Mind Your Xs and Zs: Are These Letters Too Common in Pharmaceutical Trademarks?

by Foley Hoag LLP - Trademark, Copyright & Unfair Competition

x and zAn interesting debate recently occurred in the New England Journal of Medicine between a physician and the U.S. Food and Drug Administration (FDA) regarding whether the letters X and Z are used too frequently in pharmaceutical trademarks.

As most of our readers are well aware, the touchstone of whether any two trademarks can coexist in the U.S. — on the United States Patent and Trademark Office (PTO) registers and in the marketplace — is “likelihood of confusion.”  The question, to put it simply, is whether the relevant consumers for a given product or service are likely to be confused as to source, sponsorship, or affiliation by virtue of a trademark’s similarity to another trademark. 

To evaluate whether confusion is “likely,” courts and the PTO evaluate a number of factors, including the similarity of the marks (appearance, pronunciation, and overall commercial impression), the relatedness of their respective goods and services, the similarities of their customers and trade channels, and the existence of actual confusion.  Needless to say, application of the relevant likelihood of confusion test (which varies, to some extent, depending on the forum) is intensely fact-specific, shifting to emphasize different factors depending on the types of goods and services and the relevant industry or field.

Confusion in the Pharmaceutical Context

When evaluating pharmaceuticals or other medicinal products, the PTO tends to apply a stricter likelihood of confusion analysis, stemming from the fact that customers — healthcare providers, pharmacists and, ultimately, patients — have much more to lose when it comes to medicine.  A consumer that purchases a vacuum under the mistaken belief that it comes from a certain manufacturer has still purchased a vacuum, whereas a pharmacist that mistakenly prescribes amphetamines instead of similarly-named beta blockers for high blood pressure has made a grave error, with dire patient safety implications.

Not surprisingly, the FDA, which must approve the names of all pharmaceuticals before they enter the marketplace, has additional naming guidelines that go above and beyond likelihood of confusion standards, such that two trademarks that could happily coexist under a traditional trademark analysis might be conflicting in the FDA pharmaceutical approval context.  For example, the FDA scrutinizes phonetic and orthographic similarities, including appearance in handwriting, as the relevant customers are likely to encounter the names in a number of special circumstances (e.g., shouting for a certain IV-delivered medication above the din of emergency surgery, or interpreting a hastily scribbled prescription).

Beyond the stricter scrutiny with regard to possible confusion with other proprietary drug names, the FDA guidelines prohibit names that misleadingly imply unique effectiveness or composition, overstate product efficacy, minimize risks associated with the product, suggest broader uses than the approved indications, make unsubstantiated claims of superiority, improperly suggest dosage, or bear similarities to or incorporate generic-name stems.  Naturally, the combination of these prohibitions (a marketing department’s nightmare) and the increased scrutiny with regard to possible confusion with other pharmaceutical names make pharmaceutical brand clearance a long, arduous, and expensive process — and that’s just in the United States.  A foreseeable side effect of this process is that pharmaceuticals tend to launch with names that  are entirely fanciful and uniquely spelled.

A Perceived Abundance of X and Z

A recent Letter to the Editor in the New England Journal of Medicine from oncologist and Harvard Medical School Professor Marc B. Garnick, M.D. laments this situation, and specifically “manufacturers’ insatiable proclivity to include the letters X and Z” with respect to several new drugs approved for the treatment of prostate cancer, which he believes will “undoubtedly lead to confusion both by the physician prescribing and the pharmacy dispensing these agents.” (The specific drugs referenced are Zometa, Xgeva, Zytiga, Xtandi, and Jevtana.)  Garnick suggests that manufacturers consider incorporating “unique and distinguishing portions” of the relevant generic names in creating new pharmaceutical names.

In reply, Kelly A. Taylor and Carol A. Holquist of the FDA explained that this “insatiable proclivity” is illusory, and that only about 2% of the more than 6,000 approved drug names begin with X or Z and, indeed, “[s]election of infrequently used letters is prudent, provided the names are uniquely constructed. Discouraging manufacturers from incorporating the letters X and Z unnecessarily restricts name possibilities.” With respect to use of generic names or portions thereof in pharmaceutical marks, this “may be counterproductive to preventing confusion and errors” because generic names “convey information about the chemical or pharmacologic properties of the drug” which could result in greater similarity between brand names for a particular pharmaceutical formulation. 

In response to the FDA, Garnick notes that in his particular sample for prostate cancer, 80% of the names begin with X and Z.  (It stands to reason that the percentage of pharmaceutical trademarks generally that prominently include X and Z anywhere in the mark is much higher.)   While Garnick sticks to his guns, he diplomatically gives a nod to the FDA, specifically commending the FDA “for providing a mechanism for clinicians to bring forth safety concerns about drug nomenclature” and noting that this collaborative effort “should minimize the possibility of medication errors stemming from confusing and suboptimal names.” 

A Trademark Practitioner’s Perspective

Having reviewed my fair share of pharmaceutical name clearance search reports, I can attest, anecdotally, that the letters X and Z do indeed seem to show up frequently.  More to the point — and maybe this is what Garnick was getting at — it sometimes seems that the FDA’s strict name review gauntlet has created its own language: a body of pharmaceutical names so uniquely pharmaceutical in nature so as to become “indistinguishably distinctive.”  To the extent that pharmaceutical companies are being pushed towards the adoption of random strings of letters devoid of any particular commercial impression, one might legitimately ask whether such a system is more or less likely to cause confusion among prescribing physicians, pharmacists, and consumers. The fact that physicians themselves are raising the issue in the pages of premier medical journals certainly gives one food for thought. 

There are other good reasons for the FDA to revisit its naming procedures.  According to some estimates, approximately 40% of drug names are rejected by the FDA.  This is a surprisingly high figure, particularly taking into account that, in most cases, pharmaceutical companies have spent substantial resources to “clear” the name from a trademark and regulatory perspective before submitting the name to the FDA in the first place.  The high incidence of rejection has been a source of great frustration to companies seeking to launch a new drug, as has the timeline for the FDA’s review, which does not allow for the final approval of the name until immediately before launch.

While there are no easy answers to these questions, it is an interesting and important dialogue with significant implications for patient safety as well as trademark policy.  Let’s hope the Garnicks of the world continue to pay close attention to the impact of drug naming policy in the real world and inform the debate.

Photo courtesy of e-Magine Art.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Foley Hoag LLP - Trademark, Copyright & Unfair Competition | Attorney Advertising

Written by:

Foley Hoag LLP - Trademark, Copyright & Unfair Competition

Foley Hoag LLP - Trademark, Copyright & Unfair Competition on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.