7

Intellectual Property

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Note: Nothing in this chapter should be taken as a legal advice. Readers who desire
legal advice related to patents, copyrights, or trademarks or other forms of intellec-
tual property (IP) should consult with an IP attorney.

History and Overview of Intellectual Property

In previous chapters in this text we have mentioned intellectual property (IP) when
discussing research misconduct, data sharing, and collaborations with industry. In
this chapter, we discuss IP issues in more depth. The material covered in this chapter
will also be useful in understanding conflicts of interest.
When most people think of their property, they imagine their house, their land,
their car, their book collection—​something that they can touch, see, feel, hear, smell,
or taste. Many of the property rights that people have pertain to tangible objects
located in time and space. But people also claim to own things that are not located
in any particular time or space, such as songs, poems, computer software, plays, for-
mulas, or inventions. These kinds of intangible things that we claim to own are known
as IP (Foster and Shook 1993). In general, property rights are collections of rights
to control something. Someone who owns a house has a right to sell, rent, modify,
paint, use, or tear down the house. People who have IP have rights to control intan-
gible objects that are products of human intellect (Garner 1999). For instance, if you
have a copyright on a play, you are granted the right to prevent other people from
performing the play without your permission. You also have the right to sell your cop-
yright on the play.
Modern property right laws have their basis in Roman laws, which influenced
the development of legal systems in Europe and the United States. Nations recog-
nized property before the advent of the Roman Empire—​Jewish laws dating to the
time of Moses address property issues, for example—​but the Romans developed what
was at that time the world’s most comprehensive and precise legal system. The U.S.
Constitution draws heavily on the property rights theories of the eighteenth-​century
English philosopher John Locke (1632–​1704).
Although the Western world has recognized property for thousands of years, IP
is a more recent development. While ancient Greek and Roman authors and inven-
tors were concerned about receiving proper credit for their discoveries, the Greeks
and Romans did not have IP laws per se. Although the origins of patents are obscure,

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

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and Shook 1993).
The steam engine (1769) was probably the single most important patent awarded
by the British government. This invention helped to provide additional justification
for patents and served as a model of science–​industry collaboration. As discussed in
Chapter 4, James Watt (1736–​1819) developed a more efficient version of the steam
engine, which had been originally developed by others. He was awarded a patent in
1769 titled “A New Method of Lessening the Consumption of Steam and Fuel in Fire
Engines.” Watt and Matthew Boulton made a considerable sum from the steam en-
gine, which was the product of scientific ingenuity and private investment and mar-
keting (Burke 1995).
The need for copyright coincides with the development of the printing press in the
1500s. Before the printing press, copying of books and author’s writings was rare, and
most people were illiterate. Books and other documents were copied laboriously by
hand in Europe. Because it took so much effort to copy a book, the problem of un-
authorized copies did not arise often. After the printing press was invented, it was
possible to make thousands of copies with relative ease, and literacy increased. The
question naturally arose as to who would control the making and selling of these
copies, and whether “unauthorized” copies would be allowed. Thus, the idea of a
“copyright” was developed in eighteenth-​century England as a way of giving authors
and publishers some control over printed works. In 1710, the English Parliament
passed a statute granting copyright protection to books and other writings. Prior to
this statute, copyrights were protected by common law (Miller and Davis 2011).
The first U.S. patent was awarded in 1641 to the Massachusetts Bay Colony for
the production of salt. The framers of the U.S. Constitution were aware of the sci-
entific and technical developments that were occurring before their eyes and of the
need to grant IP rights to authors and inventors to encourage the advancement of
science, technology, industry, and the practical arts. One of the primary authors
of the Constitution, Thomas Jefferson (1743–​1826), was himself an author and in-
ventor. Benjamin Franklin (1706–​1790), who helped draft the Constitution and the
Declaration of Independence, was both a statesman and a prolific inventor whose
inventions included the harmonica and the lightning rod. Given their familiarity with
science and technology and their appreciation of the importance of free enterprise
and commerce, it should come as no surprise that the founding fathers included a
provision about IP rights in the U.S. Constitution. Article 1, Section 8 provides the
basis for IP laws in the United States when it states that Congress shall have the power
“to promote the progress of science and useful arts, by securing for limited times to
authors and inventors the exclusive right to their respective writings and discoveries.”
158  Responsible Conduct of Research

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).

