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The BRCA Gene Patents: Arguments Over Patentability

and Social Utility

Bonnie Chojnacki and Ronald F. White

Beginning in 2011, a series of contradictory U.S. court decisions cast doubt on the patentability of

Myriad Genetics’ BRCA1 and BRCA2, the primary genes responsible for breast and ovarian cancer.

Similar legal and political opposition materialized within the European Union, Great Britain,

Canada, and the rest of the modern world. Despite years of global debate, the long-term public

policy implications for the BRCA gene patents—and indeed all gene patents—remain unclear. This

essay will examine the two primary argument forms that have been presented in the BRCA gene

patent debate: “patentability arguments” and “social utility arguments.” Neither line of argument

has yielded much in terms of national or international consensus. But both have generated

increasingly complex, convoluted, and ultimately irreconcilable debate within and between nations.

These endless cycles of legal, political, and scholarly debate cast serious doubt upon the long-term

sustainability of the patent institution as a “one-size-fits-all” funding mechanism for genomic

science, the genomic industry, and genomic medicine.

KEY WORDS: gene patents, genetic tests, BRCA1, BRCA2, Myriad Genetics

Introduction

By 2005, the U.S. Patent and Trademark Office (USPTO) had granted between

3,000 and 5,000 patents on human genes. About 63 percent of the patents were

held by private firms and 28 percent by universities. The top assignee was the

California-based drug company Incyte, which held about 2,000 genetic patents

(Jensen & Murray, 2005). Today, four corporations hold the majority of gene

patents: Incyte Corporation, Celera Genomics, Myriad Genetics, and Isis Pharma-

ceuticals. A growing number of those patented genes are now associated with

genetic diseases that are diagnosed via patented genetic tests. Although gene patents

have been codified in all modern nations, they continue to generate arguments

over the patentability of specific genes, and over the social utility of the patent

institution in the context of genomic science, the genomic industry, and genomic

medicine.

World Medical & Health Policy, Vol. 5, No. 3, 2013

276

1948-4682 # 2013 Policy Studies Organization

Published by Wiley Periodicals, Inc., 350 Main Street, Malden, MA 02148, USA, and 9600 Garsington Road, Oxford, OX42 DQ.

From the outset, let us acknowledge the obvious; namely that, worldwide, the

legal, socioeconomic, and political dimensions of gene patents are dauntingly

complex. Therefore it is not surprising that the scholarly research associated with

the BReast CAncer (BRCA) gene patents is ponderous, multidisciplinary, and

complex. But it is also often myopic and/or overly simplistic. For example, there

is a distinct genre that approaches the BRCA1 and BRCA2 patents in the larger

context of “intellectual property rights”: patents, copyright, trademarks, and trade

secrets (Gosseries, Strowel, & Marciano, 2008). Other works are primarily

historical accounts of those gene patents and/or gene test patents (Williams-

Jones, 2002). Other works propose alternative regulatory and funding mecha-

nisms (Chahine, 2010; Dreyfuss, 2010; Van Overwalle, 2009). Although much of

the scholarship is critical of gene patents (Gold & Carbone, 2010; Koepsell, 2009;

Schacht, 2006; Soini, Aymé, & Matthijs, 2008; Williams-Jones, 2002), very few of

these works really capture the “big picture.”

This essay will, therefore, develop that “bird’s-eye view” by focusing on the

two main lines of argument within that BRCA debate: patentability arguments

and social utility arguments. While this “bird’s-eye view” will be primarily

philosophical and theoretical, it will also shed much-needed light on some thorny

public policy issues relating to the role that gene patents now play in funding

genomic science, genomic industry, and genomic medicine. Although much of

the analysis will emphasize the U.S. experience, other nations have been similarly

trapped by these open-ended arguments.

Historically, the patent institution emerged as a “one-size-fits-all” solution to

a cluster of problems associated with the economics of research. Today, scientific

research requires a significant long-term investment of time, energy, and

resources, including costs associated with hiring and training a highly skilled

scientific workforce, purchasing and maintaining expensive equipment and

technologies, and complying with governmental regulations. Historically, science

often pays for itself in terms of the production of useful knowledge and/or

inventions, but not always. Therefore sustainable research institutions (public and

private), somehow, must recoup the costs, not only of their occasional successes,

but also their more frequent failures. Modern nations view science as a “public

good,” and therefore directly and/or indirectly subsidize the cost of scientific

research. Since the 1980s, the United States has subsidized scientific research,

indirectly, via the patent institution; that is, by providing economic incentives for

public and private universities, and private corporations to patent their inven-

tions.

The social purpose of the modern patent is to promote research and

innovation and to allow for the return of new benefits for society (Soini

et al., 2008, p. S10). Since researchers must pay the costs of both their successes

and their failures, they often pursue external (public and/or private) investment.

In order to attract private investors, researchers must demonstrate the future

potential for marketable applications of their research, most notably inventions.

Defenders of patents in science argue that in the absence of patent protection, the

incentive for private investment in scientific research would be undermined by

Chojnacki and White: The BRCA Gene Patents 277

the invasion of opportunistic “free riders”; that is, competitors who would “copy”

and “sell” the scientific inventions of others. Since “free-riders” do not pay the

initial costs of research and development, they can (and will) copy and sell those

inventions at a much lower price. Therefore, in the absence of governmental

intervention, the potential invasion by free-riders provides a powerful disincen-

tive for inventors and investors to expend their time, energy, and resources.

Given the enormous costs associated with scientific research, the wedding of the

age-old, patent institution with scientific research seems to be a logical, “one-size-

fits-all” solution. But is it?

The patent institution is a legal mechanism originally designed to address the

free-rider problem. It does so by employing the coercive power of government to

reward inventors with a 20-year, legally enforced monopoly, which includes the

legal right to exclude others from making, using, or selling patented inventions;

and, the legal right to charge users a license fee. In exchange for these benefits,

inventors are legally required to disclose enough information for licensed users to

copy and/or utilize their inventions. But does that “one-size” really “fit all?”

Worldwide, patent policies are implemented by “patent agencies” such as the

United States Patent and Trademark Office (USPTO) or the European Patent

Office (EPO) (Merz & Cho, 2005, p. 203). In the United States, there are two

primary political bodies with the power to review the patentability of genes:

Congress and the courts. Many scholars observe that Congress has attempted to

take up the issue and the lack of significant impact (Andrews, 2002; Demaine &

Fellmeth, 2002, p. 359). Therefore, for better or worse, the primary battleground

for the gene patent debate in the United States has been within the courts.

Because patents are granted, monitored, and enforced by national govern-

ments, inventors interested in participating in the global market must apply for

patents in multiple jurisdictions. The most potentially lucrative jurisdictions

include: the United States, the European Union, Great Britain, and Japan.

However, the application process of awarding patents in any jurisdiction is

enormously complex, expensive, and can take many years to complete; thus, the

familiar term “patent pending.”

The most patent-savvy inventors seek to patent not only their individual

inventions, but also the various components of their inventions. Therefore the

most coveted patents tend to be multiple patents that are both “broad” and

“interlocking.” Genomic corporations often patent not only the multiple genes

associated with a disease and the processes used to isolate those genes, but also

partial sequences of DNA, expressed sequence tags (ESTs), and single nucleotide

polymorphisms (SNPs). Ultimately they also seek patent protection for any

genetic tests that they develop for identifying those genes.

