Building trademark expertise since 1986 PHARMACEUTICAL TRADEMARKS

The pharma name game

K The challenge of deciding the correct name

Patrick Concannon and Lin Hymel of Edwards Angell Palmer & Dodge reveal the problems that can
arise when naming pharmaceutical products and provide a way through the resulting maze

T
here are unique challenges associated with evaluating and
establishing pharmaceutical trademarks. These challenges
result from the safety risks that result from confusion
between drugs with similar names, the lengthy pharmaceutical
product development process, and the regulatory approval process
for both proprietary and nonproprietary pharmaceutical names.
Trademark professionals assisting pharmaceutical clients can
meet these challenges with success if armed with an
understanding of the details of these processes. The first part of
this article identifies some of these challenges as they are
confronted at the clearance and filing stages of a pharmaceutical
trademark’s life cycle and suggests best practices to be employed
by trademark practitioners in dealing with them. The second part
of this article details the FDA drug name approval standards and
process and the standards and process for obtaining a
nonproprietary drug name.
Risk of medication errors
The consequences of marketplace confusion between
pharmaceutical trademarks can be serious. According to the FDA,
medication errors injure about 1.3 million people annually and cause
at least one death every day in the United States.1 A significant
percentage of those injuries result from prescription communication
errors and dispensing errors that result from pharmaceutical name
confusion. For example, if a pharmacist were to mistake a drug
prescribed at a given dosage level with another drug for which the
indicated dosage level were unsafe, or contraindicated for the
patient’s condition or other medications, the patient could be
seriously harmed. Even though such an error should not be a
reflection on the safety of the prescribed drug, the reality is that bad
publicity resulting from a prescription error can harm the
marketability of a drug and the viability of the trademark that
identifies it.

In summary
K According to the FDA, medication errors injure about 1.3 million people annually and cause at least one death every day in the United
States

K Bad publicity resulting from a prescription error can harm the marketability of a drug and the viability of the trademark that identifies it

K The same phonetic quirkiness typical of pharmaceutical marks can unintentionally cause the marks themselves or elements of the marks to
seem similar to foreign words.

K Under CDER’s recommendation, chlorpormazine and chlorpropamide should be written chlorproMAZINE and chlorproPAMIDE.

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PHARMACEUTICAL TRADEMARKS Building trademark expertise since 1986

