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IL SOLE 24 ORE Venerdì, 15 Ottobre 2010 13:07
    IL SOLE 24 ORE - SANITA' - 27 APRILE 2010 Di Umberto Izzo e Matteo Macilotti,  LA NEBULOSA DELLE BIOBANCHE, Privacy proprietà e brevetti i nodi più spinosi - In Italia troppi lacci allo sviluppo         Read more
UNITN Venerdì, 15 Ottobre 2010 13:07
    UNITN n. 117 09.2010 - IL MONDO DELLE BIOBANCHE Le prospettive della medicina personalizzata, i problemi giuridici e le garanzie a tutela dei donatori.  Read more
IL SOLE 24 ORE Venerdì, 22 Ottobre 2010 09:09
       IL SOLE 24 ORE - SANITA' - 19 OTTOBRE 2010 Di Umberto Izzo e Matteo Macilotti,  RISCHIO PARALISI DAL NUOVO CODICE SUI BREVETTI L'ultima mossa del legislatore italiano       Read more
News: "Myriad Genetics Case" Venerdì, 05 Novembre 2010 15:10
  The New Brief as Amicus Curiae for the US Government in support of Neither Party in the "Myriad Genetics Patent" Case: The Twilight of Gene Patenting?  Read more
The Issue: What is Meant by the term 'human embryos' in Article 6 (2) (c) of Directive 98/44/EC? Lunedì, 06 Giugno 2011 14:47
  EU Court of Justice, Case C-34/10, Prof. Dr. Oliver Brüstle v Greenpeace e.V.   The case concerns the interpretation of Directive 98/44/EC on the legal protection of biotechnological inventions. German Supreme Court (Bundesgerichtshof) asked the following questions about the directive on the interpretation of the term "human embryo" and related matters:  What is Meant by the term 'human... Read more
Health Data and Re-identification: The Case SORRELL V. IMS HEALTH INC. Giovedì, 30 Giugno 2011 17:07
 Prescription drug records, which contain information about patients, doctors, and medical treatment, exist because of federal and state regulation in this highly regulated field.  This case is about information from prescription records known as "prescriber-identifiable data." Such  data identifies the doctor or other prescriber, links the doctor to a particular prescription, and reveals... Read more
Myriad Case: The Empire strokes back (?) Venerdì, 11 Novembre 2011 16:37
  The Court of Appeal for the Federal Circuit riversed the decision made by the District Court of New York. The latter invalidated the patent owned by Myriad Genetics and the University of Utah Research Foundation over the genes BRCA1 and BRCA2, on the base of the doctrine of "products of nature": isolated DNAs are not “markedly different” from native DNAs, so such molecules are... Read more
News: Brüstle v Greenpeace Venerdì, 11 Novembre 2011 17:22
In this recent case, the ECJ was asked for a preliminary ruling on the interpretation of Article 6 (2) (c) of Directive 98/44/EC on the legal protection of biotechnological inventions. Adopting a broad definition of embryo, the European Court ruled that: " 1. Any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been... Read more
News from Spain Venerdì, 20 Gennaio 2012 11:16
  Published in BOE (Boletin Oficial del Estado) the "Real Decreto" about biobanks. real_decreto_biobancos.pdf Read more

Biobank Law

Intellectual Property



Mueller J.M., Facilitating Patient Access to Patent-Protected Genetic Testing, Journal of Business & Technology Law, Vol. 6, No. 1, 2010





SIMON B.M., How To Get a Fair Share: IP Policies For Publicly Supported Biobanks, Stanford Journalof Law, Science and Policy, 2009 


VAN OVERWALLE G. (ed.), Gene Patents and Collaborative Licensing Models. Patent Pools, Clearinghouses, Open Source Models and Liability Regimes, Cambridge, Cambridge University Press, 2009




GOLD R., CARBONE J., Myriad Genetics: In the Eye of the Policy Storm, 2008, in rete, www.theinnovationpartnership.org




HOLMAN C.M, The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litigation, 76 UMKC L. Rev. 295 (2007)

HOPKINS M.M., MAHDI S., PATEL P., THOMAS S.M., DNA Patenting: The End o fan Era?, 25 Nat. Biotech, 185 (2007)


CAFORIO G., I trovati biotecnologici tra i principi etico-giuridici e il codice di proprietà industriale, Torino, 2006


