European Bolar Provisions in United Kingdom

1. How is Bolar implemented?

The Bolar exemption is implemented into UK law by Section 60(5)(i) Patents Act 1977 (as amended). There is also a ‘New Experimental Use Exemption’ contained in Sections 60(6D) to (6G) Patents Act 1977, which covers activity that is conducted "for the purpose of a medicinal product assessment".

2. How does the Bolar provision work?

In summary, section 60(5)(i) Patents Act 1977 states that an act which would constitute an infringement of a patent shall not do so if it consists of: 

“(i) 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 (ii) any other act which is required for the purpose of the application of those paragraphs”.

3. Is Bolar restricted to exempting studies for generic marketing authorisations?

The Bolar provision is limited to acts which are required for the purpose of a marketing authorisation application via Article 10 (i.e. an abridged application). Therefore, whilst the Bolar provision is not strictly limited to true generic applications (i.e. applications under Article 10(1)), it does not extend to full applications under Article 8(3). 

However, the ‘New Experimental Use Exemption’, which is contained in sections 60(6D) and (6E) Patents Act 1977, was introduced to expand the protection offered by the Bolar exemption. Pursuant to the New Experimental Use Exemption “anything done in or for the purposes of a medicinal product assessment which would otherwise constitute an infringement of a patent for an invention is to be regarded as done for experimental purposes”. Therefore, the New Experimental Use Exemption also applies to the preparation and running of clinical trials on innovative drugs.

4. Has Bolar been litigated in your jurisdiction?

To date, the Bolar exemption has not been litigated in the UK. 

5. Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 

The Bolar exemption only applies to acts necessary for a marketing authorisation application under Article 10 of Directive 2001/83/EC and therefore would not apply to any acts which were undertaken for the purpose of obtaining a marketing authorisation outside the EU. However, the New Experimental Use Exemption is drafted more broadly and applies to acts which are done for the purpose of a medical product assessment. Section 60(6E) Patents Act 1977 defines “medicinal product assessment” as any testing or other activity undertaken with a view to providing data in relation to marketing authorisations in the UK or elsewhere.

6. Does Bolar extend to a third party who assists the MAH in carrying out the activities? 

The legislation does not state whether the Bolar exemption extends to acts done by third parties