Quantum of proof to show likelihood of either sound like chemical names or include Apart from the need for greater care in
confusion between pharm marks letters that can be phonetically mimicked by searching and clearing trademarks from the
Courts have consistently ruled that the other letters can often be replicated through legal viewpoint, a pitfall to be wary of at the
amount of proof required to demonstrate various corrupted spelling variations. It is trademark generation and clearance stage is
likelihood of confusion, the key element that therefore especially important where the possibility that the trademark candidate
must be demonstrated to prevail in a evaluating the availability of pharmaceutical that your English-speaking marketing team is
trademark infringement suit, is lower in cases trademark candidates to obtain and review so enthused about and that your legal team
involving medicinal products than in cases trademark research results generated by has blessed has negative connotations as it
involving trademarks that identify products sophisticated computer database queries appears or is pronounced in one or more key
that do not give rise to similar health and crafted to account for all relevant spelling overseas markets. The same phonetic
safety concerns.2 As examples, the mark variations. quirkiness typical of pharmaceutical marks
HERBROZAC as applied to an over- can unintentionally cause the marks
the-counter herbal dietary themselves or elements of the marks
supplement was deemed an to seem similar to foreign words.
infringement of Eli Lilly’s mark Due to the fact that slang and other
PROZAC identifying a prescription “A common phenomenon among local language nuances must be
anti-depressant3 and the mark accounted for, this risk cannot be
ALTOCOR as applied to a less established pharmaceutical addressed simply by consulting
competing medication was deemed companies is that services are foreign language dictionaries.
an infringement of the mark Connotation research services that
ADVICOR for a prescription anti-
rendered to third parties under a are based upon consultation with
cholesterol drug.4 In non-medicinal house mark well before any local linguists or that survey
situations, arguments stressing the pharmaceutical product will be consumers in a given foreign market
distinguishing elements of such are available to help assess the
marks might have prevailed. Where commercialised under the name” impression made by a trademark
one or both products identified by candidate in that market.
the allegedly similar trademarks at Moreover, while a pharmaceutical
issue is sold over the counter, the company typically does not apply for
fact that unsophisticated consumers FDA approval until several years
may become confused makes a case for Pharmaceutical brands are typically from the trademark generation and selection
likelihood of confusion stronger than it intended to be global brands, and where this is stage, the scrutiny that awaits a would-be
otherwise would be.5 the case at least some level of foreign pharmaceutical brand should nonetheless be
trademark research for drug candidate names anticipated and an appropriate analysis should
Pharmaceutical trademark research and should also be conducted and reviewed. In be undertaken in view of the FDA standards
clearance anticipation of global trademark filings in during the trademark clearance and selection
The lower evidentiary bar for proving support of a major branding initiative, stage. The FDA drug name approval process
likelihood of confusion must influence the pharmaceutical companies regularly spend and the FDA’s standards are described in more
analysis employed by trademark practitioners over $100,000 in obtaining local research and detail below. Nonproprietary drug names can
advising their clients as to the availability of local opinions. While such an expenditure is also be cited as conflicts for proprietary names
proposed pharmaceutical trademarks. Prior obviously not practical or even possible for by the FDA. Further, applications and
third party marks that in other contexts might lower budget pharmaceutical companies or for registrations for marks that are the same as or
be comfortably viewed as distinguishable many research and development companies closely similar to recognized nonproprietary
require extra scrutiny where clearing that want to register their company names names are vulnerable to refusals, challenges
pharmaceutical mark candidates. abroad for potential use as house marks for and cancellation actions based upon
Adding to the pharmaceutical trademark eventual drugs, there are less costly (though genericness in the U.S. Patent and Trademark
clearance challenge is the fact that many drug less thorough) alternatives. Trademark Office (USPTO). It is therefore important that
trademark candidates are comprised of registry information from many key directories or databases of nonproprietary
elements that to most seem to derive from jurisdictions is searchable online. Local pharmaceutical names be carefully searched.
names of chemicals or chemical compounds research and opinions, which are more costly, Most commercial search firms search
(though marketers have recently tended might make sense only for limited strategic nonproprietary drug name resources as part
toward more consumer-accessible names, markets. It is possible to narrowly search of their trademark clearance research services.
especially where a drug might eventually be publication records from over 200 countries As a practical matter, the approach to the
sold over the counter). Many other desirable through a separate search option. While a trademark generation and clearance process
pharmaceutical trademarks include letters consistent global brand is the ideal, often the and the resources devoted to wrestling with
that can be interchanged with others while reality is that the landscape is dotted with the issues raised above will vary depending
retaining the same sound, such as “x” and “z” prior conflicting marks and that variations of upon the likelihood that a drug will ever be
where those letters begin a word. The the core brand will be necessary to settle or commercialised under the mark or marks that
phonetic impression made by such marks that avert conflicts in some jurisdictions. are cleared. Many less-established life sciences

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Building trademark expertise since 1986 PHARMACEUTICAL TRADEMARKS

