Transcript TLO professionals in the USA: Responsibilities and skills

Ownership of genetic materials,
and benefits sharing
(ATRIP, 4 August Session 3)
Robert Kneller, J.D., M.D.
Professor, Department of Intellectual Property
Research Center for Advanced Science and
Technology (RCAST)
University of Tokyo
[email protected]
5 hypothetical cases
4 August 2003
Robert Kneller
ATRIP Session 3
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Case 1
A UK woman with family history of leukemia is
asked to take part in large scale epidemiology
survey:
• Her blood is collected for genetic and other studies.
• Family history and lifestyle data are also collected.
• It is unlikely that a commercially valuable gene,
protein, etc. will be discovered.
4 August 2003
Robert Kneller
ATRIP Session 3
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Case 2
A US patient with rare form of leukemia,
seeks surgical care:
• Surgeons think that the patient’s tissues will
be useful for discovering new drugs.
• Some of the patient’s cancerous cells are
removed and analyzed in the course of
standard surgical treatment.
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Robert Kneller
ATRIP Session 3
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Case 3
Same situation as (1), except that the donor
is a member of a small tribe in a
developing country, and blood samples
are collected under a collaborative
project involving a Japanese university.
• The blood samples are to be analyzed in the
Japanese university.
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Robert Kneller
ATRIP Session 3
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Case 4
Same situation as (2) except that the patient
is a member of a small tribe in a
developing country, and the analysis of
his cancer cells will be done in a Japanese
university under a cooperative research
agreement.
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Robert Kneller
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Case 5
Same situation as (3), but this is a small
collaborative study focusing on this tribe.
• Information from tribal members is valuable
for determining the hereditary pattern and
other information related to the disease.
• These factors make this tribe a unique and
valuable focus of research.
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Suppose:
• The researchers in the UK, US or Japan
discover a receptor on one of the donor’s
cells that may be the basis for a way to
diagnose and treat this type of lymphoma.
• They apply for a patent on the receptor.
• Eventually (and unexpectedly) a drug is
developed that is effective against this and
other types of lymphomas.
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Questions for all 5 cases
• According to current laws, who probably
owns the patent on the cell-surfacereceptor?
• Who ought to own the patent?
• What would be a practical and fair way to
allocate rights and benefits?
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Robert Kneller
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Importance of ownership for the
researchers who collect the
blood:
• Allows them freedom to do important
research.
• Allows them to sell or license the patent
rights to a company that will develop a drug
based upon the receptor.
• Without exclusive patent rights, it is
unlikely the company will obtain the private
investment needed for its development work.
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Robert Kneller
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Importance of ownership for the
blood donor:
• Control over use of what was once part of
his/her body (autonomy).
• Confidentiality (especially, protection of
privacy and prevention of discrimination).
• Maybe control can increase access to
medical care or medical information.
• Right to share in commercial benefits.
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Main points:
• Donors probably have no ownership rights.
• But access to medical care, medical information,
and commercial benefits may be more important.
• Bargaining and contractual agreements probably
are the best hope for donors of tissue samples.
• Technology transfer to LDCs is called for under
the Doha Declaration
• Developing country governments are enacting
laws to ensure governmental organizations share
in benefits.
• Some developed country organizations are
promoting benefits sharing.
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