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During the 1800s, science–​industry and government–​industry collaborations
continued to bear fruit (see discussion in Chapter 4). By the end of the century, many
companies had their own laboratories and employed scientists, engineers, and tech-
nicians. The great master of invention, Thomas Edison (1847–​1931), obtained thou-
sands of patents for inventions developed at his private laboratory in Menlo Park,
New Jersey, including the electric light bulb (1879), the phonograph (1877), the stock
ticker, and the duplex repeating telegraph (Burke 1995). In the twentieth century,
many new science–​industry and government–​industry collaborations produced
more inventions and discoveries, such as the automobile, the airplane, plastics, syn-
thetic fabrics, and computers. In most of these cases, governments funded the basic
research that laid the foundations for practical applications and commercial products
(Dickson 1995).
There are some international treaties pertaining to IP. The first international IP
treaty was the Paris Convention of 1883, which was adopted by 20 countries initially
and has been adopted by many others since then. Other important IP treaties include
the Agreement on Trade-​Related Aspects of IP Rights (TRIPS), which was signed by
120 countries in 1994. Although a patent or a copyright grants legal protection only in
the country in which it is issued, nations that abide by international IP treaties agree
to honor each other’s IP laws. For example, a nation that abides by TRIPS does not
allow the importation of pirated software or unauthorized generic drugs. However,
TRIPS allows for some compulsory licensing to address public safety or public health
crises (Resnik 2001a, 2003a, 2003b). For example, a nation facing a devastating epi-
demic, such as COVID-​19, could use the compulsory licensing provisions of TRIPS
to require a pharmaceutical company to license another company to manufacture
COVID-​19 medications.
As one can see from this brief history, one of the main rationales people have
offered for IP protection is utilitarian: IP laws promote social welfare by encouraging
ingenuity and progress in science, technology, and the arts (Kuflik 1989). They en-
courage ingenuity and progress because they provide authors and inventors with
economic incentives to produce original works and inventions and to share the prod-
ucts of their labor with the public. Without such protections, authors and inventors
may decide to not pursue their original works or inventions or to keep them a secret
(Foster and Shook 1993). When an inventor is granted a patent, the patent application
becomes a public record, which enables other scientists and inventors to learn from
the invention. This allows researchers to share information while also granting them
IP rights. The IP laws also protect the financial interests of businesses and therefore
encourage business to invest in research and development (R&D). Businesses view
 Intellectual Property  159

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).

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According to Locke, all human beings have some inalienable rights relating to life,
liberty, and property. The main function of government is to protect these rights
and prevent citizens from violating each other’s rights. We can acquire property, ac-
cording to Locke, through original acquisition or transfer, such as through commer-
cial transactions or gifts. Original acquisition of property occurs when one imparts
one’s labor to a thing or common resource. For example, if we view the forest as a
common resource, if I remove a piece of wood from the forest and carve it into a
flute, then the flute becomes my property because I have added my labor to the wood.
This libertarian approach implies that laws can be crafted to protect IP rights and
that people can acquire IP through original acquisition or transfer. For example, one
might acquire a new invention (e.g., a better mousetrap) by adding one’s intellectual
or creative labor to previous ideas and inventions (e.g., the old mousetraps). One
could acquire property rights to a song by using or putting together melodies, words,
and harmonies from previous songs to make a new one (Resnik 2001a; Kuflik 1989).
Regardless of whether one adopts a utilitarian or a libertarian approach to IP, the
most basic theoretical issue with respect to IP rights is finding the proper balance
between public and private control of IP (Resnik 2007b). Most theorists agree that
some form of private ownership is necessary to provide rewards and incentives to
individuals and corporations, and most theorists agree that a public domain of infor-
mation is needed to ensure that people have freely available resources to create new
inventions and make new discoveries. But finding the proper balance between public
and private control is not always easy, and that balance may change as new technol-
ogies, such as computers and recombinant DNA, emerge and as social institutions,
such corporations and universities, evolve. This is one reason that it is necessary to
reevaluate and revise IP laws as the situation warrants.

