice, it is really complicated for a pharm TM to
get approved for registration and to pass the likelihood of confusion test.

The second factor which is taken in deliberation during the establishment of the
likelihood of confusion is the similarity of the TMs. The similarity is analysed from the
consumer's perspective who see the TM as a whole69 because as a rule, he has the chance to
compare the TMs only in an imperfectly remembered picture. When it comes to the similarity of
the pharm TMs, case law declared that the visual similarity is less important in comparison to
the phonetic or conceptual similarity. This is because the end consumer doesn’t have the
possibility to take the product by himself from the shelf or to see the two similar TMs together
because they always have to ask for the product or to get a prescription in order to be able to see
them.70 In present, this decision can be arguable because of the presence of internet sales of
pharm products. On the internet, all the arguments against importance of the visual similarity of
pharm TM are not anymore applicable. In this context, we should look again to the relevant
public and see in each case what similarities can create a relative or high likelihood of confusion.

The last issue regarding the likelihood of confusion is the assessment of similarity of
goods and services. When we look at the similarity between products and services we should
take into account several factors, such as their nature, purpose, the method of use if they are
complementary or in competition to each other71 and if they use the same channels of
distribution.72

In case of pharm products, we have contradictory judgements. In Tolposan case73 the

Court mentioned that we have the same nature of products (pharm products), purpose (treatment
of human health issues), the average consumer (patients and professional workers) and channel
of distribution (mainly pharmacies). At the same time, one product was for headaches and the
second for muscles aches. The Court said that the different therapeutic porpoise of the products
is enough to not have a likelihood of confusion between them. On another hand in the Kremazin
case74 the Court stated another decision. They found the same similarities between the nature of
the product, porpoise, average consumer and channel of distribution as in Tolposan case. One
product was sought for a wide range of diseases including heart diseases and the second one just
for heart diseases. As a result, the Court affirmed that their therapeutic indications were different

69
Ibidem58.
70
Ibidem64.
71
Ibidem63.
72
Case T-443/05, El Corte Ingle´s vs OHIM – Bolan˜os Sabri. Judgement of the General of 11 July 2007.
73
Case T-331/09, Novartis AG vs Sanochemia Pharmazeutika AG. Jud of the General Court of 15 December 2010.
74
Case T-487/08, Kureha Corp vs Sanofi-Aventis SA. Judgment of the General Court of 16 June 2010.
19
but this dissimilarity is overcovered by all other similarities, respectively, the products created a
likelihood of confusion.

The approach from Tolposan case is unacceptable because we cannot say that there
doesn't exist a likelihood of confusion only in the base of one-factor difference. All the relevant
factors should be taken into consideration, in the end, we should make a general assessment
regarding the similarity of goods or services. We should remember that in some cases one or
more criteria can be more important than others. This doesn’t mean that respective factor is the
only decisive one but that it deserves more attention. For example, we cannot ignore if the TM
creates a likelihood of confusion regarding the assimilation of undertakings because this comes
in contradiction with the basic function of the TM.75

Knowing that all the pharm products have a similar general porpoise: healing of people,
we should not put the therapeutic indications as a core factor. However, in some cases, this can
be crucial for the determination of the similarity of the products. Such an example can be the
TMs representing sedatives versus painkillers which are highly similar or anti-epileptics versus
pharm preparations, except products which cure diseases related to the central nervous system
which was as well found to be similar.76

In this chapter, we emphasized the special conditions in which pharm TMs are registered.
The existence of the double control is a mandatory requirement for such class of marks. Only in
this way we can be sure that the public health will be protected. On another hand, such a system
is not perfect. It consumes a lot of time and money and can make highly difficult for the applicant
to get a pharm TM which will represent his interests but in the same would be accepted by the
EMA. Here is essential to remember that the pharm names should not contain INNs and even if
the international regulations in this direction have a more permissive character than mandatory
still the Court will always declare a TM confusing if it contains INN or its stem. This attitude is
essential for protection of the distinctive character of INNs but and to be able to represent
generics as an alternative option for the labelled products without patent protection.

Likelihood of confusion of the pharm TM leads not just to the infringement of the TM
owner's rights but and to the creation of safety risks. In this case, confusion of the medical
products can directly affect consumers. This is way in the process of establishment of existence
of confusion the Judge will always start from the perspective of how this will affect the end user
and what should be done to protect him.

75
Guide for examination EUIPO Part C, Section 2 Double Identity and likelihood of confusion 01.05.17. Pag.35.
76
Ibidem. Pag.45.
20
 CHAPTER II. MARKETING

2.1. Advertisement strategies and their limitations

After obtaining a marketing authorization the pharma product can be finally put on the
market. Marketing a product is realized through different advertisements strategies which make
the product known to the public. In this context, the registered pharma TM name becomes the
face of the product and in fact, represents it. It is believed that a good TM name can make popular
an ordinary product, while a weak name will make unattractive an excellent pharma product.

TMs are exceptionally important because of their economic contribution. An economical

study confirmed that brand-awareness and brand-associated TMs leads to the rise of future cash
flows and stock returns. This proves that the investments in advertisement ensure the firm's
financial value.77 TMs' advertisement helps to create a link between the brand and TM in the
consumer's mind and it contributes to the future protection of the product. When the patent
protection of a pharmaceutical expires, the TM is the only thing which differentiates the original
product from the generics. From this context advertisement of TMs participates to current and
future incomes of the product’s owner.

It was demonstrated that a good TM advertisement campaign helps to sell the product
after patent's expiration. Hence, when the generics come into the market a well-known pharm
TM reduce its price by 2% in the first year of competition with generics and minus 0.2% with
each new generic firm coming on the market. In the same time, the generics who come with low
prices have to compete not just with the branded product but and with all other generics. In the
case of generics, the price will go down with 6% in the first year, 48% the next year and 70% in
the third one. Such a comparison shows to us the importance of the marketing for TMs.

