Rebranding Trademark Agreement

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					Key issues of pharmaceutical trademarks
JONAS Rechtsanwaltsgesellschaft mbH
                                                                                    Pharmaceutical trademarks

                       Key issues of

                                                                       interests of the trademark owner in
                       Due to their importance to public               securing the identification of its products,
                       health, pharmaceutical trademarks               thereby informing the patient’s or doctor’s
                       are affected not only by IP law, but            decision as to which product to buy or
                                                                       prescribe, and securing the commercial
                       also by regulatory law. Trademark               success of the product. Otherwise, it would
                       owners must thus be prepared to                 not be possible for the owners of conflicting
                       tackle questions which are often                trademarks to resolve their disputes by
                       rooted in the political, financial or           restricting the use and coverage of their
                       technical context                               marks in such a way as allows them to
                                                                       coexist. In entering into a coexistence
                                                                       agreement, the owners of conflicting
                       By Martin Viefhues,                             trademarks often commit to use their marks
                       JONAS Rechtsanwaltsgesellschaft mbH             in different therapeutic areas, in order to
                                                                       ensure that the trademarked products of
                       Unlike marks in most other business fields,     one rights owner cannot accidentally be
                       and due to the dichotomy between rights         confused with the other’s.
                       ownership and public safety, pharmaceutical          Under pharmaceutical law, the key issue
                       trademarks are affected by regulatory law.      is the danger that the accidental use of a
                       This influence accompanies the trademark        trademarked product in a different
                       throughout its existence. Pharmaceutical        therapeutic area could result in serious
                       trademark owners therefore face a number        health risks. In its Guideline on the
                       of specific questions which often have their    Acceptability of Names for Human
                       background in political, financial or           Medicinal Products Processed through the
                       technical conditions and circumstances –        Centralised Procedure, issued on 11th
                       be it ongoing reforms of social security        December 2007, the European Medicines
                       systems, changes in ethical rules or the        Agency (EMEA) explicitly stated that its
                       challenges of the Internet. Within this         primary concern is the public health issues
                       context, key issues of pharmaceutical           arising from the names of medicinal
                       trademarks arise in relation to trademark       products and any conflicts with existing
                       protection as well as trademark defence.        names, rather than any potential trademark
                                                                       infringement issues.
                       The different purposes of trademark and              These differing perspectives can
                       pharmaceutical law                              sometimes lead to conflicting results.
                       Both trademark law and pharmaceutical law       Where similar trademarks are used for the
                       seek to prevent potential confusion in the      same medical indication, the matter
                       relevant business circles (patients and         becomes a trademark issue; where similar
                       medical professionals) due to similarities      trademarks are used for different medical
                       between conflicting trademarks. However,        indications, the matter becomes a health
                       the respective perspectives are very            safety issue.
                       different.                                           Even with considerable search efforts, it
                            Trademark law is not intended to           is increasingly difficult to come up with
                       protect the public against medication errors.   new pharmaceutical trademarks, due to the
                       It rather aims to protect the business          distance which must be maintained from                                                            IP in the life sciences industries 2009 41
Pharmaceutical trademarks

   The likelihood of confusion between
two trademarks can depend significantly
on the levels of knowledge and
attentiveness that characterise the
relevant business circles

