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
1 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
2 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
3 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
4 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.
5 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).
6 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).
7 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.
8 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.
9 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.
10 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.
11 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.
12 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).
13
“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.
14 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.
15 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.
16 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.
53Ibidem. Art.57.
54Ibidem41.Pag.13-14.
55Ibidem. Art.1.
56Ibidem. Art.59-63.
57Ibidem15. Pag.6–7.
17 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.
18 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.
19 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.
20 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.
21 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.
22 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.
23 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 2006/11483 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.
24 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.
25 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 3rd c., 3rd sect., 16 December 2011.
