7 Intellectual Property
7 Intellectual Property
7 Intellectual Property
Intellectual Property
Responsible Conduct of Research. Adil E. Shamoo and David B. Resnik, Oxford University Press. © Oxford University Press
2022. DOI: 10.1093/oso/9780197547090.003.0007
Intellectual Property 157
some of the world’s first patents were granted in England in the 1400s when the mon-
archy granted privileges, known as letters patent, to manufacturers and traders. King
Henry VI (1421–1471) granted the first known English patent in 1449 to John of
Utynam for a method of making stained glass. During the next 200 years, patents be-
came a routine part of commerce and industry in England, although disputes arose
concerning the length of the patent period and the conditions for patenting (Foster
In 1790, Congress enacted the first patent and copyright laws, long before the U.S.
Patent and Trademark Office (USPTO) was officially established in 1836. The patent
laws have since been amended numerous times (Miller and Davis 2011). Congress
also enacted laws establishing the U.S. Copyright Office. These laws have also been
revised several times, with the most significant revision occurring in 1976 (Miller and
Davis 2011).
R&D funding as a financial risk that can be justified only if there is some expectation
of a reasonable return on investment. IP laws enable businesses to take these risks
by allowing them to control the products of their R&D investments (Resnik 2001a,
2007b; Kuflik 1989).
Another type of justification for IP comes directly from the work of John Locke
(1764 [1980]), who was a strong defender of individual rights (i.e., a libertarian).
Under U.S. law, a patent is a type of IP granted by the USPTO to an inventor. A patent
gives an inventor exclusive rights to prevent anyone else from using, making, or
commercializing his or her inventions without permission. Inventions may include
machines, products of manufacture, methods or techniques, compositions of matter,
or improvements on any of these. Individuals as well as corporations or the govern-
ment can own patents. The length of a patent is 20 years from the filing date of the
160 Responsible Conduct of Research
patent application (Kayton 1995). Patents are not renewable. Inventors can sell their
patent rights, or they can grant others a license to use, make, or commercialize their
inventions. A licensee may provide the licensor with royalties in the form of a one-
time payment or a percentage of profits. In academic research, inventors usually as-
sign their patents to the institution in exchange for a share of royalties from licensing
(typically about 50 percent). Similar arrangements occur in industry. An exclusive
jeopardize the patent, most inventors keep their patentable work secret until
they are ready to file an application. In the U.S. and most other countries, the
first person to file a patent application is awarded the patent.
Non-obviousness: The invention must not be obvious to a person trained in the
2.
relevant discipline or technical field. Whether an invention is or is not obvious
is subject to a great deal of debate (Duft 1993).
Although the patent system encourages public disclosure in exchange for IP rights,
some corporations use the system mostly to prevent competing companies from de-
veloping new inventions (Resnik 2001a). For example, to secure the market for their
trademarked drugs, large pharmaceutical companies have purchased patents on
competing generic drugs owned by smaller companies. Other companies have de-
veloped “blocking” patents designed to prevent competitors from developing new
products. For example, if a company is developing a new internal combustion engine,
a competing company could block production of this engine by acquiring a patent on
a part needed to make the engine. Some have argued that these types of patents are an
abuse of the patent system (Heller and Eisenberg 1998).
Copyrights
Copyrights are exclusive rights granted by the U.S. legal system that allow the authors
of original works to make copies of the work; make other works derived from the
original work; perform or display the work; and distribute, sell, or rent copies of the
162 Responsible Conduct of Research
work. People who perform any of these actions without the permission of copyright
holders violate copyrights. Original works include written works, such as books, pa-
pers, software, databases, and poems; performances, such as plays or dances; audi-
ovisual recordings, such as movies, music, photographs, and televisions shows; and
artistic works, such as paintings and sculpture. A work can be original without being
new or novel because the author is the first person to put the work into tangible form.
without permission (A&M Records, Inc. v. Napster, Inc. 2001). It is also important to
note that many types of knowledge, such as government documents, public records,
weight conversion tables, temperature measures, calendars, known titles, phrases,
and lists of ingredients, are considered to be in the public domain and are not copy-
righted (Chickering and Hartman 1980).
Data Ownership
Individuals, corporations, universities, and government agencies often assert owner-
ship claims over data. For example, private companies claim to own all the data pro-
duced in their laboratories or using their funds. As noted in Chapter 3, universities
also claim to own data generated by means of university funds or resources. People
claim to own research data mainly to protect their financial interests. Suppose a re-
searcher does animal toxicology studies on a drug that a pharmaceutical company
is developing. She has a contract with the company and is employed by a university.
Suppose a dispute arises over publishing the data: The researcher wants to publish but
the company objects to publication. Who owns the data, the researcher, the company,
or the university? Or suppose a researcher obtains data at a university through a gov-
ernment grant and then leaves the position for a job at another institution. Does the
university have the legal right to prevent the researcher from taking copies of the data
when he or she leaves? If questions such as these are not resolved up front by means
of contracts or agreements, such as CRADAs or material transfer agreement (MTAs),
then costly legal battles may arise concerning the control of data and IP (Shamoo
1989; Shamoo and Teaf 1990).