In many cases was observed that after the appearance of generics some brands increased
their prices. This is due to the strong link in the consumers’ minds of the product with the brand,
presence of the fear of incorrect substitutions of products and the costs of the process to
understand which ones are analogous.78 In fact, the TM owner just extracts the benefits from a

77
Krasnikov A., Mishra S., Orozco D., Evaluating the Financial … (2009), Vol.73 J.M., pag.154-166. Pag.155-163.
78
Feldman R., Lobo F., Competition in prescription … (2013), Vol.14 No.4 E.J.H.E., pag.667-675. Pag.671-672.
21
good realized advertisement. Marketing specialists concluded that consumers get psychological
satisfaction from using the same brand. In the end, they choose to pay more just because they
are comfortable with this and not because they necessarily believe that this product is safer or
better. This theory was demonstrated through the success of the “Purple Pill”. In fact, the pill
(Prilosec) was advertised everywhere: TV, internet, newspapers etc. The accent was put on the
pill’s color- purple and therefore consumers were asking from doctors the "purple pill" being
incapable of remembering the name but being sure of what they want to get. In future
AstraZeneca (owner of Prilosec) managed to get a patent for a new product which slightly
differentiates from Prilosec and offered to that new product again a purple color and marketed it
as the "new purple pill". In this way, they maintained high sales even after expiry of the patent
for Prilosec and made the new product very attractive in a brief period of time.79

Aiming to make the product as popular as possible the owners of the pharm products
invests a lot of time and money in getting a memorable TM name for their product. From this
perspective, the process of choosing the TM name for pharm product is the first major step which
is made during a marketing strategy.

A good name will make the product more distinguishable from competing products and
will offer a character of unicity for the represented product. A catchy name will contribute to the
consumers’ loyalty, therefore increasing product’s commercialization.80 A study article
mentioned that a good trade name should be "short, easily remembered, "nice" to say, and most
importantly, must interrupt the speech flow". These characteristics could be applied for pharma
TM as well. Therefore, in many pharm names we can find such letters as "Z" or "X". They will
force the consumer to pronounce it slower and in the same time, the presence of rarely used
letters will be more memorable81.

To get a popular TM name, owners of pharma products can also opt to create their names
from taking a part of an existing, successful pharma TM and to add to it some new elements. An
example can be “Penagra” and “Kamagra” which were derived from “Viagra”. Another trendy
way of creating a new name is by use of INNs, as an example can serve “Zestril” derived from
lisinopril. Both these methods, de facto, represents a bad practice because in the first case it
brings to TM's confusion and infringing of others ownership rights. Regarding INNs, we spoke
in the previous paragraph, here we will emphasize one more time that use of INN as a TM name
is prohibited because they are non-proprietary names. Also, their use in a TM can bring to the

79
Brennan H., The Cost of Confusion. The Paradox of TM … (2015) Vol.22:1 M.T.T.L.R., pag.1-52. Pag.33-35.
80
Boring D., The Development and Adoption of Non-proprietary … (1997), Vol.31. D.J.I., pag.621–634. Pag.627.
81
Ganter F., Schweiger C., Schlander M., Naming, classification ... (2002), Vol.36 D.I.J., pag.807-824. Pag.820.
22
INN oblivion or create a stronger association with the TM instead with INN. This can lead to
medical errors because the doctors are misled by the TM name of the product. Respectively the
use of INN in TM names can bring to grave consequences for public health.82 Of course, we
should mention that in present such practices are less likely to succeed due to the strict process
applied regarding the registration of pharm TM names.

At the general level, the process of advertising is regulated by the Dir 2006/114 83 but
more specific characteristic we can find in the Dir 2001/83 in the title VIII a. Since consumers
treat the product and TM as a whole, we will analyze how the advertisement is realized in
connection with pharm products. Respectively, advertisement of a pharm product can be directed
to the general public or to the qualified one. A common provision for these categories is that
member states shouldn't allow advertisement of products which didn't obtain an MA. The
advertisement must present the trade and generic name of the product. The obligation to provide
both names can be avoided if the advertisement is made only as a reminder. Such an exception
gives to the TM holder the possibility to put in evidence the trade name and not the generic one
even though the vice versa option is also available. The advertisement shouldn't be misleading,
it should describe the proprieties of the product in an objective way, in conformity with what is
presented in the summary of the product.84

When the advertisement is made for the large public exists the obligation to afford
information regarding the correct use of the product but and the necessity to read carefully the
package leaflet.85 The advertisement variations and free will of its creation will be limited by the
provision of art.90 Dir. 2001/83 which mainly has the aim to protect the consumers from
misleading information. In a case decision, the CJEU mentions that the Dir doesn’t require that
all the points specified in the advertisement must be present or derived from the product’s
characteristics. The Court says that the advertisement may offer information which comes to
complete the product’s characteristics if this information comes to confirm or clarify it and
doesn’t come in contradiction.86 This decision affords the possibility to make an attractive
advertisement with less headache about respecting word in word what is present in the package
leaflet.

82
Kappoori M. Gopakumar, Nirmalya Syam, INN and ... (2008) J.W.I.P. Vol. 11, Issue 2, Pag.63–104. Pag.72.
83
Directive 2006/114/EC … concerning misleading and comparative advertising.
84
Ibidem3. Art.87-91.
85
Ibidem.
86
Case C-249/09, Novo Nordisk AS vs Ravimiamet. Judgement of the Court of 5 May 2011.
23
 We can assume that the best way of advertisement of pharm products and their TMs for
the large public, is through television broadcasting. In the same time, the owner of pharm TM
must keep in mind the category of the product, if it can be obtained without are prescription or
only with professional's indication. In the latter case, the TV advertisement of such products is
prohibited.87 Paragraph 44 of this Dir 89/552 mentions that the same approach should be applied
for all other media as well. From provision, we can conclude that it is prohibited to advertise
prescription-only products on radio or internet.

