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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

The Last Act of the Gene Patents (?)

The US Supreme Court has recently written the last chapter of the "Myriad trilogy".

The issue at stake was about the patentatibility of the sequence of BRCA-1 and BRCA-2 linked to breast and ovarian cancer. The Court unanimously ruled that DNA as such is a product of nature and, as a consequence, is not patent eligible, but the cDNA (i.e. the synthesized DNA deprived of the segment that do not code for proteins) is a patentable subject's matter.

 

See the full decion Association for Molecular Pathology v. Myriad Genetics, Inc.

NEWS ABOUT BIOBANKS & THE LAW

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Comparative Issues in the Governance of Research Biobanks  

(NEW!) Giovanni PascuzziUmberto IzzoMatteo Macilotti (Eds.)

Comparative Issues in the Governance of Research Biobanks

Property, Privacy, Intellectual Property, and the Role of Technology

SPRINGER, 2013

Contents and Contributors

Read a review here

 

 

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Case Law

District Court Finds Isolated DNA To Be Unpatentable Subject Matter 

 

The United States District Court of NY issued a decision, which invalidated seven patents related to the genes BRCA1 and BRCA2, whose mutations have been associated with cancer. The Court held that "DNA represents physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA's existence in a "isolated" form alter neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue direct to "isolated DNA" containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101." 

 

(United District Court for the Southern District of New York, Association for Molecular Pathology et. Al. v. United States Patent and Trademark Office, et. Al., 09 Civ. 4515, march 29, 2010)

Read the decision 

 

EXPLORING THE LAW AND TECHNOLOGY RELATIONSHIP

EXPLORING THE LAW AND TECHNOLOGY RELATIONSHIP

 

Law has often to deal with technologies, i.e. with human activities which, employing the attainments of science, bring into existence new media, tools, devices, systems which  improve the quality of life of human beings.

 

Some examples:

-  law and exploitation of natural resources (energies): energies can be exploited thanks to technologies. The law regulates the production, processing, distribution of energies and natural resources;

 

-  law and food: the food chain requires the regulation of technologies related to food in order to guarantee, for example, high quality standards;

 

-  law and biology: in order to provide a legal framework for medically assisted procreation or for cloning we have to deal with the technologies which allow to obtain gametes, stem cells, crossbreds, chimeras;

 

-  law and medicine: some choices related to the end-of-life issues which are legally significant are dependant on medical notions such as that of brain death. The same notion of therapeutic tenacity must be measured against the available technologies

 

- law and information technologies: IT has made available tools such as e-documents and e-signatures. The law must cope with these technologies to regulate them or to make them legally available.

 

The relation between law and technology has several implications. Let’s focus on three of them.

 

1.  LAW AND TECHNOLOGY: RECIPROCAL INFLUENCES

 

On the one hand law is used for the regulation of technology; on the other law employs technologies to pursue its own goals.

 

a)     Technology may change the contents of protected legal interests (as it is the case of the right to privacy, which has been transformed by the rise of IT from the right to be let alone to the right of controlling the information pertaining to the individual);

 

b)    the emergence of new technologies can transform well-established scenarios. For example the so called technology convergence in telecommunications swiped away the features which framed telecommunications as a natural monopoly, opening the market to a potential infinite number of operators, enhancing the free competition within of the sector. This is also true for the vanishing distinction between article 15 and article 21 of the Italian Constitution. Traditionally the former is enforced whenever, for example, the freedom and secrecy of personal correspondence is at play. The latter protects freedom of expression toward a public audience. Which of the two constitutional provisions must be applied for the regulation of phenomena such as pay-tv, chat lines, mailing lists and newsgroups?

 

c)     Law can employ new technologies to pursue goals which were pursued by other technologies in the past: this is the case of the e-document, the e-signature, the payment of obligations through e-money, the conclusion of contracts through Internet, and so on. In all these examples, new rules set the modalities of employment of digital technologies in order to attain this or that goal which was reached through other technologies in the past;

 

d)    the rules arising from technologies are shaped by the features characterizing such technologies: for example, one thing is to have rules concerning the matter (atoms), another is to have rules concerning the bits. In some cases this implies the need to re-frame concepts which traditionally refer to material things (such as ownership and possession) or to draw on new concepts (such as the ideas of title and legitimization in the case of dematerialized financial instruments);

