As raised at the last PTMG conference in
Vienna, recurring questions which
pharmaceutical companies encounter in
relation to the maintenance of their trade
marks are whether use of a trade mark in
clinical trials, before the product is
actually put on the market, constitutes
genuine use or whether the necessity for
a product to undergo such trials may
amount to a proper reason which excuses
non-use of the mark. In jurisdictions such
as US and Canada, this question will also
arise at the stage of the trade mark
application, where the applicant must
establish use or intent to use,
notwithstanding that the product is still
under the clinical trial process.
With such a high percentage of trade
marks being rejected by the authorities
charged with approving the naming of
pharmaceutical products, it is crucial to
ensure that, once a trade mark has been
accepted for a particular product, it
achieves protection and such protection is
maintained.
Following a brief review of the position in
the European Union, certain Asian
territories, US and Canada, it would
appear that not all jurisdictions take the
same approach.
European Union
In the EU it appears that use of a trade
mark in connection with clinical trials will
not generally be considered as "genuine
use" of the trade mark as seen in the
Opposition division decision No 421/1999
dated 01 July 1999, Mucos v Genzyme.
However, the fact that the placing of the
product on the market under the mark is
delayed due to the requirement for the
trials may amount to a "proper reason for
non-use" (under Article 12 of Trademark
Directive 2008/95, "a trade mark shall be
liable to revocation if [...] it has not been
put to genuine use [...], and there are no
proper reasons for non-use").
This approach is based on Article 19 (1) of
the TRIPS' agreement which provides that:
"If use is required to maintain a
registration, the registration may be
cancelled only after an uninterrupted
period of at least three years of non-use,
unless valid reasons based on the exis-
tence of obstacles to such use are shown
by the trade mark owner. Circumstances
arising independently of the will of the
owner of the trade mark which constitute
an obstacle to the use of the trade mark,
such as import restrictions or other
government requirements for goods or
services protected by the trade mark, shall
be recognized as valid reason for non-
use".
As will be apparent from the above, TRIPS
specifies that only situations arising
independently of the trade mark
proprietor may constitute valid reasons
for non-use. In this respect, clinical trials
and other processes related to marketing
authorization, being requirements imposed
on the trade mark proprietor by
regulation, should be considered as
circumstances independent of the trade
mark proprietor.
However, it appears from OHIM's
decisions and the approach of certain
national courts in member states, that
clinical trials will be recognized as "proper
reasons for non-use", only if the trade
mark proprietor is able to establish that it
has been active in seeking to progress the
clinical trial process.
Indeed, the evidence which will enable a
proprietor to successfully claim valid
justification for non-use of a mark as a
result of clinical trials remains a concern,
as evidenced by OHIM's approach to this
issue. For instance, as early as 1999 in the
above cited case, OHIM considered that
the fact that only one document was
produced, establishing that clinical trials
were under way, with no indication of
what had occurred since the trials were
commenced, or whether they were still
pending, did not show a valid excuse for
non-use of the mark.
Nearly 15 years later, OHIM's position
appears to remain the same. Indeed, in
the 25 April 2013 Opposition Division
decision in the Onyx Pharmaceuticals, Inc.
v Alimirall SA case (which has now been
appealed), the opponent was asked to
produce proof of use of the earlier mark
on which the opposition was based. The
opponent produced various documents
evidencing that clinical trials had been
requested for a particular medicine in
various EU countries, that authorizations
to conduct the trials were granted and
that it had also attended various
exhibitions. However, as the clinical trials
were conducted before obtaining a
marketing authorization, none of the
documents explicitly referred to the trade
mark in dispute.
The Opposition division considered that
the documentation was not sufficient to
reveal the opponent's intention to use the
trade mark in relation with the product as
such documentation only referred to the
active molecule. It concluded that such
documentation was insufficient to prove
that the earlier trade mark was put to
genuine use during the relevant period.
Upon review of this decision, although the
opposition division appears (confusingly)
to have switched from an analysis of valid
reasons for non-use to an analysis of proof
of genuine use, it appears to confirm that
the mere existence of on-going clinical
trials may not be sufficient to constitute a
valid excuse for non-use and that the
trade mark proprietor must be prepared
to demonstrate its active behaviour in
relation to the clinical trials, in pursuit of
bringing the product to the market under
the trade mark.
At national level too, relying on clinical
trials to establish valid reason for non-use
may not be sufficient. For instance, in the
German case GRUR, 1999, 1002 SAPEN
II, the Federal Patent Court denied a
justification of non-use of a 25 year old
trade mark registration, as the proprietor
was deemed not have seriously progressed
the two product registration proceedings
initiated during the 25 year period.
In France, the approach appears more
straightforward, as existing case-law does
not show any particular difficulties for
trade mark proprietors to establish valid
reasons for non-use, provided that they
can demonstrate that a clinical trial or a
request for a marketing authorization is
on-going. This position is upheld by past
decisions such as Paris Court of First
Instance 01 June 1999 SA Almonda
Sociedade Gestora de participacoes
Sociais v Opfermann Arzneimittel GmbH
and Orleans Court of Appeal, 13
Fegbruary 2003, A. Deschamps v SA
Mermet
Outside the European Union
If we look at the position outside the EU,
it appears that Japan, China and Hong
Kong, broadly speaking, share the EU
approach i.e., other than post-marketing
trials or in other exceptional circum-
stances, use of a mark in connection with
clinical trials does not constitute genuine
use of a trade mark, but may be accepted
as a valid excuse for non-use.
In US and Canada, where the question of
use of a trade mark arises at the stage of
the trade mark application, we understand
that it is generally accepted that use of a
trade mark during clinical trials will
constitute sufficient use to file an
application, as clinical trials are part of
pharmaceutical companies' "ordinary
business". This approach will, however,
only be relevant when the mark is actually
used on the product, which appears likely
only to be the case in the later phase
clinical trials.
In view of this, filing a declaration of actual
use or trying to support use in a non-use
cancellation action on the basis of clinical
trials may be difficult in both US and
Canada and, consequently, a trade mark
application based on use is probably only
viable in later phase clinical trials, if and to
the extent that the trade mark applied for
is marked on the product.
Summary
To summarize, it would appear that clinical
trials are capable of being accepted as
providing proper reasons for non-use of a
mark. Trade mark proprietors must
however be prepared to ensure that the
evidence filed clearly establishes their
active engagement in the trials and their
intention to use the trade mark once such
trials have been completed. Clinical trials
may be accepted as genuine use only in
certain countries, such as North America,
and where the trial is in its late stages.
Clinical trials genuine use or legitimate excuse?
Frédérique Potin and Adrian Smith, Simmons & Simmons
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