In addition to the pharmaceutical strategy for Europe[1], the European Commission adopted a new action plan for intellectual property[2] in November 2020, which is intended, through various measures, to support companies in protecting their intellectual property and contribute to promoting the use of intellectual property rights by small and medium-sized enterprises (SMEs) and the better enforcement of intellectual property rights.
The first two articles in this three-part series deal with document protection and the planned changes to supplementary protection certificates for medicinal products. This article deals with the so-called Roche-Bolar rule.
The Roche-Bolar rule
Status Quo
For the European harmonization of an experimental privilege, in particular for obtaining marketing authorizations for medicinal products, the so-called Bolar privilege was introduced in Section 11 No. 2 lit. b) of the German Patent Act (PatG) in 2005 in implementation of Art. 10 para. 6 of Directive 2001/83/EC[3] . This market access privilege represents a further exception to comprehensive patent protection and, as a lex specialis in relation to the experimental privilege of Section 11 para. 2 PatG, allows studies and trials to be carried out which are necessary to obtain marketing authorization for medicinal products in the European Union or a marketing authorization for medicinal products in the member states of the European Union or in third countries. This rule is intended to enable generic manufacturers to enter the market immediately after the patent protection of the respective reference medicinal product has expired.
However, different interpretations of the provisions in the national laws make it difficult to assess the scope of application. This applies in particular with regard to acts of provision by third parties. For example, in 2013, the Higher Regional Court of Düsseldorf referred the question to the ECJ[4] as to what requirements suppliers of patented active substances must impose on generic manufacturers so that they, in turn, can carry out the research privileged under Art. 10 para. 6 of Directive 2001/83/EC with regard to the authorization of the generic product “the necessary studies and tests and the practical requirements resulting therefrom”. Since the ECJ did not provide a corresponding answer due to the discontinuation of the national proceedings, the opinion of the Higher Regional Court is often used when assessing the questions in this context. According to the Higher Regional Court of Düsseldorf, the import of an active ingredient manufactured in a patent-free foreign country and imported into a patent-protected country for the purpose of conducting trials also falls under the Roche-Bolar rule if the third party can assume, based on the overall circumstances, at the time it performs the act of ‘making available’, that the active ingredient it has made available will actually be used exclusively for privileged approval trials and studies.
Other national interpretations make the assessment more difficult. The status quo is therefore characterized by some uncertainty throughout the EU.
Proposed new regulation
With Art. 85 of the proposed Directive, the Commission aims to specify and extend the scope of the exemption and harmonize it across the EU.[5] According to Art. 85 lit. a) of the draft Directive, acts of use for studies, trials and other activities carried out to obtain data for an application for the following procedures are to be privileged: (i) an authorization of generics, biosimilars, hybrid medicinal products or biohybrid medicinal products and for subsequent variations; (ii) an assessment of health technologies within the meaning of Regulation (EU) 2021/2282, and (iii) pricing and reimbursement. As a result, the proposed measures are intended to facilitate faster market entry of generics and biosimilars, thereby strengthening competition and contributing to the objectives of affordability of medicines and patient access.[6]
Amendments by the Parliament
For ease of reference, a comparison[7] of the main changes to the text by the Parliament compared to the Commission proposal is included below:
Article 85
Commission proposal
Patent rights or supplementary protection certificates […] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
(a) studies, trials and other activities conducted to generate data for an application, for:
(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;
(ii) health technology assessment as defined in Regulation (EU) 2012/2282;
(iii) ricing and reimbursement.
[iiia] not available
Amended text (Parliament)
Patent rights or supplementary protection certificates […] shall not be regarded as infringed when necessary studies, trials and other activities are conducted for the purpose of:
(a) deleted
(i) obtaining a marketing authorisation and subsequent variations;
(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;
(iii) obtaining pricing and reimbursement approval; and
(iiia) the subsequent practical requirements associated with such activities.
While the currently vague wording of the “subsequent practical requirements associated with such activities” had been deleted from the Commission’s proposal, Parliament has now reinstated precisely this wording. In addition, the reference to the reference medicinal product has been deleted. The reference to “generic, biosimilar, hybrid or bio-hybrid medicinal products” has been deleted without replacement in para. 1 (a) point (i), so that the wording now only provides for “(i) obtaining a marketing authorisation and subsequent variations “.
If one assumes that the content of para. 1 lit. b) intended by the Commission will prevail, this will in any case improve legal certainty for generics manufacturers and their suppliers but will also be a future disadvantage for originators.
Article 85a
Commission proposalAmended text
not available
Amended text (Parliament)
Article 85a
Non-interference of intellectual property Rights
1. Member States shall consider the procedures and decisions referred to in Article 85 as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights.
2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions referred to in Article 85.
3. Paragraphs 1 and 2 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.
Further alignment
In the amended version adopted by Parliament, the newly inserted Article 85a on the “Non-interference of intellectual property rights“, which provides that the proceedings and decisions referred to in Article 85 are to be considered as legal or administrative proceedings “which, as such, are independent from the enforcement of intellectual property rights“, is surprising. In particular, it is unclear how paragraph 3 is to be understood: ” Paragraphs 1 and 2 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.”
It remains to be seen whether the Parliament’s proposal can prevail in the further procedure.
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[1] On the Commission’s proposal and the European pharmaceutical strategy, we refer to previous blog posts (January 4, 2021 and March 8, 2023) as well as Stief/Grabow: Quo vadis pharmaceutical law – an overview of the revision of EU pharmaceutical legislation, PharmR 2023, 317 ff.
[2] Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Making the most of the EU’s innovation potential – An Intellectual Property Action Plan for the EU’s recovery and resilience, COM(2020) 760 final.
[3] As amended by Directive 2004/27/EC and Directive 2004/24/EC, of April 30, 2004, OJ 2004 L 136, p. 34 (58, 85).
[4] Decision of December 5, 2013, case no. I-2 U 68/12.
[5] Cf. p. 20 of the proposal (explanatory notes) for a Directive on the Union code relating to medicinal products for human use and repealing Directive 2001/83/EC and Directive 2009/35/EC, COM(2023) 192 final.
[6] Cf. footnote 5, p. 20, last paragraph, last sentence.
[7] Cf. p. 115 f. of the legislative resolution of the European Parliament of April 10, 2024, COM(2023)0192 – C9-0143/2023 – 2023/0132(COD).