Regarding the presentation of information of the only prescription products on the

internet, we have an “exception” from the basic rule. If “that information is accessible on the
website only to someone who seeks to obtain it and that dissemination consists solely in the
faithful reproduction of the packaging of the medical product, and in the literal and complete
reproduction of the package leaflet or the summary of the product’s characteristics.”88 On
another hand, the same decision says that this kind of information should not have advertisement
character, but to establish if this character exists remains at the latitude of the national courts.
We consider that persons can imitate the "only informative porpoise" regarding the product and
will avoid the legal limitations provided by the Dir 2001/83.

When the advertisement is aimed for qualified persons they need to get the short
descriptions of what the product represents and what is its supply classification. Member states
can impose additional requirements like the obligation to offer the price and the circumstances
in which the prices will be recovered by social security bodies. All the information offered to the
professionals should be accurate, relatable, complete and presented in such a way that the person
can make his own opinion about the product’s efficiency. A mandatory rule is that the persons
in charge of such advertisement must have adequate training and knowledge to be able to explain
the necessary scientific information related to the product. 89

Even though from the legal provisions we get the impression that it is quite hard to
advertise a pharma product, actually it works well. In the case of advertisement to the
professionals, the accent is always put on the thing that the medical worker will face problems
to remember the long generic name. The sale representative will repeat the trade name as many
times as possible and will leave samples or promotional stuff with the product's name. This tactic

87
Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by law, Regulation
or Administrative Action in the Member States concerning the pursuit of television broadcasting activities. Art.14.
88
Case C-316/09, MSD Sharp & Dohme GmbH vs Merckle GmbH. Judgement of the Court 5 May 2011. Para 49.
89
Ibidem. Art.91-93.
24
is based on the presumption that people have a bad memory and in future, the professional worker
will prescribe or recommend the product which he managed to remember.90

An American study demonstrated that after the contact of professional workers with the
pharm representatives they were 13 times more likely to ask that advertised drug to be included
on insurance list. In the same time, the rate of prescription of that drug significantly increased
even though medical workers were saying that they take the decisions objectively.91 This proves
what significant role has the advertisement for the process of recognition of pharma TMs and
how it leads to increase of sales. As long as the most expensive and life important pharma
products are offered only by the professional worker's prescription, a successful marketing
strategy should focus primary on this category of the public.

Despite the provisions from art.4 in Dir 2006/114 which prescribes strict conditions in
which is possible the comparative advertisement we have an interesting court decision related to
pharm sector. A Court of France stated that even though Lytess company distributed a journal
where they were denigrating the Skin's Up pharm products, they are not liable for infringement
of the TM. Lytess used the competitor's TM in a comparative advertisement which the plaintiff
found as an infringement and unfair competition. The Court stated that if the catalog is aimed
just to medical professionals then the comparison is needed in order to differentiate the products.
If such actions will be prohibited it will be impossible to make a comparison between the
products, which is a part of the free competition.92 Such a Court decision extends the limits
regarding the comparative advertisement in case of pharm products if the end consumer is the
professional worker. Recognizing of such a practice can be risky for the future development of
comparative advertisement in this sector. Also, we should remember that the decision is at the
member state’s level and maybe if the question will be put up in front of the CJEU we will get a
different outcome.

In general comparative advertisement is not a frequent practice in the pharm sector due
to the specific limitations. Still, a significant case was judged regarding the comparative
advertisement between generic drugs and the name of the trademarked pharm product. The
advertisement was realized in a medical journal. The outcome was that the action was completely
legal. Besides the fact that advertisement in a medical journal is aimed just to professionals the
here are involved and public health concerns so the right to know everything related to the pharm

90
Stuyck J., Product differentiation in terms … (1983) Springer Science + Business Media Dordrecht. Pag.44-46.
91
Hoiman C., Selling drugs … (2005), Explorations: an undergraduate research journal pag.89-94. Pag.90.
92
Case 2007/08785, Skin’Up vs Lytess. TGI Paris 3 rd c., 3rd sect., 16 December 2011.
25
product is more crucial than the rights of the TM owner.93 The presumption that the medical
workers should know the INN equivalent of medical products shouldn't be extended to absolute
because they cannot remember everything. The outcome of the case is especially curious because
in a case from the UK the Court stated that the comparative advertisement of a generic product
and TM product is not allowed, the only difference is that there the case was about fragrances.94
This emphasizes one more time the different approach which the courts have when it comes to
pharm TMs and health issues.

From the public health point, the success of marketing strategies of pharm TMs brings
up several negative effects for the end consumers. Hence, prescription by medical workers of
brand names instead of generic ones’ forces patients to buy more expensive alternatives instead
of the cheap, generics. In the same time promotion of TMs requires additional investments which
later will contribute to the product’s price increase. A higher price of the product will force the
consumers again, to pay more than they should. The incapability to choose a cheaper product is
because of the aggressive marketing strategies which create a monopoly for the respective
product on the market.95

The dominant position of pharm firms leads to the disadvantageous outcomes for the end
consumers. This is why the legislation in this sector is consumer orientated, trying to minimize
the existing inequality. EU actively promote the use of generics and INNs rising consumer's
awareness about the availability of cheap equivalents. We don’t analyze the generics
phenomenon in the current work but should mention that at the moment their use is still low due
to the freedom of the member states to choose by themselves how to promote them.

2.2. Parallel importation

Inside EU we have free circulation of goods and services which aim to extinct the barriers
and boost the economy.96 Such a concept favoured the development of import and export but
also and the parallel trade inside the EU.

