Abstract
This paper focuses on the relation between patentable biotechnological innovations and the human, animal or plant genetic material from which they derive. The Italian Parliament recently decided on the issues of “provenance” and “ownership” of biological material within the framework of the Intellectual Property Code. The provision is open to criticism for several reasons. The first problem is the issue of informed consent “to the use” of the biological material, which seems to legitimize some sort of availability of the genetic material itself and of control on the innovative outcome. The cases of uncertain patentability include innovation derived from human embryonic stem cells, for which “provenance” plays a central role. The provenance of animal or plant genetic material and the solutions proposed by the legislation within the framework of international agreements are also mentioned; in this case the “ownership” of the biological material is defined in terms of the sovereignty of the State over its own natural resources.
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- 1.
On the decisive changes under way in the relationship between nature and culture see S. Rodotá, Il nuovo habeas corpus, in Trattato di Biodiritto, Milan, 2010, 219; S. Jasanoff, Taking Life: Private Rights in Public Nature; Id, Fabbriche della natura, Milan, 2008; A. Di Lauro, Esplorazione del diritto fra naturale e artificiale, in Diritto Agrario, 2010, at 47.
- 2.
For this methodological progression, P. Spada, Diritto Commerciale, vol. I, Parte Generale, Storia, lessico, istituti, Padua, 2009, at 42.
- 3.
G. Van Overvalle, Gene Patents and Collaborative Licensing Models, Cambridge University Press, Cambridge, 2009 and more generally L. Pilotti e A. Ganzaroli, Proprietá Condivisa e Open Source, Franco Angeli, 2009.
- 4.
For some historiographical references in this direction V. Di Cataldo, Nuove tecnologie e nuovi problemi. Chi inventa le nuove regole e come? in Le matrici del Diritto Commerciale tra storia e tendenze evolutive, Varese, 2009, at 135.
- 5.
P. Spada, Liceità dell’invenzione brevettabile ed esorcismo dell’innovazione, in Riv. dir. priv. 2000, at 5.
- 6.
S. Rodotà, op. cit 169.
- 7.
Most instructive in this sense is the case Moore v. Regents of University of California described and analyzed by S. Jasanoff, Fabbriche della natura, Milan, 2008.
- 8.
The issue of ownership as it relates to one’s body parts is dealt with and analyzed in depth by P. Zatti, Maschere del diritto volti della vita, Milan, 2009, who highlights the multiple facets of ownership and its configuration as a “nebula (…) where around the nucleus everything ‘belonging’ to the subject whirls following different orbits”.
- 9.
In this sense see P. Spada, Liceità dell’invenzione brevettabile ed esorcismo dell’innovazione, in Riv. Dir. Priv. 2000, at 5.
- 10.
Actually, the first comments on the new provisions hold that the requirement to include informed consent in the application is an additional obligation for biotechnological inventions but that it does not impact on their patentability; in this sense see O. Capasso, in Codice della Proprietà Industriale: la riforma 2010, edited by C. Galli, Milan, 2010 at 127.
- 11.
The ambiguity of the new provisions is confirmed by C. Galli, L’inserimento nel Codice della disciplina delle invenzioni biotecnologiche in C. Galli, ed., Codice della Proprietà Industriale: la riforma 2010, Milan, 2010, at 119, who underlines both the optional aspect of the presentation of the declarations of provenance to the Office and the “cryptic” aspect of those same declarations.
- 12.
On the relationship between titular rights and non-titular rights and on the spillovers on competition, see R. Romano, Diritti titolati e diritti non titolati nel campo dell’innovazione tecnologica (dalla creazione alla segretazione?), in Studi in Memoria di Paola A.E. Frassi, Milan, 2010, at 599.
- 13.
P. Zatti, op. cit. 97 to whom we refer to for an approach to the topics only mentioned and not developed here.
- 14.
