8
the fact that the NRG now wants exclu-
sive use of electronic submission and that
the number of NRG meetings per year
has been halved (current response time is
3 months). There is presently a large NRG
database of approved names, the majority
of which, have never been used. Industry
have successfully worked together to
suggest to the EMA ways of cleaning the
database resulting in the introduction of a
3 year limit on acceptance of the intended
name. Remaining on the topic of
regulatory practice in relation to the
approval of trade mark candidates, Susan
Keri of Bereskin & Parr offered us a
vibrant insight into recent and proposed
changes to Health Canada guidance.
Several areas remain unclear, for example
what information must be contained in
submission with respect to brand name. It
seems as though with all the regulatory
authorities, the biggest challenge that
brand owners face is that of uncertainty
or lack of transparency over the process.
In Canada, like many countries, name
submissions are confidential and current
rejection levels are not tracked or public
thereby making the process challenging for
applicants. We look forward to hearing
more from Canada in the near future as a
final version is expected any time from-
now through the first quarter of 2014.
Susan Proulx of Med ERRS joined the
stage to reflect on the US position. Whilst
the new risk assessment guidance was
released in December 2012 (relating to
data collection, potential error scenarios
etc.) and Package & Label guidance in April
2013, the pharma trade mark community
are still waiting with baited breath for the
Nomenclature Draft guidance which is
delayed in part as a result of the ongoing
government shutdown that coincided with
the conference. The FDA is often
considered to be one of the most strict
regulatory regimes and, as Susan joked,
sometimes it seems that the FDA use a
"Murphys law" approach i.e., assuming
that if anything can go wrong it will! Susan
also offered an overview of the December
2011 Medicines Control Council guidance
from South Africa, one of the most
surprising facts being that the MCC
review candidate marks in 11 languages.
Overall the current regulatory
environment leaves us with more
questions than answers. What struck me
is the wide variety of differences between
those countries that have highly developed
naming processes for medicines. It is
definitely a concern that as more
countries further develop their regulatory
systems, we as trade mark lawyers may
have more and more hurdles to jump
over leading to ever increasing costs. As
many of the regulatory speakers
highlighted this is likely to lead to the
need to start name creation a little earlier,
or to consider a "name bank" and also
raises questions around filing strategy: US
first due to rejections? Or Canada first
due to most comprehensive evaluation?
Or might the EU have a better chance of
approval? On this sombre but thought
provoking note we finished the day's more
formal presentations looking forward to a
more light hearted evening ahead.
Departing on coaches into the surprisingly
crisp and chilly Viennese air whisked at
twilight through mist tinged vineyards to
Gumpoldskirchen some 30km outside
Vienna where an old world cobbled town
lies at foot of hills to be welcomed by a
traditional brass oompah band and
restorative glasses of schnapps. After a
reception we were led by the band
through the streets to a restaurant which
was a veritable rabbit's warren of smaller
rooms swallowing our large group up. We
were treated to an evening of typical
Austrian food including meats, sauerkraut,
dumplings and strudel. After a display of
folk dancing our carriages whisked us back
to Vienna to conclude a long but fruitful
day.
Our second full day began with a lively
presentation from PTMG committee
member Frank Meixner of Bayer on the
topic of Coexistence and Prior Rights
Agreements. Many of us routinely use
such agreements; however we rarely
discuss the varying legal ramifications in
different jurisdictions of what are often
template agreements. To those outside of
the day to day vagaries of the pharma
industry it will likely come as a surprise
that an estimated 50% of class 5
applications involve some form of co
existence. The fact that very few court
precedents can be found involving such
agreements highlights their success.
What is clear is that there are significant
differences between what is and isn't
permissible between Member States and
the US. For example in both France and
Germany an agreement can only be
limited to the territory of the current
conflict whereas UK law is not as strict
and arguably does permit global
agreements (Apple v Apple). There are
also other areas of the law to take into
account, in particular restraint of trade
considerations. I certainly came away
questioning my approach to such
agreements and will revisit practical
considerations.
It is always nice to have a non-legal
perspective in the mix of presentations
which was provided by Stuart Hurst
(formerly of Pfizer and Eli Lilly & now a
public affairs consultant). He offered an
overview of the implications of the
Falsified Medicines Directive in the EU.
Sadly the business of counterfeit medicines
is increasingly attractive to criminals. It is
particularly shocking to hear that the
profit margin for fake Viagra is 200%
greater than for cocaine. The FMD
focuses on standardisation of the legal
supply chain and involves measures at all
stages from manufacturing of APIs through
to the distribution chain and ultimately
patient dispensation via the use of
serialisation to enable verification. There
is however a need to try and standardise
systems between countries to ensure
pharma companies aren't left having to
incorporate 28 different serialisation
systems into their packaging. This will take
time, in fact it is expected that
serialisation and verification systems will
begin implementation between 2014-2017.
After the coffee break, we were whisked
off to the African continent for a joint
presentation by Sarah Jeffery of GSK and
Chris Walters from Spoor & Fisher.
Susan Keri
Susan Proulx
Frank Meixner
Stuart Hurst