companies develop and screen chemical application while extending the “parent” upon a U.S. registration. Where the company
compounds with the expectation that they will owns a subsidiary in a Madrid Agreement or
application covering the goods. It is generally
eventually partner with a larger recommended that separate trademark Madrid Protocol member jurisdiction,
pharmaceutical company to produce the end however, that subsidiary can obtain an
applications covering services as opposed to
product. In such cases the larger International Registration based upon a
products be filed where this is likely to be the
pharmaceutical company will typically drive national registration in its home jurisdiction
case to avoid the expense and complications
the branding process and decisions. associated with the need to divide an and, assuming that broad registrations are
application. accepted there, attempt to extend the broader
Pharmaceutical trademark filing strategy rights to other countries.
As for foreign trademark filings, the short
Apart from research and clearance, there are and long term cost savings and administrativeFinally, while a detailed discussion of this
pharmaceutical-specific considerations that simplicity associated with extending subject is beyond the scope of this article,
should be taken into account when pharmaceutical companies should
filing pharmaceutical trademark attempt to arm themselves with
applications. Where filing in the registrations of not only their word-
U.S., pharmaceutical companies only marks, but also with logo
must strike a delicate balance in registrations, trade dress
choosing the product description to registrations covering packaging
be included in a pharmaceutical “While the reliance on common elements and, where possible, trade
trademark application. On the one generic naming stems for drugs with dress registrations covering product
hand, there is value in initially design elements.
phrasing the product wording in a
related activities makes sense for a
broad manner so as to allow as much lot of reasons, it can lead to Establishing use of
flexibility in refining the product confusion in some cases” pharmaceuticals to support
description when the scope and registration at the USPTO
nature of the actual product comes Due to the lengthy pharmaceutical
better into focus. On the other hand, product development cycle, the
a broadly worded application is more thirty-six month period from the
likely to trigger a likelihood of mailing of a Notice of Allowance
confusion refusal by the USPTO or a challenge during which intent-to-use trademark
from a third party on that basis. This risk is protection to many countries of the world applicants are permitted to prove use of
obviously heightened by the wider zone of through an International Registration under trademarks is often not long enough to reach
protection afforded prior third-party marks as the Madrid Protocol are attractive for the actual product launch. Fortunately,
a practical result of the uniquely lower pharmaceutical companies. Due to the Congress made clear during the legislative
evidentiary standard that applies in requirement under the Madrid system that the hearings leading up to the enactment of the
pharmaceutical infringement proceedings. An International Registration mirror the home Trademark Revision Act of 1988 that the type
effective general approach is to file relatively registration, and due to the relatively high of use accepted as “use in commerce” to
narrowly where the treatment targeted by the level of specificity required by the USPTO, support federal registration in the case of
drug is known at the time of filing. Where the however, International Registrations based pharmaceutical applications can include
nature of the product is less certain, and while upon U.S. trademark registrations generally shipments for purposes of clinical trials.6
keeping known potential conflicts in mind, cannot be used to designate the same broad Communications with those at the company
pharmaceutical companies might in the rights available by directly approaching non- responsible for preparing the labels for vials
interest of flexibility choose to indicate U.S. trademark offices. Unlike in the U.S., it is and other drug containers is important
broader goods descriptions even in the face of possible in many jurisdictions to obtain because label space limitations encourage the
the increased risk of citation of unknown third trademark registrations that broadly cover abbreviation of marks, potentially rendering
party marks that such breadth may trigger. “pharmaceutical preparations” with no the labels useless as specimens for supporting
A common phenomenon among less requirements that a particular disease federal trademark registration.
established pharmaceutical companies is that treatment be indicated. It is always more
services are rendered to third parties under a desirable to obtain the broadest possible FDA approval of proprietary names
house mark well before any pharmaceutical registration protection, no matter what As mentioned above, an understanding of the
product will be commercialised under the industry. The option to include such broad regulatory approval process for
name. This means that owners of intent-to- language is particularly important for pharmaceutical names is useful for trademark
use applications for their company names that pharmaceutical companies in cases where the practitioners and marketing decision-makers
cover both goods and services are typically particular disease or condition that a drug will that are not part of the regulatory team per se.
faced with deciding whether to extend be marketed for is not known at the filing and As part of the approval of new prescription
Statement of Use deadlines for entire examination stages. For these reasons and over-the-counter drugs, the FDA
applications or alternatively “divide” the emerging pharmaceutical companies will considers the manufacturer’s suggested
application and file a Statement of Use in often shy away from obtaining a Madrid proprietary name as well as the appearance of
connection with the new “child” services Protocol International Registration based the package insert and labelling. The goal of

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PHARMACEUTICAL TRADEMARKS Building trademark expertise since 1986

