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ISSUE 1 2014 MASCHIO & SOAMES IP LTD As so often with European legislation, there have been inconsistencies in the application of the Directives. The following are two recent developments in this fast-moving area of the law.
United Kingdom – Extension of Scope of the Bolar Exemption
Some EU countries, including Germany, France, Switzerland and Italy, have implemented the Directives so as to exempt trials carried out for authorization of any medicinal product in any country. So, for example, trials related to new medical uses or modes of administration of a patented medicine would be exempt from infringement. Likewise, trials carried out in e.g. Germany for the purpose of gaining regulatory approval in the USA would be exempt from infringement.
However, the United Kingdom has hitherto implemented only the minimum requirements of the Directives. Currently, the only activities exempted from infringement in the UK are trials carried out for the authorisation of generic or biosimilar products, and then only for the purpose of obtaining authorisations within the EEA. Similarly narrow Bolar exemptions have also been enacted in the Netherlands, Belgium, Sweden and Ireland
The current, limited scope of the Bolar exemption in the UK has been an issue for stakeholders for some time, with concerns that the current regulatory framework may put stakeholders at risk of patent infringement when carrying out clinical trials for innovative or non-generic drugs. In some cases, stakeholders have decided to run some trials in more favorable jurisdictions resulting in a potential loss to the UK economy.
The UK government has now decided to level the playing field by extending the scope of the Bolar exemption to better reflect commercial realities and public policy objectives. Accordingly, the Legislative Reform (Patents) Order 2014, which will come into force on 1st October 2014, provides that “anything done in or for the purposes of a medicinal product assessment” is exempt from infringement. The term “a medicinal product assessment” is defined to include complying with any regulatory requirement in any country of the world. This should make the Bolar provision in the UK at least as broad as that of any other European country.
Psst Mum, its BOLAR not Polar
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