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22 July 2021GenericsSophie Topham

UK experimental use exemptions: Part 2—the Bolar exemption

As mentioned in the first of this four-part series of articles discussing the experimental use exemption from infringement in the UK, Section 60 UKPA 1977 in fact provides for three categories of experimental use exemption from infringement.

This article looks at the second category, which is commonly referred to as “the Bolar exemption”.

Bolar exemption

The Bolar exemption is provided for by Section 60(5)(i) UKPA 1977, which reads:

An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if ­[…]

(i) 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…

This sub-section provides an exemption for some clinical trials on medicinal products for human use and for trials on veterinary products.

However, it should be noted that this provision extends only to studies, tests, and trials that are required in order to take advantage of the abridged regulatory approval procedures available for generic and biosimilar medicines.

Thus, the exemption would apply where trials are required to show that the generic product is bioequivalent to an approved patented product (where this is required to obtain marketing authorisation), and to providing supplementary data for biosimilars.

However, the exemption does not extend to trials of new medicinal products that have not previously received a marketing authorisation, or of new indications for a previously authorised product.

While there has not, so far, been any case law on the implementation of the Bolar exemption, the UK Intellectual Property Office (IPO) issued a practice notice, which sets out a list of exemplary activities that the IPO considers are covered by the Bolar exemption. This list includes:

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More on this story

Big Pharma
15 July 2021   In the first of a four-part series, Sophie Topham of Marks & Clerk explores how experimental use provides life sciences products with essential relief from patent infringement
Generics
5 August 2021   In the third article of a four-part series on experimental use exemptions from infringement in the UK, Sophie Topham of Marks & Clerk considers the expansion of the original exemption.
Europe
10 August 2021   In the final article of a four-part series, Sophie Topham of Marks & Clerk discusses the supplementary protection certificate manufacturing waiver.

More on this story

Big Pharma
15 July 2021   In the first of a four-part series, Sophie Topham of Marks & Clerk explores how experimental use provides life sciences products with essential relief from patent infringement
Generics
5 August 2021   In the third article of a four-part series on experimental use exemptions from infringement in the UK, Sophie Topham of Marks & Clerk considers the expansion of the original exemption.
Europe
10 August 2021   In the final article of a four-part series, Sophie Topham of Marks & Clerk discusses the supplementary protection certificate manufacturing waiver.

More on this story

Big Pharma
15 July 2021   In the first of a four-part series, Sophie Topham of Marks & Clerk explores how experimental use provides life sciences products with essential relief from patent infringement
Generics
5 August 2021   In the third article of a four-part series on experimental use exemptions from infringement in the UK, Sophie Topham of Marks & Clerk considers the expansion of the original exemption.
Europe
10 August 2021   In the final article of a four-part series, Sophie Topham of Marks & Clerk discusses the supplementary protection certificate manufacturing waiver.