Inventors that are price-sensitive to the cost of conducting scientific research,

obviously prefer “monopolistic” patent licensing policies, characterized by

unlimited exclusionary rights and unregulated license fees. However, patent

agencies in most democratic nations are politically sensitive to the interests of

competing stakeholders, and therefore tend to award narrower, less monopolistic

patents. Since the 1980s, the United States has been noted for its extremely

278 World Medical & Health Policy, 5:3

“monopolistic” patent policies, which favor large genomic corporations; while

European and Japanese policies tend to be much more “restrictive” and are more

sensitive to competing interests (Soini et al., 2008, p. S11). Typical restrictions

include statutory limits on the patent holder’s right to “block” other stakeholders’

access to their inventions, especially competing scientists and/or heath care

providers. And most nations with highly “socialized” health care systems control

the price that patent holders can charge licensees.

Beginning in the early 1990s, worldwide controversy over Myriad Genetics’

gene patents for BRCA1 and BRCA2 raised complex arguments concerning the

patentability of genomic material and the social utility of employing the patent

institution as a funding mechanism for genomic science, the genomic industry,

and genomic medicine.

The BRCA Gene Patents Controversy

Worldwide, breast cancer is the second most commonly diagnosed cancer for

both sexes combined. In the United States, it is the most frequently diagnosed

cancer across all racial and ethnic groups of women. In 2009, in the United States

the most recent year for which statistics are available, 40,676 women diagnosed

with the disease died (United States Centers for Disease Control and

Prevention, 2013). In 2008 more than 332,000 new cases of breast cancer were

diagnosed in the European Union (Cancer Research UK, 2008, 2011, p. 4).

Hereditary breast cancer is responsible for 5�10 percent of breast cancers in women in the United States. Additional risk factors related to breast and ovarian

cancers include: age, reproductive and surgical histories, oral contraceptives, and

physical activity (National Cancer Institute, 2012). Those who have the genetic

mutations have a 40�85 percent risk of developing breast cancer and 16�40 percent risk of developing ovarian cancer over their entire life span (Williams-

Jones, 2002).

There are several scholarly books that critically explore the history of the

BRCA controversy in the larger context of the gene patent controversy

(Koepsell, 2009; Palombi, 2010), and many journal articles that provide historical

background on the European context (Dreyfuss, 2010; Matthijs, 2006;

Parthasarathy, 2005). As one peruses these works, the reader is struck by the

complexity generated by the BRCA gene patents. The following is a brief account

of the international origins of the BRCA controversy.

As early as 1988 seven major international groups were engaged in research

to identify the location of the genes associated with breast cancer. The initiative

was recognized as an international priority with research groups consisting of

scientists from many countries in laboratories in the United Kingdom, France,

Canada, and two groups from the United States. An awareness of the value of

cooperation in identifying genetic mutations and its ability to promote future

research led to formation of the Breast Cancer Linkage Consortium (BCLC), an

international alliance of researchers from the United States, the United Kingdom,

Canada, France, Belgium, and the Netherlands.

Chojnacki and White: The BRCA Gene Patents 279

An initial breakthrough in the search for those breast cancer genes occurred

in 1990, when one team from the United States led by Mary Claire King

announced the discovery of a gene associated with breast cancer on chromosome

17 at a meeting of the American Society of Human Genetics. Collaborators

included Francis Collins and other notable researchers. Following King’s

announcement, Gilbert Lenoir and Steven Narod published an article confirming

those findings. In addition, Lenoir and Narod reported that a hereditary

disposition for ovarian was identified at the same location (Gold &

Carbone, 2010, p. S40).

The next step in furthering state-of-the-art molecular-level science was to

identify the specific genes on chromosome 17 associated with the cancers. In

order to assemble sufficient data for a statistically relevant analysis, the BCLC

began collecting information from families with possible inherited predispositions

to the cancers. From their analysis of 214 families BCLC scientists arrived at two

conclusions. One, a gene located on chromosome 17, BRCA1, was associated with

hereditary breast and ovarian cancers. Two other genes, as yet uncharacterized,

were associated with the related breast and ovarian cancers. BCLC published a

series of articles reporting these results in the American Journal of Human Genetics

in 1993 (Gold & Carbone, 2010; Williams-Jones, 2002).

At the same time, Marc Skolnick, Adjunct Professor in the Department of

Medical Informatics, University of Utah’s Center for Genetic Epidemiology, was

leading another research group from the United States in a search to identify the

location of the genes for breast and ovarian cancers. Skolnick’s group had an

initial advantage through access to databases that were already populated.

Skolnick’s international team of scientists mined the Utah Population Database

and cross-referenced it with the Utah Cancer Registry. Although the Population

Database was previously developed as part of Skolnick’s doctoral work, in the

1970s, it had become the property of the University of Utah, and was accessible

for new research. By the time the database was mined for the new research it

contained data from 200,000 Mormon families and 1.6 million decendents of the

original 10,000 settlers of Utah. Linking the data to the 100,000 entries in the Utah

Cancer Registry resulted in 40,000 cross-linked entries that formed the founda-

tional data for future research.

In 1991, Skolnick became the Chief Scientific Officer of a business venture

founded in conjunction with the University of Utah; Peter Meldrum (well-known

venture capitalist) and Walter Gilbert (Nobel prizewinner, and faculty member in

the Department of Molecular and Cellular Biology at Harvard University) joined

the venture. Together they formed Myriad Genetics, Incorporated. But why

would a public university join forces with a “venture capitalist?” Good question!

The short answer is that the enormous costs of genomic research and the legal

complexities associated with patents provided a powerful incentive for public

and private universities to “spinoff” for-profit corporations.

The legal foundation for the use of gene patents as a funding mechanism for

genomic research was firmly established in the early 1980s by a series of

legislative, judicial, and regulatory decisions in the United States, most notably:

280 World Medical & Health Policy, 5:3

the Human Genome Project (which marked the first major effort by the United

States to provide direct public funding for genomic research); the Bayh–Dole Act

(which cleared existing legislative barriers that prevented publically funded

colleges, universities, small businesses, and not-for-profits from holding intellec-

tual property rights on “inventions” developed with federal funds); and the U.S.

Supreme Court case, Diamond v. Chakrabarty (which ruled that an oil eating

bacterium created in a laboratory fulfilled the legal criteria for patentability and

that “anything under the sun that is made by man” can be patented”). Taken

together, these three public policy decisions cleared the way for the patenting of

living things, especially DNA (Koepsell, 2009, p. 140).

