A Dissenting Opinion.

Abstract

Authored by Ingrid Schneider The essence of this Opinion is supported by Christoph Then This document is a dissenting opinion to the Report on patents in the field of human stem cells (hereinafter referred to as the “Report”) of the Expert Group on the development and implications of patent law in the field of biotechnology and genetic engineering (E02973). As in the Report, this dissenting opinion is focused on human stem cells, human embryos and gametes as well as the application of the ordre public and morality clause of Art. 53 EPC and the respective Articles 5 and 6 in the Directive 98/44/EC. Summary  The Report does not object to “non‐destructive uses” of human embryos (cf. Report, page 18). Article 6(2)c of the Directive, however, considers unpatentable "uses of human embryos for industrial or commercial purposes" and does not distinguish between "destructive" and "non‐destructive" uses of human embryos. It is arbitrary to exclude "destructive uses" from patentability and to allow "non‐destructive" uses of human embryos.  Even if "non‐destructive" uses of human embryos were deemed patentable, the method disclosed in Chung et al. 2008 does not provide sound evidence for a "non‐ destructive" use of human embryos, contrary to the Report (page 20)  Stem cells derived from activated human egg cells (parthenogenetic embryonic stem cells, hpES) are not identical to human embryonic stem cells, and therefore it is inadmissible to grant patents for processes and products on human embryonic stem cells, based on such hpES methods.  Novel methods enable the use of iPS or embryonic stem cells to create artificial gametes and embryos genetically derived from two partners of same sex or from one individual only. It is recommended that both the European Commission and the EPO specify and clarify that the term “germ cell” also includes artificially created egg and sperm cells, and that the term embryo also covers those artificially fused embryos.  Genome editing technologies such as CRISPR have reignited the debate on human germline modification. It is paramount that both the European Commission and the EPO specify and clarify that Articles 6(2)b and 6(2)c apply to CRISPR‐Cas9 and CRISPR‐ Cpf1, if practiced in human germ cells and human embryos.  Transparency and accountability of the work of the EPO requires disclosure of data on patent applications and grants, and revelation of changed granting practices in the EPO's Guidelines for Examination. There is a strong need for a better balance in patent law to secure the proper interpretation of the ordre public and morality exemption in European patent law, in accordance with the purposes and intentions of the European legislator and with the EU's Charter of Fundamental Rights. This requires the European Commission to take the initiative in strengthening the patent exclusions in Articles 5 and 6. In view of the rapid scientific developments it is urgently needed to provide an adequate clarification and precise guidance for the correct interpretation of the Directive 98/44/EC. This would comprise the following possibilities: