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Patents, Governance and Control: Ethics and the Patentability of Novel Beings and Advanced Biotechnologies in Europe

Published online by Cambridge University Press:  10 June 2021

Aisling McMahon
Aisling McMahon*
Affiliation:
Assistant Professor in Law, Maynooth University, Mariavilla Maynooth, Co. Kildare, Ireland
*
Corresponding author. Email: [email protected]
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Abstract

This article focuses primarily on to what extent novel beings, and particularly, beings which display something akin to human consciousness or agency would be (or should be) patentable under current European patent law. Patents grant the patent holder a right to exclude others from using the patented invention for the period of patent grant (usually 20 years). This allows the patent holder to control how that invention can or cannot be used by others downstream, granting patent holders a governance like function over the patented technology for the duration of the patent. Accordingly, the potential for patentability of novel beings gives rise to a myriad of ethical issues including: to what extent is it appropriate for patent holders to retain and exercise patents over “novel beings”; how issues of “agency” displayed by any “novel beings” would fit within the current patent framework, if at all; and to what extent existing exclusions from patentability might exclude patents on “novel beings” or whether changes within patent law may be needed if patents in relation to “novel beings” are deemed ethically problematic. This article focuses on such issues, and in doing so, also sheds light on the role of ethical issues within the patenting of advanced biotechnologies more generally.

Keywords

PatentsPatent ethicsbiotechnologynovel beingsmorality provisionsEuropean patent law
Type
Commentary
Information
Cambridge Quarterly of Healthcare Ethics , Volume 30 , Issue 3 , July 2021 , pp. 529 - 542
Copyright
© The Author(s), 2021. Published by Cambridge University Press

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References

Notes

1. For example, see Boseley S. Calls for action on patients denied £100,000 cystic fibrosis drug. The Guardian 2019 Feb 3; available at https://www.theguardian.com/science/2019/feb/03/nhs-cystic-fibrosis-drug-orkambi-vertex (last accessed 30 Nov 2020).

2. Lawrence DR, Morley S. Regulating the Tyrell Corporation: The emergence of novel beings. Cambridge Quarterly of Healthcare Ethics 2021;30(3):421–34; available at 10.1017/S0963180120000973. See also: Lawrence, DR, Brazier, M. Legally human? The status and challenge of novel consciousness in law. Medical Law Review 2018;26(2):309–27CrossRefGoogle Scholar.

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4. See discussion in: Parthasarathy, S. Use the patent system to regulate gene editing. Nature 2018;562:486–8CrossRefGoogle ScholarPubMed.

5. See: McMahon, A Biotechnology patents as private governance tools: The good, the bad and the ugly. Intellectual Property Quarterly 2020;3: 161–179.Google Scholar

6. In the context of patentability of de-extinction in the animal context see: McMahon A, Doyle DM. Patentability and de-extinct animals in Europe: The patented woolly mammoth. Journal of Law and the Biosciences 2020;forthcoming, advance access: https://doi.org/10.1093/jlb/lsaa017.

7. There are provisions which explicitly exclude patents on the human body within European patent law (Art 5 Biotechnology Directive) and on humans per se. However, given that it would be highly ethically contentious and therefore arguably unlikely someone would seek to claim patents on any former human species if developed, it is nonetheless, plausible. In such contexts, it is likely existing exclusions on patents related to humans within European patent law may be interpreted or extended to apply to, for example, any potential patent claim related to a de-extinct human species, or something resembling this, but questions and uncertainty arguably may still arise in this context.

8. Art 27(1) TRIPS Agreement; these requirements are also evident in regional patent treaties, for example, Art 52(2) European Patent Convention 1973.

9. For a discussion see Pila, J The Requirement for an Invention in Patent Law. Oxford University Press; United Kingdom, 2010Google Scholar.

10. European Patent Office. Guidelines for Examination Part 3.1 Discoveries; available at https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_3_1.htm (last accessed 8 May 2020).

11. This is the case in Europe—(Art 5(2) Biotechnology Directive).

12. See note 5, McMahon 2020.

13. Currently, there are 164 State Parties to the WTO—see available at https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm (last accessed 8 May 2020).

14. In the past, countries such as Brazil and India abolished patents on pharmaceuticals which allowed less restrictive development of these areas, and of generic medicines. This is not now possible for WTO State Parties.

15. Case T0149/11 of 24 Jan 2013: Method and device for processing a slaughtered animal or part thereof in a slaughterhouse; available at http://www.epo.org/law-practice/case-law-appeals/pdf/t110149eu1.pdf (last accessed 8 May 2020).

