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Acts done for experimental purposes relating to the subject matter of the patented invention have long been provided for as an exemption to patent infringement across the majority of European countries, i.e. those who have adopted the provisions of the Community Patent Convention in their laws. In the UK this exemption is in section 60(5)(b) of the Patents Act 1977.
Specifically, in relation to pharmaceutical patent law, after the turn of the century, the EU recognised the need to expedite generic entry upon patent expiry without regulatory processes creating an additional unnecessary barrier. Therefore, the Bolar exemption was introduced through Directive 2001/83/EC.
The Bolar exemption complements the existing experimental use exemption by specifically allowing activities necessary for obtaining regulatory approval for generic medicinal products. This includes the manufacturing, importing, and processing of materials required for relevant studies and trials, such as bioavailability studies to demonstrate bioequivalence. In the UK this was implemented in section 60(5)(i) of the Patents Act 1977 and exempts from patent (and SPC) infringement acts done in conducting studies or trials necessary for obtaining regulatory approval for a generic medicinal product. The EU Directive refers to the consequential practical requirements also being exempt, whereas the UK Act specifies any other act required as being exempt. It has generally been understood that these elements cover the manufacturing, importing and processing of the material for the relevant necessary studies.
The Bolar exemption has since had a significant impact in facilitating timely market authorisation for generic pharmaceuticals across the UK and EU, assisting access to affordable medicines.
However, in 2014, the United Kingdom recognised that an expansion to this exemption was necessary to cover other related activities necessary for market entry for certain pharmaceutical products and broadened its Bolar provision through Sections 60(6D) -(6G) of the Patents Act. This expansion aimed to incentivise clinical trials within the country by extending the experimental use exemption to encompass activities undertaken for any medicinal product assessment. This encompasses not only regulatory approval but also activities related to:
As a result, the exemption in the UK now allows for comparative studies and activities promoting the recommendation of both generic and novel drugs.
While the UK’s expanded approach demonstrated a progressive stance towards balancing innovation and access, the situation across the EU remained narrow and fragmented. Member states have adopted varying interpretations and implementations of the Bolar exemption, leading to inconsistencies and potential challenges for navigating the complex regulatory landscape within the region.
On 26 April 2023, published a draft reform of pharmaceutical legislation, which has been called the EU Pharma Package[1]. One of the key aspects addressed is the simplification of market entry for generics and biosimilars by an expansion of the Bolar exemption in the EU.
Article 85 of the draft Directive attempts to broaden the Bolar exemption to include studies and trials necessary for health technology assessments, and pricing and reimbursement. It also expands it beyond generics and biosimilars to hybrid, biohybrid and subsequent variant drugs. Importantly, it also proposes to clarify that commercial suppliers of active pharmaceutical ingredients for the conduct of such studies are covered by the exemption.
The effect of this proposal appears to be likely to more or less bring the EU in line with the expanded Bolar / experimental use provisions in the UK and ensure consistent application of the exemption across the EU.
It is currently not known when this may come into force or what form it may be in when and if that happens.
[1] “Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC”
If you have any queries regarding this topic, or would like assistance creating or implementing an IP strategy, please contact Geoff Hussey of our team.
Category: Latest Insights | Author: Geoff Hussey | Published: | Read more