Myriad Genetics was the product of a new form of creative financing that

merged public and private revenue streams. It included $10 million (U.S.) in

private stock and $1 million (U.S.) in equity from the Eli Lilly pharmaceutical

corporation. The U.S. National Institutes of Health (NIH) contributed $5 million

(U.S.) to the Utah research group. Eli Lilly provided another $1.8 million (U.S.)

over 3 years for the search for genes associated with breast cancer in exchange for

licensing on diagnostic kits and therapeutics. At the time it was launched, Myriad

Genetics held no patents as collateral for investment. Myriad filed its first patent

application with the U.S. Patent and Trademark Office (USPTO) on BRCA1 in

August 1994 with coassignee the University of Utah. The results of the research

were published several months later in the October 7 issue of Science. In 1996,

Myriad opened a $30 million (U.S.) laboratory and launched a gene discovery

corporation. In December 1997, the USPTO granted the first patent to Myriad

covering 47 separate mutations. By 1998 Myriad secured a patent covering all

uses of the BRCA1 gene (Gold & Carbone, 2010, p. S41).

A second gene associated with breast and ovarian cancers was found on

chromosome 13. The race to report the discovery of BRCA2 came down to

competition between a group from the United Kingdom led by Michael Stratton

and Myriad. Stratton’s group published an article on the discovery BRCA2 co-

authored by 31 scientists in Nature in 1995. Skolnick’s research team at Myriad

reported that they had already identified BRCA2 and had submitted their

findings to GenBank, a public database for genetic information sponsored by

the U.S. National Center for Biotechnology Information (NCBI). Myriad further

claimed the information published by Stratton’s team from the U.K. was less

complete than the profile it had submitted to GenBank. The USPTO awarded

patents on BRCA2 to Myriad in 1998 and 2000. Like the U.S. patents on BRCA1,

the patents on BRCA2 were broad and interlocking, and covered “BRCA2 DNA,

mutations, and diagnosis … and for a patent over the method of detecting

BRCA2 mutations and antibodies” (Gold & Carbone, 2010, pp. S41�S42). By leveraging its patents and rigorously exercising its rights of exclusivity

worldwide, Myriad Genetics has become a major biopharmaceutical corporation

with a significant international market currently “specializing in the use of

proteomic and genomic technologies to create break-through medical, diagnostic

and therapeutic products” (Parthasarathy, in Williams-Jones, 2002, p. 129).

Although, it has been a very “successful” from the standpoint of its investors,

Chojnacki and White: The BRCA Gene Patents 281

Myriad’s gene patents spawned worldwide controversy over the patentability of

genes, social utility of gene patents, and the overall ethics of Myriad’s behavior as

a university-owned corporation.

Legal Arguments over the Patentability of the BRCA Genes

Worldwide, gene patents are complex legal entities steeped in arcane legal

arguments embedded in ambiguous historical precedent. In the United States,

Myriad’s BRCA1 and BRCA2 patents led to a series of conflicting high court

decisions over whether those genes fulfill the traditional legal criteria for

patentability. While laws governing the patentability of specific objects and

procedures vary between nations, it is widely agreed that the following legal

criteria must be met:

C1: The object or procedure must be an invention and not a discovery.

Therefore, you cannot patent a natural object or a natural process.

C2: The object or procedure must be innovative (or novel). Therefore you cannot

patent something that already exists through the efforts of someone else.

C3: The object or procedure must be non-obvious. Therefore, you cannot patent

something that has already been fully anticipated by a previous patent,

publication, or other knowledge within the public domain. It must require

substantial time, effort, and resources to create it.

C4: The object or procedure must be useful. Therefore, you cannot patent

something that is useless in the hope that it might someday become useful

(Schacht, 2006).

According to the U.S. Patent Act of 1952 (Title 35) an inventor may patent “…

any new and useful process, machine, or any composition of matter, or any new

and useful improvement thereof … .” These criteria became obfuscated when

the U.S. Supreme Court issued its decision on Diamond v. Chakrabarty (1980),

which ruled on the patentability of a bacterium that, with the insertion of four

plasmids, became an efficient way of managing oil spills. Initially patent

examiners rejected the patent application for two reasons, (1) the bacteria are

“products of nature” and (2) “they are living.” A series of appeals brought the

case to the Supreme Court which ruled: “the patentee has produced a new

bacterium with markedly different characteristics than those found in nature, and

one having significant utility … .” The Court went on to rule that, “the relevant

distinction was not between living and inanimate things, but between products of

nature, living or not, and human-made inventions” (Brody, 2006, pp. 10�11). However, as Chahine points out, the “natural products doctrine” is itself vague

and there has been “little consistency in the manner it has been applied”

(Chahine, 2010, p. 1251). Nevertheless, this early decision opened the way for

subsequent courts to rule that “usefulness” and “human made inventions” trump

the other criteria of patentability, a decision that favored large corporations like

Myriad whose products are pure biotechnology. Henceforth, the legal defense of

gene patents consisted in the argument that genes encoding proteins are

282 World Medical & Health Policy, 5:3

analogous to chemicals (Eisenberg, 2006, p. 318). And the social utility of gene

patenting became identified with the rapid discovery of naturally occurring,

useful molecules (Demaine & Fellmeth, 2003, p. 5624).

Myriad and other defenders of gene patents also argued that the BRCA genes

are patentable because, in order to be rendered “useful,” they must be first

“isolated” from the human genome, and that the process of isolating genes is

complex and therefore “non-obvious.” Critics like Palombi would later refer to

this line of argument as the “isolation contrivance” (Palombi, 2010, pp. 205�223). European critics also argued that the BRCA genes isolated by Myriad are not

sufficiently innovative, because those genes had already been mapped to chromo-

some 17 by the international researchers and the BCLC and thus Myriad’s gene

patents simply added the “last brick in the wall” to a set of previous discoveries.

Many also argue that most (if not all) patents in Science are inherently unfair

because they arbitrarily and therefore unfairly reward one inventor at the expense

of other deserving predecessors. So if Myriad merely put the “last brick in the

wall” (Gold & Carbone, 2010, p. S64), then justice implies that the courts either

require Myriad to share exclusionary rights and license fees with those previous

bricklayers or completely disallow those patents and rule that the BRCA genes

belong in the public domain.

On May 12, 2009, a challenge to Myriad’s patents on the BRCA genes was

brought in the Southern District of New York (SDNY) by more than 20 plaintiffs

including the American Civil Liberties Union (ACLU), Association of Molecular

Pathology, Public Patent Foundation (PubPat), medical professional organiza-

tions, patient advocacy groups, individuals, and physicians. The defendants

included the United States Patent and Trademark Office (USPTO), Myriad and

the University of Utah Research Foundation. On March 29, 2010, Justice Robert

Sweet, in a 156 page opinion, invalidated 15 claims in 7 patents. He ruled that,

[b]ecause the claimed isolated DNA is not markedly different from native

DNA as it exists in nature, it constitutes unpatentable subject matter. …

The identification of the BRCA1 and BRCA2 gene sequences is un-

questionably a valuable scientific achievement for which Myriad deserves

recognition, but that is not the same as concluding that it is something for

which they are entitled to a patent. (Sweet, 2010, p. 135)

Justice Sweet, basing his ruling on nineteenth century precedent, significantly

departed from the convention of the USPTO and many lower courts decisions

from the twentieth century and ruled in favor of the plaintiffs that mere isolation

or purification as a product of human invention is insufficient:

