3402: BSC Theory and
Practice
in the Biological
Sciences
Intellectual Property
27 October 2010
1
Organizational for Today
Name cards
Return response paper #4. Comments on web
site. Incorporate these into future papers.
Next week 3 Nov.
Must write on one of the three topics for RP#5
Future in-class responses
This week:
In-class response
Discuss patents on life
Other intellectual properties and data issues
Conflicts of interest
2
Comments on Response Paper #4
These are discussed on the web site. For the
last two response papers, you should not make
the technical errors that are discussed, i.e. I will
take off.
Response Paper #5. You need to submit the
response papers in the week in which they are
assigned (by Friday 5 PM), which will give you a
chance to change your mind. I will give you the
best grade of the two or three if you do more
than one.
3
In-Class Response
What are the issues of concern to
scientists regarding patents on genes such
as BRCA? (name 2)
What other issues should we discuss in
connection with intellectual property issues
(such as conflicts of interest and data
ownership and use, i.e. the issues for this
week) name 1
4
Questions from the Book (chap 3)
Who Owns Life?
Copyrights protect unique expressions in tangible form
including works of art, writings, music, software and so
on
Trademarks protect unique and valuable expressions or
symbols that gain recognition in the commercial
marketplace as indicators of quality or genuineness.
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Questions (chap 3): Who Owns Life?
Patents protect useful inventions and discoveries.
Includes nonunique product made by an otherwise
patentable method.
Patents require
revealing enough details to enable another person to reproduce
the invention and in return
the inventor is rewarded with a period of exclusive use of the
invention and the right to prevent others from making, using or
selling the claimed invention without permission.
Federal government has march-in rights if necessary for public
health or defense
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Questions (chap 3): Who Owns Life?
Gene patents are of three types
Diagnostics or disease gene patents claim the characterization
of an individuals genetic makeup at a disease-associated gene
when performed for the purpose of disease diagnosis or
prognosis. Clinical and research labs pay royalties for the use of
patented technologies. In a few cases, patent owners have used
the patents to monopolize the testing service, as in the case of
BRCA and Myriad Genetics.
Compositions of matter (purified and isolated genes) such as
recombinant proteins or drugs, viral vectors, cell lines and animal
models in which the patented gene has been inserted or
knocked out. Examples include human insulin, human growth
hormone and the genetically modified bacteria that eat oil.
Functional uses of genes based on the discovery of the role
genes play in disease or other functions or pathways such as
Cox-2 gene
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Other Research Related Patents:
Balancing Innovation and Access
Patents are important for spurring drug
innovation
Industry revenues support continued R&D and
patents support revenues. Drug companies rely
on patent-protected revenues to recoup R&D
expenditures.
Generics and patent challenges have reduced
revenues
Type and timing of new products offered to the
public are affected
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Who Owns Life? Mr. Moores Spleen
John Moore suffered from hairy cell leukemia, cancer of white blood cells
Dr. David Golde UCLA Med Center removed Moores spleen. Initially gave
consent but later declined
Golde and a research, Shirley Quan developed and together with UCLA
patented the cell line derived from these cells. Mo overproduces certain
lymphokines caused by infection with Human T-cell Leukemia virus Type II.
Commercialization agreements with Genetics Institute and Sandoz
Pharmaceuticals which gave the researchers salary support and interests in
future earnings from the commercialization of the Mo cell line and the
products derived from it.
Moore sued (a) trial court dismissed the case; (b) Court of Appeal reversed
decision; (c) CA Supreme Court reversed decision again but identified conflict
of interest as a problem.
Who are the stakeholders in this dispute? What are their
interests? Should patients be told about developing
research interests? Should patients be allowed to retain a
share of profits derived from patents on their own cells?
Should patents on cell lines be allowed at all? What about
donating organs or blood (are they different)?