existing third-party marks and the               pharmaceutical (eg, when preferences are
multitude of trademarks already on the           expressed by the patient). This should lead
market. Each change in examination practice      to a consideration of the end user in all
is a double-edged sword for trademark            cases. Any reduced likelihood of confusion
owners: while they may benefit from a            can then no longer relate to the special
stricter practice when defending their           skills of professionals, but only to the
trademarks against later marks, they will        special interest and attentiveness of end
suffer when applying for registration of a       users in health matters. It remains to be
new trademark and faced with existing            seen whether the European courts will thus
third-party trademarks.                          refrain from making any reference to health
                                                 professionals in future – with a stricter
Assessment of the relevant public                approach regarding conflicting trademarks.
It is thus unsurprising that a key issue in
balancing the various interests is the proper    Similarity of trademarks and
assessment of the relevant public. This          international non-proprietary names
assessment centres on two sets of criteria:      In addition to distinctive trademarks that
end users versus health professionals and        identify each individual product,
prescription-only preparations versus over-      pharmaceuticals have a unique but generic
the-counter preparations. The likelihood of      international non-proprietary name (INN),
confusion between two trademarks can             which identifies the active ingredient and
depend significantly on the levels of            thus assists healthcare professionals in
knowledge and attentiveness that                 identifying the drug’s pharmacological
characterise the relevant business circles. In   properties. Pharmacologically related
general, the courts regard patients as the       substances have an INN with a common stem
end users where over-the-counter                 to allow for recognition of similar
pharmaceuticals are concerned, and tend to       pharmacological effects in different products.
focus on doctors and pharmacists as skilled           As an INN is generic, an application to
health professionals where prescription-         register a trademark that is similar to an
only pharmaceuticals are concerned.              INN may be rejected as being descriptive of
However, some uncertainty arose after it         a quality of the product and therefore a term
was admitted that consideration should also      that cannot be monopolised. In this regard,
be given to the end user, who is generally       the trademark is compared with the INN in
regarded to be particularly attentive and        its entirety, not only with regard to the stem.
circumspect in choosing products relating        The authorities must determine whether a
to health and medical care, in the case of       proposed registration is a coined derivative
prescription-only products also – a finding      of an INN, which can coexist with it, or
that raises more questions than it answers.      whether it is too close to the INN and is
The European Court of Justice (ECJ) has          therefore barred from protection. The key
since pointed out, in TRAVATAN/                  criterion is not whether the trademark may
TRIVASTAN (Case C-412/05, 26th April             mislead the relevant public as to the
2007), that the involvement of skilled           product’s pharmacological effect, but rather
professionals in the distribution of             whether the trademark, if registered, would
prescription-only pharmaceuticals does not       monopolise a term that needs to be kept free
exclude the possibility that end users can       for general use. The trademark examination
influence the actual prescription of the         practice of, for example, Germany – as the

42 IP in the life sciences industries 2009                                               
                                                                                   Pharmaceutical trademarks

                       third largest pharmaceutical market in the     product might be a cosmetic or medicinal
                       world and the largest in Europe – shows that   product rather than a pharmaceutical. In
                       there must be more than just minimal           such cases it is common trademark practice
                       differences between the mark and an INN,       to refer to definitions of the regulatory law.
                       but that there can nonetheless be quite a          The definition of a “pharmaceutical”,
                       close correlation.                             however, is unclear, notwithstanding its
                           The EMEA and the national health           inclusion in EU Directive 2004/27/EC
                       authorities which grant marketing              relating to medicinal products for human
                       authorisations for medicinal products have     use. In particular, the meaning of “function
                       another approach to INNs. As the names of      pharmaceuticals” – defined as “any
                       medicinal products must not be liable to       substance or combination of substances
                       confusion with an INN, and as                  which may be used… either with a view to
                       pharmacologically related substances have      restoring, correcting or modifying
                       INNs with a common stem, the EMEA will         physiological functions by exerting a
                       examine the closeness of a suggested           pharmacological, immunological or
                       trademark with its own or a different INN –    metabolic action, or to making a medical
                       taking into consideration in particular any    diagnosis”, which is applied with a focus on
                       similarity in the medical indication of the    pharmacological action – is less clear than
                       product and its supply and administration      it may seem. Judicial attempts to shed light
                       – to ensure that any similarity of a           on the definition often turn out to be
                       trademark component with an INN stem is        unhelpful, as they raise new questions and
                       not misleading as to the pharmacological       make arriving at a clear definition an
                       effect of the medicinal product.               ongoing project.
                           Thus, a trademark accepted by the              Consequently, trademarks for borderline
                       trademark authorities may still be rejected    products should be registered for both
                       by the health authorities.                     possible categories in a sufficiently detailed
                                                                      way as ensures that the product is covered
                       Over-the-counter products and the              by the trademark registration regardless of
                       definition of “pharmaceuticals”                how it is defined.
                       In the first instance, the definition of
                       “pharmaceuticals” is an issue of               Parallel imports
                       pharmaceutical law with relevance in court     Parallel imports remain a key issue,
                       cases mainly to over-the-counter products      particularly in Germany and the United
                       – in particular, nutritional supplements,      Kingdom, where pharmaceuticals are more
                       vitamins and mineral preparations. It          expensive than elsewhere in the European
                       determines whether a certain product is a      Union. The ECJ has established the relevant
                       pharmaceutical product and is therefore        criteria for a justified prohibition against
                       subject to an expensive and time-              parallel imports, but certain issues remain
                       consuming proceeding to obtain a               to be clarified. In particular, as a result of
                       marketing authorisation, or rather a food      questionable statements by the ECJ, there
                       product which can be sold without              are still questions in relation to the
                       permission from the authorities. However,      rebranding and repackaging of imported
                       the definition can also become a trademark     pharmaceuticals. Unfortunately, national
                       issue, as a trademark registration usually     courts have repeated and thereby
                       covers entire groups of products, such as      corroborated these statements, instead of
                       “pharmaceutical preparations and               challenging them.
                       substances, dietetic products for medical          In Bristol-Myers Squibb and Boehringer
                       purposes”, even though the trademark is        the ECJ stated that a trademark owner must
                       then used for one particular preparation       tolerate the rebranding of imported
                       only. The trademark must be used for the       pharmaceuticals if, among other things, the
                       registered goods within a certain period       rebranding “is necessary in order to market
                       following registration in order to maintain    the product in the member state of
                       its protection. The question may then arise    importation” (Case C-427/93, 11th July 1996
                       as to whether the trademark has in fact        – Bristol-Myers Squibb v Paranova; C-
                       been used for the registered goods –           348/04, 24th April 2007 – Boehringer v
                       “pharmaceutical preparations and               Swingward) – however, not only “if
                       substances” – if the relevant product might    necessary”, but also “only in so far as
                       actually be a food product. The same issue     necessary”. Nevertheless, the ECJ did not
                       can arise if the manufacturer has              consider the use of the product’s INN
                       undertaken (eg, through a trademark            combined with the importer’s name as an
                       coexistence agreement) to use its trademark    option for the rebranding – something
                       for certain pharmaceuticals only; or if the    which is quite common for generic products                                                           IP in the life sciences industries 2009 43
Pharmaceutical trademarks