 

e)     technologies create new commodities: this was true in the past for the new value prompted by the invention of printing, from which after a lengthy process the new right of copyright emerged. In more recent years this is happening with regard to data banks (of human tissues for example, but several other examples may be offered). The law is continuously confronted with the need of regulating new commodities which were unknown in the past;

 

f)     the change in technologies influences also the source and the structure of the rules. Sometimes legal systems prefer to regulate given phenomena by making recourse to international instruments or to regulatory patterns which are not imposed from outside (for example codes of conduct);

 

g)  technology sometimes may itself become the rule because: i) it imposes the operational rules (for example: the regulation of the digital signature); ii) it incorporates the rule (see art. 3 of the Italian Data protection code; see also Commission Recommendation of 12 May 2009 on the implementation of privacy and data protection principles in applications supported by radio-frequency identification; iii) it guarantees the enforcement (for example: Digital Rights Management);

 

h)    the norms which regulate the employment of new technologies for establishing  documentary evidence are characterized by high technological contents, as they are expressed by individuals who have specific competences.


 

2. THE DIALOGUE BETWEEN LAW AND THE OTHER BRANCHES OF KNOWLEDGE

 

Since technologies exploit the advancements of sciences, in order to study in depth the relationship between law and technologies it is unavoidable to establish a dialogue between law and the other branches of knowledge (biology, medicine, neurosciences, computer science, engineering, economics, philosophy, sociology, history).

 

Consequences:

 

a)     it is important to build up a common frame of references or, at least, to be aware of the specificities of the jargon or lexicon of the other sciences;

b)    it is impossible to study the relationship between law and technology if we do not grasp the logic and functioning mechanisms which lay behind the technology we are examining;

c)     it is crucial to imagine tools for the representation of knowledge designed in a way which enables experts of a given science to understand in a easy and quick way the outcomes of other sciences and vice versa;

d)    the teaching techniques of each discipline should encompass the mission to foster mindsets enabling students to master different and transversal branches of knowledge.

 

In this sense it is interesting the opinion expressed by the United District Court for the Southern District of New York, Association for Molecular Pathology et. Al. v. United States Patent and Trademark Office, et. Al., 09 Civ. 4515, march 29, 2010. The judge writes first as a biologist, then as an economist and eventually as a lawyer.


 

3. THE DIALOGUE BETWEEN DIFFERENT BRANCHES OF KNOWLEDGE AND THE ROLE OF THE LAWYER

 

In the last decades the branches of knowledge have incremented exponentially both from a quantitative and a qualitative point of view: new disciplines were borne, while traditional branches have remarkably enlarged their knowledge basis. The confluence among branches has also allowed the creation of more and more sophisticated technologies: for example, in the field of diagnostic medicine, the invention of machineries such the TAC or the ultrasound scanner has been favored by the joint research of doctors, physicists, engineers and computer scientists. More generally, we  must face complex, interrelated problems which are considered under the idea of global sustainability, such as:

 

a)   the protection of the environment;

b)   the demographic problem, coupled with the aging of the populations of certain areas of the world;

c)   the growing demand for energies and fuels;

d)   etc.

 

We cannot deal with such problems by making recourse to specific branches of knowledge. We must establish a dialogue between the different branches of knowledge. When tackling problems of this magnitude our skills should act like a zoom on an image: we must have an overall vision and, at the same time, the ability to go into the details. The problem is to understand how to set up the dialogue between the different branches.

 

Do law and lawyers play a special role in this process?

 

Branches of knowledge must learn how to speak to each other. The law should act as a connective element or a bridge between different branches of knowledge. In many respects lawyers are in the best position to prepare the ground for a dialogue between different fields of knowledge (for example biology and philosophy) as a prerequisite to facilitate the production of new knowledge. The problem of mastering the huge amount of knowledge which has been piled up over the time and the trend to the hyper-specialization make difficult to show how such knowledge can solve the daily problems and improve life. Lawyers can favor both the spreading of the results attained by the other branches of knowledge and the singling out of the effects of the different discoveries.


 

THE TRENTO LAW AND TECHNOLOGY RESEARCH GROUP

 

The Law and Technology Research Group at the Department of Legal Sciences of the University of Trento was created in order to study the issues mentioned above. The group is formed by professors and researchers who explore, from several years and from different starting points, the relationship between law and technology. Some members of our research team have recently obtained important achievements. Ours is an open group and we welcome any useful contribution from other single researchers or research teams from all over the world.


 

VISITING THE TRENTO LAW AND TECHNOLOGY CENTER

 

As a research group open to international collaborations we strongly encourage both young researchers and senior scholars from all over the world who are interested in our topics of research to spend a period in Trento visiting our Center.

