SEPTEMBER 2008
EU Bolar exemption is not so simple
The EU directive to introduce a US-style Bolar provision promised to harmonise the law on clinical trials. But, says Marina Barnden, inconsistent application has led to uncertainty
| One-minute read |
| The EU adopted a Bolar provision, modelled on similar legislation in the US, in 2004. The provision was designed to provide consistency in the EU on the question of what studies, trials and other acts a pharma company can undertake before a patent expires without infringing the patent. But the scope of the provision is highly ambiguous and member states have not implemented it uniformly. While the EU Bolar provision has provided a welcome degree of harmonisation for generic companies performing clinical trials within the EU, many questions remain for research-based companies as it appears that clinical trials in support of innovative marketing authorisation applications may still constitute patent infringement in some jurisdictions (such as the UK) but not in others (such as Germany and France). The European Court of Justice may be called on to bring clarity and consistency. With plans afoot to widen access to information on clinical trials in the EU, patent owners may be alerted earlier than otherwise to companies' reliance on the Bolar exemption. |
The EU Bolar provision was introduced by an amendment in 2004 to the Directive on the Community Code Relating to Medicinal Products for Human Use 2001/83/EC (the Medicinal Code). As patent law largely remains within the prerogative of EU member states, the introduction of the exemption under cover of the regulatory pharmaceutical regime has posed difficult questions of interpretation. In addition, member states have not adopted a uniform approach to the implementation of the exemption into national law, which means that its scope is uncertain.
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