93
Case 09-70.722, SBG vs Laboratoire GlaxoSmithKline. Cour de cassation, Chambre commerciale. 24 May 2011.
94
http://fordhamipconference.com/wp-content/uploads/2010/08/Pezard_GenericUse.pdf. Accessed on 02.06.17.
95
Ibidem58. Pag.63-104.
96
Consolidated version of the Treaty of the Functioning of the European Union 26.10.12. art.36.
26
 A key moment connected to the pharm products is the existence of active PI. Since the
owner of a pharm TM cannot control the distribution of pharm products by the argumentation of
ensuring the protection of the market from counterfeits the PI of pharm took a very ample scale.97
When we speak about PI of pharm products we should realize that this process is special through
the presence of the different price policies of the member states. Therefore, analyzation of the
economical part of the pharma products PI is a key issue which needs attention.
When a product is placed on the market in one member state its exclusive right of
distribution is exhausted and everyone inside the Union can use the TM without asking the
authorization from the initial trademark holder.98 The Court stated that existence of price
differentiation between members states because of their governmental policies doesn’t play any
importance in the process of the parallel trade and cannot hinder it.99 Consequently, the initial
owner of a pharma product meets competition from his own product but coming through a form
of PI. Such an outcome constrains the initial owner of TM to react to the situation in a way or
another.

An economical study analysed how the price of pharm products changes in case of PI.
As a study case was taken Sweden because till 1995 it wasn't part of EU and didn't allow any PI
but after that, they had to apply the new rules. Therefore, during 1995-1998 was established the
appearance of PI of pharm products representing top 50 pharm products in Sweden at that time.
We should remember that the imported products were cheaper. As a result, was found out that
during these years the average price of products who had an imported analogous increased with
only 2.88% while those without competitors increased the price with 7.57%. A more visible
difference was observed between 1997-1998 when the manufacturing firms of products
supposed to PI declined the price with 0.25% but those not influenced by PI rose the price with
0.95%.100

From Sweden’s example, we can see that PI leads not just to a cheaper price of products
from a parallel importer but and to the lowering of the prices by the initial producers. Such an
outcome is favourable for the end consumers who can benefit more affordable prices.

97
Case 16/74, Centrafarm BV vs Winthrop BV. Judgment of the Court of 31 October 1974.
98
Ibidem8. Art.15(1).
99
Ibidem97.
100
Ganslandt M., Maskus K.E., The Price Impact of Parallel … (2004) Vol.23 J.H.I. pag.1035-1057. Pag.1047.
27
 2.2.1. Price control factor

Pharm TM is involved in a legally restricted market. Because of the special characteristic

of the medical products and the high interests of the society in this sphere the pharm products'
owner in many cases is limited in the possibility to choose a price which he would prefer.
Respectively, many member states of EU have price control policies regarding the pharm
products. Consequently, this is influencing pharm TMs.

Different price limitations in the member states stimulate the development of PI. If
country A is obligated to import pharm product in country B at a low price because of national
regulations than country B can import the same products in country C (with higher price
limitations) and obtain a profit. When the country A will want to enter the market of the country
C they will face the presence of an analogous which represents a cheaper version of the initial
pharm product.

The same problem exists in the USA. The USA has the "free market" approach when it
comes to pharm producers. They can impose any prices which they would like and this
contributes to expensive medicines.101 In the same time the undertakings exhaust their rights by
placing their products on the European market (for example) through an affiliate (is not applied
in the case of a licensee or are materially different product 102). Because of the price control in
the Europe the products, of course, have a lower price. A next step what happens is that those
products are imported back to the USA but cheaper. Subsequently, we have the same products
but at two different prices. An outcome which highly diminishes the incomes of initial producers.
Because of this practice was put the question if this leads to unfair competition103 or to a risk for
the public health.104

Under WTO law was mentioned that governments can have price control for pharm
products because it is important for the protection of public health. We don’t have direct
interdiction of parallel importations from countries with controlled prices for pharm products. In
the EU case law, we have the decision of the Court which says that blocking of PI it not
authorized even if it comes from a price-controlled state. On another hand, the Court stated that

101
Abbott F.M., Parallel Trade … (2015) 2015/2016 Research Handbook on IP Exh and P.I., Pag.1-28. Pag.1.
102
Case No.04-1588, Bourdeau Bros vs I.T.I. Decision of Fed. Cir. Of 30 March 2006.
103
Ibidem. Pag.17.
104
Ibidem. Pag.9.
28
supplies which are used for parallel trade can be limited in specific conditions if it is reasonable
and proportionate.105

From the premise that PI of pharm products from price-controlled states is not anti-
competitive the initial producers of the pharma products have to take some actions which will
defence their earnings. In this way, the theory and practice came with two strategies. The first
one is the accommodation model and the second one the deterrence method.

Accommodation model is in fact what we saw in the Sweden’s example. The

manufacturing firms dealing with PI had to change the prices in order to be able to compete. The
deterrence scheme is the idea to limit the export of pharma products to countries which have
price control. The idea is that the importing country will have the exact amount of pharm
products which it needs and will not be able to realize PI. In such a case, the initial firm can
maintain the soaring prices for its pharm products.