 

Due to financial constraints, we cannot provide grants/scholarships/reimboursements, but we can provide for free access to our research facilities and to the library, as well as to the other facilities needed in order to carry on your research while here.

 

In order to explore the idea of setting up a period as visiting researchers or visiting scholars at our Center you are welcome to send us ( Questo indirizzo email è protetto dagli spambots. E' necessario abilitare JavaScript per vederlo. ) a motivation letter and a detailed CV at least 6 months before the starting time of your planned visit.

 

We look forward to meeting you in Trento!   


 

PAST VISITING PROFESSORS AT THE TRENTO LAW AND TECHNOLOGY CENTER

 

ERIC FELDMAN (2005, 2006)

 

RICHARD GOLD (2010)

 

LARA KHOURY (2008) 

 

DAVID LAMETTI (2007, 2010, 2011, 2012, 2013, 2014, 2015)

 

LAURENT MANDERIEUX (2009, 2010, 2011, 2012, 2013, 2014, 2015, 2016)

 

STEPHEN MUNZER (2010)

 

DONAL NOLAN (2009, 2010)

 

GIDEON PARCHOMOVSKY (2010, 2011, 2012, 2013, 2014, 2015, 2016, 2017)

 

TINA PIPER (2008)

 

DAVID WINICKOFF (2011)

 

CRAIG NARD (2015)

 

THOMAS MARGONI (2015, 2016, 2017)

 

MARK PERRY (2015, 2016, 2017)

 

DAVID NIMMER (2015, 2017)

 

PIERRE-EMMANUEL MOYSE (2017)

 

 

 

 

 

 

General Bibliography

ARTICLES AND BOOKS COVERING THE LEGAL IMPLICATIONS OF BIOBANKING IN GENERAL

 

 

2011

 

GIBBONS S., HEENEY C., KAYE J., PARKER M., SMART A. (eds.), Governing Biobanks: Understanding the Interplay Between Law and Practice, Hart Publishing, due in 2011

 

 

2010

 

 

2009

 

KAYE J., STRANGER M. (eds.), Principles and Practice in Biobank Governance, Ashgate, 2009

 

BRAY D., Wetware: A Computer in Every Living Cell, Yale University Press, 2009

 

STAYN S., Biobanking of Blastocysts for Research To Improve Human Health: The Need for Coherent National Policy, Stanford Journal of Law, Science and Policy, 2009

 

DEHAYES C.L., Managing Global Biospecimen and Data Collection & Placement Programs, Stanford Journal of Law, Science and Policy, 2009

 

GRIGORENKO E.L. , BOUREGY S., Biobanking on a Small Scale: Practical Considerations of Establishing a Single-Researcher Biobank, Stanford Journal of Law, Science and Policy, 2009

 

GIBBONS S. M. C., Regulating Biobanks: A Twelve-Point Typological Tool; 17 Med. Law Rev. 2009,  pp. 313-346

 

BORRY P.,  DIERICKX K., New Challenges for Biobanks: Ethics, Law and Governance, Intersentia, 2009

 

 

2008

 

ELGER B.,  BILLER-ANDORNO N.,  MAURON A.,  CAPRON A. M., Ethical Issues in Governing Biobanks, Ashgate, 2008

 

SLEEBOOM-FAULKNER M., Human Genetic Biobanks in Asia: Politics of Trust and Scientific Advancement, Routledge, 2008

 

GOTTWEIS H., PETERSEN A., Biobanks: Governance in Comparative Perspective, Routledge, 2008

 

EDWARDS L.C., Tissue Tug-of-War: A Comparison of International and U.S. Perspectives on the Regulation of Human Tissue Banks, 41 Vand. J. Transnat’l L., 639 (2008)
 

 

2007

 

HAYRY M., CHADWICK R., ARNASON V., ARNASON G., The Ethics and Governance of Human Genetic Databases, Cambridge University Press, 2007

 

V. LAUNIS, RÄIKKÄ J., Genetic Democracy: Philosophical Perspectives, Springer, 2007

 

GREELY H.T., The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks, 8 Annual Review of Genomics and Human Genetics 343 (2007)

 

CAMPELL V., The Ethical Challenges of Genetic Databases: Safeguarding Altruism and Trust, 18 King's Law Journal, 227 (2007)

 
 