Types of Intellectual Property

Patents

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

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license is a license between the licensor and only one licensee. A nonexclusive license
allows the licensor to license the invention to more than one licensee. Different com-
panies often reach agreements allowing them to use, make, or commercialize each
other’s inventions, known as cross-​licensing agreements and reach-​through licensing
agreements. These agreements enable companies to avoid costly and time-​consuming
patent infringement litigation.
Patent infringement occurs when someone makes, uses, or commercializes a
patented invention without permission of the patent holder. If someone infringes a
patent, the inventor can file an infringement claim with any U.S. federal court (Foster
and Shook 1993). The patent holder can sue the infringing party for damages and
obtain an injunction requiring the infringing party to cease infringement. The party
accused of infringement may challenge the patent or the infringement claim or both,
and the court will make a determination. Because all appeals in patent cases go to the
same federal court, the Court of Appeals for the Federal Circuit in Washington, D.C.,
patent laws are uniform throughout the United States. Appeals of these cases, such as
Diamond v. Chakrabarty (1980), are heard by the U.S. Supreme Court.
Research (or experimental) use is a narrow provision in patent law that allows a
researcher to make or use an invention for research purposes, but not for commercial
purposes. For many years, academic researchers believed that they were protected
from patent infringement under the research use exemption in patent law. However,
an important decision made in a legal case, Madey v. Duke University (2002), has lim-
ited the research use. In this case, the Court of Appeals for the Federal Circuit ruled
that Duke University had infringed John Madey’s patent on a laser by using the device
without his permission. Duke University argued that its researchers could use the
laser under the research use exemption, but the court ruled that the university could
not claim this exemption because it was using the laser to further its business inter-
ests. The court treated the university as similar to a private company. Because most
scientists work for either universities or private companies, the Madey case effectively
ended the research exemption in the United States.
To obtain a U.S. patent, the inventor must file an application with the USPTO. In
deciding whether to award a patent, the office considers the following criteria (Foster
and Shook 1993; Miller and Davis 2011):

Novelty: The invention must be new or innovative. It must not be previously

1.
patented or disclosed in the prior art, which includes patents, publications,
or public uses. Because publication or public disclosure of an invention can
 Intellectual Property  161

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).

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Usefulness: The invention must serve some worthwhile practical use. “Trivial”
3.
uses, such as providing material for a landfill or serving as a subject of medita-
tion, do not count as practical uses, nor do uses as research tools. For instance,
the USPTO has ruled that basic genome sequence data is not in itself patentable;
DNA patents must specify specific uses for DNA in drug development, diag-
nostics, or bioengineering (Resnik 2001a). If the invention has a military use or
implications for national security, the U.S. government has the right to co-​opt
the invention and compensate the inventor, who may also sign a contract with
the government.
Enabling description: Inventors must reduce their inventions to practice; that
4.
is, they must describe the invention in enough detail that someone trained
in the relevant discipline or field could make and use the invention. This de-
scription of the patent becomes a public document and is part of the patenting
“bargain.”
Patentable subject matter: The invention must be the type of thing that can
5.
be legally patented. The courts have ruled that natural phenomena, laws of na-
ture, and abstract ideas cannot be patented (Miller and Davis 2011). Deciding
whether something is or is not patentable has proven to be very controversial in
some cases.

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.

