EUROPE

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Patent Term
20 years from date of filing

Pharmaceutical Patent Extension?
Yes. EU Regulation 1768/92
In European Union member countries, an extension of the patent term is obtained by seeking a supplementary protection certificate (SPC). The SPC regime came into force in the European Community on 1 January 1993 but has not been uniformly implemented by all European countries.

The SPC takes effect for a maximum of 5 years after the expiry of the original patent term, however, the exact length of the extension granted under the Regulation is determined by national law. The SPC is capable of extending the exclusivity for particular medicinal products, such as drugs, and plant protection products, such as insecticides, and herbicides to a maximum of 15 years. Applications for the SPC must be filed on a country-by-country basis. There is no unitary European SPC.

Bolar Provision
Yes. EU Directive 2004/27/EC and Directive 2001/82/EC.

In March 2004 the European Council adopted a new pharmaceutical regulatory package which included a specific 'Bolar' exception in relation to medicinal products for human use and veterinarian use.

In relation to products for human use, Directive 2004/27/EC (amending Directive 2001/83/EC on the Community Code relating to medicinal products for human use) introduced an exception to patent infringement, including SPCs, for conducting 'necessary studies and trials' and the 'consequential practical requirements' for the procedure for obtaining European Union marketing authorization of a generic or similar medicinal product.

Directive 2004/28/EC (amending Directive 2001/82/EC on the Community Code relating to veterinary medicinal products) introduced a similar provision for veterinary medicinal products.

The two directives have been implemented into the national laws of European Union member states, with some divergence in the implementation between the member states.

The UK has introduced a 'bolar' provision in the form of the directives by amending s60(5) of the Patents Act 1977 (UK). This provision provides that conducting necessary studies, tests and trials for the further marketing of pharmaceutical and veterinary products for which marketing authorization had previously been given to another “shall not be regarded as contrary to patent related rights or supplementary protection certificates”. This provision came into effect on 1 May 2006.

Germany has also introduced a broad “springboarding” provision that extends to all applications for marketing approval – however, the exception is not limited to authorizations for generic medicinal products. It also extends to activities conducted in order to obtain regulatory approval outside of the European Union.

References
http://www.derwent.com/patentguides/gpe/ep_june.htm
http://www.egagenerics.com/facts_figures/intellectual_property/eurohealth_2000.pdf  

Prepared for IP Organisers by Dr Grace Chan, David Tadgell and Virginia Beniac-Brooks, Phillips Ormonde & Fitzpatrick - November 2007.