16. See note 15. The EPO’s Technical Board of Appeal stated patents could not be applied for involving human beings as this could amount to potential for slavery. It stated: “[s]ince patents are instruments of private property and as such freely transferable, a patent for an invention that includes one or more human beings among its features gives rise to serious concerns as to these fundamental freedoms of the particular human beings that would be the subject of such a patent when commercialized, however far-fetched such an interpretation may seem.”

17. Case T 0272/95 (Relaxin/Howard Florey Institute) of 23 Oct 2002.

18. There are likely to be significant broader ethical objections to any de-extinction attempts in the context of former human species (aside from questions of patentability); such questions are beyond the scope of this current article, but for a discussion see: Hank Greely, On Not De-Extincting Homo Neanderthalensis; available at https://law.stanford.edu/2013/02/18/lawandbiosciences-2013-02-18-on-not-de-extincting-homo-neanderthalensis/ (last accessed 26 Feb 2020); see also: Cottrell, S, Jensen, JL, Peck, SL. Resuscitation and resurrection: The ethics of cloning cheetahs, mammoths, and Neanderthals, 10(3) LSSP 1–17; 2014Google Scholar. On patents and de-extinction in the animal context, see note 6, McMahon, Doyle 2020.

19. See also: Laurie, G. Fore-warned is fore-armed: Is intellectual property a suitable case for foresight? International Review of Intellectual Property and Competition Law 2008;29:507–10, 39 ppGoogle Scholar.

20. Art 52(2) EPC.

21. There remains uncertainty in relation to the patentability of algorithmic inventions; patents tend to be granted for applications of algorithms to solve technical problems but not for algorithms per se: see Strange H, Barnfather K. Patentability of artificial intelligence and machine learning inventions in Europe (Withers and Rogers, 2018); available at https://www.withersrogers.com/news/ip-case-law/patentability-of-artificial-intelligence-and-machine-learning-inventions-in-europe/ (last accessed 8 May 2020).

22. Art 6(1) Directive 98/44EC.

23. For a discussion of the relationship between the EPC and Biotechnology Directive, see Bakardjieva-Engelbrekt A. Institutional and jurisdictional aspects of stem cell patenting in Europe (EC and EPO): Tensions and prospects. In: Plomer, A, Torremans, P, eds. Embryonic Stem Cell Patents in Europe: European Law and Ethics. OUP; United Kingdom; 2009Google Scholar; McMahon, A. An institutional examination of the implications of the unitary patent package for the morality provisions: A fragmented future too far? International Review of Intellectual Property and Competition Law 2017;48:42CrossRefGoogle Scholar.

24. Art 6(2) excludes patents on: (1) processes for cloning human beings; (2) processes for modifying the germ line genetic identity of human beings; (3) uses of human embryos for industrial or commercial purposes; (4) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

25. The Directive took over 10 years to adopt and questions arose around ethics of patenting technologies, which some may be reluctant to reopen. See: Porter, G. The drafting history of the European biotechnology directive. In: Plomer, A, Torremans, P, eds. Embryonic Stem Cell Patents. European Law and Ethics. Oxford University Press; United Kingdom, 2009Google Scholar.

26. European Patent Office, Guidelines for Examination (Section 4.1); available at https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_4_1.htm (last accessed 8 May 2020).

27. See note 26.

28. For further discussion of the morality provisions see: Warren-Jones, A. Vital parameters for patent morality—a question of form. Journal of Intellectual Property Law and Practice 2007; 2(12):832CrossRefGoogle Scholar; Warren-Jones, A. Finding a “common morality codex” for biotech—a question of substance. International Review of Intellectual Property and Competition Law 2008;39(6):638–61Google Scholar; Warren-Jones, A. Morally regulating innovation: What is “Commercial Exploitation”? Intellectual Property Quarterly 2008; 2: 193Google Scholar; Drahos, P. Biotechnology patents, markets and morality. European Intellectual Property Review 1999;21(9):441Google Scholar; Mills, O. Biotechnological Inventions, Moral Restraints and Patent Law. Revised ed. Ashgate; 2010Google Scholar.

29. Such cases to date in Europe have arisen primarily in the context of biotechnology.

30. EPO, Opposition Division, Leland Stanford, 16 Aug 2001 (2002) E.P.O.R. 2, para 44.

31. (2002) E.P.O.R. 2, para 51.

32. McMahon, A. An institutional examination of the morality provisions in the “European” patent system for biotechnological inventions [PhD Thesis]. University of Edinburgh; United Kingdom 2016Google Scholar.

