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An 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.