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Canavan Disease Patent
Dan and Debbie willing Greenberg, participants
Dr. Reuben Matalon developed a successful prenatal screening test
(moved to Miami Childrens Hospital MCH)
MCH filed a patent & marketing plan
Canavan Foundation & others criticized MCH and sued
Lost except for showing that MCH profited unfairly at the plaintiffs
expense
Should patients be told that the discovery of their gene
could or would result in a patent?
Should participants have a say in the nature of the
benefits that may result from the research?
Are there differences between the HeLa cell line, Mo cell
line and Canavan disease cases?
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BRCA Patent Case: Myriad Genetics and
University of Utah
May 2009. filed by
ACLU
Jan 2010. US District
Court heard case
March 29. court ruled
patents are illegal
because genes are
products of nature
Oct 25. Myriad
appeals ruling
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With Gene Patents, Whose Rights
are Violated and Why?
Scientific researchers because gene patents
prevent them from freely engaging in research
Clinical geneticists and genetic counselors
rights because gene patents infringe on their
freedom to provide information to their patients.
Individual patients because gene patents
impede access to medical information and care.
American publics rights because gene patents
permit an unfair monopoly that limits the publics
right to benefit from scientific discoveries
ACLU document
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Should Doctors be Required to Reveal
Conflicts of Interest?
California Supreme Court stated The possibility
that an interest extraneous to the patients health
has affected the physicians judgment is
something that a reasonable patient would want
to know in deciding whether to consent to a
proposed course of treatment. It is material to
the patients decision and thus a prerequisite to
informed consent.
Should doctors be required to reveal their
financial interests to their patients? Which ones?
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Patents, Universities, Hospitals and
$$
What is the role of Universities and other
Institutions in patenting research
discoveries?
Office of Technology Licensing OTL
http://www.research.ufl.edu/otl/
What should the role of a university be?
Case study: The Gatorade patent
What if you made a patentable discovery?
What would you do?
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The sports and energy drink industry
led by Gatorade and worth more
than $19 billion last year, began in
1965 when Dwayne Douglas, a
football coach at UF asked Dr. Robert
Cade, a nephrologist at UF: Why dont
the players urinate after a game? The
result was Gatorade.
When he first approached university
officials about marketing the drink,
they declined. So he sold the formula
to Stokely-Van Camp. The deal gave
him and his associates a cut of the
royalties.
A few years later, when his income
reached $200,000, the university
noticed.
They told me it belonged to them and
all the royalties were theirs, Dr. Cade
said. I told them to go to hell. So they
sued us.
After a 31-month legal battle, the
parties settled. The product was later
sold to Quaker Oats. which merged
with Pepsico and royalties continued to
flow to Dr. Cades group and the
university. He donated some of his
money to the university.
The Gatorade
Patent
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Data Ownership Issues
Who owns data that researchers collect?
Before data are collected, ownership
issues must be worked out.
Who owns the data?
What rights do I have to publish the data?
Does collecting these data impose any
obligations on me?
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Data Issues
Responsible for permits
Data records are legal tender
Data records must be permanent, backed
up and curated so they dont degrate
Stored as a permanent file
Confidentiality protected
Data sharing (p. 96)
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Does the Source of Funding Taint the
Research?
Mayo clinic study
Tobacco study
BP Gulf oil
What would be your requirements for
considering such a position?
Why would it matter?
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Analysis of an Ethical Dilemma
principles
Stakeholders:
respect for
Well-being
(greatest good)
Autonomy
(individual dignity)
Fairness
(justice)
Different human
interest groups
such as
consumers,
patients or
farmers
Animals, such as
agricultural or
research
Environmental
impacts
This approach acknowledges the plurality of perspectives that sincere people bring
to an ethical analysis and provides a means of registering the importance of each
principle in an particular context.
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Who are the Stakeholders?
Henrietta Lacks
Family members
The public in general
Science
Researchers using the cells
A tension in science between the reverence for life, and the
desire to have knowledge that is objective.
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