Pharmaceutical Trademarks:
Likelihood of Confusion vs. Likelihood of Harm

Oftentimes consumers purchase the wrong product because they were confused by the product’s name or packaging. Although this may cause some aggravation, has it really caused any harm? What if the product they mistakenly purchased meant the difference between life and death? This is the reality when dealing with consumer confusion associated with pharmaceutical trademarks that are similar.

Human nature has evolved with industry’s need to distinguish itself from the rest of the pack. Whether it is clothing, electronic devices or automobiles, the fact is brand names do matter. We don’t just walk into a department store to buy a shirt, rather it is the embroidered emblem that suits our fancy. Likewise, our technology bug is more specific than a simple abacus. Amongst many other examples, today’s choice of an automobile is not as simple as the days of the Model T. With this reality, trademark law in the United States has developed significantly since the industrial revolution.

Although the owner’s right to a trademark is of concern under United States trademark law, the Lanham Act’s express purpose has been to protect the public. Protection of the public takes on even a greater meaning, however, when more than just one’s image is at stake. When the product at issue has a direct effect on the health of an individual, such as pharmaceutical products, the selection of a name for the product could be of dramatic or traumatic significance.

To protect the public, pharmaceutical trademarks must withstand heightened scrutiny. This has resulted in what is called the “doctrine of greater care.” Not only are trademarks reviewed by the U.S. Patent and Trademark Office (USPTO) during the federal registration process, they are also reviewed by the FDA. The dual review process of pharmaceutical trademarks by both the FDA and the USPTO may appear to overlap. However, a more careful reading of the statutes involved demonstrates that the USPTO regulates the registration of trademarks for drugs while the FDA regulates the use of trademarks for drugs. At the same time, conflicts do arise under the dual system. For instance, the USPTO has generally followed a “first to file” policy, whereas, the FDA has generally followed a “first to receive approval” policy.

The USPTO prohibits the registration of any mark that so resembles a mark of a senior user, thereby likely to cause confusion. The USPTO only searches its own database of federal registrations and applications for confusingly similar marks. In making its determination as to whether a trademark should be allowed, the USPTO applies a number of factors, including: (1) similarities in sound; appearance, connotation, and commercial impression; (2) similarities in the goods or services with which the marks are used; (3) similarities in the established and likely-to-continue trade channels; and (4) conditions under which and buyers to whom sales are made, that is, impulse versus careful, sophisticated purchasing by ordinary versus educated consumers.

There are a number of instances where the USPTO has found pharmaceutical trademarks to be confusingly similar. Examples of such include Nicostatin for hyperlipidemia and Mycostatin for an antibiotic preparation; Paxetol for cancer treatment and Paxil for an antidepressant; Premarin for menopausal conditions and Presamine for an antidepressant; and Nalex and Nolex, both used as nasal decogestants.

The FDA applies a different set of standards to determine whether the drug name may be misleading. According to FDA standards, a drug name may be misleading if it designates a “drug or ingredient by a proprietary name that, because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient.” The FDA also regulates the use of pharmaceutical names that are deceptive or misleading in connotation. Perhaps the most famous of these examples involves the trademarks for the hair regrowth product known worldwide as both Regaine and Rogaine. After finding that the clinical data did not support the company’s inferences of “regaining” hair, the FDA objected to the use of the trademark “Regaine”. The company, in turn, changed the name to Rogaine in order to appease the FDA.

With this dual review process, pharmaceutical companies are faced with a more difficult task of selecting an appropriate name for a drug. To assist pharmaceutical companies in the selection of a trademark, a number of private companies now offer searchable databases directed solely to the pharmaceutical industry. Thomson & Thomson, for example, offers a service called “Full Pharmaceutical Search” that covers not only Federal, State and Common Law trademarks and domain names, but also non-trademark data pertaining to pharmaceutical trademark decisions. The availability of these resources should provide pharmaceutical companies with the ability to select a trademark that will not only survive the dual review process, but also protect the public.

© HASEEB R. JABBAR, 2003