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IP Cases & Commentary – Details

29 November 2011

UK IPO's Consultation on the Research and Bolar Exceptions - Report Published

Catherine Mallalieu

In June 2011 the UK IPO launched a consultation to investigate the impact, if any, of UK patent legislation on the conduct of clinical and field trials involving pharmaceuticals in the UK; the results have just been published.

Under section 60(5) of the UK Patents Act 1977 an act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if, inter alia:

b) it is done for experimental purposes relating to the subject-matter of the invention;

i) it consists of –

  1. an act done in conducting a study test or trial which is necessary for and is conducted with a view to the application of paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC, or
  2. any other act which is required for the purpose of the application of those paragraphs

The UK courts have followed a narrow interpretation in the past regarding section 60(5)(b). As a result, the section is seen as not providing a safe harbour for field and clinical trials where regulatory approval is required in order to obtain marketing approval.

The EU Directives referred to in section 60(5)(i) exempt from infringement certain activities performed for regulatory approval of generic drugs. The UK fully implemented these Directives, and thus only those acts specifically required to obtain marketing authorisation of a generic drug are exempt for patent infringement. For example, pre-clinical trials and obtaining marketing authorisation for generic drugs are exempt under current legislation, but clinical trials for combination drugs, obtaining marketing authorisation for biosimilar products through the non-generic route, and acts done to provide additional evidence for the UK’s National Institute for Health and Clinical Excellence (NICE) are not. Furthermore, national legislation in this area differs throughout the EU, eg, Germany, France and Italy are widely seen as having implemented a broader exemption.

As a result of the consultation, the UK Government has acknowledged that the current wording of the patent law does put some parties at risk of patent infringement when running UK clinical or field trials involving innovative drugs.

The next step will be for the UK IPO to formally consult on options for amending the UK Patents Act to exempt from infringement activities involved in clinical or field trials and also look at exempting activities relating to regulatory approval of a drug product or activities relating to public health issues such as additional studies required by NICE.

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Results of the UK IPO's Consultation on the Research and Bolar Exceptions

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