Abstract
Synthetic biology poses interesting iterations of familiar legal and ethical questions raised in modern biotechnology. These are particularly interesting in relation to patents, privacy, and property. These questions ask us whether there are inconsistencies in our approach to safeguarding individuals and, at the same time, encouraging innovation. The first issue explored here is about the procedural inclusion of morality within the patenting process. Morality is a seemingly different question from legality and there seems to be reluctance in many places to embrace morality as a full and appropriate part of the patent granting agenda. However it is arguable that the patenting process has to change to include a more effective evaluation of the morality of innovations. A second tension arises when one considers the regulation of privacy alongside the patenting process over innovations with their origins in human data and tissue. Considering this tension opens up the question of what the concept of property should be that is used in the regulation of innovations in modern biotechnology. This requires us to consider the social context of the definition of property. The paper then considers these discussions in relation to the broader human rights debate, and particularly how a more extensive application of the human rights agenda is necessary to ensure consistency in the regulation of modern biotechnology.
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Notes
- 1.
- 2.
It is difficult to pin down evidence of this. However, the suggestion is made on the basis that (1) there are few formal challenges to a decision not to grant a patent on the basis of Article 53; (2) there are few Article 53 challenges to patents that have been successful; and, (3) there is an argument that those engaged in the patent granting process are not equipped to make judgments under Article 53. One might also point to the sense of novelty that has attended the Norwegian Patent Office’s work with the National Research Ethics Committee to develop a patent ethics board (see Forskningstetiske Komiteer 2008).
- 3.
In jurisdictions that adopt the option in Article 27 (2) of the TRIPS agreement.
- 4.
See Forskningstetiske Komitteer 2008.
- 5.
Universal Declaration of Human Rights, Article 12; European Convention on Human Rights, Article 8.
- 6.
In relation to the regulation of personal data in Europe, see particularly the Data Protection Directive 95/46/EC. For a discussion of the regulation of the use of human tissue in research see Wright et al. (2010).
- 7.
It is arguable that the intellectual property regime has a similar ‘front end’ approach, concentrating on the granting of the right rather than on the use of the property generated through the operation of the monopoly.
- 8.
For example, that an individual might be able to sell his or her kidney.
- 9.
These are the requirements long established in Patent Law, but expressed today in Article 27 of the TRIPS agreement, Article 52 of the European Patent Convention and variously in domestic laws (see, for example, the UK Patent Act 1977, Section 1). World Trade Organization (1994).
- 10.
Indeed, we are fully used to restrictions being placed upon our ‘property’, again because property is a social construction, for example in compulsory purchase, restrictive covenants, or other licensing requirements.
- 11.
For an example of how this can be argued, see Beyleveld and Brownsword (2002) Human Dignity in Bioethics and Biolaw. Oxford: Oxford University Press, pp. 173–175.
- 12.
Hubbard and Love are keen to point out this investment (see below).
- 13.
- 14.
Universal Declaration of Human Rights, Article 17; Protocol to the Convention for the Protection of Human Rights and Fundamental Freedoms, Paris, 20 March 1952, Article 1.
- 15.
Universal Declaration of Human Rights, Article 27 (2).
- 16.
Universal Declaration of Human Rights, Article 19; European Convention on Human Rights, Article 10.
- 17.
Universal Declaration of Human Rights, Article 27 (1).
- 18.
Universal Declaration of Human Rights, Article 25.
- 19.
International Covenant on Economic, Social and Cultural Rights, Article 12 (although this would require a broad reading of the four duties placed on the signatory States under the Article).
- 20.
Article 2 of the Universal Declaration of Human Rights states that “Everyone is entitled to all the rights and freedoms set forth in this Declaration, without distinction of any kind, such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status”. Article 14 of the European Convention on Human Rights has the same scope. ‘Property’ could arguably extend to one’s financial or economic status.
- 21.
See for example the development of the ‘world wide web’ and the attitude of Sir Tim Berners-Lee towards his invention. See also the treatment of Trade Marks that have become generic terms (and are thereby outside protection).
- 22.
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Townend, D. (2014). Patents Originating in Human Tissue and Data: Questions on Benefit Creating and Benefit Sharing, on Morality and Property. In: de Miguel Beriain, I., Romeo Casabona, C. (eds) Synbio and Human Health. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-9196-0_7
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