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The Future of Stem Cell Patents in Europe after WARF Regenerative Medicine Stem Cells Clifford Chance, London, 13th F

Moral Exclusions in the Directive. Article 6(1) /Article 53(a) EPC: Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality ? Article 6(2)(c)/Rule (23)d(c)[now 28(c)] EPC: Uses of human embryos for industrial or commercial purposes..

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The Future of Stem Cell Patents in Europe after WARF Regenerative Medicine Stem Cells Clifford Chance, London, 13th F

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    1. The Future of Stem Cell Patents in Europe after WARF Regenerative Medicine & Stem Cells Clifford Chance, London, 13th February 2009

    2. Moral Exclusions in the Directive Article 6(1) /Article 53(a) EPC: Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality … Article 6(2)(c)/Rule (23)d(c)[now 28(c)] EPC: Uses of human embryos for industrial or commercial purposes.

    3. … does rule 23d(c) [now 28(c)] EPC forbid the patenting of claims directed to products (here hESC cultures) which – as described in the application – at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, if the said method is not part of the claims? Referral of Technical Board of Appeal to EBA(T 1374/04)

    4. E.B.A. WARF ruling Legislative purpose “… was to prevent a misuse in the sense of commodification of human embryos … with one of the essential objectives of the whole Directive to protect human dignity” (para. 18). Case G 002/06

    5. EU objective was to prevent destruction of human embryos, as evidenced by Commission’s funding policy under the FP7 programme.

    6. Scope of exclusion “… not confined to claims but includes “the technical teaching of the invention as a whole as to how the invention is to be performed..”

    7. Application Here the “only teaching of how to perform the invention to make hESC cultures is the use (involving their destruction) of human embryos.” (Para. 22)

    8. Making the claimed product remains commercial or industrial exploitation of the invention even where there is an intention to use that product for further research (para. 25).

    9. It is not the fact of the patenting itself that is considered to be against ordre public or morality, but it is the performing of the invention, which includes a step (the use involving its destruction of a human embryo) that has to be considered to contravene those concepts (para. 29).

    10. Beyond WARF? .... This decision is not concerned with the patentability in general of inventions relating to human stem cells or human stem cell cultures. It holds unpatentable inventions concerning products (here human stem cell cultures) which can only be obtained by the use involving their destruction of human embryos. (para. 35)

    11. The EBA’s Raising of the Moral Bar Drift of key legal definitions/rules from: ‘Use’ ‘Destruction’ Scope of Exclusion ‘practice/teaching of the invention’ Uses for Commercial/Industrial Purposes Research purposes Morality of the patent Morality of the invention

    12. Legally (un)justified? EBA’s construction: Takes no notice of the jurisprudence the ECJ and the EPO boards distinguishing between a ‘moral’ reading of the general exclusion clause and a literal reading of the specific list of exclusions. Does not advert to the broader legal architecture of the EU and State autonomy on moral exclusions . Overlooks the existence of permissive EU regulatory controls on uses of human embryos.

    13. The Broader EU Legal Context EU controls on uses of human tissue/cells vary depending on the nature of the activity and whether it relates to research or commercialization. - Directive 2004/23/EC: not applicable to in vitro research or animal models. - Regulation (EC) 1394/2007: not applicable to ‘non-routine’ or custom made products. In all cases, hESC based products may be made and commercialized in the EU subject to State autonomy on moral exclusions.

    14. Systemic Tensions hESC research is lawful in the EU. hESC based products may be manufactured, produced on an industrial scale and licensed, marketed and commercialized in the EU. hESC inventions are lawful/moral in the EU But EU patent on hESC inventions excluded on moral grounds???

    15. The Future in Europe EU law has supremacy over national laws. National patent laws and policy/practice must be aligned with EU law. Narrower interpretation(s) of Article 6(2)(c) may be adopted consistently with the jurisprudence of ECJ.

    16. Updated UKIPO Policy Human Embryonic Pluripotent Stem cells “… the Office will continue to grant patents for inventions involving such cells provided that … at the filing or priority date, the invention could be obtained by means other than the destruction of human embryos.” 3rd February 2009

    17. Practical Options Applicants should file directly with national patent offices with a more permissive policy, i.e. UKIPO.

    18. Thank You

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