TTAB Says Clinical Trial Label Sufficient Specimen for Registration

On June 18, 2015, in a non-precedential opinion, the TTAB overturned the USPTO’s refusal of registration of Eli Lilly and Co.’s application for the word mark TRULICITY for diabetes treatment based upon alleged failures in the specimens submitted.

During the registration process, Eli Lilly submitted as a specimen the label applied to goods distributed in clinical trials, as follows.

The crucial wording on the label was:

Carton contains 5 syringes.  Syringe contains a 0.5mL solution for injection of Trulicity™ (dulaglutide) or placebo.

The Examining Attorney objected to the specimen contending that the mark set forth in the application was not a “substantially exact representation of the mark on the specimen” and therefore did not provide evidence of use of the mark in connection with Eli Lilly’s goods. In support of this position, the Examining Attorney argued that the term: (1) appeared as part of a sentence; (2) was represented in the same size and font as the surrounding wording; (3) was not set out from the surrounding text; and (4) was not so prominent as use that consumers will recognize it as a trademark.

The TTAB found the PTO’s objection was more accurately stated as an objection to registration on the ground that the term did not function as a trademark (i.e., a lack of “use in commerce”) rather than whether the nature of the use matched the applied-for mark or whether TRULICITY was a mark at all. In disagreeing with the PTO’s determination, the TTAB noted that (1) TRULICITY is a fanciful mark and is the only coined term in the text of the label; (2) the term appears with a “TM” symbol, indicating it is a trademark; and (3) although it appears beside other text, it would not be interpreted as merely descriptive or informational. The Board also concluded that the term’s placement immediately adjacent to the generic name of the goods (dulaglutide) would encourage the customer to associate it with the goods.

The Board also emphasized the importance of context in evaluating whether the use made qualifies as a trademark use. A particular trademark does not need to be displayed in any particular size or with any particular degree of prominence to qualify as a trademark use. Rather, the issue is whether the mark is used in a manner understood by the relevant consumers as indicating the origin of goods. Goods packaged for a clinical trials are delivered to sophisticated users such as medical or scientific professionals. In such an instance, the Board held that the critical sentence “conveys exactly the message that a trademark is supposed to convey, i.e., that the package contains Trulicity brand goods.” Though understated compared to displays in other industries such as general consumer products, “it is well within the province of [Eli Lilly] to decide how it wishes to display its mark to customers in the scientific research field.” Accordingly, the Board concluded, the term TRULICITY as used on the specimen, did satisfy the use requirements to justify registration.