In reality, it is more common for the manufacturing firms to adopt the accommodation
behaviour and not the deterrence one because the limitations of export in price control countries
can be appreciated as anticompetitive practice if they are not justified. As an outcome, PI creates
pressure on prices in the high-priced countries and can substitute sales in low-price countries if
the initial firms are not ready to afford such low prices.106

Another way of controlling the negative effects for manufacturing firms could be the
contracting of a license agreement with will provide direct provisions limiting the produce and
distribution of products or by applying of dual-pricing for pharm products in concrete states.107
Dual-pricing can serve to the breach of competition law notwithstanding this tactic was
successfully applied by GSK. They were setting the prices considering if the wholesalers would
export or sell the products to Spain (which have low prices for pharm). The CJEU stated that
even if the actions of GSK restrict the competition such a practice can be exempted from EU
competition law in certain conditions in accordance with art.101(3) of TFEU. 108 In another case
where GSK was applying the same actions regarding Greece, the Court explained clearer when
such behaviour is allowed, mainly they said that “it must be ascertained whether the orders of

105
Joined cases C-486/06 to C-478/06, Sot. Lelos kai Sia EE and others vs GlaxoSmithKline AEVE Farmakeftikon
Proionton. Judgment of the Court 16 September 2008.
106
Stothers C., State of the Art. Parallel trade and free … (2006), Vol.1, No.9 J.I.P.L. & P., pag.578-592. Pag.578.
107
Ibidem.
108
Bertold B., Cooke A., Marelus M.A., Zdravkova I., Pharmaceutical IP and competition law in the EU, (2016).
https://uk.practicallaw.thomsonreuters.com/9-617-
0567?originationContext=document&transitionType=DocumentItem&contextData=(sc.Default)&firstPage=true&
bhcp=1 Accessed on 02.06.2017.
29
the wholesalers are out of the ordinary”.109 Such an approach can bring to the appearance of new
cases regarding the limitations of parallel importations because the outcome can be different in
each case, depending on the circumstances of the case.

In this context, it is interesting to notice that the ample parallel trade has also a negative
effect on countries with a lower price for pharm products. From Greece's example, we can
conclude that de facto parallel exports from countries with lower price limit for pharm led to a
serious diminishing of a number of those products. The Greek government had to offer the state's
production in order to be able to cover the lack of pharm products which cures severe or chronic
diseases.110 This small example demonstrates that even if at the beginning, it seems that those
countries should be in an advantageous position by getting affordable products and increasing
their economy, in reality, the wish of traders to export as much as possible can create a lack of
medicines in their own country.

Even though the price of pharm products depends firstly because of the existence of a
patent and price control policies still the TM of pharm product play a significant role as well.
When it comes to commercialization of pharma products their TM play a key role in the attraction
of consumers and obtaining of their fidelity. This is way in case of PI of pharma products the
owners of the products are concerned not just about the competitions of prices but also and about
their TMs. The owners of the TM would like that their TM to be recognized and associate with
their own product. However, the Reg mentions that they cannot prohibit the use of their TM if it
was put on the market by them or with their consent.111 From the impossibility to keep the
authenticity of the TM we obtain the presence of two identical TMs representing two identical
products but from different manufacturers. Such a situation can contribute to the likelihood of
confusion of the TMs.

2.2.2. Repackaging factor

Besides the fact that a TM holder has to accept the use of his TM, in certain conditions
he must accept the repackaging and relabel of it. Such a practice decreased the chances that the
end consumer will associate the initial TM with the new one, repackaged TM. The will of initial
TM holder to protect his TM and the active repackaging strategies of the third parties led to the

109
Ibidem104.
110
Lyberis N., Greece, (2014) Pharmaceutical trademarks 2013/2014, pag.36-41. Pag.38.
111
Ibidem1. Art.13.
30
appearance of several decisive Court decisions regarding this topic. They had the aim to make
clearer the special technique which should be applied for pharm TMs.

A relevant case here is the BMS case which establishes that in the base of the art.15 of
Dir 2015/2436 the owner of a pharm TM should accept the repackaging and reaffixing of his
TM even if this was realized without his authorisation. Yet, this should be possible only if the
repackaging will avoid the artificial partitioning of the markets and at the same time will not
affect the product from inside of the package. The package should offer information about who
over-stickered or repackaged the product and the name of the producer. The information
regarding the repackaging company shouldn't be in capital letters and must not obscure the
owner's TM. The most crucial moment is that the new package should not damage the reputation
of the TM’s owner. The importer must send a notice to the TM owner about the change of the
package so the last one can ask a specimen and conclude if this can affect him in a negative way
or not.112 It is important to remember that besides the conditions enumerated above the
repackaging of the product should be a necessity and not a personal will of the parallel importer.
Respectively, repackaging will be allowed only if there exists an objective need which will make
possible to entry on the market.113

The Court practice has also mentioned the possibility to change, in certain cases, the size
of the packs as a process of repackaging. Company B got the product from company A and then
reduced the size of the containers and start selling them. The question put in front of the Court
was if Company B could have such a practice without application for an MA. The Advocate
General said that if the product had the initial MA related to a specific pack than changing the
size of the pack needs a new MA even if there is no modification of the composition of the
product.114 Such an outcome is completely logic, still, we should remember that from this rule
exist exception through the art.3 (1), (2) or art.5(1) of Dir 2001/83. Nonetheless, the first two
situations will be inapplicable if the product is not prepared in a pharmacy and in the last case it
will be applicable only if there is no authorized equivalent on the market or if the authorized
analogous is unavailable.115

The possibility of repackaging a pharma TM diminish the value of the TM. It makes less
obvious for the consumers the connection between initial TM and the repackaged one. Besides
the competition at the price level, this can serve as an additional factor to lower the market

112
Joined cases C-427/93, C-429/93 and C-436/93, BMS and others vs Paranova. Jud of the Court of 11 July 1996.
113
Case C-379/97, Upjohn SA vs Paranova A/S. Judgement of the Court of 12 October 1999.
114
Case C-535/11, Novartis Pharma GmbH vs Apozyt GmbH. Judgement of the Court of 11 April 2013.
115
Ibidem.
31
realization in a concrete market. In the same time, it raises awareness for the owner of pharma
product regarding protection of his TM.