2006

 
KAYNE J., Do we Need a Uniform Regulatory System for Biobanks across Europe?, 14 (2) European Journal of Human Genetics 245 (2006)
 
KNOPPERS B., KENT A., Ethics Watch: Policy Barriers in Coherent Population-Based Research, 7 Nature Reviews Genetics, 8 (2006)
 
KNOPPERS B.M., Biobanks: New Challenges for Bioethics and Biolaw, in Iustitia, 2006, n. 59, 47


2005

 
KNOPPERS B.M., Biobanking: International Norms, 33 J. Law Med. Ethics 832 (2005)

BOGGIO A., Charitable Trust and Human Genetic Databases: The Way Forward?, 1 Genomics, Society and Policy 41 (2005)

DESCHENES M., SALLEE C., Accountability in Population Biobanking: Comparative Approaches, 33 J.L. Med. & Ethics, 40 (2005)

KLAUS L.H., RICHARD T., ‘Ethics Was Here’: Studying the Language-Games of Ethics in the Case of UK Biobank, 15 (4) Critical Public Health 385 (2005)


2004

 
BROWNSWORD R., Regulating Human Genetics: New Dilemmas For A New Millennium, 12 Med. Law Rev., 2004, pp. 14-39

GUTTMACHER A.E., COLLINS F.S., Welcome to the Genomic Era, 349 N. Eng. J. Med., 996 (2004)

MCHALE J.V., Regulating Genetic Databases: Some Legal and Ethical Issues, 12 Med. Law Rev., 2004, pp. 70-96

ERIKSSON S., Should Results from Genetic Research Be Returned to Research Subject and Their Biological Relatives?, 8 Trames J. Humanities Soc. Sci., 46 (2004)

MCHALE J.V., Regulating Genetic Databases: Some Legal Ethical Issues, 12 Med. Law. Rev., 70 (2004)

CAMBON-THOMSEN A., The Social and Ethical Issues of Postgenomic Human Biobanks, 5 Nat. Rev. Gen. 866 (2004)

KAYE J, HELGASON H.H., NOMPER A., WENDEL L., Population Genetic Database: A Comparative Analysis of the Law in Iceland, Sweden, Estonia and the UK, 8 Trames, 15 (2004)

KORTS K., WELDON S., GUÐMUNDSDÓTTIR M.L., Genetic Databases And Public Attitudes: A Comparison Of Iceland, Estonia And The UK, 1-2 Trames, 131 (2004)

 
 
2003

 
KNOPPERS B.M., Population and Genetics. Legal and Socio Ethical Perspectives, Hotei Publishing, 2003

AZAROW K, Olmstead F., Hume R., Myers J., Calhoun B., Martin L., Ethical Use of Tissue in Genetic Research, 168 Mil. Med., 437 (2003)

BAEYENS A.J. ET Al., The Use of Human Biological Samples in Research: A Comparison of the Laws in the United States and Europe, 5 Bio-Sci. L. Rev. 155 (2003)
 
 

2002

 
HARRISON H., Neither Moore nor the Market: Alternative Models for Compensating Contributors of Human Tissue, 28 Am. J. L. and Med. 77 (2002)


 
2001

 
KAYE J., Genetic Research on the UK Population – Do New Principle Need to be Developed?, 7 Trends in Molecular Medicine, 528 (2001)


2000

 
ASHBURN T.T, WILSON S.K., EISENSTEIN B.I., Human Tissue Research in the Genomic Era of Medicine: Balancing Individual and Societal Interests, 160 Arch. Intern. Med. 3377 (2000)

INDECH B., The International Harmonization of Human Tissue Regulation: Regulatory Control Over Human Tissue Use and Tissue Banking in Select Countries and Current State of International Harmonization Effort, 55 Food Drug L.J., 343 (2000)

EISEMAN E., Stored Tissue Samples: an Inventory of Sources in the United States, in, National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, 2000, Vol II, D1-D5

KAYNE J., MARTIN P., Safeguard for Research Use Large Scale Dna Collection, 321 BMJ, 1146 (2000)


 
1992

 
KNOPPERS B., LABERGE C.M., La généteique humaine: de l’information à l’informatisation, Litec, Parigi, 1992, 42

BERSON B., The Taking of Human Tissue for Research and Commerce: A Comparison of U.S. And French Approaches, 10 Wisconsin Inter. L. J. 348 (1992)

 
 
1990

 
KNOPPERS B., L’integrità del patrimonio genetico: diritto soggettivo o diritto dell’umanità?, in Pol. Dir., 1990, 341