DNA represents the physical embodiment of biological information,

distinct in its essential characteristics from any other chemical found in

nature. It is concluded that DNA’s existence in an “isolated” form alters

neither this fundamental quality as it exists in the body nor the

information it encodes. (Sweet, 2010, p. 3�4)

Chojnacki and White: The BRCA Gene Patents 283

On July 29, 2011, Judge Sweet’s ruling was reversed by the United States

Court of Appeals (CAFC) for the Federal Circuit. In a divided opinion the

Appellate court affirmed that isolated DNA is patentable and ruled that only one

of the plaintiffs had legal standing to bring charges against Myriad et al. The

CAFC overturned Justice Sweet’s opinion based on the twentieth century

precedent that genes are equivalent to chemicals and, as such, both the genomic

material and the process claims remain valid (Conley & Vorhaus, 2010). However,

the Supreme Court “remanded” that decision back to the CAFC for reconsidera-

tion in light of the high-court’s recent decision in Mayo Collaborative Services versus

Prometheus, where they unanimously invalidated a patent on a medical test

because it was tantamount to patenting “a law of nature.” The CAFC reaffirmed

their support for the patentability of gene patents but cast doubt on the

patentability of Myriad’s gene test.

Meanwhile in Australia (as was the case in the United States) members of the

public rather than competing corporate interests challenged the BRCA patents.

When Australian courts considered the impact of prohibitions on genomic

patents, they also weighed the impact banning patents on DNA would have on

biotechnology (Simmons & Wickham, 2012, p. 323). Their ruling affirming

legitimacy on patents on DNA might be construed a nod to the argument Myriad

has put forth. Myriad’s case before the U.S. Supreme Court will strictly examine

the law and legal precedent when it decides on the composition of matter issue

put before it.

Cook-Deegan has argued that a ruling opposing claims on DNA molecules,

now in front of the U.S. Supreme Court, is likely to have little impact on

biotechnology industries except for a few who hold “service monopolies,” like

Myriad and Athena Diagnostics. Other biotechnology corporations whose geno-

mic patents include narrow claims are unlikely to notice a significant difference

(Cook-Deegan, 2012, p. 747). The challenge each country will need to grapple

with is aligning law and policies with international trade agreements like the

World Trade Organization Agreement on Trade-Related Aspects of Intellectual

Property Rights (TRIPS) and ethical considerations related to provision of health

care especially those that have national health care systems (Simmons &

Wickham, 2012, p. 323).

As the world anxiously awaits the U.S. Supreme Court’s second decision on

the Myriad case, again the primary question will be whether genes do or do not

constitute patentable subject matter (Liptak, 2012). Indeed, as one peruses the

various court cases, which are rife with dense scientific jargon, one might question

the competence of legal experts, especially judges, to rule on technical matters of

science, business, or medicine. Regardless of the outcome, legal scholars,

philosophers, and scientists (and future courts) from all over the world will

continue to argue over whether newly identified human genes are discoveries or

inventions, and whether they are sufficiently innovative, non-obvious, and useful.

In sum, as Cho (2010) rightfully observed: “It is clear that the intellectual

property model challenged by the Myriad decision will have to be replaced if

new genetic technologies are to achieve their full potential in promoting the

284 World Medical & Health Policy, 5:3

“progress of science and useful arts” (Cho, 2010, p. 551). Therefore, at this point

in time, it seems highly unlikely that patentability arguments will ever provide a

stable legal foundation for global genomic science, the genomic industry, or

genomic medicine.

Social Utility Arguments over the BRCA Gene Patents

Patentability arguments are, by their very nature, unlikely to generate stable,

legal consensus within and/or between nations. However, the BRCA debate has

also produced a variety of arguments over the social utility of gene patents.

Unfortunately, those arguments are similarly destined to generate open-ended

debate.

First, some basics. As Rachels (1986) observed, classical utilitarianism can be

summarized in three propositions: “Actions are to be judged right or wrong

solely in virtue of their consequences”; “in assessing consequences, the only thing

that matters is the amount of happiness or unhappiness that is caused”; and “in

calculating the happiness or unhappiness that will be caused, no one’s happiness

is to be counted as more important than anyone else’s”. Hence, any utilitarian

analysis of gene patents is grounded in the meta-ethical proposition that the

“social good” is manifest in future consequences. However, there is longstanding

debate over the foundations of “classical utility” and interpretation the “social

good” (Glover, 1990). One puzzle involves whether the “social good” lies in

increased quantities of happiness (or measuring happiness) and/or increased

numbers of happy persons (or “counting heads”). Regardless of the unit of

measurement, if the estimated future benefits of a given policy outweigh the costs,

then that policy is “justified” and conversely, if estimated costs outweigh the

benefits, then it is “unjustified.” Based on “head-counting,” public policies that

benefit at least 51 percent of stakeholders are deemed justified. However, in the

real world, the anticipation of future consequences is enormously difficult and

requires highly fallible social scientific calculations. Not surprisingly, there are

hidden puzzles associated with accurately calculating cost and benefits of the

BRCA gene patents.

The most obvious utilitarian criticism of the BRCA gene patents and (and

gene patents in general) has been the subsequent emergence of “unanticipated

costs” (and benefits) to various stakeholder groups. One of the most pernicious of

the unanticipated costs has been their tendency to inspire organized political

resistance. The primary source of political resistance to the BRCA gene patents

has been that the would-be benefactors are often unwilling to pay the cost of

advancing the interests of those would-be beneficiaries. Worldwide, the BRCA

gene patents distribute benefits and costs unequally among a wide variety of

competing stakeholder groups, most notably genomic scientists, research univer-

sities, genomic corporations, medical professionals, patent lawyers, breast cancer

patients, and taxpayers. Thus, the political challenge for any utilitarian analysis of

gene patents is that they require cooperation between patent-holding and non-

patent holding genomic researchers and health care providers.

Chojnacki and White: The BRCA Gene Patents 285

One time-tested strategy for fostering cooperation among stakeholders is to

invoke feelings of sympathy among potential benefactors and argue that the

primary beneficiaries of a given public policy are the “least advantaged,” that is,

women with breast cancer. However, unless the “least advantaged” turn out to

be a majority, this is no longer a utilitarian argument. Moreover, gene patents

benefit not only the “least advantaged” but also patent-holders (and patent

lawyers) who are not among the “least advantaged.” Hence, political resistance to

the BRCA gene patents can be attributed to the perception that Myriad Genetics

has benefitted more than breast cancer patients.

Another puzzle associated with justifying the BRCA gene patents based on

classical utility is deciding whether utility ratios ought to be calculated based on a

national or a global scale. Nationalism argues that utility ratios ought to be

calculated within sovereign nation states. However, nation states are often

composite entities comprised of political subentities with conflicting interests. For

example, in the United States there are longstanding political conflicts between

local, state, and federal levels of government; between upper, lower and middle

classes; and between various racial and ethnic groups. Within the European

Union there are frequent political conflicts between the individual member nation

states, and in Canada the political conflicts occur between its various provinces.

