1. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 20071 Dr. Felix Addor Deputy Director General, Swiss Federal Institute of Intellectual Property Lecturer on International Intellectual Property Law, World Trade Institute and University of St.Gallen WIPO Life Science Symposium on IP and Bioethics Geneva, September 4, 2007 Adressing bioethics issues : A Swiss – EC Perspective

2. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 20072 Considering the exclusive right to invention as given for the benefit of society, I know well the difficulty of drawing a line between the things which are worth to the public the embarrassment of an exclusive patent, and those which are not. (Thomas Jefferson, 1813) As the value that society places on intellectual property has increased, that line has become murkier. (The Economist, 2004)

3. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 20073 Patenting of life forms: Patent examiners playing God?

4. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 20074 Misconceptions about patents n A patent is not a permission to use an invention (not a marketing authorization). n A patent is not an approval of an invention or of the possible exploitation of an invention. The patent system is not a tool to guide the research and technical development or to prevent abuses of new technologies!

5. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 20075 What can be protected by a patent? 1. Invention product or process that offers a new technical solution to a problem 3. Novelty not comprised in the state of the art = unavailable to the public 4. Inventive step not obvious for the person skilled in the art 5. Industrial application commercially exploitable 2. No exclusion

6. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 20076 What is an invention in the biotech field? Discovery = Description of something existing = Extension of human knowledge Invention = Instruction how to solve a problem with technical means = Extension of human abilities Penicillin Penicillium notatum

7. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 20077 The human body = patentable subject matter? The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, […], cannot constitute patentable inventions. (Article 5(1) EU-Directive) The human body as such, at all phases of his formation and development, including the embryo, is not patentable. (Article 1a(1) new Swiss Patent Law)

8. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 20078 Elements of the human body: patentable subject matter? An element isolated from the human body or otherwise produced by means of a technical process, […], may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. (Article 5(2) EU-Directive) Elements of the human body in their natural surrounding are not patentable. Such elements are patentable as invention if they are produced by means of a technical process, if a technical utility is indicated and if the other criteria of article 1 (novelty, inventive step, industrial applicability) are fulfilled. ( Article 1a(2) new Swiss Patent Law)

9. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 20079 Gene sequences = patentable subject matter? … a mere DNA sequence without indication of function does not contain any technical information [teaching] and is therefore not a patentable invention. (Recital 23 EU-Directive) A naturally occurring sequence or partial sequence of a gene as such is not patentable. (Article 1b(1) new Swiss Patent Law) Isolated genes = as a tiger in a cage!

10. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200710 Gene sequences = patentable subject matter? An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. (Article 5(2) EU-Directive) Sequences deriving from a naturally occurring sequence or partial sequence of a gene are patentable as inventions, if they are produced by means of a technical process, if their function is concretely disclosed and if the other criteria of article 1 (novelty, inventive step, industrial applicability) are fulfilled. ( Article 1b(2) new Swiss Patent Law)

11. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200711 Main problems with gene patents (acc. to participants of CH empirical survey) CH Survey: 8.2 Extent of Experience of Problems with DNA Patents, Fig. 34 (1=never, 5=very often) (http://www.ige.ch/E/jurinfo/documents/j10005e.pdf)

12. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200712 Possible remedies CH Survey: 8.2 Remedies, Fig. 35 (named as many times as effectively to...) (http://www.ige.ch/E/jurinfo/documents/j10005e.pdf)

13. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200713 Assessment of a protection limited to the concrete disclosed functions of DNA? CH Survey: 8.2 Extent of Experience of Problems with DNA Patents, Fig. 39 (1=no agreement, 5=total agreement) (http://www.ige.ch/E/jurinfo/documents/j10005e.pdf)

14. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200714 Gene F Uses B A C D E ProteinsDerived Sequences Reasoning: Is the absolute protection a too generous reward for the patent owner ?

15. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200715 Gene F Uses B A C D E ProteinsDerived Sequences Alternative: Purpose-limited product claims ?

16. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200716 Gene F Uses B A C D E ProteinsDerived Sequences The approach of the new Swiss Patent Law

17. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200717 The approach of the new Swiss Patent Law (2): Absolute product claims on restricted sequences Article 8c new Swiss Patent Law : (DNA sequences: Scope of protection) The protection of a claim, containing a nucleotide sequence, which is derived from a naturally occurring sequence or partial sequence of a gene, is restricted to those parts of the sequence, which is performing the concretely described function.

18. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200718 Ethical limits to patentability: Inventions contrary to ordre public or morality Some subject matter is excluded from patentability even if it constitutes an invention: Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. (Article 6(1) EU-Directive / Article 2(1) new Swiss Patent Law)

19. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200719 How to deal with the human embryo? Ethical controversy Source: University of Wisconsin-Madison The issue of human stem-cells

20. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200720 Ethical limits to patentability: Human embryonic stem-cells n Adult, foetal and embryonic human stem-cells are elements of the human body n Adult and foetal human stem-cells are patentable in principle no specific ethical issues n But: Embryonic human stem-cells are obtained from an human embryo that has to be destroyed controversial situation in Europe n Decisions by EPO: n Edinburgh patent (EP 0 695 351) partly revoked n Thomson patent (EP 0 770 125) refused n (appeals are pending in both cases)

21. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200721 Ethical limits to human embryonic stem-cells Subject matterEPOEGECH Unmodified ESExcluded from patentability Rule 23 d (c) EPC Excluded from patentability Art. 2(1)(e) PatG Modified ES Excluded from patentability (?) Rule 23 d (c) EPC Patentable Procedures to obtain ES Excluded from patentability (?) Rule 23 d (c) EPC Patentable

22. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200722 Assessment Art. 5(1) EU-Directive Art. 1a(1) new Swiss Patent Law Art. 6(2)(a) EU-Directive Art. 2(1)(a) new Swiss Patent Law (incl. the clones thus obtained) Recital 38 EU-Directive (transgenic animals?) Art. 2(1)(b) new Swiss Patent Law (transgenic animals not excluded) Invention concerns human body/human genome (reproductive and therapeutic) cloning of human beings processes for producing chimeras or hybrids Ethical limits to patentability

23. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200723 Assessment EU-Directive unclear Art. 2(1)(c) new Swiss Patent Law Art. 6(2)(b) EU-Directive Art. 2(1)(d) new Swiss Patent Law (incl. germ line cells thus obtained. Somatic gene therapy not excluded) EU-Directive unclear Art. 2(1)(d) new Swiss Patent Law (only non modified ESC) Art. 6(2)(c) EU-Directive (for industrial or commercial uses) Art. 2(1)(f) new Swiss Patent Law (for non medical uses) Invention concerns processes for human parthenogenesis germ line therapy human embryonic stem- cells use of human embryos ? ?

24. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200724 Assessment not contrary to ordre public/morality Art. 6(2)(d) EU-Directive Art. 2(1)(g) new Swiss Patent Law Invention concerns diagnostic processes involving genes organs somatic cells genes processes for genetic modification of animals likely to cause unjustified suffering

25. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200725 Assessing the morality of claimed inventions Post grant opposition procedure (Art. 59c new Swiss Patent Law) Any person may file an opposition against a granted patent if the ethical limits seem not to be respected, in particular with regard to patents: n of the human body n of elements of the human body in their natural surrounding n of naturally occurring sequence / partial sequence of a gene as such n of inventions where their exploitation would violate human dignity, or would disregard the dignity of plants and animals n of inventions where their commercial exploitation would be contrary to ordre public or morality

26. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200726 Biotechnology Patents – Access and Benefit Sharing n What role can patent system play? n Focus of international discussions: New disclosure requirements

27. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200727 Approach of the new Swiss Patent Law n Requirement to declare the source of genetic resources and traditional knowledge in the patent application (Art. 49a) n Sanctions for wrongful declaration (Art. 81a): n fines up to CHF 100,000 n publication of ruling

28. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200728 Research/experimental use exemption (Art. 9.1b new Swiss Patent Law) When do you need a license to use patented inventions for research purposes? All research (commercial or not) = free – if aimed at gaining new knowledge about subject matter of the invention Introduction of bolar exemption: Use of the invention to obtain the authorisation of a pharmaceutical product = free use of invention e.g. through Clinical trials = possible Even production of specimens = possible BUT Production of the new drug only after expiration of the patent (= no stockpiling)

29. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200729 Limits of research exemption: The issue of research tools Research exemption: the used invention must be the object and not the instrument of research: Problem: no free use of research tools, (such as polymerase chain reaction) if instrument = license needed Solution: Access guaranteed through legal licence (Art. 40b new Swiss Patent Law): = right to use the research tool for everybody + obligation to pay licence fee no agreement = fee fixed by a court no reach through licence fees

30. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200730 Compulsory licence for diagnostic testing Access to reliable diagnostic methods may be hampered if disease caused by specific gene sequence or single nucleotide polymorphisms (SNPs), and diagnostic method based on the relevant nucleotide sequence patented Art. 40c new Swiss Patent Law provides for a compulsory licence in case of Anticompetitive behaviour = breach of antitrust law/abuse of dominant position/agreement restricting competition/abusive behaviour (e.g. BRCA1- breast cancer gene)

31. WIPO Life Science Symposium on IP and Bioethics - Felix AddorSeptember 4, 200731 Transparency Knowledge Research & Private Use Exemption Public Patent Owner Innovation Exclusive Right Incentive Protection of Investments Goal = Balancing of Interests