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In the United States a copyright extends for the lifetime of the author(s) plus 70 years,
and it may be renewed. To register copyright, one may file for a copyright with the
U.S. Copyright Office at the Library of Congress. However, authors of original works
have copyright protections even if they do not take this step. To ensure that others
are aware of their claims to a copyright, many copyright holders write “copyright”
on their original works, such as “Copyright © 2022 Shamoo and Resnik, all rights re-
served.” Copyrights protect original works but not the ideas expressed by those works
(Office of Technology Assessment 1990; Chickering and Hartman 1980). Although it
is illegal to sell copies of the book Jurassic Park without the permission of the copy-
right holder, it is perfectly legal to discuss (or profit from) the ideas expressed in the
book without the owner’s permission.
Many copyright holders sell their rights to publishers or other distributors for a
one-​time fee or a percentage of profits. A work produced by an employee of a busi-
ness is considered a “work for hire,” so the copyright belongs to the business, unless
the business grants the employee some portion of the copyright as part of contract
negotiations. For example, most academic institutions allow faculty members to re-
tain copyrights over their works. In some instances, universities or colleges may seek
copyrights for special, commissioned works, such as online courses or educational
software. Works created by U.S. government employees as part of their official duties
are considered to be in the public domain, and the employees have no copyrights per-
taining to such works.
One important exception to copyright law is the doctrine of fair use. According to
this doctrine, it is permissible to copy portions of the author’s work or even the whole
work without his or her permission if the copying is for personal, educational, or re-
search purposes and does not jeopardize the commercial value of the work (Miller
and Davis 2011). For example, the doctrine of fair use allows a person to use a device
to record a television show to watch later, but it does not allow a person to use a device
to make or sell copies of the television show for a large audience. During the 1980s,
the copying company Kinko’s compiled, copied, and sold course packets—​selections
of readings from journals or books—​for professors who were teaching university or
college courses. Publishing companies sued Kinko’s for copyright violations, and the
courts ruled in their favor in 1991 (Basic Books, Inc. v. Kinko’s Graphics Corp. 1991).
Even though the use was for an educational purpose, it was not a fair use because it
defrayed the commercial value of the published works. The dispute over the legality
of the Napster file-​sharing website illustrates the continuing evolution of the doctrine
of fair use. Many companies from the recording industry sued Napster for copyright
violation because the company was distributing copyrighted music over the Internet
 Intellectual Property  163

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).

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Trademarks znaki handlowe

A trademark is a distinctive symbol or mark, such as a name, phrase, device, stamp,

logo, or figure, that businesses use to distinguish themselves. Some examples of trade-
marks include the name “Coca-​Cola,” the phrase “have it your way,” the McDonald’s
golden arches, the Hot Wheels® flame logo, and the Planter’s peanut man. Trademarks
are useful to businesses for marketing their goods and services because they provide
consumers with a way to easily recognize the business and its products. Trademarks
are protected by state and federal laws and are important in commerce, but they play
only a minimal role in research. To obtain federal trademark protection, a business
may submit an application to the USPTO. Trademarks are renewable indefinitely for
10-​year periods (Miller and Davis 2011).

Trade Secrets sekrety handlowe

The forms of IP discussed above—​patents, copyrights, and trademarks—​are rights

granted by the government designed to promote the dissemination of information
while protecting proprietary interests. The key policy issue in these forms of IP is
finding the proper balance of public and private control of information. Trade secrets,
on the other hand, are designed to prevent information from becoming publicly
available. The law recognizes trade secrets because they promote the interests of com-
merce and industry and can be more useful than other forms of IP for some busi-
nesses (Foster and Shook 1993). For example, consider the formula for Coca-​Cola,
one of the best-​guarded trade secrets. If the company had patented its formula for the
product, then the patent would have expired decades ago, and the company would
have lost its share of the market for this product. As far as the company is concerned,
it can make more money by keeping the formula a secret instead of patenting it. The
company can do this because the secret is well-​guarded and difficult to discover.
Although many companies have manufactured products that taste similar to Coca-​
Cola, no company has manufactured a product that tastes just like “the real thing” be-
cause it is difficult to master all the subtle variations in ingredients and manufacturing
processes that the company employs. Other types of trade secrets may include other
formulas, instruments, business plans, customer lists, and company policies. State
and federal laws protect trade secrets provided that the company makes an attempt
to keep the secret and the secret has commercial value. Companies may protect their
164  Responsible Conduct of Research