Compound political entities also harbor competing (and cooperating) universities,

corporations, scientific organizations, health care providers, and patient advocacy

groups. So while it may be true that the BRCA gene patents benefit Myriad

Genetics, social utility requires that a majority of stakeholders within those

national borders benefit. Here, the most common rhetorical device employed by

the defenders of gene patents is to invoke the “trickle-down effect” and argue

that lucrative benefits afforded gene patent holders, like Myriad, will produce

benefits for the other stakeholders over the long run. However, these long run

arguments are often tantamount to “kicking the can down the road.”

Utilitarians, like Peter Singer, advocate “an abandonment of state sovereignty”

in favor of universal principles (Singer, 2002, p. 5). Globalism (or universal

utilitarianism) argues that utility ratios ought to be calculated with impartiality

on a global level. Hence, a positive utility ratio for one nation may (or may not)

generate negative utility ratios for other nations and/or the rest of the global

community. Positive utility ratios for Europe and/or Canada may not yield

positive ratios for the United States and, conversely, positive utility ratios for the

United States may not be “good” for the rest of the world. At a global level, the

BRCA gene patents are most likely to yield positive utility ratios within

economically developed nations, especially those with national health care

systems, such as the United States, Canada, Europe, and Australia. Under-

developed nations, however, are not likely to immediately benefit. Therefore,

globalists might argue that gene patents benefit, primarily, economically devel-

oped nations, a minority of global stakeholders. Defenders might respond that

over the longer run under developed nations will also benefit, but are unable to

specify how and/or when those benefits might flow their way.

286 World Medical & Health Policy, 5:3

The fact that utility can be estimated over both the long run and the short

run gives rise to another notoriously vexing problem associated with classical

utility—the “problem of future generations” (Rawls, 1999, pp. 251�262). Here is how that argument goes. Utility ratios calculated over the short run benefit the

present generation; while projected long-run ratios aim to benefit future

generations. This, inevitably, leads to conflict of interest between present and

future generations. For example, a utilitarian might argue that future stakeholders

are potentially more numerous and inherently “disadvantaged” in their power

relationship with the present stakeholders. Therefore, negative ratios in the short

term (for the present generation of stakeholders) might be acceptable if they

produce positive long-term utility ratios (for future generations of stakeholders).

Unfortunately, all of this raises a menagerie of problems, including the matter of

“intergenerational justice” (Gosseries, 2012).

Perhaps the most problematic and puzzling is that knowledge of the long-

term future consequences of any complex public policy is highly fallible and,

therefore, long-term “one-size-fits-all” public policies, like gene patents, are likely

to be undermined by unanticipated costs.

In sum, any utilitarian defense of gene patents as a “one-size-fits-all” public

policy mechanism will have to address at least four notoriously thorny issues:

unanticipated future costs and benefits, inequality in the distribution of costs

and benefits, and the problem of future generations. One might add that the

mind-boggling complexity of the BRCA patents and the ongoing legal controver-

sy also generate unanticipated costs. Another dimension of the “one-size-fits-all”

nature of gene patents is the assumption that they solve complex problems

relating to genomic science, the genomic industry, and genomic medicine. Let’s

take a closer look at each of those arguments.

Genomic Science

Genomic science consists of the systematic search for the laws of nature

governing biological inheritance; especially the human genome. Research is

typically conducted by public and private research laboratories around the world,

with a growing number of genomic researchers associated with private corpo-

rations that are owned by public and private universities.

Recall that the original impetus for employing gene patents was to solve a

cluster of funding issues in genomic science. But what are the long-term and

short-term costs and benefits of continuing to fund genomic science via the patent

institution? Who are the primary stakeholders? And, in the final analysis is it a

positive or negative utility ratio? Let us begin by acknowledging that there is a

general consensus among developed nations that the anticipated social benefits of

gene patents are associated with the provision of economic incentives that

contribute to the future production of scientific knowledge and useful inventions.

However, critics of gene patents argue that patent institution has already

generated unanticipated costs for genomic science. So what is science and do the

Chojnacki and White: The BRCA Gene Patents 287

BRCA gene patents advance or undermine its fundamental principles and

institutions?

Philosophers of science often distinguish between genomic theory as “pure

science” and the genomic applications as “applied science.” Pure science seeks to

discover the “laws of nature”; a collective human activity that is often “justified”

based on the idea that knowledge of the Truth is “intrinsically good” or “good for

its own sake.” The most idealistic defenders of the pursuit of pure science argue

that the primary incentive for scientists to expend their time, energy, and

resources on pure science is (or ought to be) the worldwide honor bestowed upon

successful scientists, and not financial gain. Moreover, “pure science” is a “public

good,” therefore there must be universal access to its findings via a “scientific

commons” or “public domain.” Therefore, unlike inventions, knowledge must

remain universally open at its source (open-source). Hence, the most idealistic

proponents of pure science often argue that the very idea of buying and selling

scientific knowledge undermines the collectivist “ideals” of science, and argue

that scientific patents and copyrights on scientific information are unjustifiable.

Another puzzle for the advancement of pure science is that it requires an

extraordinary degree of impartiality and objectivity on the part of researchers. Since

new discoveries build on previous knowledge, it is the nature of pure science to

continually inquire and challenge old discoveries based on new research.

Research works best when those engaged in scientific endeavors are

dispassionate about the outcome and when scientific honors are bestowed

based on merit alone. Scientific claims are expected to be original—to

build on but extend beyond the work of others. And scientific research

should be governed by an underlying skepticism, meaning that all claims

are tentative, theory-dependent, subject to empirical verification and

rigorous scrutiny by other scientists. (Angrist & Cook-Deegan, 2006, p. 88)

In short, the hallmark of scientific inquiry is that it is self-corrective; that is to

say that, over time, Science replaces or modifies beliefs that are false. Any public

policy that impedes this self-corrective function destroys the essence of science.

In contrast to pure science, applied science employs scientific methods and

technologies in the production of useful products and services. So if pure science

seeks “intrinsic value,” then applied science pursues “extrinsic value,” or utility.

As for motivation, the most realistic proponents of applied science argue that the

primary motivation for discovering the laws of nature is the production of useful

inventions. However, other motivations, such as earning tenure and promotion,

selling scientific books, journals, and video documentaries are perfectly accept-

able. Idealistic critics, however, say that the pursuit of gene patents has already

“crowded out” the cooperation and impartiality necessary for the discovery of

objective Truth, universal access to the Truth, and the pursuit of science as a

“social good.” However, realistic defenders of gene patents observe that the

traditional “ideals of science” can no longer sustain modern science and/or that

national governments can no longer afford to pay the open-ended costs of both

288 World Medical & Health Policy, 5:3

successful and unsuccessful scientific research. Gene patents, they argue, provide

the incentives necessary for the continued production of scientific knowledge and

applications, especially genomic tests and genomic therapies.

The most frequently cited utilitarian argument offered against the BRCA gene

patents, and all gene patents, is that those coveted, multiple, interlocking patents

may produce a “patent thicket,” which provides disincentives for the future

development of genomic science, genomic industry and genomic medicine. Here

is how the “patent thicket argument” works in the context of genomic science.