FDA review is to limit errors in prescribing nonproprietary stem. Doing so invites both and once published they cannot become
and using medication, in addition to avoiding confusion with other drugs in the same class registered trademarks.8
names that are confusingly similar to existing and the potential for dangerous mistakes by A nonproprietary drug name is requested
pharmaceutical trademarks. A further medical personnel and consumers. Therefore, by the sponsor (usually the manufacturer or
consideration is to ensure that the trademark this strategy should be avoided, or at least developer of the drug) from the appropriate
does not resemble too closely the drug’s very carefully considered. authority after the filing of an IND
generic name, or the stem it derives from. There are many examples of similar drug (Investigational New Drug) application. In the
After the completion of Phase II trials, a trademarks that have given rise to concerns U.S., a nonproprietary drug name, or USAN
drug’s manufacturer can submit two proposed about medication errors. For example, (United States Adopted Name), is approved by
trademarks together with graphics of the REMINYL, a treatment for Alzheimer’s the USAN Council, which is administered by
proposed labeling to FDA’s Center for Drug disease, was recently renamed to the American Medical Association in
Evaluation and Research (CDER), specifically RAZADYNE due to possible confusion with conjunction with the United States
to CDER’s Division of Medication Errors and AMARYL, a diabetes drug. Other names Pharmacopeial Convention (USP) and the
Technical Support (DMETS). American Pharmacists Association.
DMETS then reviews the proposed The USAN Council coordinates its
names, in order of the applicant’s review with the international review
preference, to determine whether they process for obtaining an
are confusingly similar to other drug “Under CDER’s recommendation, International Nonproprietary Name
names, both proprietary and (INN). The USAN and the INN for a
nonproprietary, and whether they are chlorpormazine and chlorpropamide drug may be identical; however, the
likely to cause prescribing errors. A should be written chlorproMAZINE INN refers only to the active drug
written report is forwarded to CDER, compound, whereas the USAN
which approves or disapproves the
and chlorproPAMIDE” includes reference to the chemical
trademark. If approved, another form of the drug product, such as a
review is conducted at ninety days salt or ester of the active drug
prior to final approval of the drug to compound. Thus, the USAN may
check for confusing similarity with any which have raised concern include have an additional expression such as
trademarks approved by CDER since the first CELEBREX, CELEXA, and CEREBYX; “hydrochloride” or “sodium” or “maleate” that
review. An appeal process is available for cases NARCAN and NORCURON; FLOMAX and is not part of the INN for the same drug. The
where the proposed trademark is rejected. FOSAMAX. In some cases, the standards for World Health Organization (WHO)
The process of FDA review of confusing similarity of the PTO and the FDA administers the INN Council and is
pharmaceutical trademarks is authorised by are not the same. For example, the PTO responsible for approving INNs. Its goals are
federal regulation 21 C.F.R. §201.10, which is found LAMICTAL not confusingly similar to to improve the safety and usefulness of
primarily concerned with drug labelling. LAMISIL, yet the FDA documented 22 cases nonproprietary drug names. The USAN and
Paragraph (c) of that regulation states that the of erroneous prescriptions, resulting in INN councils are responsible for creating and
labelling of a drug may be misleading if a seizures in three patients, and leading to maintaining standard naming practices,
proprietary name is used “to imply that the suggestions for a label change for particularly the use of common stems for
drug or ingredient has some unique LAMICTAL. drugs sharing a common mechanism of action.
effectiveness or composition” or if a They also strive to avoid confusion with other
proprietary name “because of similarity of The rationale for nonproprietary names generic names or trademarks, and to avoid
spelling or pronunciation may be confused Nonproprietary drug names offer standard names that would be confusing or offensive in
with the proprietary name or the established names for use during clinical studies as well as another language.
name of a different drug or ingredient.”7 the names used commercially by generic
A good example of a case in which the FDA manufacturers after patent protection expires. Obtaining nonproprietary drug names
disapproved a proposed name based upon its Nonproprietary names are very useful during In the United States, the USAN Council is the
implied efficacy is the FDA’s disapproval of the clinical trials, because they avoid confusion starting point for obtaining a nonproprietary
name REGAIN as proposed by Upjohn to when using a new drug, where no brand is drug name.9 The USAN list of approved
identify a hair growth preparation. The FDA established, clinicians and patients lack stems for nonproprietary names should be
argued that the mark would imply that users familiarity, and the regulatory authorities of consulted to identify the appropriate stem for
would “regain” their hair, a result the FDA several countries may be involved. the category, and if relevant the subcategory,
concluded was not supported by the Nonproprietary or generic names for of drugs to which the candidate drug belongs.
manufacturer’s studies. Upjohn thereafter pharmaceuticals are built of two main parts: a Once the proper stem is identified from the
changed the mark to ROGAINE. generic stem that denotes the class of drug approved list, a prefix is added to create the
Generally, it is advisable to select a and a prefix that is specific for a single candidate USAN. The choice of prefix should
proprietary name that is not too similar to chemical entity. Thus the full nonproprietary be carefully considered, as this is the part that
either a nonproprietary name or a stem for name, while “generic” in its purpose, is has the potential to cause rejection of the
nonproprietary names, or even to a scientific actually unique. However, nonproprietary USAN application. The prefix, together with
name which may later be chosen as a names for drugs belong in the public domain, the stem, should not overtly suggest

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PHARMACEUTICAL TRADEMARKS Building trademark expertise since 1986