CAULFIELD T., COOK-DEEGAN R.M., KIEFF F.S.,WALSH J.P., Evidence and Anectodes: an Analysis of Human Gene Patenting Controversies, 24 Nature Biotech, 1091 (2006)

GREENFIELD D.L., Greenberg v. Miami Children’s Hospital: Unjust Enrichment and the Patenting of Human Genetic Material, 15 Annals of Health Law, 213 (2006)


EBERSOLE T.J., GUTHRIE M.C., GOLDSTEIN J.A., Patent Pool as a Solution to The Licensing Problems of Diagnostics Genetics, 17 Intellect. Prop. Technol. Law J., 6 (2005)

GOLD R., CAULFIELD T., JOLY J., Genetic Research Tool, The Research Exception and Open Science, 3 GenEdit, 1 (2005)

JENSEN K., MURRAY F., Intellectual Property. Enhanced: Intellectual Property Landscape of Human Genome, 310 Science, 239 (2005)

LIIVAK O., The Forgotten Originality Requirement: A Constitutional Hurdle for Gene Patents, 87 J. Pat. & Trademark Off. Soc'y, 261 (2005)


MATTHIJS G., Patenting Genes May Slow Down Innovation, and Delay Availability of Cheaper Genetic Tests, 329 British Medical Journal, 1359 (2004)


CHO M.K., Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Service, 5 J. Molecular Diagnostics, 3 (2003)

CHO M., ILLANGASEKARE S., WEAVER M., LEONARD D., MERZ J., Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Service, 5 J. Mol. Diagn., 3 (2003)


ANDREWS L.B, Genes and Patent Policy: Rethinking Intellectual Property Rights, 3 Nat. Rev., 803 (2002)

ANDREWS L.B., The Gene Patent Dilemma: Balancing Commercial Incentives With Health Needs, 2 Houston Journal of Health Law & Policy, 65 (2002)

BARTON J.H., United States Law of Genomic and Post Genomic Patents, in 33 Intenational Review of Industrial Property and Copyright Law, 779 (2002)

GOLD R., CAULFIELD T., The Moral Toolboth: a Method that Makes Use of the Patent System to Address Ethical Concern in Biotechnology, 359 Lancet, 2268 (2002)


BOBROW M., THOMAS S., Patents in a Genetic Age, 409 Nature, 763 (2001)

FAELLI T., La tutela delle invenzioni biotecnologiche in Europa: prime valutazioni di insieme, in Dir. ind., 2001, I, 129


CAULFIELD T., GOLD R., CHO M.K., Patenting Human Genetic Material: Refocusing the Debate, 1 Nat. Rev., 227 (2000)


CAMPIGLIO C., I brevetti biotecnologici nel diritto comunitario, in Dir. comm. internaz., 1999, IV, 849

DI CATALDO V., La brevettabilità delle biotecnologie. Novità, attività inventiva, industrialità, in Dir. ind., I, 1999, 177

GUIDETTI B., La Direttiva 98/44/CE sulle invenzioni biotecnologiche, in Contratto e Impresa, 1999, I, 482


BAGGOT B., Patenting Transgenic in the European Union, 16(3) Nat. Biotechnol., 299 (1998)

BEGHÈ LORETI A., MARINI L., La protezione giuridica delle invenzioni biotecnologiche, in Diritto dell’Unione Europea, 4-1998, 793

HELLER M., EISENBERG R., Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 Science, 698 (1998)


CAPLAN A.L., MERZ J.F., Patenting Gene Sequences, 312 British Med. J., 926 (1996)


BEIER F.K. , MOUFANG R., Patentability of human genes and living organism, in Dir. ind., 1994, I, 340

GRUNWALD R., VOGEL F., Patenting of Human Genes and Living Organism, New York, 1994


CASUCCI G.F., Onco-mouse Harvard: 3° atto. Il problema della liceità, in Dir. ind., 1992, II, 158

EISENBERG R.S., Genes, Patents, and Product Development, 257 Science, 903 (1992)

KILEY T.D., Patents on Random Complementary DNA Fragments?, 257 Science, 915 (1992)

KO Y., An Economic Analysis of Biotechnology Patent, 102 Yale L. Rev., 1992, 777


DI CERBO V., "Il topo di Harvard" ovvero la manipolazione genetica di animali all’esame dell’Ufficio europeo dei brevetti, in Foro It., 1991, IV, 178

GREENFIELD M.S., Recombinant DNA Technology: A Science Struggling with the Patent Law, 44 Stanf. f. L. Rev., 1991, 1051


BEIER F.K., CRESPI R.S., STRAUSS J., Biotechnology and Patent Protection: an International Review, OCSE, 1985


Informed consent


D’AVACK L., Sul consenso informato all’atto medico, in Diritto di famiglia e delle persone, 2008, fasc. 2, 759


CAUFILED T., Biobank and Blanket Consent: The Proper Place of the public Good and Public Perception Rationales, 18 King's Law Journal, 209 (2007)


CAPLAN A.L., ELGER B.S., Consent and Anonymization in Research Involving Biobanks, 7 Embo reports, 661 (2006)

FONG M., KATHYRIN L. B., MEI-LING CHANG, Native Hawaiian Preferences for Informed Consent and Disclosure of Results From Genetic Research, 21 Journal of Cancer Education S47 (2006)


CLAYTON E. W., Informed Consent and Biobanks, 33 Journal of Law, Medicine and Ethics, 19 (2005)

HELGESSON G., JOHANSSON L., The Right to Withdraw Consent to Research on Biobank Samples, Vol. 8 n. 3, Medicine, Health Care and Philosophy 315 (2005)

ERIKSSON S., HELGESSON G., Anonymization and Withdrawal from Biobank Research, 13 Eur. J. Hum. Gen., 1071 (2005)

MALLARDI V., The Origin of Informed Consent, 25 Acta Otorhinolaryngol. Ital., 312 (2005)


ARNASON V., ARNASON G., Informed Democratic Consent? The Case of the Icelandic Database, 8 Trames, 164 (2004)

KEGLEY A.K., Challenges to Informed Consent, 5 Embo report 832 (2004)


ANNAS G. J., Reforming Informed Consent to Genetic Research, 18 Journal of the American Medical Association, 2326 (2001)

DALLA VORGIA P., LASCARTOS J., SKIADAS P., GARANIS-PAPADATOS T., Is Consent in Medicine a Concept only of Modern Times?, 27 J. Med. Ethics 59 (2001)


GREELY H.T., Breaking the Stalemate: A Prospective Regulatory Framework for Unforeseen Research Uses of Human Tissue Samples and Health Information, 34 Wake Forest L. Rev. 737 (1999)


FERRANDO G., Il consenso informato del paziente e responsabilità del medico, principi, problemi e linee di tendenza, in Riv. crit. dir. priv., fasc.1-2, 1998, 37


FENWICK P., BERAN R.G., Informed Consent – Should Bolam Be Rejected?, 16 Med Law 215 (1997)


FADEN R., BEUCHAMP T. M., KING M.P., A History and Theory of Informed Consent, Oxford Un. Press, New York, 1986


CRISCUOLI G., Ragionevolezza e consenso informato del paziente, in Rass. Dir. Civ., 1985, 480




STEINMANN M., SÝKORA P., WIESING U., Altruism Reconsidered. Exploring New Approaches to Property in Human Tissue, Ashgate, 2009 


HEANEY C., CARBONE J., GOLD R., BUBELA T., HOLMAN C.M., COLAIANNI A., LEWIS T., COOK-DEEGAN R., The Perils of Taking Property Too Far, Stanford Journal of Law, Science & Policy, 2009


HOPPE N., Bioequity. Property and the Human Body, Farham, Ashgate, 2009




NWABUEZE R. N., Donated Organs, Property Rights, and the Remedial Quagmire, 16 Med. Law Rev., 2008, pp. 201-224 


HARDCASTLE R., Law and the Humam Body, Hart publishing, 2007


ANDREWS L., Two Perspectives: Rights of Donors: Who Owns Your Body? A Patient's Perspective on Washington University v. Catalona, 34 J.L. Med. & Ethics 398 (2006)


PALMERINI E., Le scelte sul corpo: i confini della libertà di decidere, Atti della relazione tenuta presso il Consiglio Superiore della Magistratura – Roma, 9-10 giugno 2005, pubblicati dal sito del CSM


D’ARRIGO R. C., Il contratto e il corpo: meritevolezza e liceità degli atti di disposizione dell’integrità fisica, in Familia, 2005, n. 4, 777

