After years of promise, in May 2014
the U.S. Food & Drug Administration
(FDA) finally released its long-awaited
draft guidance document on "best
practices" for developing trade marks
for pharmaceuticals, including
nonprescription and biological drug
products. The draft guidance is
designed to help industry adopt trade
marks that minimize health risks and
potential confusion with other existing
marks.
FDA approval of a mark for a
pharmaceutical product can be
notoriously challenging. Approximately
one-third of marks are rejected. The
draft guidance document helps to
verify the FDA's position and solidify
numerous practices of what many in
industry have been following for years.
Adhering to the draft guidance can
maximize the chances that any
particular name will win FDA approval.
Recommendations for
"Pre-screening" Pharma Trade
mark Candidates
The FDA recommends that
manufacturers consider the following
issues when considering potential
name candidates:
l
Avoid obvious similarities in
spelling and pronunciation
compared to existing trade marks,
generic names, or ingredient names;
l
Avoid incorporating medical
abbreviations, dose designations, or
symbols that might contribute to
medical errors;
l
Avoid incorporating reference to
inert or inactive ingredients in a
way that creates an impression that
the ingredient has greater value
than it really does;
l
Avoid incorporating generic stems
in the stem position;
l
Avoid "recycling" the trade mark of
a discontinued product;
l
For fixed combination drug
products, avoid trade marks that
include or suggest the name of one
or more, but not all, of the active
ingredients.
Naming Attributes That Might Be
Misleading or Contribute to
Errors
After narrowing the list of candidates
based on the initial "pre-screening,"
the FDA recommends manufacturers
consider the following characteristics:
l
Avoid incorporating product-
specific attributes such as
manufacturing characteristics
("NameLyophilized"), dosage form
("NameTabs"), or route of
administration ("NameOral");
l
Avoid modifiers of trade marks
("Name XR") that do not have an
established meaning or that
otherwise might cause confusion;
l
Avoid modifiers that consist of
numerals;
l
For combination drug-device
products, avoid incorporating a
device-related modifier into the
trade mark that implies the device
component operates in a way
inconsistent with the modifier;
l
Avoid modifiers that are
inconsistent with the proposed
labeling or otherwise hard for the
end user to understand;
l
Avoid incorporating the sponsor's
name in multiple trade marks;
l
Avoid terms that may suggest the
product has some unique
effectiveness or composition it
does not actually have (such as
"best").
The use of brand name "extensions",
also known as family marks or
umbrella names, are evaluated by the
FDA on a case-by-case basis,
considering whether the products
share at least one common active
ingredient, are differentiated by
labeling, and have appropriate
modifiers. The FDA will also evaluate
on a case-by-case basis the use of
different trade marks by the same
manufacturer for products that
contain the same active ingredient but
for different indications.
When a product goes from
prescription to over-the-counter
(OTC), use of the same trade mark
may be acceptable if there is no
change in indications, dosing, or
strength. However, if the OTC and Rx
versions are not identical, the FDA
believes it "might be appropriate" to
market the OTC product under a
different or modified trade mark.
The FDA will review a proposed trade
mark for an OTC drug that will be
marketed pursuant to a New Drug
Application or Abbreviated New Drug
Application. However, many OTC
drugs are marketed under an FDA
monograph and are not individually
scrutinized by the FDA. For these, the
FDA still recommends that the trade
marks be evaluated by the sponsor for
safety considerations.
Finally, the draft guidance contains
detailed descriptions of how the FDA
conducts and how sponsors should
conduct name simulation studies to
try to gauge how likely any given name
will cause end-user error based on
phonetic, spelling, and orthographic
similarities. Although sponsors are not
required to submit their own studies,
the FDA "believes more
comprehensive simulation studies
would be useful."
FDA Releases Draft Guidance on "Best Practices" for
Pharma Trade marks
Keith Barritt, Fish & Richardson P.C.
7
PTMG 90th
Spring Conference
Venice
23rd 24th March 2015
Registration will open on
PTMG website in mid
January 2015