**Reviewing Pharmaceutical Trademarks -- A New Frontier or Familiar
Legal Territory?**

by

Maury M. Tepper, III

Womble Carlyle Sandridge & Rice, PLLC

Raleigh, NC

I would like to thank each of the sponsors of this program for
addressing the important topic of how best to review pharmaceutical
trademarks in order to minimize the potential for medication errors. My
hope is that today's discussion will demonstrate that all of the groups
represented here will come to understand that we are working toward a
common goal -- to maximize patient safety. While there may be some
disagreement as to how best to reach that goal, the process of
understanding the viewpoints represented by the participants in this
conference is an important first step towards developing a more
predictable and reliable system. In the field of pharmaceutical
trademarks, both trademark attorneys and the FDA have valuable insights
that should play a role in reviewing trademarks. The key is to develop a
system that capitalizes on the expertise of both. The review of
pharmaceutical trademarks can best be accomplished by employing new
methodologies within the context of well-settled legal principles,
rather than creating an entirely new system of review.

***The Trademark Law Perspective***

In developing systems for reviewing proposed pharmaceutical trademarks,
it is important not to overlook or to slight the utility of existing
legal constructs and the body of expertise that has been developed under
the trademark laws and within the U.S. Patent & Trademark Office
("PTO"). For more than a century, the trademark system has been designed
to protect consumers against confusion and to facilitate the development
and protection of unique brands that manufacturers can use to
distinguish their products from those of others and that consumers can
rely upon in making purchasing decisions. During this time period,
courts and the PTO have developed analytical tools for assessing the
likelihood of consumer confusion between trademarks. This analysis
employs factors that take into account the way in which products are
displayed and purchased, always with the end result of ensuring that
consumers will be protected against any likely confusion in the
marketplace.

These legal doctrines also establish priority in trademark rights,
bringing predictability to the market and providing a clear set of rules
for resolving competing claims to similar marks.

***The FDA Perspective***

It is clear that prescription drugs are marketed and dispensed in a
unique way, as compared to other goods and services. Prescription drugs
may be the only products where the ultimate consumer (*i.e.*, the
patient) does not make the purchasing decision. Rather, a medication is
selected by a physician and dispensed by a pharmacist. In this
particular marketplace, the consumer's traditional role in product
selection and purchasing control have been supplanted by third-party
prescribers and dispensers. The system is further complicated by the use
of handwritten prescriptions, medical abbreviations and other
system-related factors that accompany any order for a particular
medication. The FDA possesses a detailed understanding of this unique
marketplace. For nearly a decade now, the FDA has played an increasingly
active role in reviewing and commenting on proposed pharmaceutical
trademarks.

***The Current System -- A Recipe for Conflict***

Unfortunately, the roles of the FDA and the PTO in reviewing proposed
trademarks for prescription pharmaceuticals have not been clear in
recent years, and the differing analyses employed by these agencies has
sometimes led to conflict and to divergent results. Further, the FDA's
decisions regarding a sponsor's right to use a proposed trademark do not
take into account the existence of any potentially conflicting prior
legal rights, creating the potential for discord. While some of this
conflict may be unavoidable, it appears that little deference has been
given to the decision-making expertise of the PTO, or of that agency's
ability to predictably analyze consumer confusion. At the same time, the
PTO has not been provided with the benefit of the FDA's familiarity with
the prescription market. The expertise of both agencies should be
combined in the model for reviewing pharmaceutical trademarks.

***Combining the Best of Both Worlds -- A System for Pharmaceutical
Trademark Review***

Given the unique situation in the prescription market, it is appropriate
to analyze trademarks in a way that takes into account prescribing and
dispensing conditions. Such an analysis, however, need not represent a
radical departure from the trademark system. Indeed, legal tests for
trademark infringement look at the way in which marks are encountered in
the marketplace. In this connection, the safety review being presented
and discussed today can and should be seen as a part of, rather than, a
replacement for the legal test for trademark availability.

The tools and approaches being presented at this conference are a useful
starting point for any analysis of pharmaceutical trademarks. The
touchstone of the analysis must be to determine whether any proposed
mark creates a likelihood of consumer confusion in the relevant
marketplace. Thus, tests that take into account ways in which the mark
will actually be encountered are the most probative. While little may be
known about fields such as handwriting analysis or voice recognition,
the best learning from these fields should be employed to develop tests
that approximate conditions in the relevant prescription market. The FDA
has, for several years now, been employing this type of "field testing"
in its review process, and this morning's presentations demonstrate ways
in which that testing can be conducted as a part of the trademark
clearance process.