In this chapter, we concentrated our attention on the economic part of the pharm products
and their TMs. Thus, it is essential to see how this function is realized in the case of pharm
products. Advertising strategies are the best way to see how significant are the TMs for pharm
products in special after the expiry of the patent protection. In this context, we can see that the
end consumers interests influence not only the strategies of the TM holders but and the Court's
practice which in other situation would adopt a totally different decision.

Regarding the PI of pharm products, we see its influence on the TM as a side effect. The
exhaustion of the TM rights within EU serves to the rise of the parallel trade and chance to alter
the initial TM concerning the ability to enter the new market. This practice increases the
competition between the pharm TMs. Also, it contributes to the appearance of the likelihood of
confusion. PI is a hot topic when it comes to pharm products, here we have the interests of the
initial producer against the parallel traders'. Conflicts between these two parts leads to the
creation of new methods of trade behaviour. On one hand the aggressive, restrictive sales of the
pharm firms and on another hand the alteration of initial packages and labels in order to come in
new markets. As a rule, the end consumer wins from this situation but the legal uncertainty in a
long run can create anticompetitive practices which will affect inclusively the consumer.

32
 CHAPTER III. TRADEMARK LAW AND PHARMACEUTICAL
TRADEMARKS

Pharm TMs obtains existence, protection, and development in accordance with the TM
law established by the EU. During this work, we had the possibility to emphasize some specific
particularities characteristic to this category of TMs. In the current chapter, we will analyse the
inner influence between the TM law and pharm TMs What inconsistently exists and what
negative effects appear. As well we will figure out what alternatives exist that can help to
overcome these issues.

3.1. Trademark cluttering

Graevenitz defines the cluttered TM registers as "registers containing such a large number
of unused or overly broad TMs, that the costs of creating and registering new marks substantially
increase for other applicants."116 This description perfectly matches with the pharm TM class.
As mentioned before a pharm name is supposed to a double control, registration at EUIPO and
EMA. A general practice is that firstly the firm applies to registration of TM and only after this
to the application for the name in the process of getting the MA. In the same time, EUIPO and
EMA have different approaches when it comes to the admissibility of a pharm name. More than
this when it comes to EMA the name will be supposed to the control from all member states for
the sake of that it will not come against public health.

The severe control from EMA’s side leads to 50% of rejection of the proposed names,117
this motivates firms to register more pharm TMs than they really need. Such a tactic is explained
by the costs which are implied in these two processes. Application for one name at EMA, in
which the pharm undertaking will be completely sure that it will pass will cost much more than

116
Graevenitz G. von, Trade Mark Cluttering … (2013), June 2013 Oxford Economic Papers, pag.1-24. Pag.1.
117
Study on the overall functioning of the … M.P.I. for Intellectual Property and Competition Law. 2011. Pag.106.
33
application at one time of several TMs from which one, later can be approved by EMA.
Consequently, we have registered pharm TMs which in fact nobody uses.

It was estimated that between 1997 and 2009 at EUIPO (OHIM) was registered a surplus
of 15.44% of pharm TMs.118 This fact forces other undertakings to raise their research costs for
identification of new pharm TMs.119 Somebody can say that this complication is for a short term
because of the obligation of genuine use of TM. However, removing of a TM due to the lack of
genuine use is done only on request120 which in reality is a rare practice, representing just 0.04%
of registered applications before 2006. This means that all the unused TMs are more likely to be
removed only after 10 years from the moment of filing121, as an outcome of lack of renewing.122
Hence, we have a cluttered TM class which makes more complicated to obtain in future a pharm
TM, a process that even in normal conditions were requesting a lot of time and money
investments.

The actual situation needs to be solved through legislative instruments. An optimal

solution can be the creation of a better collaboration between EUIPO and EMA. It is difficult to
say how this is possible. Both evaluate different perspectives of pharm names so the outcomes
can be also different. Taking into consideration that firstly an undertaking will apply for TM and
only after for MA maybe EUIPO in the process of registration of a pharm TM should keep in
mind the possibility that a TM will not get EMA’s approval if it doesn’t come in accordance with
their requirements. To impute EMA’s burden on the shoulders of EUIPO isn’t the perfect
solution because without health concerns they have a lot of things to keep in mind when it comes
to registration of TMs. After all, this problem cannot be ignored. Gathering of “empty” pharm
TMs contribute to future administrative complications and no efficiency of TM system.

We believe that an option can be the creation of a new subdivision inside EUIPO which
will deal only with pharm TMs. This will be a symbiosis between actual NRG and EUIPO that
will focus both on TM's and public health’s issues. Such a concept will help to optimize the
process of control of pharm TMs. In present in both cases, the name is checked in relation to the
possibility of confusion, in one case with other TMs and in another with the pharm name which
in practice are the same TMs or outdated TMs, these two processes are similar and can be united.
Of course, the activity of such subdivision will have larger responsibilities but it will reduce the
time and money expenses and what is the most important will create a certainty about the statute

118
Ibidem115. Pag.10–16.
119
Ibidem116. Pag.43.
120
Ibidem1. Art.51(a).
121
Ibidem. Art.46.
122
Ibidem119.
34
of pharm TM. If an applicant will apply with three different TMs in order to be sure that one will
pass in the end he can get an exact answer that will say which from the proposed names are in
accordance with TM’s concerns and those related to public health. The applicant has just to
register that one name which was accepted or in case if two or more names were accepted he can
choose which one will serve better for his purposes. Such a practice will reduce to the minimum
the phenomenon of cluttering in the 5th Nice class.

The issue here is the existence of the actual legal competence afforded to EUIPO and the
need to create a new entity just for a simple class of TMs. In the same time in 2016 the 5th Nice
class was on 6th place regarding the number of applications123, correlating this with the high
interests regarding pharm products but and with the future contribution to the incentive for
research and development of pharm firms124 this idea starts to have more sense. Still, now this
question remains open to discussions.

