Pharmaceuticals

Pharmaceutical name clearance in the United States can be complicated.   This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names.  This information will allow drug manufacturers to make more informed decisions during the pharmaceutical name selection process so that they can arrive at a viable name, and get to market, more quickly.

Dual Tracks: FDA and PTO

A pharmaceutical manufacturer that seeks to use and register a new drug name in the United States must submit the candidate name to not one, but two, federal agencies: the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (PTO).  While both federal agencies aim to improve consumer safety by reducing the risk of consumer confusion between conflicting drug names, each agency looks at a different set of data to make its determination.  The approval of a drug name by one agency has no bearing on the evaluation or approval of that name by the other agency.  In addition, while PTO approval of a drug name is important, FDA approval is essential – without it, the product simply cannot be marketed in the U.S. under that name.

FDA Review

As part of the FDA’s overall evaluation of a new drug, the agency assesses the manufacturer’s proposed “proprietary name,” or trademark, for safety risks.  The primary safety risk associated with a drug name is the risk of medication error.

A medication error can occur at any point along the distribution chain – by doctors writing the prescription, pharmacists filling the prescription, or patients or health care providers administering the drug.  A medication error can also occur for a variety of reasons.  Perhaps the drug name suggests the frequency of administration which could conflict with a doctor’s instructions.  Consider a doctor that prescribes a hypothetical drug called XyzOnce for use twice a day.  Will some patients be confused about how often to take the drug?  Or perhaps the new drug name suggests the route of administration.   If a patient receives a medication in liquid form called XyzOra, will the patient automatically assume that it is intended for oral ingestion?  This could cause serious adverse consequences if the drug is, in fact, designed for topical administration.  One important way the FDA seeks to reduce medication errors is to evaluate a new drug name to determine whether it looks or sounds too much like an existing drug name and whether that similarity – combined with similarities in the product characteristics – creates an undue safety risk that requires rejection of the candidate drug name.

“Look Alike” Concerns

The driving question for the “look alike” evaluation is whether two names will look similar when handwritten or entered electronically into a prescription.

The FDA considers spelling similarities such as whether two names share identical prefixes, suffixes, or infixes, and whether the names are a similar length.  The FDA also considers the overall “shape” of the words.  Do both names have similar looking letters in similar positions in the names – including “tall” letters (“l” “t” “f”), “round” letters (“o” “a” “c” “e” “u”), cross-stroke letters (“T” “Z” “F” “J” “I”), or down-stroke letters (“v” “r” “n” “u”)?  The FDA will balance these factors, along with an analysis of the phonetic similarities, to determine the overall similarity between two drug names.

“Sound Alike” Concerns

The driving question for the “sound alike” evaluation is whether two names will sound similar when spoken.  What does the patient hear when the doctor tells him what medicine he has to take – and what does he repeat to the pharmacist?  What does the pharmacist hear on a recorded voicemail or over a poor telephone connection?  The FDA considers, among other factors, the number of syllables in the names, the placement of vowel sounds, consonant sounds, and stresses, and the placement of common sound alike letters.  For example, the sound produced by “t” may be similar to the sound produced by “d” or “k”.  The sound produced by “b” may be similar to the sound produced by “p” “v” or “d.”

Evaluation Process

To evaluate each new drug name, the FDA convenes an expert panel that reviews both objective and subjective criteria.  To obtain an objective assessment of the similarity of two drug names, the FDA runs the new drug name through its Phonetic and Orthographic Computer Analysis (“POCA”) database.  The POCA database evaluates the candidate name against all active drug names in the U.S. market.  The database assigns a percentage evaluation, ranking the new drug name on phonetic similarity, orthographic similarity, and an average of the two.  Any ranking of 70% or higher will invite additional scrutiny by the agency.  The FDA also conducts prescription simulation studies in which it asks volunteers to write out prescriptions, read handwritten prescriptions, and listen to voicemail recordings for the new drug name.  The agency then analyzes the results to see what types of mistakes were made and how often.  Safety evaluators assemble all the available data on whether the candidate name is likely to be confused with existing names, compares the product characteristics of the drugs to determine whether they have similar indications, dosages, administration methods, or storage requirements, which would increase the risk of medication errors, and make overall determinations as to whether the candidate name is likely to pose safety risks due to possible confusion with existing names.