MARCHANT E., Property Rights and Benefit-Sharing for DNA Donors?, 45 Jurimetrics J., 153, 160 (2005)


ANDEWS L., NELKIN D., Il mercato del corpo, Il commercio dei tessuti umani nell’era biotecnologia, Milano, 2002

FERRANDO G., Il principio di gratuità, biotecnologie e "atti di disposizione del proprio corpo", in Europa dir. priv., 2002, 761

MAGNUS D., CAPLAN L. A., MCGEE G., Who Owns Life?, New York, 2002


ANDREWS L.B., NELKIN D., Body Bazaar: The Market of Human Tissue in The Biotechnology Age, New York, 2001

LAURIE G. T., MASON J. K, Consent or Property? Dealing with the Body and its part in the Shadow of Bristol and Alder Hey, 64 Mod. L. Rev.  710 (2001)


GOLD R. E., Body Parts: Property Rights and the Ownership of Human Biological Materials, Georgetown University Press, 1998

ANDREWS L.B., NELKIN D., Homo Economicus; The Commercialization of Body Tissue in the Age of Biotechnology, in Hastings Center, 28(5):30-39, 1998

GOTTLIEB K., Human Biological Samples and the Laws of Property: The Trust as a Model for Biological Repositories, in Weir R.F., Stored Tissue Samples: Ethical, Legal and Public Policy Implications, University of Iowa Press, 1998


MARTINEZ J., A Cognitive Science Approach to Teaching Property Rights in Body Parts, 42 J. Leg. Education 920 (1992)


CALABRESI G, Una introduzione al pensiero giuridico: quattro approcci al problema del regime giuridico delle parti del corpo, in Riv. crit. dir. priv., 1991, 75


DOGLIOTTI M., Atti di disposizione sul proprio corpo e teoria contrattuale, in Rass. dir. civ., 1990, 291


EISENBERG R. S., Proprietary Rights and Norms of Science in Biotechnology Research, in Yale L.J., 1987, 97, 181

HELLER M., EISENBERG R., Proprietary Rights and the Norm of Science in Biotechnology Research, 97 Yale L.J. 177 (1987)


HARDIMAN R., Toward the Right of Commerciability: Recognizing Property Rights in the Commercial Value of Human Tissue, 34 UCLA L. Rev. 209 (1986)


CRISCUOLI G., L'acquisto delle parti staccate del proprio corpo e gli art. 820-821 c.c., in Riv. dir. fam., XIV, 1985, 271


D’ADDINO SERRAVALLE P., Atti di disposizione del corpo e tutela della persona umana, Napoli, 1983


DE CUPIS A., Teoria generale, diritto alla vita e all’integrità fisica, diritto sulle parti staccate dal corpo e sul cadavere, diritto alla libertà, diritto all’onore e alla riservatezza, Milano, 1959


CARNELUTTI F., Il problema giuridico della trasfusione del sangue, in Foro it., IV, p. 89, 1938



BLYTH E., FRITH L., Donor-Conceived People's Access to Genetic and Biographical History: An Analysis of Provisions in Different Jurisdictions Permitting Disclosure of Donor Identity, 23 Int. J. Law Policy Family, 2009,  pp. 174-191


KIMBERLY Y.J., Department: Heads Up: The GINA Is Out of the Bottle: the Genetic Information Non-Discrimination Act of 2008, 53 B.B.J., 9 (2008)



CAGGIA F., Il trattamento dei dati sulla salute, con particolare riferimento all’ambito sanitario, in Cuffaro V., D’Orazio R., Ricciuto V. (a cura di), Il codice del trattamento dei dati personali, Torino, 2007, 405

LAURIE G, Genetic Privacy. A Challenge to Medico-Legal Norms, Paperback edition, Cambridge University Press, Cambridge 2007

MCGREGOR J.L., Population Genomics and Research Ethics with Socially Identifiable Groups, 35 (3) J. Law Med. & Ethics 356 (2007)

AA.VV, Policy Papers on Biometrics & Genetic Data, made available by the European Commission, Department of Justice and Home Affairs (2006-2000)

BREGMAN-ESCHET Y., Genetic Databases and Biobanks: Who Control Our Genetic Privacy?, 23 Santa Clara Computer & High Tech. L.J., 1 (2006)

LORD D.B., The HIPAA privacy rule and medical records discovery, 30 AK Bar Rag, 6 (2006)


