Trademark Use for Clinical Trials: Be Careful How You Use Them

Posted September 19, 2019 by

Viridis Pharmaceuticals was brought to suit by third-party Hecht Pharmaceuticals for the trademark “Boswelan.” The Board of Appeal of the EU Intellectual Property Office revoked the trademark and the General Court (of the EU) upheld the revocation. Viridis argued their case to The Court of Justice of the European Union (CJEU) who also upheld the revocation. 

Hecht’s argument was that “Boswelan” was not put to genuine use in the EU within 5 years. Viridis counters that it was used in clinical trials and that its non-use, meaning commercial use, was reasonable.  The CJEU found that a medicinal product that has not been authorized in the EU cannot be used commercially. Additionally, the argument that clinical trials constituted preparation for commercial use of a trademark was shot down because they have no commercial value to the public. There is “wiggle room” left by the CJEU, however. If the time spent in clinical trials is long due to circumstances outside the trademark applicant’s control proper non-use may still be viable. In Viridis’ case the time spent in clinical trials was found to be by their own decision.  What the distinction of controllable circumstances is unclear and likely to be evaluated on a case-by-case basis. 

These conclusions are based on the specific circumstances of this case, but it does point a general direction for using a trademark in clinical trials. By their very nature, the results of clinical trials are never certain and may never result in an approved pharmaceutical product. Attaching a trademark to a product that may never exist in a saleable commercial form is a bad use of the trademark. What’s worse in this case is that Viridis entered into clinical trials three years after the registration of the trademark, meaning that the clock on proper use was already more than half up. From this it can be assumed that using a trademark at the beginning of clinical trials is also not advised as trials can go on for years and stand the risk if never progressing beyond the trail stage.

A possible better way to have used a trademark for a clinical trial was to use a freshly registered mark on nearly completed clinical trials with positive looking results. If the outlook for commercialization is good and the registration of the mark is properly timed, it may be possible to claim proper non-use if submission of the mark to regulatory bodies falls outside of the five-year proper use time-window.  

Tags:

Clinical Trial | Pharmaceutical Naming | Regulatory | Trademark

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