The human genome is comprised of millions of interacting genes. When

Myriad patented BRCA1 and BRCA2, it created a legal obligation for other

researchers to secure permission from Myriad to use that information. Myriad,

however, aggressively exercised its exclusionary rights by “excluding” other

researchers or charging multiple, prohibitively costly licensing fees. Thus, any

scientists interested in either improving the BRCA1 and BRCA2 inventions, or

hoping to “invent” (or isolate) other genes associated with breast cancer like

BRCA3, BRCA5, and BRCA6, had to negotiate with Myriad from a position of

legal disadvantage. Moreover, compound gene patents have generated so much

complexity that is difficult for competitors to determine which patents might

apply. The more patent licenses that are required, the costlier the research. So

rather than risk litigation for patent infringement, rational researchers will choose

not to compete in areas where patent thickets are present. However, it is

important to note that the empirical question as to whether patent thickets do, in

fact, stifle competition in genomic science, the genomic industry, and genomic

medicine is open to debate (Merz & Cho, 2005).

Genomic science currently resides at the intersection of “pure science” and

“applied science,” and gene patents seem to straddle the ground between the

“laws of nature” and “inventions.” By legal precedent, the laws of nature fall

beyond the bounds of patentability. In the 1854, the U.S. Supreme Court in

O’Reilly V. Morse found that Morse’s patent was “too broad” and argued that by

granting a monopoly on electromagnetism, which it held to be a law of nature,

rather than the invention of the telegraph “would be unjust to the public … and

defeat the manifest object of the law” (Andrews, Paradise, Holbrook, &

Bochneak, 2006, p. 1394). However, inconsistencies in the decisions of the lower

and intermediate courts in the U.S. courts have added to the confusion (Demaine

& Fellmeth, 2002). Eisenberg has argued that this confusion is due, at least

partially, to the fact that genomic science is relatively new and rapidly changing,

which creates tension with time-honored stability expected of the courts. She

explains that, “Strategic claim drafting (of patents) is itself an evolving art that

advances in tandem with technology, subject to constraints of patent law”

(Eisenberg, 2006, p. 317). However, one might question the social utility of

constantly altering the rules of the game.

Critics of gene patents, therefore, conclude that because private research

facilities lack the requisite incentives to pursue Truth for its own sake, govern-

ments must fill the void and finance that research. But again, all scientific research

is costly and it does not always arrive at the Truth. And even when the Truth is

Chojnacki and White: The BRCA Gene Patents 289

discovered, it may not “pay off” in terms of future discoveries or inventions.

Moreover, the public investment in pure science, inevitably, competes for

budgetary considerations with other more “practical” political priorities such as

infrastructure, welfare, and/or national defense. Hence, the most attractive

feature of the BRCA gene patents (and all gene patents) is that they offer an

alternative to the direct funding of pure science by providing economic incentives

for private investment, by resolving the free rider problem, and by rewarding

inventors with legal monopolies. But then again, critics question whether the

pursuit of research patents by colleges and universities undermines their mission

to educate students.

In the final analysis, the BRCA gene patents inspired a much-needed debate

over funding genomic science via gene patents. However, that debate has become

increasing complex and difficult to evaluate. As Salzberg suggests, “Gene patents

are antithetical to scientific progress.”

Patent lawyers have no business in the laboratory. But scientists have

invited them in, and now we are finding that they are hard to chase out.

Once a gene is patented, court cases drag on for years, taking up

countless hours of scientists’ time. Lawyers charge by the hour, and these

are “productive” hours for them. Scientists measure progress by how

many discoveries they make (and publish), and every hour spent on legal

dispute is an hour taken away from real work. Thus, rather than being

productive, gene patents are destructive of the scientific enterprise.

(Salzberg, 2012, p. 970)

Genomic Industry

The genomic industry is comprised of private corporations that seek to earn a

profit by investing in genomic science. One of consequences of funding genomic

science via the patent institution has been the rise of a handful of highly

profitable corporations such as Myriad Genetics. But how have gene patents

affected the overall competitive structure of that industry, and what are its

prospects for the future? In other words, what are the long-term and short-term

costs and benefits of continuing to fund genomic science and the genomic

industry via gene patents?

Again, let us begin with the basics. The purpose of any corporation is to serve

the financial interests of its primary stakeholders: stockholders, employees,

consumers, suppliers, financiers, and local communities. More specifically,

corporations provide: investment opportunities for stockholders, employment

opportunities for employees, products and services for consumers, lending oppor-

tunities for financiers, markets for suppliers, and a variety of benefits (including tax

advantages) for local communities (Boatright, 2011). Predictably, the interests of

these “stakeholder groups” often conflict. Therefore, the primary public policy

question is to what extent governments ought to be engaged in resolving those

conflicts of interest.

290 World Medical & Health Policy, 5:3

In business ethics there are two competing theoretical perspectives. Stock-

holder theory holds that the primary goal of an industry or corporation is to earn

a profit for stockholders and that the free market (and not the government) ought

to determine economic winners and losers. Stakeholder theorists argue that the

primary goal of an industry or corporation is to advance the collective interests of

all stakeholder groups (nationally or globally), and not just the stockholders and

that government must play a major role in distributing costs and benefits among

stakeholder groups. At a global level, European and Canadian economic policy

leans toward stakeholder theory, while U.S. policy leans toward stockholder

theory.

Stockholder theorists argue that in a free market corporations and industries

that effectively serve the financial interests of their primary stakeholders are

rewarded by earning a profit. Companies that do not earn a profit are “creatively

destroyed” by competitive market forces. So, if the long-term goal of genomic

science is to “creatively destroy” (modify or replace) “unfit” (false or inadequate)

theories or suboptimal inventions, then the long-term goal of the genomic

industry is to modify or replace “unfit” products, services, corporations, and

perhaps even entire industries. So how do gene patents affect this process of

creative destruction?

The most obvious problem is that gene patents provide patent holders with a

20-year legal (artificial) monopoly; that is, the right to exclude competitors from

using their patented inventions, and the right to charge license fees. In short, gene

patents by their very nature “protect” patent holding corporations like Myriad

from economic competition, which means that patent holders earn monopolistic

profits for 20 years. Again, these monopolies are traditionally justified based on

social utility; that is, the claim that the long-term benefits of gene patents

outweigh the short-term costs. But do those long-term economic benefits really

outweigh the costs?

Critics of the BRCA gene patents insist that the long-term costs outweigh the

alleged long-term benefits; and that the global industry would be better off

without them. Although the genomic industry is comprised of competing

corporations, that industry also competes with other industries for both public

and private investors. Although, so far, the genomic industry has already

benefitted greatly from both public and private investment, critics question the

long-term sustainability of continuing to directly subsidize the genomic industry

via the National Institutes of Health and the National Science Foundation. Hence,

the attraction of gene patents as an alternative funding mechanism.

Anticipating the long-term and short-term costs and benefits of gene patents

for the genomic industry is enormously complex and highly fallible. One of the

unanticipated costs of gene patents has been the worldwide costs associated with

monitoring and enforcing patent laws in multiple jurisdictions. Patent-holding

corporations must invest a lot of time, energy, and resources protecting

themselves from legal challenges to their patents. Competing researchers must

expend time, energy, and resources determining the patent status of the genes

they need to conduct their own research. This task is ongoing and complicated by

Chojnacki and White: The BRCA Gene Patents 291

the fact that many gene patents are pending, and therefore, may be subject to

license fees at a later date. If competing researchers are accused of failing to

comply with patent law or if they discover that another company is infringing

upon their patent rights, they will have to employ the services of any army of

highly paid patent lawyers to represent them in long, drawn-out court proceed-

ings. These kinds of legal “interferences” can cost somewhere between $100,000

and $500,000 to resolve (Merz & Henry, 2004, p. 154). Whether the overall costs of

DNA-based patents outweigh their benefits requires much more empirical

analysis (Mills & Tereskerz, 2008).