secrets through confidentiality policies and non-​disclosure agreements. Violators of

trade secrecy laws may bring civil lawsuits and fines.
One problem with trade secrets is that they are difficult to protect. First, employ-
ees may disclose trade secrets either intentionally or inadvertently. Second, there are
legal methods that competitors can use to discover trade secrets, such as reverse en-
gineering. It is perfectly legal for another company to reverse engineer Coca-​Cola

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by purchasing some of the product and analyzing it to determine how it is produced.
Trade secrets are not protected if they are derived from independent research, open
meetings, and a host of other methods. In the biotechnology industry, it is virtu-
ally impossible to keep trade secrets due to the open nature of biotechnology R&D.
Most of the materials used in biotechnology, such as organic compounds, organisms,
common tools, and techniques, are available to the public. Thus, in biotechnology
and pharmaceuticals, patents are generally a better form of IP protection than trade
secrets (Resnik 2001a; Office of Technology Assessment 1990; Adler 1993).

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-

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mitted by private companies in support of a drug application to the U.S. Food and
Drug Administration (FDA) are not all made public, even after the drug has been
approved. Although U.S. law protects this type of information, researchers may still
face an ethical dilemma in situations where promoting the good of society requires
them to break the law. For example, a scientist conducting secret research for a drug
company who discovers a problem with the medication, which the company does not
want to report to the FDA, must choose between abiding by the company’s policies
and serving the public good (Resnik 1998b).

Other Types of Property in Science

In addition to IP, many other different types of property are related to scientific re-
search, including:

• Research materials, such as pharmaceuticals, reagents, cell lines, anti-​bodies, ge-

netically engineered organisms, fossils, and blood samples
• Research tools, such as microscopes, telescopes, mass spectrometers, satellites,
assays, computers, satellites, and test tubes
• Research venues, such as laboratories, greenhouses, archeological sites, jungles,
reefs, and lecture halls

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

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to share not only data but also materials that have been developed or purchased with
public funds. Grant applications may include plans for sharing research materials.
Researchers may charge a reasonable fee for sharing, or they may license private com-
panies to help them answer request to share materials. Obligations to share materials
need not undermine researchers’ plans to publish or patent.

Additional Ethical Concerns

Before concluding this chapter, we return to some more fundamental issues in IP.
This first issue is the question of who has an ethically defensible claim to ownership
of IP; the second is the question of what ethically can be treated as IP. Here we are not
concerned with what the law says about IP, but with what the law should say.

Who Has Intellectual Property Rights?

Consider an invention or an original work. Many different individuals and institu-
tions may assert ownership claims over an invention, such as a transgenic mouse or a
chemical process, or an original work, such as television show or computer software.
Who should be granted patent rights on the mouse or copyrights on the software? In
many ways, this question parallels questions about authorship discussed in Chapter 5,
where we argue that authorship and accountability should go hand in hand: An au-
thor is someone who makes an important contribution and can be held publicly ac-
countable for the research. If all authors have copyrights, then the question of who
should have copyrights is the same as the question of who should be an author. One
may argue that the same point applies to patent rights. An inventor, like an author, is
someone who makes an important contribution to the invention and can be held ac-
countable for the invention. In patent law, an inventor must make significant intellec-
tual contribution to at least one element claimed in the patent application (Dreyfuss
2000; Konski and Wu 2015). Interestingly, an invention often has more authors
listed in the paper describing it than it has inventors listed on the patent application
(Ducor 2000). One might speculate that in these cases people are listed as authors
even though they do not deserve authorship (i.e., honorary authors) or people are not
listed as inventors who deserve to be listed as such (i.e., ghost inventors?).
Although relying on some principle of accountability may settle many con-
cerns about IP rights, it does not address the role of “contributors” and any morally
 Intellectual Property  167