3.2. Genuine use

Genuine use of a TM is a common issue analysed in the case law when it comes to
revocation process. In the case of pharm TMs, it can be very difficult to prove the genuine use
because the TM represents a product which didn't yet pass the clinical trials and doesn't have an
MA. Without an MA and possibility to put the product on the market we have to find other ways
which will confirm the genuine use of a pharm TM.

From art.15(1) of Reg 207/2009, we understand that a TM is put in genuine use if it is

used in conformity with its core functions and it maintains and creates a market share for the
goods and services which are represented. Case law practice mentions that the genuine use is
present in the case when the TM ensure the realization of its functions, such as creating the link
between the goods or services to a concrete undertaking.

To assess the presence of genuine use all factors should be examined, especially those
which will demonstrate the economic activity of the TM and the existence of the aim to create a
market share.125 A key moment is that the use should be related to goods or services which are

123
Statistics of the European Union Trade Marks, May 2017, SSC009. Pag.35.
124
Ibidem115. Pag.8.
125
Case C-149/11, Leno Merken BV vs Hagelkruis Beheer BV. Judgement of the Court of 19 December 2012.
35
marketed or are almost ready to be marketed, offering to the costumers the impression that the
product will be soon released, particularly through advertisement.126 From the Court’s decisions
we understand that the genuine use can be proved through external preparatory actions but not
any of them, only through some specific ones as “price authorisation of a medicine and reference
to the products in the Indice Nacional Reapeutico”127. Clinical trials which can last more than 5
years block the possibility to get an MA and as a result the chance to advertise the pharm TM.
Preparations of labels, packages or containers are treated like internal activities and cannot serve
as evidence of genuine use.128

Demonstration of genuine use of pharm TM after finishing the clinical trials and
obtaining of MA will represent a typical procedure as for any other TMs. In the case when there
is no MA the chance to prove the use seems quite foggy. We should specify that the owner of a
pharm TM cannot confirm the existence of external preparations through clinical trials. Clinical
trials are made to ensure the future commercialization of the product, respectively to obtain an
economic advantage but in the same time this activity can be perceived only as an internal
activity which will lead in future to the marketing but now it doesn’t have the necessary external
character, so doesn’t prove the genuine use of the TM.

Being hard to demonstrate the genuine use at this stage some authors proposed the idea
that in order to not lose the period of the 5 years the firm should apply once again for the
registration of the pharm TM. Even if such a practice will constitute a bad faith application the
authors affirm that in fact, the bad faith from the Court's case law practice means only the actions
which are made against third parties.129 Respectively, in the case of re-application for the own
TM, no third parties will be affected so no bad faith is present.130 This way of thinking seems to
resolve the problems for pharm TMs holders but we don’t think that such an interpretation of the
norms is made with good faith. Moreover, EUIPO in recent guidelines mentions that the
assessment of the bad faith is made in the base of all the relevant factors. Respectively, the
examples which we can find in the Court’s decisions doesn’t represent an exhaustive list.131
From this perspective, we see such a practice as unacceptable.

In such conditions, a way to protect the interests of pharm TM owner can be made through
the demonstration of the existence of the proper reasons for non-use.132 Reasons of non-use

126
Case C-40/01, Ansul BV vs Ajax Brandbveiliging BV. Judgment of the Court of 11 March 2003.
127
Case R 878/2004-1, DINAXIL vs DINAXIL Decision of the Board of Appeal of 16 September 2005.
128
Ibidem125.
129
Case C-529/07, Chocoladefabriken Lindt & Spru¨ngli AG vs Franz Hauswirth GmbH. ECR 11 June 2009.
130
Ibidem137. Pag.667.
131
Guide for the exam of EU TM. EUIPO Part D Cancellation, Section 2 Substantive Provisions, 01.08.16. Pag.12
132
Ibidem1. Art.42(2).
36
should represent circumstances which appear independently from the TM’s owner will and
which make impossible the use of TM. Situations as import restrictions or government
requirements are mentioned as reasons for non-use in art.19(1) of the TRIPS agreement.133
Relevant for pharm TMs a reason for non-use can be the government requirements that
represents the State monopoly making impossible the use of TM. Though, even such reasons in
some cases can be not recognized if they were present only for a limited time during the time of
5 years or from the moment when they were actual passed a long period of time.134

An example of government obstacle in case of pharm TM could be treated the waiting

for authorization for the medical product. This idea is supported by one of EUIPO’s (OHIM)
decision where was admitted that the owner of the pharm TM was in the impossibility to use the
TM because during the last three years from the five relevant ones he was waiting for the
approval of MA.135 From analyzation of recent cases of EUIPO, we have the chance to observe
that indeed the Court is taken into consideration the process of applying for MA as a reason for
non-use.136 Respectively, they made it as a consecutive law practice in cases related to pharm
TMs. Such an approach at a large scale can generate a negative practice of extending the term of
five years for a too wide category of cases.137

An interesting turnover appears from the recent case law practice in which the Court
stated that the genuine use is realized only through external, economic activities made in the
Community, where the use of TM in the inner borders of the state is not treated as such.138 Having
a very low possibility to advertise the TM (without MA) and having only the chance to prove
the genuine use through a price authorization would this be enough? Price for pharm products
are regulated at national level, so if it is realized in the applicant’s country this will not be a
genuine use in the Community. Can an owner of pharm TM apply for several price authorizations
for a product which yet didn’t pass the clinical trials in order to prove the genuine use? Doesn’t
sound like a practical idea.