There is certainly a sense in which one might view data as property, but there are no
laws designed specifically to protect data. To treat data as property, one must therefore
apply existing copyright, patent, trade secrecy, property, contract, criminal, or civil
laws to research data or enact specific institutional policies. For example, an employ-
ee’s contract with a university or private company can settle data ownership issues.
If the employee discloses or uses data without permission, the university or private
company can sue the employee for breach of contract. Similarly, trade secrecy laws
can permit companies to prevent employees from disclosing data. Research records,
such as lab notebooks or computer disks, are physical objects that can be protected by
Intellectual Property 165
property laws. Someone who takes a lab notebook from an institution without per-
mission can be charged with theft. Trade secrecy laws can provide companies with
some data ownership provided that the data are properly protected trade secrets. For
example, tobacco companies sought for many years to protect their research on nico-
tine’s addictive properties under the cloak of trade secrecy (Resnik 1998b).
In the private sector, data are treated as propriety information. The data sub-
Ethical and legal issues can arise concerning the stewardship of these resources. One
might argue that scientists have an ethical obligation to share these resources so that
other researchers may benefit from them. However, some reasons that scientists may
refuse to share research resources include the following:
• Financial interests: Researchers and research sponsors may have financial inter-
ests related to research materials, tools, or venues. Sharing these resources ad-
versely affects those interests.
• Scientific priority: A researcher who shares research materials, tools, or venues
may give an edge to his competitors and lose the race for priority.
• Cost and inconvenience: Sharing research materials and tools can be costly and
inconvenient. Researchers may not want to maintain stockpiles of materials for
others to use or ship them out upon request.
• Scarcity: Some research materials and tools are scarce resources. Researchers
may want to limit their sharing to preserve resources for their own work.
166 Responsible Conduct of Research
The sharing of research resources, therefore, raises many of the same issues that
arise in data sharing (see discussion in Chapter 3). Deciding whether, and how, to
share resources used in research requires a careful examination of the facts, circum-
stances, and options pertaining to the decision. Given the importance of sharing in-
formation and resources in science, the burden of proof falls on those who refuse to
honor legitimate requests to share. Many government agencies require researchers
legitimate claims they may make to IP. Because contributors do not, by definition,
play a significant role in research, most of the IP claims made by contributors relate to
concerns about fairness, not about accountability. Consider the following examples:
• A lab technician carries out a great deal of the work in developing a patented
mouse and is listed as an author on the paper but not as an inventor on the
Questions about “fairness” raise fundamental issues about how to allocate benefits
and burdens. According to the libertarian approach exemplified by Locke, fairness
is strictly a matter of contribution or merit: If you contribute something to a project,
then your fair share (i.e., your benefits) should be in proportion to your contribution.
According to the utilitarian approach, what is fair is what best promotes the good
of society, and IP principles and laws should promote the social good. Thus, it may
follow, on this view, that it is fair not to allocate benefits, such as royalties, on the
basis of contribution. The best way to maximize utility may be a system that rewards
authors and inventors who are the first to create an original work or invention.
and researchers and laypeople have objected to patents on human genes since the
mid-1990s (Resnik 2004a). Other controversial types of patents include patents on
computer software, business plans, and medical diagnostic tests.
In thinking about these controversial cases, the courts, patent offices, and policy-
makers have wrestled with two distinctions: (1) product of nature (not patentable) vs.
product of human ingenuity (patentable); and (2) abstract ideas and natural laws (not
methods were invalid because they were patents on products of nature (i.e., the gene
patents) or abstract ideas (i.e., the methods patents).
The case eventually reached the U.S. Supreme Court, which held that Myriad’s DNA
patents were invalid and that some of its methods patents were invalid (Kesselheim
et al. 2013). In a 9–0 opinion issued in June 2013, the U.S. Supreme Court declared
that Myriad’s patents on naturally occurring DNA sequences were not valid because
is patentable, but the mathematical equations and algorithms used by the program
are not (Miller and Davis 2011). Lower courts had held that one of Myriad’s methods
patents was invalid because it did little more than restate a natural law, and the U.S.
Supreme Court allowed these rulings to stand (Association for Molecular Pathology
et al v. Myriad Genetics 2013; Kesselheim et al. 2013). The invalidated patent was on a
method to determine breast cancer susceptibility by comparing the patient’s DNA to
10. In some European countries, patents can be rejected because they violate
public morals. Do you think this is a useful criterion for denying patents?
What are the possible advantages and disadvantages or applying a morality
test to patents?
John Moore went to University of California, Los Angeles (UCLA) Medical Center
in 1976 to receive treatment for a rare type of cancer known as hairy-cell leukemia.
Moore’s physician, Dr. David Golde, recommended that Moore have his spleen
removed. After the surgery, Golde asked Moore to provide samples of blood, skin,
bone marrow, and sperm, which required him to travel a considerable distance to
make several visits to the UCLA Medical Center. Moore was led to believe that Golde
needed the samples to monitor his health, but, in fact, the purpose of gathering the
samples was to develop a cell line from Moore’s cancerous tissue (Resnik 2004a).
