Ana Nordberg

The Impact of Broccoli II & Tomato II on European Patents in Conventional Breeding, GMO's and Synthetic Biology: The Grand Finale of a Juicy Patents Tale?

On 25 March 2015, the Enlarged Board of Appeal of the European Patent Office (EBA) finally delivered its’ much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”). The EBA affirmed that products, namely plants or parts thereof, obtained by essentially biological processes are – unlike individual plant varieties – principally patentable under the European Patent Convention (EPC). This decision leaves considerable leeway for patenting novel and inventive plants and products thereof, which have been produced by “conventional” methods including breeding steps. The EBA has also clarified that this applies irrespective of if such claims are formulated in a product-by-process format or as a per se product. Moreover, the combined effect of Broccoli & Tomato I & II opens new opportunities for patenting GMOs. Although major industry players had challenged the relevant patent-claims and it is uncertain how the CJEU would decide if confronted with similar issues, this is generally good news for innovative plant breeders and agrochemical companies. Meanwhile, the fierce European opposition against genetically modified organisms (GMOs) and Synthetic Biology remains a major obstacle to the industry, research and innovation in an increasingly significant area of science.

Study on Legislative Measures Related to Online IPR Infringements: A Project Commissioned by the European Union Intellectual Property Office

Intellectual property right (IPR) infringement has taken and increasingly takes place in the online environment, in particular on the internet, which has raised concerns on many different levels, and has led to a number of recent European initiatives. A number of legislative measures have been adopted at both international and European levels whose purposes are to strengthen and harmonise the protection of IPR. These measures include remedies, which aim to enable rights holders and law enforcement authorities, such as prosecutors, to enforce IPR in an effective manner. However, the provisions in the abovementioned legislation are, for the most part, not drafted in ways that specifically address how to prevent or combat online IPR infringement, but are -merely in the form of minimum requirements, which leave room for individual Member States to adopt and apply specific national measures.The main purpose of this study commissioned by the EUIPO is, therefore, to establish whether and to what extent a number of specific legislative measures, which can be applied to prevent or combat IPR infringement in the online environment, are available in the Member States. The legislative measures that the study will focus on are measures that can be characterised as providing ‘practical solutions to practical problems’, such as the option to require that an online service provider discloses the identity of a customer who is suspected of infringing the IPR rights of a third party and the option to apply the European Investigation Order (EIO) to crimes involving IPR. (Less)

Cutting Edges and Weaving Threads in the Gene Editing (Я)evolution : Reconciling scientific progress with Legal, Ethical, & Social concerns

Abstract Gene-editing technology, such as CRISPR/Cas9, holds great promise for the advancement of science and many useful applications technology. This foundational technology enables modification of the genetic structure of any living organisms with unprecedented precision. Yet, in order to enhance its potential for societal benefit, it is necessary to adapt rules and produce adequate regulations. This requires an interdisciplinary effort in legal thinking. Any legislative initiative needs to consider both the benefits and the problematic aspects of gene editing, from a broader societal and value-based perspective. This paper stems from an interdisciplinary research project seeking to identify and discuss some of the most pressing legal implications of gene-editing technology and how to address these. While the questions raised by gene editing are global, laws and regulations are to a great extent bound by national borders. This paper presents a European perspective, written for a global audience, and intends to contribute to the global debate. The analysis will include brief references to corresponding USA rules in order to place these European debates in the broader international context. Our legal analysis incorporates interdisciplinary contributes concerning the scientific state of the art, philosophical thinking regarding the precautionary principle and dual-use issues as well as the importance of communication, social perception, and public debate. Focusing mainly in the main regulatory and patent law issues, we will argue that (a) general moratoriums and blank prohibitions do a disservice to science and innovation; (b) it is crucial to carefully consider a complex body of international and European fundamental rights norms applicable to gene editing; (c) these require further developments grounded in consistent and coherent implementation and interpretation; (d) legal development should follow a critical contextual approach capable of integrating interdisciplinary contributions and broad multilevel societal dialog.