Aspects of pharmaceutical trade marks

After choosing potential names for a new pharmaceutical product and conducting global trade mark searches, pharmaceutical trade marks must secure both regulatory and legal approval.

This is an extremely challenging process, which is time-consuming and expensive.

Pharmaceutical trade marks require regulatory approval before the product can be sold under the name. The relevant agency in the UK is the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is concerned with protecting patients since brand confusion in this sector presents potential health risks. The test for whether a name can be approved by the relevant agency is whether (i) it will cause confusion with the name of an existing medicine; (ii) it is misleading as to the composition of the product or use; or (iii) it is otherwise unsafe.

The regulatory assessment is entirely independent of the examination undertaken by the UKIPO as to whether a trade mark is acceptable for trade mark registration. The UKIPO will reject a trade mark application if it considers the mark descriptive or non-distinctive. Once accepted, the mark is published for opposition by third parties, and so care must be taken with pre-filing searches in order to avoid conflict with earlier trade marks. 

Top Tips

• Begin the naming process as early as possible, preferably at the start of phase II clinical trials, with the objective of having a distinctive, invented brand name capable of global protection. It is not unusual to have 200+ names for pre-screening in order to produce one trade mark plus two backup marks. Screening searches should knock out marks which face clear obstacles in key territories. Those that survive will then undergo full legal availability searches, including ‘pharma in use’ searches in all territories where commercialisation of the product is likely.
• Apply to register your candidate trade marks at the UKIPO when you are reasonably sure that clinical trials will be concluded. Ideally, trade mark applications should be filed prior to the submission of marketing authorisations.
• Secure approval of the candidate names by the appropriate body regulating medicines in the relevant country, i.e. the MHRA in the UK (EMA in the EU and FDA in the US). Marketing authorisations are usually applied for during phase III clinical trials. Since the rejection rate of candidate names is typically around 50%, it is vital to have one or two backup names to fall back on.