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Ethical aspects and Patents in Lifescience

Ethical aspects and Patents in Lifescience. Peter R. Thomsen Manager Global IP Litigation, Corporate Intellectual Property, Novartis WIPO symposium on IP and Bioethics Geneva, 4. Sep 2007. Overview. Role of Patents and boundaries to ethics Example: Human Stem Cells

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Ethical aspects and Patents in Lifescience

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  1. Ethical aspects and Patents in Lifescience Peter R. Thomsen Manager Global IP Litigation, Corporate Intellectual Property, Novartis WIPO symposium on IP and Bioethics Geneva, 4. Sep 2007

  2. Overview • Role of Patents and boundaries to ethics • Example: Human Stem Cells • Other Ethical considerations in connection with patents 2 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  3. Role of PatentsWhat is a patent? • A right to exclude others from doing or using what is claimed in the patent • For a certain Country, for which patent was applied in kept in force • For a limited time period (at least 20 years from Filing Date, TRIPs Art. 33) 3 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  4. Role of PatentsWhat is a patent not? • A patent is not a positive right • By having a patent the patentee is not automatically entitled to use the patented invention • Provisions of other laws may make it impossible for patentee to use patented invention, e.g. • Health safety Law • Environmental Law • Restrictions of activities by Embryonic Protection Law • Earlier dominating Patent 4 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  5. Role of PatentsWhat are patents good for? • Patent system gives incentive to invest in Research and Development to promote • that more new inventions are made • that those new inventions are not kept secret but published • Reward for providing and publishing inventions • Technical progress, e.g. huge investments to bring a medicament with a new active ingredient to the market 5 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  6. Role of PatentsPatentability Criteria (see Art. 27.1 Art. 29 TRIPS) • For Technical inventions • Mere scientific discoveries, findings in nature, are not patentable • Novelty • Different from what is known • Inventive/Non-obvious • Not easily conceivable by a trained person • Industrial applicable/Useful • Enablement/ Sufficient Disclosure • Disclosed in a way that a trained person can repeat invention 6 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  7. Patents and boundaries to EthicsRole of Ethics in Patents • Ethics are about what is regarded right or wrong by a society • Ethical norms and values may vary from culture group to culture group, or even from country to country • Ethical norms and values may change over time • Technology may progress over time 7 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  8. Patents and boundaries to EthicsRole of Ethics in Patents • Implications for Patents? • Differentiation between activities for which patent protection will be sought and the act of patenting those activities • Activities claimed in a patent may be ethically problematic • However, patenting it does not add anything, because the patent does not include the right to perform the problematic activities 8 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  9. Role of Patents and boundaries to ethicsProposals/Conclusions • Patent system cannot be the primary tool to deal with ethical considerations for research and commercial activities • Other institutions necessary to solve ethical problems or to enforce ethical norms • Since ethical standards may vary, only those inventions should be excluded from patentability for ordre public or morality reasons, for which there is a clear consensus in overwhelming parts of society that the underlying activities are contrary to ethical standards 9 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  10. Ethics in Patent LawInternational Standards • According to TRIPs, WTO-members may exclude from patentability inventions in order to protect ordre public or morality, provided that such exclusion is not made merely because the exploitation is prohibited by their law (see TRIPS, Art. 27.2) • Illegality of an activity is not sufficient to exclude it from patentability for ordre public or morality reasons 10 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  11. Ethics in Patent LawExample Biotechnological Inventions • EU-Directive on legal protection of biotechnological inventions (Dir 98/44) • Parallel provisions in the European Patent Convention (R. 23b-f, EPC1973) • Patents shall not be granted for • Processes for cloning of human beings • Processes for modifying the germ cell line genetic identity of human beings • Uses of human embryos for industrial or commercial purposes • Processes for modifying the genetic identity of animals which are likely to cause them suffering without anysubstantial medical benefit…and animals resulting from such processes 11 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  12. Example: Human Embryonic Stem Cells (hEC) Patents on human stem cells? Patents on human stem cells? Patents on processes to cultivate cells? 12 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  13. Example: Human Embryonic stem Cells (hEC) „Patents shall not be granted for uses of human embryos for industrial or commercial purposes“ (EU-Biotech Dir 98/44) • Patents on methods to cultivate or differentiate hEC • Patents are NOT directed to uses of human embryos • Patent Offices have taken different positions: • European Patent Office: excluded from patentability, because it was contended that hEC are necessarily consumed in order to provide the starting material for the claimed process; question is pending before the Enlarged Board of Appeal (G2/06) • Patent Offices in Sweden, Great Britain and Germany: allowed patents, because carrying out the process as claimed does not make use of human embryos for industrial or commercial purposes 13 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  14. Example: Human Embryonic stem Cells • Federal Patent Court in Germany revoked part of a patent which was directed to a process to prepare purified cells with certain properties wherein the first step was „cultivating [human] embryonic stemcells…“ • reasoning: patents that do not claim but require as a precondition to be carried out with human embryonic stem cells which were derived by consuming an embryo fall under the exclusion due to „uses of human embryos for industrial or commercial purposes “ • Court did not address that human embryonic stem cells may be legally derived from other sources, e.g. existing embryonic cell lines and that such research is substantially funded and promoted by public institutions (e.g. EU-commission or DFG) • patentee appealed and case is pending before German Federal Supreme Court 14 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  15. Other ethical considerations in connection to patents • Patenting in Least Developed Countries (LDC) • Swiss Pharmaceutical Industry has decided to voluntarily abstain from filing patent applications in LDCs • Enforcing patents against a product of a third party • If a third party sells the only effective product that infringes a patent and neither the patentee nor somebody else could provide a substitute product • Serious ethical considerations how to enforce the patent • Injunction may not be appropriate as this would prevent access of patients to the product in need 15 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

  16. ConclusionsEthical aspects and Patents in Lifesciences • A functioning patent system is essential for development of new pharmaceuticals and treatments • The Patent System is not suited to enforce ethical norms • Ethical problems should be solved by other legal instruments or institutions, e.g. Research regulations, ethical advisory committees etc. • Since ethical standards and technology may develop over time exclusions from patentability for ethical reasons should be limited to clear cases with society-consensus (e.g. reproductive cloning of human beings) 16 | Ethical Aspects and Patents |Peter R Thomsen | 04.09.2007 | WIPO Symposium, Geneva

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