This article first appeared in Pharmaceutical Trademarks 2015/16: A Global Guide, a supplement to World Trademark Review, published by Globe Business Media Group-IP Division. To view the guide in full, please go to www.worldtrademarkreview.com.
Selection, clearance and registration A drug name can be registered as a trademark in advance of its approval by the Food and Drug Administration (FDA). An application for registration at the US Patent and Trademark Office (USPTO) can be based on intent to use a trademark or use of the mark in clinical trials, or ownership of a foreign trademark application that matures into a registration. Foreign applicants should keep in mind that a US application should include only those goods for which they actually use or have a good-faith intent to use the mark in US commerce. It is not permissible to claim simply “all of Class 5”, and it is unlikely that the same mark would be used for products that both treat children’s colds and kill vermin.
While registration is an important step, it has no bearing on FDA approval. The FDA’s review of a proposed drug trademark is complex and fraught with potential risks. The rejection rate is high and even if a name is tentatively approved, there is no guarantee that the name will ultimately be approved if a subsequent product is authorized for marketing first.
In May 2014 the FDA released draft guidance on best practices for developing pharmaceutical trademarks. The draft guidance gives drug makers valuable insight into how the FDA scrutinizes proposed trademarks so that manufacturers can choose names with a better chance of FDA approval. The draft guidance complements the FDA’s 2010 final guidance on information required in an application for name approval.
Rationale for FDA involvement: preventing medication errors Three billion retail prescriptions are sold annually in the United States, and there are an estimated 1.3 million injuries from medication errors each year. About 12.5% of medication errors are attributed to confusion between drug brand names by healthcare professionals.
The FDA Division of Medication Error Prevention and Analysis (DMEPA) is responsible for reviewing drug trademarks both before and after marketing. In reviewing names, the FDA considers whether a drug name will be confusing not only for consumers, but also for physicians, pharmacists and nurses. The DMEPA reviews all proposed names for confusing similarity to the names of other drugs or drug ingredients, including both trademarks and established or generic names.
The DMEPA typically rejects about one-third of all names reviewed in order to avoid, among other things:
names that suggest potentially exaggerated efficacy claims (eg, the hair-growth product known as REGAINE around the world is marketed as ROGAINE in the United States, as the FDA would not approve the name REGAINE since it does not work for everyone);
names that could lead to erroneous prescriptions (eg, the wrong drug or dosage); and
names that look or sound confusingly similar to other drug names (eg, while CELEBREX is an oral pain reliever, CEREBYX is an anti-seizure drug and CELEXA is an oral anti-depressant).
For a company seeking to introduce a new drug, DMEPA rejection can substantially increase time to market and threaten competitive advantage. Therefore, it is important to understand the FDA’s perspective and select names with both the FDA and the USPTO in mind.
Avoid misleading names To reduce the risk that the FDA will find a name misleading, a company should avoid:
names that refer to an inactive ingredient in a way that suggests effectiveness;
names that incorporate generic stems in the stem position;
names that imply unique effectiveness (eg, ‘Wonder’);
terms that imply maximum strength (eg, ‘Ultra’); and
‘recycled’ trademarks of discontinued products.
Avoid names risking medication errors To reduce the risk of choosing a name that the FDA will consider prone to potential medication errors, a company should avoid:
names that contain numbers that might be misinterpreted – some pharmacists have interpreted ‘Percocet 5’ to mean five tablets per dose; and
letter prefixes, suffixes and abbreviations that may have different meanings in the medical field (eg, ‘BID’, which means twice daily to pharmacists).
In general, the FDA gives greater scrutiny to the names of prescription drugs than to those of over-the-counter (OTC) drugs. Illegible handwriting on written prescriptions and mispronounced phone orders can lead to pharmacy errors. ‘XL’ in a drug name may sound like ‘SL’, which indicates ‘sublingual’ to pharmacists. With OTC drugs, prefixes and suffixes are viewed directly by consumers so there is less risk of misinterpretation by pharmacists. As a result, the FDA allowed TAGAMET HB for heartburn and PEPCID AC for acid control.
The potential consequences of a medication error are also factors in the FDA assessment. The more severe the potential consequences, the more stringent the review.
Avoid names confusingly similar to other drug trademarks The FDA regularly tests drug names by using volunteers inside the agency to help determine whether names are confusingly similar. This has led to the following guidelines to avoid names that might be confused with other existing trademarks:
Consider the sound of the name when spoken (eg, ZANTAC/XANAX).
Consider the appearance of names as printed (CELEBREX/CELEXA), knowing that the FDA may use computer technology to detect spelling and phonetic similarities.
Consider the appearance of a name as written by a physician (physicians typically write the first couple of letters of a drug name with more care than the remaining letters).
The following should also be considered:
the Rx status of the two products being compared (prescription drugs are less likely to be confused with OTC drugs);
marks that draw too heavily on the generic name of another drug; and
similarity with a company’s own drug
Confusion of a different sort can arise when a company uses multiple trademarks for two of its products with the same active ingredient. The FDA discourages this, since it may increase the risk of overdose. An exception may be made where a stigma might be associated with one drug, such as PROZAC and SARAFEM for fluoxetine.
To read the full United States chapter, click here.
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.