Medical Device Link.

Originally Published PMPN December 2003

Brand Matters

Kathleen  Gallagher-Duff

Have you ever gotten a prescription from your doctor that you couldn’t read? Wondered how your pharmacist could decipher your doctor’s handwriting? Worried that your pharmacist might misinterpret your doctor’s handwriting and give you the wrong medicine?

You are not alone, and you may be in the company of some of your consumers. FDA and the United States Patent and Trademark Office (PTO) worry about these things, too. And that’s why branding and marketing professionals have to be particularly careful in selecting brand names for pharmaceuticals. How can your firm avoid the pitfalls associated with the regulatory review of pharmaceutical brand names by the PTO and FDA? 

First, select a name not confusingly similar to an existing one. To do otherwise risks myriad obstacles for the brand-name owner. These include failure to obtain federal trademark registration and FDA approval to use the name. There is also risk of expensive litigation involving trademark infringement and other claims.

In assessing whether there is likely confusion between brand names under trademark laws, courts and the PTO consider a number of factors. These include the similarity between the marks in sound, appearance, and meaning; the similarity of the products; and the degree of care likely to be exercised by consumers.

The consequences of confusion with drug names can be disastrous, including physical injury to consumers. So, many courts and the PTO require less evidence of likely confusion for pharmaceutical and other medicinal products. For example, the name Herb-rozac for an herbal dietary supplement for mood elevation was found to infringe upon Prozac, an antidepressant prescription drug. Similarly, Dermostat, for treatment of wounds, and Dermostar, for acne, were deemed confusingly similar, as were Nalex and Nolex for nasal decongestants. 

Second, be aware of FDA requirements for new drug names. FDA can refuse approval of a new drug application (NDA) if the proposed drug name is confusingly similar to an existing or approved drug name in spelling or pronunciation. And FDA could require a name change after it has approved an NDA if market conditions indicate that medication errors are likely. 

FDA’s multifaceted review process, currently in flux, has included handwriting and verbal analyses to determine whether confusion is likely in visual appearance and pronunciation. Computer-assisted analysis has been used to identify potential sound-alike and look-alike proprietary names. And other risk factors have been evaluated, such as whether the drugs will be stored in the same areas and distributed to the same patient population. 
FDA, for example, recently rejected the drug name Odesa because it found it similar in look and sound to Adoxa. FDA found that the drug names each contained the same number of letters and three similar-sounding syllables and that several letters in each name looked similar when written (e.g., “A” versus “O”). 

FDA can also refuse approval of a pharmaceutical brand name if it is misleading. In a well-known case, FDA refused to approve the drug name Regaine for a hair-loss product. It believed that the name too strongly suggested than anyone who used the product would “regain” hair. Hence, the name was changed to Rogaine. 

Third, be sure to conduct a thorough trademark clearance search that is especially tailored for pharmaceu-tical brand names. Pharmaceutical trademark searches should include specialized pharmaceutical sources such as medical abbreviations and common prefixes and suffixes listed with the World Health Organization.

Finally, many pharmaceutical companies compete in the global marketplace. Keep in mind that the same issues affecting pharmaceutical brand names under U.S. trademark law and FDA regulations may also exist in foreign countries. 

Copyright ©2003 Pharmaceutical & Medical Packaging News