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Legal context This article highlights the difficulties in advising pharmaceutical clients on the selection and protection of trade marks given the dual trade mark approval process required by both the U.S. Patent and Trademark Office (PTO) and the U.S. Food and Drug Administration (FDA). Specifically, the article points out the inconsistencies between the different tests and procedures used by the PTO and FDA to evaluate and approve proposed pharmaceutical trade marks. Key points The PTOs trade mark examination focuses on (1) the inherent distinctiveness of the mark, and (2) a likelihood that the mark will be confused with a pre-existing trade mark. In contrast, the FDAs trade mark examination process focuses on (1) whether the trade mark conveys a false or confusing meaning to consumers, and (2) whether there exists another “sound alike/look-alike” pharmaceutical trade mark that could lead to prescription/dispensing errors in the marketplace. The application of the PTO and FDA examination tests and procedures often leads to different conclusions by the two agencies as to whether a particular trade mark is approved for use and registration. Moreover, the PTO and FDA each use a different method to determine which trade mark applicant has prior rights to a given trade mark. If the two agencies reach different conclusions as to which applicant has the prior rights to a given trade mark, there is no existing legal mechanism to reconcile/adjudicate these conflicting conclusions. Practical significance Trade mark practice in the pharmaceutical field must be adjusted to consider the FDAs specific examination tests and procedures alongside the traditional PTO analysis. Moreover, practitioners should also encourage pharmaceutical clients to submit multiple proposed trade marks for clearance and approval so that there will be multiple options should the trade mark preferred initially be rejected by either the PTO or FDA.