Another unanticipated cost for the genomic industry has been that gene

patents tend to favor large genomic corporations that can afford to apply

for patents around the world, can afford to defend their patents through

litigation, and can defend themselves from claims of patent infringement.

Therefore, gene patents protect, primarily, the interests of the largest and

most powerful corporations, often at the expense of smaller (and often

more innovative) corporations. However, that competitive advantage afforded

large corporations does not necessarily correlate with the production of

higher quality products and services at a lower cost. It is, however, a measure of

their ability to effectively utilize legal systems. So, over the long run, will

powerful genomic corporations, like Myriad, be able to manipulate gene

patents in such a way as to limit competition from other smaller corporations?

Will that industry end up being dominated by a few large, politically well-

connected corporations like Celera and Myriad, or will there be room for start-

up, individual entrepreneurs and small innovative corporations to enter the

market?

Again, defenders of gene patents anticipate that if most gene patents are

overturned by the Supreme Court, the genomic industry may suffer irreparable

damage. Over the long run, would that be good or bad? Will the industry adapt

to this new legal environment? How will the new legal environment affect future

private investment in the genomic industry? Will future Supreme Courts,

legislatures, and/or patent agencies revisit these issues and perhaps reverse these

decisions? Will those decisions be based on credible patentability and social

utility arguments, or will they merely advance the interests of the most powerful

genomic corporations?

Indeed, a substantial portion of the genomic industry’s income is based on

acquiring patents and collecting licensing fees from other competing corporations.

Is that a sustainable business model, or are there other alternatives? Recent

stockholders of Myriad Genetics certainly are not complaining. The company

reported earnings for the third quarter of 2012 of $129.8 million reflecting a 27

percent increase over the same quarter in 2011. Revenue from BRCA Analysis

during this period represented 81 percent of the total revenue for the quarter. The

President and Chief Executive Officer, Peter D. Meldrum, announced a commit-

ment to continued growth in expansion of diagnostics in the United States and

internationally (Myriad Genetics, 2012). From the perspective of the corporation

and its stakeholders this outcome is impressive.

292 World Medical & Health Policy, 5:3

One idealistic alternative to funding the genomic industry via gene patents

would be for either governments or nongovernmental organizations to directly

fund genomic science; that is hire its own genomic researchers, and direct all

discoveries and inventions into the public domain. Or, perhaps governments

might regulate the genomic industry as a public utility. Without getting into the

larger issue of the role of government in science-based industries, it is clear that

given the current state of Western economies, increased public funding for

scientific research and development may be a “hard sell.” So if the genomic

industry does in fact serve the public good, it will probably have to do so without

an endless flow of direct government subsidies.

It is important to note that the Supreme Court will not take into account the

impact that destroying longstanding gene patents will have upon the genomic

industry (Demaine & Fellmeth, 2002, pp. 376�78). “Thousands of patents have been issued to hundreds of universities, companies, and others researchers on

human DNA sequences” (Morgan & Haile, 2010, pp. 1172�73). If a myopic U.S. Supreme Court ultimately rules that BRCA1 and 2 genes, and all (or most) other

genes are not patentable via U.S. law, then what will be the consequences for the

industry? Will genomic corporations like Myriad adapt, diversify, and/or pursue

other ways of funding scientific research, or simply go out of business?

Genomic Medicine

Finally, it is widely acknowledged that the “discoveries of the human genome

are to be used to improve health” (U.S. National Human Research Institute, 2002).

Therefore, the social utility of gene patents is contingent upon the future

development of applications in health care, especially genetic tests and genetic

therapies. So what exactly are the short-term and long-term costs and benefits of

gene patents for genomic medicine?

First, genomic medicine is based on discoveries in genomic science. There

would be no genomic medicine without genomic science. Moreover, in the United

States, since the 1980s, corporations, in general, have made most discoveries and

inventions in science and medicine with the assistance of research grants

provided by the National Science Foundation and the National Institutes of

Health. Gene patents were initially introduced to incentivize pure genomic

science in the hope that they would “pay off” in terms of useful discoveries and

inventions. Thus, genomic medicine is conditioned by advances in diagnosis and

therapeutics. So far, that utility has been limited, primarily, to the area of

diagnostic gene tests. However, Myriad’s BRCA gene test has been challenged

globally for its suboptimal utility and its monopolistic pricing, which critics

directly attribute to the patent institution.

First, let us acknowledge that in the health care industry where price

insensitivity and quality insensitivity are both common, it is difficult to discern

“information” from “marketing.” Therefore we can expect sellers to emphasize

individual and social benefits while downplaying costs. The quality of the BRCA

gene test as a diagnostic tool is proportionate to its ability to pre-symptomatically

Chojnacki and White: The BRCA Gene Patents 293

predict the onset of a breast cancer. Therefore, reliability diminishes in proportion

to interpretative ambiguity, and false positives, and false negatives. French

physicians allege that Myriad’s test can only assess 10�20 percent of potential BRCA1 mutations (Andrews, 2002, p. 804). Moreover, the overall benefit of

Myriad’s pre-symptomatic BRCA gene test is that the presence of the BRCA1 or

BRCA2 genes indicates about a 40�85 percent probability that the patient will develop breast or ovarian cancer over the course of her lifetime. However, only a

small percentage of all breast cancers involve the two known BRCA genes, which

suggests that either there are either other unknown genetic causes (BRCA3, 4, 5,

etc.), and/or unknown environmental causes. So the mere fact that a patient tests

negative for BRCA1 and 2 does not necessarily indicate that she will not develop

breast cancer during her lifetime.

Diagnostic tests for the BRCA genes do contribute to a growing baseline of

information which may be helpful in deciding among the possible interventions

including: undergoing immediate medical treatment (chemo and/or radiation),

forgoing medical treatment, or delaying medical treatment. Many physicians

respond to a positive BRCA test by increasing the level and frequency of

screening to detect cancer in the early stages. However, those technologies are not

only costly, but they also carry with them serious long-term side effects.

However, the primary therapeutic strategy associated with BRCA testing has

been that patients who test positive get prophylactic mastectomies and/or

ovariectomies.

The overall social utility of Myriad’s BRCA gene test is also counter balanced

by the monopolistic pricing of the test and Myriad’s insistence that its own U.S.

laboratory conduct the test. Indeed, the BRCA tests are so expensive (around

$3,000) that many private insurance companies (in the United States) and

government programs (United States, Europe, Canada, and Australia) refuse to

pay for those tests, and only a few private patients are willing or able to pay out-

of-pocket. Indeed, 17 laboratories in Europe are still performing diagnostic tests

in violation of Myriad’s patents (Lecrubier, 2002, p. 1120).