Once the appropriate tests have been run, the well-developed body of
trademark law, with its consumer-based likelihood of confusion test,
should be employed by those with experience in the trademark field. The
data from these analyses must be combined and weighed in reaching a
determination as to whether a particular mark will create an undue risk
of confusion. Try though one may, however, one cannot escape the
conclusion that this decision is an inherently subjective determination.
Because there are so many different potential causes of a medication
error, and because so many different factors, in addition to the name,
play into determining whether an actual substitution between products
bearing potentially similar names would ever occur in the marketplace,
there can be no single formulaic approach to evaluating proposed drug
names for safety. Analyzing only the similarity of proposed names falls
short by not taking into account market conditions or determining
whether the two names at issue could ever actually be encountered in the
same clinical settings. Often, factors such as dosing form, dosage
strength, indications and practice setting (*i.e.*, hospital or retail
pharmacy) play an important role in increasing or eliminating the
likelihood that substitution or errors may occur when potentially
similar names are involved. These factors may, when appropriately
analyzed, reveal that potentially similar names can safely co-exist if
they are used on sufficiently distinct products with sufficient
differences to preclude any likelihood of substitution. Conversely,
these factors may indicate that two marks that otherwise do not appear
to be overly similar nevertheless present an unacceptable risk and
therefore should not be used.

Trademark attorneys applying the appropriate legal analysis for
infringement regularly balance various factors (including market
conditions) to arrive at a subjective determination of likelihood of
confusion in each case. Their expertise, and that of the trademark
system, should not be overlooked. In fact, while FDA has great expertise
in understanding the prescription marketplace, the agency does not have
expertise in developing or applying appropriate tests to weigh the
subjective factors that go into analyzing trademark availability. Given
this, the FDA's most appropriate role should be to help refine and
establish appropriate tests that take into account actual market
conditions. Once these tests have been established and agreed upon, the
FDA should ensure that the tests have been employed by a sponsor
proposing a new trademark. The FDA should not, however, readily
substitute its subjective judgment for that of the sponsor. Indeed,
there is no indication that the FDA's subjective judgment is any more
reliable or safe than that of the sponsor, which, after all, has a
vested interest in establishing a unique identity for its product and
ensuring that the product will not be confused with any other.

While we all wish for a predictable objective test that would readily
identify and eliminate any potential for medication errors, the real
world unfortunately will not provide conditions that allow for such a
test. Given that any test to analyze proposed trademarks will involve an
inherently subjective determination, the best approach is therefore to
develop and refine analytical tools that will approximate market
conditions and to ensure that the appropriate analysis is carefully
employed by a sponsor. Once the sponsor has made an appropriate analysis
of all relevant data and reached a decision, the FDA should be reluctant
to replace the sponsor's decision with the Agency's subjective judgment,
particularly when the sponsor, utilizing the trademark system, has more
extensive expertise and experience in analyzing the likelihood of
confusion between two marks.

Further, incorporating these analytical tools into the legal review and
clearance of trademarks will remove the potential conflict between
trademark priority and FDA priority when competing marks are involved.
This would provide a more predictable system for decision making.

Finally, it is important to keep all of these efforts in the appropriate
context. While the pharmaceutical industry does, and should continue to
do, everything that it can to develop and employ trademarks that will
serve as safe, unique product identifiers, we must not lose sight of the
fact that trademark similarity is only one of the many factors that
contribute to medication errors. Other factors in the system, such as
the use of handwriting, the use of medical abbreviations, cramped
storage conditions in retail pharmacies, poor lighting, lack of
indications on prescriptions and many other factors, play a significant
role in medication errors. Efforts to address these other factors would
likely have a greater impact on the overall rate of medication errors,
and we should be mindful to employ our efforts where they will have the
greatest impact. Continuing to refine and employ the best possible tests
in order to ensure the adoption of unique, recognizable and safe
trademarks should be part of an overall systemic approach to reduce
medication errors. This approach should also address the behavior of
doctors in writing prescriptions legibly, providing indications and
information necessary to enable the pharmacist to understand them,
efforts to address pharmacy practices to reduce the likelihood that the
wrong medication will be hastily grabbed from a shelf, and patient
education efforts to encourage consumers to play a more active role in
understanding the products that have been selected and dispensed for
them.

Thank you for your time and attention. I look forward to continuing to
work with all of you on this important issue.