GERARDS J. H., HERINGA A. W., JANSSEN H. L., Genetic Discrimination and Genetic Privacy in a Comparative Perspective, Intersentia, Antwerp 2005


HONG H., Dismantling the Privacy Enforcement of the Privacy Act of 1974: Doe v. Chao, 38 Akron L. Rev. 71 (2005) 


LEVIN A., NICHOLSON M.J., Privacy law in the United States, the EU and Canada: The Allure of the Middle Ground, 2 UOLTJ 357 (2005)


AA.VV, Human Genetic Testing: What Implications? Proceedings and Final Reports of the European Stakeholders’ and Citizens’ Conference on the 25 Recommendations by the European Commission’s Expert Group on the Ethical, Legal, and Social Aspects of Genetic Testing – Charlemagne Building, Brussels Belgium, 6/7 May 2004


D’ANTONIO V., I dati genetici, in Cardarelli F., Sica S., Zeno-Zencovich V. (a cura di), Il codice dei dati personali, Milano, 2004, 341

JOHNSTON C., KAYE J., Does the UK Biobank have a Legal Obligation to Feedback Individual Findings to Participants?, 12 Med. Law Rev., 2004, pp. 239 - 267



BARISON S., Contratti nuovi, nuove teconologie e tutela della persona: il trattamento dei dati genetici nell’assicurazione di long term care, in Commandé G. (a cura di), Persona e tutela giuridiche, Torino, 2003, 217


DI CIOMMO F., La privacy sanitaria, in AA.VV., Diritto alla riservatezza e circolazione dei dati personali, (a cura di) R. Pardolesi, II, Milano, 2003, 249


ANDERLIK M., ROTHSTEIN M., The Genetics Revolution: Conflicts, Challenges and Conundra: Article: Dna-based Identity Testing and The Future of The Family: A Research Agenda, American Journal of Law & Medicine, 215


LAURIE G., Genetic Privacy, A Challenge to Medical-Legal Norms, Cambridge University Press, 2002, 304


LOWRANCE W., Privacy and the Secondary Use of Data in Health Research, pubblicato per The Nuffield Trust, 2002 (2002)


BELL D., BENNETT B., Genetic Secrets and the Family, 9 Med. Law Rev. 2001, pp. 130-161


BRADBURN N., Medical privacy and Research, 30 J. Of Leg. St., 687 (2001)

DUNKEL Y.F., Medical Privacy Rights in Anonymous Data: Discussion of Rights in the United Kingdom and the United States in Light of the Source Informatics Cases, 23 Loy. L.A. Int’l & Comp. L. Rev., 41 (2001)



 JONATANSSON H., Iceland’d Health Sector Database: A Significant Head Start in the Search for the Biological Grail or an Irreversible Error?, 26 Am.J.L.and Med., 31 (2000)

LITMAN J., Information Privacy/Information Property, 52 Stan. L. Rev. 1283 (2000)


CATALOZZI M., Dati sanitari e dati genetici: una frontiera aperta?, in Nuov. giur. civ. comm., 1999, I, 831


DE CAMELIS P., Privacy e potere informatico – Cenni al trattamento dei dati inerenti la salute, in Rass. amm. sanità, 1998, 4


HARRIS R.E., The need to Know Versus the Right to Know. Privacy of Patient Medical Data in an Information-Based Society, 30 Suffolk Univ. L. Rev., 1189, (1997)


MELL P., Seeking Shade in a Land of Perpetual Sunlight: Privacy as Property in the Electronic Wilderness, 11 Berk. Tech. L.J., 1 (1996)


ANNAS G. J., Privacy Rules for DNA Databanks: Protecting Coded “Future Diaries”, JAMA, 1993; 270(19): pp. 2346-2350


CADIET L., La notion d’information génétique en droit français, dans la génétique humaine: de l’information à l’informatisation, in Knoppers B. M., Cadiet L., Laberge C. (sous la direction de), Édition Litec, Paris, 1992, pp. 41-75


MCCAIN K.W., Communication, Competition, and Secrecy: The Production and Dissemination of Research-Related Information in Genetics, Vol. 16 n. 4 Science, Technology, & Human Values 491 (1991)


DE CUPIS A., I diritti della personalità, in Trattato di diritto civile e commerciale, a cura di Cicu A., Messineo F., Milano, 1985, 159