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Key issues of pharmaceutical trademarks
JONAS Rechtsanwaltsgesellschaft mbH
Pharmaceutical trademarks
Key issues of
pharmaceutical
trademarks
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
www.iam-magazine.com 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 www.iam-magazine.com
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
www.iam-magazine.com 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: viefhues@jonas-lawyers.com
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
www.jonas-lawyers.com
44 IP in the life sciences industries 2009 www.iam-magazine.com
JONAS Rechtsanwaltsgesellschaft mbH
Hohenstaufenring 62
50674 Cologne
Germany
Tel +49 221 27758 0
Fax +49 221 27758 1
www.jonas-lawyers.com