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

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patent. Should the technician have any patent rights? If she has no patent rights,
then should she not be listed as an author on the paper?
• A medicine man in the Amazon jungle teaches a team of botanists and pharma-
cologists about some of the healing powers of a native plant, and they develop a
new drug by isolating and purifying a compound in the plant. Should the med-
icine man (or perhaps his community) be granted some share of royalties from
the patent?
• An oncologist develops a valuable cancer cell line from cancerous tissue
extracted from a patient’s tumor. Should the cancer patient have IP rights over
commercial products from his tissue? (This example is based on the famous
Moore v. Regents of the University of California 1990; see Case 1 below.)
• A graphic artist develops images for a textbook and is listed as a contributor but
not as an author. Should she be granted a share of copyright on the book?

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.

What Can Be Treated as Intellectual Property?

The final issue we consider in this chapter concerns the ethical or moral limitations
on IP. Are there some things that should not be treated as IP? In recent years, many
biological materials have been treated as IP that were previously viewed as belonging
in the public domain, such as genetically engineered organisms, cell lines, genes, and
proteins, all of which biotechnology or pharmaceutical companies have now pat-
ented. Many people find the idea of “owning” products of nature to be morally or
even religiously offensive or at least not in the best interests of science, medicine, and
technology. For example, James Thomson of the University of Wisconsin and the
University of Wisconsin Research Foundation came under attack from many promi-
nent stem cell researchers for patenting human embryonic stem cells (Holden 2007),
168  Responsible Conduct of Research

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

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patentable) vs. methods and techniques (patentable). To delineate the domain of the
patentable, patent agencies and the courts have struggled to find the right balance be-
tween private control over IP and public access research.
U.S. courts have ruled that natural phenomena and naturally occurring spe-
cies are products of nature and cannot be patented (Resnik 2004a). However, in a
landmark case for the biotechnology industry, Diamond v. Chakrabarty (1980), the
U.S. Supreme Court ruled that living things could be patented if they resulted from
human ingenuity. The Court referred to an earlier patent case, Funk Brothers Seed Co.
v. Kalo Inoculant Co. (1948) and stated that “anything under the sun made by man” is
a human invention. Ananda M. Chakrabarty had filed a patent claim on a genetically
modified bacterium useful in cleaning up oil spills. The court held that the bacterium
was patentable because Chakrabarty had modified it so that it was not the same as
the bacterium found nature (Diamond v. Chakrabarty 1980). Prior to this case, the
only living things that could be patented were hybrid species of plants protected by
special plant patenting laws, such as the Plant Variety Protection Act of 1930 (9 USC
2321) The Court’s decision helped pave the way for patenting many products of bio-
technology, including genes, proteins, cell lines, and genetically modified organisms
(Resnik 2001a; Eisenberg 1995).
From the 1980s to the early 2000s, the USPTO awarded thousands of patents on
naturally occurring DNA sequences (Resnik 2004b). The USPTO allowed scientists
to patent naturally occurring DNA sequences because it treated them as isolated and
purified chemicals. Several U.S. Supreme Court cases had held that an isolated and
purified form of a naturally occurring chemical can be patented because isolation and
purification is an inventive process that transforms a chemical into a useful product
(Parke-​Davis & Co. v. H.K. Mulford Co. 1911; Tallmadge 2017). The doctrine of isola-
tion and purification has provided researchers and companies with incentives to de-
velop many different natural products for human use, including proteins, hormones,
vitamins, therapeutic toxins, cancer treatments, and food flavorings and additives.
In 2013, the U.S. Supreme Court made an important ruling that helped clarify the
realm of patentability in biotechnology. The case involved Myriad Genetics’ patents
on BRCA1 and BRCA2 genes, mutations of which significantly increase the risk of
breast and ovarian cancer. The company patented isolated and purified BRCA1/​
BRCA2 DNA sequences as well as methods for testing for BRCA1/​BRCA2 mutations
linked to cancer. Some of these methods involved comparing DNA sequences in a
patient to mutated forms of the BRCA1/​BRCA2. Patient advocacy groups and sci-
entists sued Myriad, claiming that its patents on genes and genetic diagnostic testing
 Intellectual Property  169

