Life Sciences Law at the Law Faculty of Basel

Transcription

1 Life Sciences Law at the Law Faculty of Basel BioValley Basel Stammtisch, 27 May 2013

2 What is Life Sciences Law? An Example: Stem Cell Patents Teaching Life Sciences Law at the Faculty

3 I. What is Life Sciences Law?

4 What are Life Sciences? Medicine Pharmacy Agriculture Use of living organisms as tools and their treatment as patients In science and technology

5 What is so special about Life Sciences? Life Sciences are dynamic need huge investments have ethical implications Therefore High innovation rates have to be taken into account (protection of IP, safety, liability) Huge demand for investments has to be considered (unlikr e.g. open source software) Special rules have to be designed with respect to the ethical boundaries of interacting with humans and animals

6 What about the Law? Innovation Diffusion Application Risks and Chances Fostering Innovation Technology Transfer Safety Ethics Liability IP IP Law Contracting Competition Law Regulatory Law Tort Law Criminal Law

7 II. Stem Cell Patents

8 Quelle:

9 Patentability Requirements (EPO) Invention, Art. 52 EPC No Exceptions, Art. 53 EPC Novelty, Art. 54, 55 EPC Inventive step, Art. 56 EPC Industrial application, Art. 57 EPC

10 Swiss Patent Office (IGE) Invention, Art. 1(1) EPA No Exceptions, Art. 1a, 1b, 2 PatG Novelty, Art. 1(1), 7 PatG Nonobviousness, Art. 1(2) PatG Industrial application, Art. 1(1) PatG

11 Patentability of Stem Cells Totipotent Stem Cells Patentability might be excluded under R 29(1) EPC (human body) Pluripotent Embryonic Stem Cells Generally patentable under R 29(2) EPC BUT: According to R 28(c) EPC and Art 53(a) EPC, patents shall not be granted in case the invention uses human embryos for industrial or commercial purposes Important decisions of EPO s EBA (G 2/06) and ECJ (C-34/10)

12 Stem Cells at the ECJ (C-34/10 Brüstle/Greenpeace) The following questions were referred by the German Federal Court of Justice to the ECJ for a preliminary ruling under Art 267(1)(b)(3) TFEU: 1. What is meant by the term 'human embryos' in Article 6(2)(c) of Directive 98/44/EC? 1. any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a human embryo (ECJ C-34/10)

13 What is meant by the expression 'uses of human embryos for industrial or commercial purposes'? Does it include any commercial exploitation within the meaning of Article 6(1) of the Directive, especially use for the purposes of scientific research? 2. The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.

14 Is technical teaching to be considered unpatentable pursuant to Article 6(2)(c) of the Directive even if the use of human embryos does not form part of the technical teaching claimed with the patent, but is a necessary precondition for the application of that teaching, (a)because the patent concerns a product whose production necessitates the prior destruction of human embryos, (b)or because the patent concerns a process for which such a product is needed as base material?

15 Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.

16 Patent Law v. Regulatory Law Different legal tasks for patent law and regulatory law Patent law only knows ethical bail out in Art. 53(a) EPA

17 Art. 53(a) EPC European patents shall not be granted in respect of: (a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States; (b) (c)

18 StFG (Stammzellenforschungsgesetz) Art. 1 Gegenstand, Zweck und Geltungsbereich 1 Dieses Gesetz legt fest, unter welchen Voraussetzungen menschliche embryonale Stammzellen aus überzähligen Embryonen gewonnen und zu Forschungszwecken verwendet werden dürfen. Obtaining stem cells is legal in CH (under certain conditions) paradoxical situation

19 III. Teaching life sciences law at the law faculty of Basel

20 III. Teaching life sciences law at the law faculty of Basel Majors within the MA programme Master of Economic Law Master of Law Life Sciences Law Global Life Sciences and Sustainability (English) Life Sciences Law