Golde was interested in growing this cell line because of its scientific and commercial
value. The cell line had a mutation that caused it to overproduce lymphokines, which
are proteins that help to regulate the immune system. The estimated market for the
cell line was $3 billion. Golde signed an agreement with the University of California
and several private companies to develop the cell line. Golde and his research assis-
tant Shirley Quan applied for patents on the cell line. When the patents were awarded,
they assigned them to the University of California (Resnik 2004a).
Moore eventually discovered that the true purpose of his visits to the UCLA
Medical Center and became very upset. He sued Golde, Quan, the private compa-
nies, and the University for violating informed consent, failing to uphold fiduciary
obligations, and conversion (i.e., substantially interfering with another person’s per-
sonal property). The case went to the California Supreme Court. The court ruled that
Moore could not prove his conversion claim because he did not have a property in-
terest in the cell line (Moore v. Regents of the University of California 1990). According
to the majority opinion of the court, the researchers who isolated and cultured the cell
line had property rights on the cell line because they had invested their time and labor
in developing it. According to the majority, granting patients or research subjects pro-
perty rights in their biological samples would interfere with biomedical research and
innovation. Only inventors and companies should have property rights over biolog-
ical materials left over from medical procedures or donated research. In separate dis-
senting opinions, two judges from the court argued that Moore should have property
rights to the cell line because his cells are no different from other materials that are
exchanged on the market, such as sperm or hair, and a person should be able to con-
trol his own body and its parts (Moore v. Regents of the University of California 1990).
Although the court did not recognize Moore’s property rights pertaining to the cell
172 Responsible Conduct of Research
line, it did rule that Golde had violated his fiduciary obligation to Moore by not dis-
closing his financial interests in Moore’s tissue as part of the informed consent process
(Morreim 2005). Other U.S. courts have refused to grant patients property rights in
tissues they have abandoned or donate to researchers.
Case 2
A faculty member at a U.S. university met a very bright young postdoctoral fellow at a
meeting in Germany. The postdoctoral fellow was working for a company in Germany
and had a new chemical entity that could be developed into a product to prevent one
type of urinary tract infection. Animal testing had already been conducted, with very
promising results. The postdoc then came to the United States to work for the univer-
sity faculty member, with support from the German company. The German company,
through its subsidiary in the United States, submitted an investigational new drug
application to the FDA to start Phase I clinical trials on humans. Later that year, a
French company acquired the German company. In the meantime, the postdoctoral
fellow met a colleague at a meeting at a different U.S. university and collaborated to
test the new chemical entity. They discovered a new modality to treat another disease
with the same chemical entity. At this time, the faculty member’s U.S. university was
negotiating with the French/German company to have the research conducted at the
university’s facilities. From the start, the French/German company demanded sole
proprietorship of the drug and wanted to control all aspects of its R&D. The univer-
sity then asked the postdoctoral fellow to sign a visiting fellowship agreement assign-
ing all IP claims to the university. The postdoctoral fellow refused, on the advice of
the French/German company. Meanwhile, the French/German company filed for a
patent alone without any mention of the part of the work conducted at the university.
• What should the university do? What should the university faculty member do?
• Who owns the patent? Is the patent application valid?
• What should each party have done in the first place?
Intellectual Property 173
Case 3
Case 4
In the early 1990s, a university faculty member was collaborating with a Danish com-
pany in a joint venture on a compound with a view toward clinical trials within a year.
The company had already submitted a patent application on a portion of the project.
In written correspondence between the university faculty member and her counter-
part at the Danish company, both pledged full cooperation without mentioning any-
thing about IP. A year later, the Danish company enlisted a U.S. company to conduct
certain experiments. The university and the Danish and U.S. companies all entered
into negotiation regarding IP. The negotiations failed, and the university ordered the
faculty member to stop any further collaboration.
Case 5
A member of an NIH study section, while reviewing a grant proposal, realized she
could do part of the proposed research faster and better with a method already avail-
able in her laboratory. Under normal conditions, she would not be conducting such
• Is this plagiarism?
• What should Office of Research Integrity do?
• What should the reviewer do?
• Who should get the patent?
Case 6
Case 7
A tissue collection and storage company has signed a contract with a hospital and
medical school to collect human tissue leftover from surgical procedures and labo-
ratory tests for research purposes. The company plans to collect tissues from patients
at the hospital. Patients will sign an informed consent form giving the company ex-
clusive rights to their tissue. Patients will receive $50 for their tissue. Once the tissue
is donated, it will be placed in a tissue bank. All personal identifiers linking the tissue
to the donor will be removed. The company expects to profit by charging access to
Intellectual Property 175
its tissue database. It also plans to patent valuable cell lines and other products. The
medical school will help with the tissue collection and receive a portion of the profits.
A private university has decided to treat all of faculty member’s academic writings as
“work for hire.” Under this arrangement, the private university will own all copyrights
for faculty member’s writings. Faculty members will receive a 50 percent percentage
of royalties. The university will have the right to decide whether significant writings
(such as papers or books) will be published and to negotiate terms with publishers.