The so-called ‘Bolar exemption’ finds legal basis in EU Directive 2004/27/EC modifying Directive 2001/83/EC on the Community code relating to medicinal products for human use. Article 10(6) of EU Directive 2001/83/EC states that:
“6. Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.”
The scope of this article is limited to medicinal products intended to be placed on the market in the EU, and to generic (paragraph 1) or biosimilar drugs (paragraph 4). It has been implemented variably into the national laws of the different EU Member States, leading to a common minimal exemption, but with different rules and policies across the EU.
For example, in France, Article L613-5 d) of the French IP Code states that:
“The rights conferred by the patent do not extend to:
d) Studies and tests which are necessary in order to obtain a marketing authorization for a medicinal product, as well as any acts which are necessary to carry out such studies and trials and to obtain the authorization;”
The Bolar exemption in France is thus not limited to generics or biosimilars, but also applies to innovator trials, as well as to the different types of marketing authorizations including those outside of the EU.
The UPC (Unified Patent Court) Agreement states in Article 27 :
“The rights conferred by a patent shall not extend to any of the following:
(b) acts done for experimental purposes relating to the subject-matter of the patented invention; […]
(d) the acts allowed pursuant to Article 13(6) of Directive 2001/82/ECor Article 10(6) of Directive 2001/83/ECin respect of any patent covering the product within the meaning of either of those Directives;”
As a consequence of paragraph (b), the scope of the research exemption will depend on the interpretation of the wording “relating to” in the case law.
Furthermore, paragraph (d) limits the scope of the Bolar exemption to generic or biosimilar products, but does not include innovative drugs or new indications… Furthermore, it is geographically narrowed to marketing authorizations of the EU only.
One can thus questions whether pre-clinical and/or clinical acts for the development of drugs will be liable for patent infringement under the UPCA while they would have been exempted from patent rights in the EU Member States that broadly transposed EU Directive 2004/27/EC into their national Law.
No doubt that the first UPC decisions in this area will pave the way for an interpretation of a “Unified Bolar exemption”!