functionality, chemical structure, or any
proprietary name in use worldwide. The time
for submitting a USAN application is after the
filing of an IND application for the drug, and
preferably before the initiation of Phase II or
Phase III trials. The application requires
providing the IND number, the chemical
structure and Chemical Abstracts Service
(CAS) Registry Number,10 a description of the
pharmacologic and therapeutic use, a
description of searches performed of
trademarks and other nonproprietary names,
and a fee11. The sponsor may submit up to
three names, which will be considered in order
of the sponsor’s preference. Once a name is
found acceptable, then the remaining names
will not be considered. The entire process for
USAN and INN approval requires at least
several months, depending on the meeting
cycle for the USAN and INN councils. The
USAN Secretariat should be contacted for
meeting date information.
Following receipt of the USAN application,
USAN staff will research the application and
present it to the USAN Council. If the Council
approves the name, the sponsor is contacted to
approve further consideration of that name for
the INN. If the sponsor’s entire list of
suggested names are rejected, then the
Council may make a suggestion for an
alternative name. The sponsor or its
representative may negotiate with the
Council, through USAN staff, towards
acceptance of a name.
Once an acceptable name has been selected
by the USAN Council and approved by the
sponsor, USAN staff will prepare and submit
the INN application to the WHO INN
Council. If the name is rejected by WHO, then
USAN staff will work with the sponsor to
suggest an alternate name. After the INN is
approved by WHO, then USAN will notify the
sponsor that the name has been formally
accepted; only after receipt of the formal
approval letter from the USAN Council is the
sponsor entitled to use the USAN.
USANs and INNs are published following
approval. The sponsor is given 60 days after
USAN approval to request an optional 6-
month stay of publication. If no stay is
requested, the USAN, including the chemical
structure and CAS Registry number, is
published on the USAN web site as well as in
the USP Dictionary and the CAS Registry.
The INN is published somewhat later, at
about six months following approval,
initially as a proposed INN, and following a
four-month comment period, as a
recommended INN. In rare instances, the
USAN, and/or the INN may have to be
changed following publication, as a result of
third party objections.
While the reliance on common generic
naming stems for drugs with related activities
makes sense for a lot of reasons, it can lead to
confusion in some cases. CDER has
encouraged manufacturers to use “Tall Man”
letters to distinguish drugs with closely
related USANs.12 For example, under
CDER’s recommendation, chlorpormazine
and chlorpropamide should be written
chlorproMAZINE and chlorproPAMIDE.
This approach accomplishes for
nonproprietary names what labeling
approaches can accomplish for trademarks.
A trademark professional’s understanding
and appreciation of the nuances associated
with clearing and protecting a chosen
pharmaceutical trademark, and of the
regulatory logistics associated with securing
the ability to use a pharmaceutical product
name, is important in minimising the bumps
in the road to establishing a successful
pharmaceutical brand. K
Notes
1 http://www.fda.gov/cder/handbook/
mederror.htm
2 See, e.g, Morgenstern Chemical Co. v. G. D.
Searle & Co., 253 F.2d 390 (3d Cir. 1958).
3 Eli Lilly & Co. v. Natural Answers, Inc., 233
F.3d 456 (7th Cir. 2000).
4 Kos Pharmaceuticals, Inc. v. Andrx
Corporation, 369 F.3d 700 (10th Cir.
2004).
5 See, e.g., Pfizer Inc. v. YSK Shipping &
Trading Inc., 70 USPQ2d 1592 (E.D.N.Y.
2004).
6 S. Rep. No. 515, 100th Cong. 2d Sess. 44-
45 (1988).
7 21 C.F.R. §201.10 (c)(3) and (c)(5).
8 The nonproprietary name for a drug can
theoretically be registered as a trademark if
the registration is made prior to the drug
being used under the nonproprietary
name; however, such a trademark is not
likely to pass FDA scrutiny.
9 For information on the USAN Council
and submission of a USAN application,
see http://www.amaassn.org/ama
/pub/category/2956.html. The USAN list
of approved stems can be found at
http://www.amaassn.org/ama/pub
/category/4782.html. The USAN
application form can be found at
http://www.amaassn.org/ama/pub/
category/13296.html.
10 For a new compound, the CAS Registry
number must be obtained from CAS, a
process that can take several weeks.
11 The application fee for USAN is currently
$10,000. When the application is
forwarded by USAN to WHO for INN
approval, an additional fee is due, which is
currently $6,000.
12 See www.fda.gov/cder/drug/MedErrors
/nameDiff

About the authors

Patrick Concannon (near left) Edwards Angell Palmer & Dodge. Pat focuses his practice on U.S.
and international trademark clearance, portfolio management, and protection. He represents
companies in trademark, domain name, and copyright dispute proceedings, including
Trademark Trial and Appeal Board and domain name arbitration proceedings, and in
negotiating settlement agreements in these areas.
Dr Lin Hymel (far right) Edwards Angell Palmer & Dodge has over seven years experience in
intellectual property law, with emphasis on preparing and prosecuting patent applications in
the area of biotechnology and pharmaceuticals. Lin also specialises in counselling clients in
the analysis of freedom-to-operate, patentability, invalidity, and non-infringement, and he has experience in IP due diligence for
corporate business transactions. Prior to his legal experience, Lin served as a scientific review administrator at the National
Institutes of Health.

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