PTO Review

When the PTO receives a new trademark application for a pharmaceutical product, a PTO attorney will evaluate the application to determine whether the new trademark is inherently registrable, whether the new trademark conflicts with a prior trademark application or registration, and whether the trademark application complies with the PTO’s rules.

Inherent Registrability

For a mark to be “inherently registrable” it must be distinctive enough that consumers will perceive it as a brand name instead of a description of the underlying product.  For example, consumers would be likely to perceive the hypothetical name “Cancer Drug” as merely describing what the product is (a drug to treat cancer) rather than as a brand name that identifies the manufacturer.   The PTO would likely refuse this type of name on the basis that it is “merely descriptive.”

The PTO also prohibits registration of names that are “deceptively misdescriptive.”  For example, consumers would be likely to perceive a drug called “Anti-Cancer” as being indicated for use as a treatment for cancer.  That name would be “deceptively misdescriptive” if the drug were actually indicated for use as an insomnia treatment, not a cancer treatment.  The PTO would thus bar registration of this name for insomnia treatments.

Conflict with Prior Marks

The PTO also evaluates new trademark applications to determine whether the trademark is likely to cause confusion with a mark in a prior registration or pending application.  Due to the risk of consumer harm arising out of confusion between drug names, the PTO rules impose a stricter standard on trademark applications covering pharmaceuticals than on applications covering other types of goods, and less proof is required for the PTO to refuse a pharmaceutical application based on likelihood of confusion.

Unlike the FDA which looks at potential confusion between the candidate name and all approved brand names and generic drugs in the U.S. market, the PTO looks only at potential confusion with trademarks that are covered by an active U.S. application or registration.  The PTO analyzes the risk of confusion based on a number of non-exclusive factors including, among others: (i) the similarities of the trademarks in terms of appearance, sound, meaning, and overall commercial impression, (ii) the relatedness of the goods, (iii) the similarities in the target consumers, (iv) the similarities in the trade channels, (v) whether purchases are made on impulse or after careful consideration, and (vi) the number and nature of similar marks used on similar goods.

The first two factors are typically the most important and they operate on a sliding scale: the more similar the marks are, the less similar the goods must be for the PTO to find a “likelihood of confusion.”  The PTO considers the overall visual, phonetic, and conceptual impression created by two trademarks; it does not do a letter-by-letter analysis like the FDA.  Similarly, in evaluating the similarity of the goods, the PTO is bound by the description of goods identified in the respective trademark filings.  Unless the description of goods in a trademark filing specifies a mode of administration (i.e., “by injection”) or a specific trade channel (i.e., “administered by health care professionals in a clinical setting”), the PTO will not consider such distinctions in evaluating the relatedness of the goods.

Compliance with PTO Rules

To proceed to registration, a trademark application must also comply with a number of technical rules at the PTO.  Two rules that can trip up pharmaceutical trademark applicants are the rules to identify the goods with “particularity” and the rules to show use of the mark in commerce.

The PTO requires that trademark applicants specify the nature and purpose of the drug.  In other jurisdictions, the description “pharmaceutical preparations” may be acceptable, but the PTO requires more specificity, such as “pharmaceutical preparations, namely, anti-depressants.”  It is possible to register similar marks for pharmaceuticals covering unrelated indications.

The PTO is relatively unique in that it requires proof that a trademark has been “used in commerce” prior to issuance of a registration.  In the pharmaceutical context, shipments of branded drugs to clinical investigators during the regulatory approval process is considered “use in commerce.” Trademark applicants that file a U.S. application through the Madrid Protocol or based on a registration in the applicant’s home country are not required to submit evidence of use prior to issuance of a registration.

Practical Tips

To streamline the process to regulatory approval and trademark registration for a candidate drug name, pharmaceutical manufacturers may consider adopting the following practices:

  • Start the name clearance process as early as possible to leave sufficient time to conduct preliminary trademark clearance searches, full trademark clearance searches, and to file trademark applications prior to submitting the name for regulatory approval.
  • Have many backup names comprised of a variety of prefixes, suffixes, and infixes, to reduce the risk that a particular prior mark would block multiple candidate names. It is not uncommon for pharmaceutical manufacturers to start with a list of more than 20 candidate names.
  • Consider repurposing a name that was cleared for a prior drug, but not utilized.

For more information, please contact the author at kcalifa@foley.com or (202) 672-5319.