In this sense, in a much broader context, see P. Zatti, op. cit. at 84 nt. 60 where it is explicitly stated: “But if an isolatable or isolated part of my body, without any functional lesion to bodily integrity, can be used with economic profit, my right over my body allows me to exercise a controlling power on that part of my body also with regard to its economic exploitation”.
- 15.
For a work stressing the “openings” of the aforesaid decision, see C. Germinaro, Brevettabilità delle cellule staminali umane: divieto o legittimazione? in Il Diritto Industriale, 2009, at 105; M. Scuffi, Il caso WARF e la tutela dell’embrione umano, in Riv. dir. ind. 2008, at 558.
- 16.
On the role of the decision in European and international jurisprudence on the patentability of stem cells, see A. Plomer, Stem Cell Patents in a Global Economy: The Legal Challenges, in Stanford Journal of Law, Science and Policy, in www.sheffield.ac.uk/law/staff/academic/aplomer.
- 17.
O. Capasso, in C. Galli, ed., Codice della Proprietà Industriale: la riforma 2010, Milan, 2010, at 133, highlights the possible patentability of innovations deriving from human embryonic stem cells in the European system, although with greater difficulty than in the Italian system.
- 18.
On the origins of such provisions with regard to the provenance for genetic material see G. Floridia, Il decreto correttivo al Codice della proprietà industriale: una riforma necessaria, in Il Diritto Industriale, 2010, at 405.
- 19.
The reference to the sovereignty of States is in the Rio convention on the safeguard of biodiversity, explicitly quoted in the recitals of Directive 44/98/EC on biotechnological inventions.
- 20.
On this, see G. Dutfield, Intellectual Property, Biogenetic Resources and Traditional Knowledge, London, 2004; J. Gibson, Intellectual Property Systems, traditional Knowledge and the Legal Authority of Community, in EIPR, 2004, 280.
- 21.
See R. Romano, Lo sfruttamento delle risorse genetiche tra diritto delle invenzioni e biodiversità, in Riv. dir. ind., 2006, at 411.
- 22.
Patents on some properties of the Neem tree and of the Hoodia Cactus, which have long been known to the local populations, have been voided or modified following the decision of the EPO; on those decisions see S. Vezzani, Conoscenze tradizionali e attività inventiva: due recenti sentenze del Board of Appeal dell’Ufficio Europeo dei Brevetti riaccendono il dibattito sulla “biopirateria”, in Riv. Dir. Int. 2005, 773.
- 23.
India’s Traditional Knowledge Digital Library (TKDL): A powerful tool for patent examiners in www.epo.org www.epo.org.
- 24.
For a commentary on those agreements see C. Campiglio, I brevetti biotecnologici nel diritto comunitario, in Dir. Comm. Internaz. 1999, at 862; R. Romano, Lo sfruttamento delle risorse genetiche tra diritto delle invenzioni e biodiversità, in Riv. dir. ind., 2006, at 411.
References
P. Spada, Diritto Commerciale, vol. I, Parte Generale, Storia, lessico, istituti, Padua, 2009, at 42.
G. Van Overvalle, Gene Patents and Collaborative Licensing Models, Cambridge University Press, Cambridge, 2009 and more generally L. Pilotti e A. Ganzaroli, Proprietà Condivisa e Open Source, Franco Angeli, 2009.
P. Spada, Liceità dell’invenzione brevettabile ed esorcismo dell’innovazione, in Riv. dir. priv. 2000, at 5.
R. Romano, Lo sfruttamento delle risorse genetiche tra diritto delle invenzioni e biodiversità, in Riv. dir. ind., 2006, at 411.
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Romano, R. (2012). “Ownership and Provenance” of Genetic Material in the Rules on Biotechnological Patents. In: Bin, R., Lorenzon, S., Lucchi, N. (eds) Biotech Innovations and Fundamental Rights. Springer, Milano. https://doi.org/10.1007/978-88-470-2032-0_5
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