33. [1995] E.P.O.R. 357. For an analysis, see Sherman, Bently. The ethics of patenting: Towards a transgenic patent system. Medical Law Review 1995;275:280Google Scholar.

34. Decision of the Board of Appeal of the European Patent Office, Greenpeace Ltd. v. Plant Genetic Systems, decision of 21 Feb 1995, T 356/93, p. 17, Reasons for the decision, point 8.

35. [2000] E.P.O.R. 303.

36. Case T 0866/01 Decision of the Technical Board of Appeal 3.3.02 of 11 May 2005.

37. See note 36, para 5.2.

38. See note 36, para 5.4.

39. See note 36, para 6.12.

40. See discussion in: Beyleveld, D, Brownsword, R. Mice, Morality and Patents: The Onco-Mouse Application and Article 53(a) of the European Patent Convention. Intellectual Property Institute; 1993Google Scholar.

41. Indeed, the Art 6(2)(d) exclusion states the following is unpatentable: “processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.”

42. [1991] EPOR 525 and Board of Appeal of the European Patent Office, Decision of 6 July 2004, T 315/03.

43. See note 42, para 5.

44. There have been discussions on the appropriateness of “patents on life” but such discussions often fall short of nuanced engagement with potential ethical issues at stake. The focus is often, for example, in the biotechnological context, on the extent to which the person whose bodily material was used gave informed consent to this use. However, there is limited engagement within patent law, of the implications for other living bodies of having a patent on, for example, isolated genes. For example, see: Case T 0272/95 (Relaxin/Howard Florey Institute) of 23 Oct 2002.

45. McMahon, A. Gene patents and the marginalisation of ethical issues. European Intellectual Property Review 2019;41(10):608–20Google Scholar.

46. See note 32, McMahon 2016. See also: Bently, L, Sherman, B. The ethics of patenting: Towards a transgenic patent system. Medical Law Review 1995;3:275–91CrossRefGoogle ScholarPubMed. Furthermore, Bagley, M. Patent first, ask questions later: Morality and biotechnology in patent law. William and Mary Law Review 2003–2004;45:469–547Google ScholarPubMed.

47. The morality provisions contained in Art. 53(a) EPC developed from Art. 2(a) of the Strasbourg Convention 1963 which stated that: “The Contracting States shall not be bound to provide for the grant of patents in respect of: (a) Inventions the publication or exploitation of which would be contrary ‘ordre public’ or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.”

48. Armitage, E, Davies, I. Patent and Morality in Perspective. Intellectual Property Institute; 1994, at 16Google Scholar.

49. See note 48, Armitage, Davies 1994, at 20. This analysis was based on their reflections on the drafting of the Strasbourg Convention which they had been involved in and on reports of the committee meetings which they had inspected but which had since been destroyed.

50. See note 48, Armitage, Davies 1994, at 24.

51. See note 48, Armitage, Davies 1994, at 44–5.

52. See note 32, McMahon 2016.

53. Recital 38 also refers to exclusion of uses which offend against “human dignity.”

54. See discussion in McMahon A. An institutional examination of the morality provisions in the “European” patent system for biotechnological inventions [PhD Thesis]. University of Edinburgh; 2016. For a discussion of dignity in the context of patent law, see: Plomer A. Human dignity and patents. In: Geiger, C, ed. Research Handbook of Human Rights and IP Rights. Edward Elgar; 2014Google Scholar.

55. Patents were recently rejected on isolated genes in the USA and Australia in: Association for Molecular Pathology v. Myriad Genetics Inc. (2013) 569 U.S. 576, and D’Arcy v Myriad Genetics Inc. [2015] HCA 35, respectively. However, the decisions were not based on ethical issues related to the patents but rather based on whether genes were seen as discoveries instead of inventions for patent law.

56. McMahon, A. Gene patents and the marginalisation of ethical issues. European Intellectual Property Review 2019;41(10):608–20Google Scholar.

57. See Recital 43, Article 16. See also discussion: Plomer A. Human dignity, human rights and article 6(1) of the EU directive on biotechnological inventions. In Plomer, A, Torremans, P, eds. Embryonic Stem Cell Patents: European Patent Law and Ethics. Oxford University Press; 2009Google Scholar; European Plomer A. Towards systemic legal conflict: Article 6(2) (c) of the EU directive on biotechnological inventions. In: Plomer A, Torremans P, eds. Embryonic Stem Cell Patents: European Law and Ethics. Oxford University Press; 2009; Arvind TT and McMahon A, Commodification, control and the contractualisation of the human body, In: Bertrand E, Catto Marie-Xavière, Mornington A (eds) The limits of the market: commodification of nature and body, Paris: Mare & Martin; 2020.