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

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DNA sequences are products of nature. The court said the doctrine of isolation and
purification did not apply to DNA sequences described in Myriad’s patent applica-
tion because the sequence information (e.g., GATTCCA, etc.) is not an isolated and
purified compound. Myriad’s patent application contained information for identi-
fying DNA sequences but was not a chemical formula. The court held that modified
DNA sequences, such as complimentary DNA (cDNA), are patentable because they
are products of human ingenuity. cDNA is synthesized from messenger RNA and has
had its non-​coding sequences removed (Association for Molecular Pathology et al.
v. Myriad Genetics 2013). Following the ruling, the USPTO issued guidance stating
that it would award patents on DNA sequences only if the sequences are markedly
different from those found in nature (Tallmadge 2017). Although patents on natu-
rally ocuuring DNA sequences are invalid in the U.S., they are still valid in Europe, as
are patents on isolated and purified chemicals (Cole 2014).
While the Myriad ruling was a victory for those who oppose patents on DNA and
other biological entities on scientific or moral grounds, it is likely to have far reaching
consequences that may adversely impact the biotechnology and pharmaceutical in-
dustry. As a result of the Myriad decision, many U.S. patents on genomic sequences
became invalid, and companies that depended on those patents have lost essential IP
protections. It remains to be seen whether courts outside of the U.S. will follow the
line of reasoning in Myriad, and whether the case will have implications for patents on
other isolated and purified chemicals found in nature, such as proteins or antibodies,
or other isolated and purified biological entities, such as stem cells (Kesselheim et al.
2013; Cole 2014; Tallmadge 2017). So far, the U.S. Patent Office has interpreted the
Myriad decision as eliminating the isolation and purification exception for patents
on natural products, which could take away economic incentives for companies
to develop natural compounds for medicinal or other useful purposes (Tallmadge
2017). Some have argued that the Myriad ruling should be interpreted narrowly so
that it applies only to patents on genomic information (i.e., DNA sequence data) not
to chemical entities (Tallmadge 2017). This interpretation would allow companies to
patent medically useful natural chemicals, such as proteins, but would prohibit pat-
ents on naturally occurring DNA sequence data (Tallmadge 2017).
Myriad’s methods patents depended on the distinction between practical methods
and abstract ideas (such as mathematical algorithms) or natural laws (E =​MC2). The
reason that abstract ideas and natural laws have been regarded as un-​patentable is
that patents on these things would stifle scientific discovery, engineering, and med-
ical practice. A practical application of an abstract idea or natural law can be patented,
however. For example, a computer program that manages the operations of a factory
170  Responsible Conduct of Research

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

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BRCA1/​BRCA2 mutations. The court held that this patent was invalid because it was
simply restating the statistical association between breast cancer and BRCA1/​BRCA2
mutations. In the previous year, in Mayo v. Prometheus (2012), the U.S. Court had
ruled that a method for drug dosing based on measurements of a metabolite in the
blood was invalid because the method only restated statistical associations between
metabolite levels on disease status.
Questions concerning patentability are likely to continue to arise as scientists,
engineers, and inventors make new discoveries and innovations. Because these
questions involve legal, ethical, and policy issues, they are likely to be controver-
sial. Biotechnology and pharmaceutical patents have been and will continue to be
especially controversial. Although these patents can benefit science and society by
promoting research on and development of products and processes with medical
applications, some oppose these patents because they believe that they interfere with
the progress of biomedical science and biomedicine by undermining the sharing of
basic scientific information, or that they drive up the cost of essential medications
or therapies. Others believe that patenting of human biological materials (such as
human DNA or cells) undermines our respect for human dignity, or that patenting of
animals, plants, or microbes undermines our respect for nature. (For further discus-
sion, see Resnik 2004a, 2007b; Chapman 1999; Nuffield Council 2002).