The safest way to avoid the lack of genuine use of pharm TM before obtaining the MA
is to apply for its registration during the last stages of clinical trials. In this way, the chance to

133
Guidelines for examination of EU TM. EUIPO, Part C, Opposition, Section 6 Proof of use, 01.02.17. Pag.58.
134
Ibidem. Pag.59-60.
135
Case 1507/2001, VIADUR vs DIADUR. OHIM Opposition Decision 2001.
136
Case R 155/2006-1, Laboratorios ERN, S.A. vs Sepracor Inc. Board of Appeal OHIM of 18 April 2007.
137
Sitko J.J., Special Criteria of Trade Mark Protection … (2014), M.P.I.I.C., pag.658-678. Pag.668.
138
Ibidem124.
37
not be able to get the MA in a period of 5 years is minimum. Such a decision can keep away the
future TM owner from a series of unnecessary problems.

Another issue regarding the genuine use of TM can be associated with the way of how
the TM is used if it is a figurative one. From art.15(1) Reg 207/2009 we conclude that the mark
should be used in the form in which it was registered. However, the case law stated that in the
case when the pharm TM is used in a different way than it was registered it will still be a genuine
use if the way in which it is used doesn’t change the distinctive character of the TM. If the
figurative TM is used in a different colour than it was registered this will be the use of the mark
if the new colour managed to create an association between it and the product in a significant
part of the public.139

In the current chapter, we wanted to show that in some cases the legislation is not
perfectly adapted for the pharm TM category. Such inconsistency contributes to the rise of costs
for the research of pharm TMs but also and for the decrease of incentive to the research of pharm
firms. They will prefer to have fewer products for which they managed to obtain a distinctive
pharm TM rather have several products with a low value and with excessive costs demand
obtaining of TM.

The problems regarding the cluttered class and difficulty to prove the genuine use are
connected through the fact that the pharm TM is supposed to an "approval" from two different
authorities. Respectively, both negative outcomes could be resolved from the creation of a
harmonized system of registration of pharm TM names.

139
Case C-252/12, Specsavers vs Asda Stores Ltd. Judgment of the Court of 18 July 2013.
38
 CONCLUSION

This paperwork was made with the aim to make the reader familiar with the existence of
the pharm TM. The research was focused on the EU's area and its legal framework. EU
implemented several legal acts which should create a uniform practice of use of TMs.

Considering that pharm TM represents a specific class of products which is related to the
public health, a series of the legal act were made in this direction. Through all these legal
provisions, we find the pharm TM which struggles to be in accordance with the norms regarding
TMs but and with the specific norms of the health care's system.

During the work, we could outline several existing issues. Respectively, when we speak
about pharm TMs we should always remember that the crucial step starts with its choose.
Concentrating our attention on the pharm name we could see that the applicant should keep in
mind several things: the cost of research for TM, the creation of a distinctive, catchy TM. In the
same time, he should not use INNs or to not create a descriptive, promotional TM that can give
misleading information about the product or create the likelihood of confusion of the TM with
other TMs or INNs. The applicant must balance his interests on one side and the interests of
consumers on another one. Because of these limitations, the entire activity regarding application
for a pharm TMs is more specific than one in the case of usual TMs. All the existing restrictions
led to the appearance of some legal inconsistent like the appearance of TM cluttering, lack of
genuine use and even anticompetitive practices.

Considering that the most common pharm TMs are in the form of words, representing
pharm names we should remember the special relation between them and INNs. The major role
of INNs should be ensured through their protection. The best option in these conditions would
be the implementation of a practice where the owners of pharm products will use their company
names in combination with an INN and not the use of TM names. Such a practice will have a
double positive effect like the protection of INNs from dilution and creating in the mind of the
consumers the link of the generic name with the product, which will permit them to choose the
product by its generic name avoiding overpaying for no reason. Of course, these
recommendations come for the benefit of the end consumers mostly but even from the pharm
TMs perspective is important to prevent the confusion of them with the INNs.

39
 We contemplate that pharm TMs should have a special status from all other TMs. Our
opinion is supported by the case law of CJEU which in numerous cases mentioned that when we
speak about pharm TM we analyse the case from the perspective of protection of consumers'
rights. To ensure that pharm TM works in harmony with the legal norms related to TMs and
pharm products we should create a closer cooperation between EUIPO and EMA. Such an
approach will diminish the likelihood of confusion of these TMs and will contribute to their
economic development, decreasing the time and money costs.

CJEU should afford a more detailed explanation of how to avoid the anticompetitive
practices in case of PI. Even more useful will be if the Court would be able to pronounce itself
regarding the phenomenon of PI of pharm which comes from price-controlled member states.
This is because PI of pharm products have a direct impact on the market within the EU
community. The necessity to repackage, change labels, over sticker or in some cases even to
change the name of pharm TMs contribute to avoiding the artificial portioning of the market but
it inputs the TM holder to tolerate the use of its TM by third parties.

In general, the law is facing the most problems regarding pharm TMs but in the same
time, Reg 207/2009 should adopt an additional point regarding the genuine use of the TMs which
are facing some impediments from the state's part. Also, concrete measures should be made
against the appearance of the cluttering in the pharm TM class because the passive position of
the legislators regarding this issue will contribute to an overcrowded TM class that will make
the process of registration of new TMs even more complicated.

For sure pharm TMs have distinctive characteristics which should be investigated.
Registration of a pharm TM can be a very slow and complicated process which needs a good
planning and management starting from the stages of the clinical trials. We should not be afraid
of pharm TMs, we just have to keep in mind all the tiny details which make them so special.

40
 BIBLIOGRAPHY

Legislation

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41
 Case Law

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• Case C-379/97, Upjohn SA vs Paranova A/S. Judgement of the Court of 12 October 1999.
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• Guidelines on the use of INNs for Pharmaceutical Substances. Programme on INN
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