Companies developing pharmaceutical products know the importance of selecting and clearing a trademark early in the development cycle. However, did you know that the U.S. Food and Drug Administration (FDA) can object to a trademark while the product is before the agency for approval, or even after approval? Such objections can arise independently of any U.S. Patent and Trademark Office (PTO) objections, and even if your mark is already federally registered.
The FDA has authority to take actions which avoid the use of false or misleading labels for drugs. The FDA's Labeling and Nomenclature Committee (LNC) was created to facilitate trademark review for products (and their labeling) brought before the FDA for approval. The LNC acts as an internal consulting committee, making recommendations to the reviewing divisions of the FDA upon request. The committee consists of seven voting members and two ad hoc members who collectively provide a broad range of health care and FDA experience.
The LNC is primarily concerned with avoiding mistaken use of a pharmaceutical product resulting from trademark confusion. When determining whether an objection may be appropriate, the LNC considers a wide range of information. These considerations are quite different than the "likelihood of confusion" analysis used in the PTO. As part of its review, the LNC will examine how a trademark will appear on the label and the dosage form, regimen and indications for the product on which the mark will be used.
For example, the FDA objected to the use of the mark "Regaine" as applied to a hair growth preparation, arguing that the mark would suggest that users would "regain" their hair, a result the FDA felt was beyond the manufacturer's supporting studies. The mark was ultimately changed by Upjohn to "Rogaine."
While the FDA may object to the use of a mark because it suggests performance or efficacy beyond that achieved in supporting studies, the FDA's primary concern is safety: when a doctor scribbles the mark, might it appear similar to the name of another drug? Does the mark incorporate prefixes or suffixes commonly used with other drugs, which other drugs might then be used by mistake? Manufacturers will want to look hard at these questions when considering whether a particular trademark is the right one for their product.
Additionally, companies can influence the timing of trademark review at the FDA. Evaluation of a trademark can be requested when a new drug application is submitted or even earlier. This means that any concerns can be dealt with before the company has fully committed to the trademark, or at least in time for the company to consider alternative marks if problems arise.
Remember that the PTO is not the only "gate-keeper" for a pharmaceutical trademark. It is reported that about 25% of trademarks reviewed by LNC raised concerns, and about 10% are found unacceptable. Delays due to FDA trademark objections can be minimized by considering the types of concerns which could be raised by the FDA early in the trademark selection and clearance process. Once a mark is selected, a request for early trademark review by FDA can also avoid delays in approval and product launch.