Questions for Discussion

1. Do you think that people have a right to IP?
2. Do you think that IP benefits science and society?
3. Do you think that IP undermines free inquiry, openness, and the aca-
demic ethos?
4. How would utilitarians address IP issues? How does the utilitarian approach
differ from libertarianism?
5. Is it unethical to copy software without the copyright owner’s permission?
6. Should pharmaceutical companies be allowed to charge whatever price the
market will bear for patented drugs?
7. Should developing nations violate international IP agreements in order to make
drugs affordable to patients with HIV/​AIDS, dysentery, or malaria?
8. Do you have any objections to patenting DNA, cell lines, proteins, tissues, ge-
netically modified plants or animals, or other biological materials?
9. Would you have any objections to a patent on a genetically modified human?
 Intellectual Property  171

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?

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Case Studies
Case 1: John Moore’s Cell Line

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.

• Do you think that Moore was treated ethically? Fairly?

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• Should Moore have property rights pertaining to patented cell lines developed
from his tissue?
• Do you think patients give up their property rights to tissue when they donate it
to research or no longer want it (e.g., it is left over from a surgical procedure)?
• Should Moore’s doctors have told him about their financial interests?

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

A university investigator is in hot pursuit of a project that received a medium-​sized

grant from NIH. Her grant depends on the use of reagents from an independent com-
pany. She has had a long and fruitful relationship with the company—​she has given

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several seminars at the company, and her counterpart in the company has given sev-
eral seminars at the university. Also, the investigator has earned a few thousand dol-
lars annually from the company through consulting. She has signed a consultancy
agreement with the company without clearance from the university. Her agreement
relinquishes all her IP rights regarding the subject of the consultancy to the company.
The investigator asked the university to sign a material transfer agreement (MTA)
so that she could start using the reagents. The university refused to sign because the
MTA gave too many IP rights to the company in exchange for the reagents. The uni-
versity investigator was anxious to start her project and make progress so that she
would be able to renew her grant. One day during her frequent seminars at the com-
pany, she was asked to sign the MTA agreement, and she did.

• What should the university do?

• What should the faculty member do?
• What should the company do?

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.

• What should the faculty member do?

• What should the university do?
• What lessons are learned in this scenario?
174  Responsible Conduct of Research

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

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research. After getting back to her laboratory, she gave the project to her most reliable
postdoctoral fellow. One year later, they submitted a paper to a prestigious journal.
One of the reviewers was the investigator who wrote the original grant proposal. The
original investigator has not yet published his paper on the subject because he has ap-
plied for a patent, which delayed writing of the paper. The original investigator com-
plained to the U.S. Office of Research Integrity.

• Is this plagiarism?
• What should Office of Research Integrity do?
• What should the reviewer do?
• Who should get the patent?

Case 6

An NSF-​funded anthropologist and his team from a university have discovered a

human skeleton in a national forest in Montana. Carbon dating shows that the skel-
eton is around 10,000 years old. Further study of the skeleton will prove to be ex-
tremely useful in determining human migration to the North American continent.
However, a group representing Native Americans is taking legal action to have the
skeleton returned to their custody under the Native American Graves Protection and
Repatriation Act. They say that the skeleton is one of their ancestors and should not
be the object of a scientific study.

• Who owns this skeleton?

• How should this dispute be settled?

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.

• Do you see any ethical problems with this proposal?

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Case 8

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.

• Do you have any concerns with the arrangement?

• Should academic writings be treated as “work for hire”?