Miriam Steinhart

Journal Articles

Revisiting the Framework for Compulsory Licensing of Patents in the European Union – Reflections on the European Commission’s Initiative, GRUR Int 72, 5 (2023), 471 - 482 (together with Matthias Lamping et al.). DOI

• Within the scope of its initiative on ‘Compulsory Licensing in the EU’,8 the European Commission launched a call for evidence on 1 April 2022 and a public consultation on 7 July 2022 with the aim of gathering views from stakeholders. The objective of this initiative is to explore the possibility of revising the framework for compulsory licensing in the EU to make it more ‘adequately prepared and coordinated to tackle future crises’.9 The authors of this position paper welcome the Commission’s attempt to reinvigorate the public discourse on this important subject.
  
  Depending on the issue to be addressed and the extent of the Commission’s willingness to reform, different regulatory approaches are conceivable. Subject to compatibility with the principles of subsidiarity and proportionality, these include:
  
  Rather than making concrete recommendations on the regulatory approach, this paper addresses selected aspects by way of a preliminary, non-exhaustive note on: the proposed reform’s scope and the grounds for a compulsory licence; the requirements of prior negotiation and licensing failure; government use; procedural matters; compulsory licences for patent applications and products; the relation with other regulations and sui generis regimes (i.e. trade secret protection, regulatory data protection and supplementary protection certificates); the concept of adequate remuneration; compulsory licences for European patents with unitary effect; and the exhaustion of products placed on the market under a compulsory licence.
  
  – soft law measures, such as guidelines and recommendations;
  
  – harmonisation of national laws (substantive and/or procedural);10
  
  – judicial cooperation (i.e. mutual recognition of judgments and of decisions in extrajudicial cases);11
  
  – centralisation of granting and/or judicial review competences;
  
  – creation of a supranational compulsory licence;
  
  – or any combination thereof.

Research Papers

New Genomic Techniques and Intellectual Property Law: Challenges and Solutions for the Plant Breeding Sector (Max Planck Institute for Innovation & Competition Research Paper, No. 23-16), 2023, 40 pp. (together with Daria Kim et al.).

• On 5 July 2023, the European Commission issued a proposal for the regulation that intends to relax the requirements for marketing authorisation of plants obtained by certain new genomic techniques (NGTs) in the EU. While NGTs are expected to become more appealing to breeders and farmers, the complexity of the intellectual property (IP) landscape surrounding such techniques and resulting products can have a discouraging effect on innovation. In view of numerous concerns related to IP protection for NGTs and NGT-derived plants, the Max Planck Institute for Innovation and Competition has published a Position Statement with a set of policy recommendations that can facilitate access to and utilisation of IP-protected NGTs in the breeding sector.
• Available at SSRN

CRISPR/Cas Technology and Innovation: Mapping Patent Law Issues (Max Planck Institute for Innovation & Competition Research Paper, No. 22-06), 2022, 49 pp. (together with Daria Kim et al.).

• The paper provides a systematic overview of issues arising at the interface between CRISPR/Cas technology and patent law. In particular, it examines aspects related to the patentability of CRISPR/Cas-based methods of genome editing, on the one hand, and access to patented technologies, in view of the expanding CRISPR patent landscape, on the other hand. On the whole, our findings show that the case of CRISPR/Cas technology is prototypical of the policy dilemma in patent law as to how to balance economic incentives of multiple innovators in a cumulative innovation setting. The reviewed technical, legal and economic factors suggest the preconditions for technology underutilisation. While this paper presents the results of the exploratory phase of research, it sets a framework for the further, more targeted interdisciplinary examination of the identified issues.
• Available at SSRN

Opinions

Revisiting the Framework for Compulsory Licensing of Patents in the European Union, 2023, 27 pp. (together with Matthias Lamping et al.).

• Within the scope of its initiative on “Compulsory Licensing in the EU”, the European Commission launched a call for evidence on 1 April 2022 and a public consultation on 7 July 2022 with the aim of gathering views from stakeholders. The objective of this initiative is to explore the possibility of revising the framework for compulsory licensing in the EU to make it more “adequately prepared and coordinated to tackle future crises”. The authors of this position paper welcome the Commission’s attempt to reinvigorate the public discourse on this important subject. This paper addresses selected aspects by way of a preliminary, non-exhaustive note on: the proposed reform’s scope and the grounds for a compulsory licence; the requirements of prior negotiation and licensing failure; government use; procedural matters; compulsory licences for patent applications and products; the relation with other regulations and sui generis regimes (i.e. trade secret protection, regulatory data protection, and supplementary protection certificates); the concept of adequate remuneration; compulsory licences for European patents with unitary effect; and the exhaustion of products placed on the market under a compulsory licence.
• Opinion published as Max Planck Institute for Innovation & Competition Research Paper No. 23-07