A consultation is currently being held by the UK Intellectual Property Office (UKIPO) on the scope of the so-called "Bolar exemption" to patent infringement and the impact of the current UK legislation on the conduct of clinical and field trials on pharmaceuticals.
As it currently stands, the Bolar exemption in the UK1 protects activities involved in the regulatory approval of generic pharmaceuticals which would otherwise infringe patents from being actionable. It does not apply to innovator products or other non-generic products.
Under Section 60(5)(i) Patent Act 1977 an act will not infringe a patent if it is:
(i) "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
(ii) any other act which is required for the purpose of the application of those paragraphs"
On a literal reading of EU Directives 2004/27/EC and 2004/28/EC2 this may seem uncontroversial. However, some other EU member states (most notably France and Germany) have adopted wider implementations of the Bolar provision than the UK, either via their implementing legislation or through the interpretation of their national courts. France, Germany, Italy, Denmark and Czech Republic all permit both innovators and generics to benefit from their Bolar provisions.
The increased prevalence of combination products, biosimilars and comparator testing (e.g. for NICE approval) means that the risk of infringing patents during trials is no longer limited to generic companies. The consultation has therefore been launched in response to a concern that the UK risks being sidelined as a location for clinical and field trials because of the potential for an increased risk of infringement vis-à-vis other European countries. The UKIPO is particularly interested in hearing about specific examples where clinical trials have involved a risk of infringing a patent and whether this has led to trials being conducted outside the UK.
All responses should be sent to the UKIPO (email PatentsPolicy@ipo.gov.uk) by 31 July 2011.
A copy of the consultation document may be found here: http://www.ipo.gov.uk/pro-policy/consult/consult-live/consult- 2011-bolar.htm.