and will become even more so as a result of            gaps in trademark protection if the
the private labels of pharmacy cooperations            proposed new EU directive regarding the
and franchise systems. An obligation                   prevention of the entry into the legal supply
imposed by the health insurance or social              chain of medicinal products which are
security systems for the pharmacist to                 falsified in relation to their identity, history
replace a prescribed preparation with a                or source (Doc No KOM (2008) 688) of 10th
cheaper one (the imported product), except             December 2008 becomes a reality. The
where expressly prohibited in the                      European Commission stopped short of
prescription, may avoid a predicament that             imposing a ban on repackaging: the proposal
is a condition for rebranding of an imported           now provides for the use of safety features,
pharmaceutical. The parallel importer thus             such as seals, which make it possible to
has an option to market the product in the             identify, authenticate and trace medicinal
EU member state of importation without                 products, but which would allow for
using the manufacturer’s trademark –                   resealing in the event of repackaging.
something which is less harmful to the
trademark and avoids a de facto compulsory             Counterfeits and the Internet
licence to the manufacturer’s trademark.               The sale of counterfeit or otherwise
     In its Aventis decision (C-433/00, 19th           unauthorised pharmaceutical products is
September 2002 – Aventis v Kohlpharma),                another key issue. Online pharmacies range
the ECJ allowed for an imported                        from legitimate outlets to murky operations
pharmaceutical to be repackaged to create a            selling illegally. The dramatic increase in
unit of bigger size, instead of being bundled          counterfeit pharmaceuticals is not only a
in original packs, where the pharmaceutical            trademark issue, but also a health issue, as
was subject to a central marketing                     counterfeit products at best are often of
authorisation granted by the EMEA.                     poor quality and at worse can cause serious
However, the ECJ’s argument that bundled               damage to health.
packs of preparations with central                         Although the law is on the side of the
marketing authorisation would form a new               trademark owner, the identification of
pack size that was not covered by the                  counterfeits, the individuals who sell them
marketing authorisation is questionable, as            and the jurisdictions in which they are sold
each of the bundled packs would retain its             is often difficult and requires significant
character as a pack in itself, with its own            effort. Even then, it may be difficult to
marketing authorisation. In this case also,            enforce the law. It is thus important to
bundling would thus be the less harmful                cooperate closely with the authorities,
alternative to repackaging.                            beginning with an application to the customs
     It remains to be seen whether parallel            authorities for the seizure of products which
importers will still be able to exploit such           are likely to be counterfeit.

                            Martin Viefhues has a wide range of experience in trademark prosecution,          Martin Viefhues
                            litigation and contractual matters, and was previously in-house trademark         Director
                            counsel for one of the world’s leading food companies. He focuses on              Email:
                            trademarks, names, industrial designs and domain names, as well as all            Tel: +49 221 27758-0
                            legal aspects of all kinds of marketing activities, in particular in the health
                            and food business. He is a member of the Pharmaceutical Trade Marks               JONAS Rechtsanwaltsgesellschaft mbH
                            Group, INTA and MARQUES, among others.                                            Germany

44 IP in the life sciences industries 2009                                                                                
JONAS Rechtsanwaltsgesellschaft mbH
Hohenstaufenring 62
50674 Cologne
Tel +49 221 27758 0
Fax +49 221 27758 1

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