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Brand names can play a key part of the management of a product
over its life cycle. Unlike patents, trade-marks can enjoy an
unlimited life and are therefore valuable assets to pharmaceutical
companies. A unique brand, consistently used and promoted,
generates goodwill and brand loyalty, hence solidifying market
position. However, the road to a unique and globally acceptable
brand name is not easily travelled, and pharmaceutical companies
continue to face uncertainty in their efforts to clear brand names
for use in key markets.
Obtaining approval of a proposed brand name as a trade-mark at
the Canadian Trade-marks Offi ce (TMO) can be challenging as the
pharmaceutical fi eld is very crowded. However, securing TMO
approval is only part of the work required. Health Canada also
reviews the acceptability of proposed brand names as part of the
marketing approval process, and a rejection from Health Canada
trumps the trade-mark registration process. With health regulatory
refusal of brand names at a rate approaching 40 to 50 per cent in
Canada, the United States and Europe, it is clear that
predictability is the loser in the equation. As owners appeal for
greater certainty in the brand search game, Health Canada has
promised a consultation process that will involve the brand name
approval process as well as labelling issues. An industry meeting
scheduled for early March was postponed to an as yet unspecifi ed
date, although we are told that it should be held reasonably early
in Health Canada's fi scal year, which began on April 1. Until
then, the pharmaceutical industry in Canada must continue to
operate under a Health Canada Guidance dated January 1, 2006 as
well as a Fact Sheet dated November 9, 2009.
Over the past decade, health regulatory authorities, including
Health Canada, have become increasingly focused on the review of
proposed brand names from a safety perspective, the goal being to
avoid approving a brand name that might contribute to a medication
error. This heightened focus triggered look-alike and sound-alike
(LA/SA) trade-mark scrutiny, much of which revolved around the
United States Food & Drug Administration's use of a
computer analysis intended to identify trademarks with phonological
or orthographic similarities (POCA).
While Health Canada does not yet use the POCA analysis, it has
indicated its intention to do so, and is in the process of
implementing the POCA application, presumably to do things such as
incorporate the Canadian database of drugs on the market and create
a French version of the application.
The upcoming Health Canada consultation is eagerly awaited as
the industry searches for clarity in the process. In the meantime,
Gowlings has modifi ed its pharmaceutical searches to include a
POCA analysis as well as a review of trade-marks on the TMO
Register. We are applying the specifi c algorithm used by the U.S.
Food & Drug Administration to pharma brand names in use in
Canada. This is part of our effort to predict LA/SA issues with
greater certainty in the event that Health Canada does, in fact,
implement the POCA analysis. It is hoped that this analysis will
help to forecast what may be on Health Canada's radar during
the approval process.
In the meantime, companies should continue to observe the
January 1, 2006 Guidance. To reduce the likelihood of medication
errors, the Guidance discourages naming practices that result in
similarities in brand names or brand names that are similar to
generic names. It also discourages the use of product line
extensions (e.g., a modifying prefi x or suffi x). A company should
submit to Health Canada a risk assessment and evaluation of its
proposed trademark, supported by studies, data and analyses. A risk
assessment can include searches for similar proprietary and
non-proprietary names, computer analyses, prescription testing
studies and a review of medication error literature.
Health Canada's Fact Sheet of November 9, 2009 advises
manufacturers to reduce the incidence of offending names through
research and by choosing brand names that are distinctive and
easily written and pronounced. To be acceptable, a brand name must
not be liable to cause confusion in print, handwriting or speech
with the brand name of another medicine.
Stay tuned for further news on the Health Canada
consultation!
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