In Great Britain, Myriad’s patents inspired organized resistance from British

scientists, health care professionals, and breast cancer patients (Parthasarathy,

2005, p. 236). In Canada, organized response to the BRCA patents was mounted

at the provincial level. In Ontario, the response endorsed by the National

Healthcare System was to ignore Myriad’s patent claims. Diagnostic testing for

breast and ovarian cancers in British Columbia and Quebec ceased while options

were considered. Australia initially ignored Myriad’s patent rights. However, in

2002 Myriad granted an Australian biotechnology company an exclusive right to

conduct diagnostic testing for BRCA1 and BRCA2 for Australia and New Zealand

(Paradise, 2004). In addition, as noted earlier in this article, Australian courts

upheld patentability of BRCA1 in February 2013 ruling in opposition to a suit

brought by a patient advocacy group and breast cancer survivor (Simmones &

Wickham, 2012).

Critics argue that patents on genetic tests undermine the self-corrective

function of medicine by inhibiting other researchers from modifying or replacing

294 World Medical & Health Policy, 5:3

Myriad’s diagnostic tests. First, because Myriad also held patents on both the

BRCA1 and BRCA2 genes, it was able to legally “block” other genomic scientists

and corporations from improving upon those tests or developing other more

reliable gene tests. Myriad aggressively enforced its patent rights when it began

diagnostic testing in 1998 by sending “cease and desist” letters to many

competing laboratories already performing diagnostic tests for breast cancer. In

fact, Myriad was also the first corporation to sue a university to insure

enforcement of its monopolistic control of testing (Gold & Carbone, 2010, p. S42).

Myriad’s patents made it difficult to negotiate mutually acceptable alternatives

(Paradise, 2004). Once the BRCA gene test was patented, there was little incentive

for Myriad to improve the quality of that test. There is also that lingering question

of how the gene patents for BRCA1 and 2 will affect the future development of

gene tests for BRCA3, 4, and 5 … ? Would Myriad’s gene and diagnostic test

patents create a “patent thicket” that discourages rather than encourages the

future development of gene therapies? However, some scholars acknowledge that

the degree to which Myriad has been actively thwarting other researchers is itself

complex and difficult to establish (Carbone et al., 2010, p. 785).

There is an overlapping consensus among health care policy analysts that a

“good” health care system provides universal access to high quality health care at

a reasonable cost. Given the enormous costs associated with applied genomic

medicine, critics might doubt the future potential for positive utility ratios. Any

beneficiaries of genomic medicine will be limited to patients residing in nations

that have well-developed health care systems (United States, European Union,

Canada, Japan, Australia, etc.). Within those nations, access will be greater in

urban than rural areas. However, not all health care systems in the developed

world will be willing to provide expensive, patent-protected genetic tests and

therapies. Highly socialized health care systems in England and Canada routinely

refuse to pay for expensive, high-tech health care.

If the long-term utility of genomic science and the genomic industry are,

ultimately, contingent upon applications in genomic medicine, then one might

question the long-term consequences of continuing to invest in an ever-growing

number of expensive diagnostic tests for genetic diseases. So far, genetics tests

have been of variable reliability and expensive. Gene tests that are protected by

multiple compound gene patents are also immune from external scientific

scrutiny, and prohibitively expensive. Critics doubt whether gene patents and/or

gene test patents undermine the future development of more reliable tests. If and

when more useful genomic tests and genomic therapies are developed, there is

always the question of whether individual patients, private health insurance

companies, and/or socialized health care systems will be willing and/or able to

afford to pay monopolistic prices for those therapies? Finally, after the patents

expire on genetic tests and therapies, one might question whether genomic

corporations and/or governments will be willing to continue to provide those

less lucrative “generic” tests and therapies?

If and when genomic scientists develop genomic therapies, genomic medicine

will certainly have to employ an army of technically trained providers. Training

Chojnacki and White: The BRCA Gene Patents 295

these providers will require the expenditure of large quantities of time, energy,

and resources with no guarantee that these expenditures will “pay off” in terms

of improved health care. How will governmentally enforced wage and/or price

controls affect the availability of these downstream jobs?

Finally, it is important to acknowledge that since the 1980s there has been a

substantial body of scholarly literature that questions the social utility of the

growing number of diagnostic tests that have emerged out of the genomic

revolution (Nelkin & Tancredi, 1989).

So although defenders of gene tests, especially corporate CEOs of genomic

corporations, assure us that that a flood of new therapies are in the pipeline, those

therapies remain (for the most part) elusive. If and when those therapies do

arrive, scholars will no doubt debate the access, quality, and costs of those

therapies. In sum, the questions of whether patents advance or impede the future

development of genomic medicine and whether genomic medicine really

advances national or global health care involves enormously complex utility

ratios.

Conclusion

Since the 1980s, gene patents have served as the primary mechanism for

financing genomic science, the genomic industry, and genomic medicine. One of

the purposes of this essay has been to examine some of the arguments that have

emerged for and against this “one-size-fits-all” mechanism. It is always tempting

to follow the path of other scholars and argue that the BRCA gene patents are

either “justified” or “not justified” based on either patentability or social utility

arguments. However, based on this “bird’s-eye view,” it is not at all obvious

whether (1) the BRCA gene patents are consistent with internationally recognized

patentability criteria nor (2) the BRCA gene patents are worth the time, effort,

and resources already expended.

Patentability arguments invariably invoke highly debatable metaphysical

assumptions and arcane legal distinctions between genetic material versus

genetic information and between natural objects (and processes) versus inven-

tions. The impending U.S. Supreme Court decision will almost certainly

gloss over subtle differences between the patentability of different genetic

technologies. It may even destroy genomic science, the genomic industry, and

genomic medicine. Indeed, the very fact that a relatively narrow U.S. Supreme

Court decision concerning the patentability of genes has the potential to upend

the entire genomic revolution suggests that there is something fundamentally

amiss.

Social utility arguments for and against gene patents have also generated a

lot of irreconcilable debate, with little consensus within or between nations. Some

stakeholders (genomic researchers, genomic corporations, genomic health care

providers, and patients) benefit from gene patents while some do not. Future

stakeholders may or may not benefit from gene patents. Of course some nations

no doubt benefit from gene patents, while most do not. All of this suggests that

296 World Medical & Health Policy, 5:3

the costs and benefits of gene patents involve infinite complexity and endless

political activity.

Despite these mind-boggling complexities, many critics of gene patents agree

with Lauer that the gene patent mechanism can be tweaked and that the

“ultimate goal should be to narrowly tailor the law in order to counteract the

disparate effects that gene patents have on different types of scientific research”

(2011, p. 198). Others follow Johnston and Wasunna’s nuanced, but nonetheless

optimistic, conclusion that “patents are not always the optimal tool for encourag-

ing biomedical innovation …” (Johnston & Wasunna, 2007, p. S30) But, given the

open-ended nature of patentability and social utility arguments, it is hard to be

even modestly optimistic.

We really should not be surprised by the controversy raised by the BRCA

gene patents and the BRCA gene tests. The laws governing “intellectual property”

have always been controversial, and subject to global debate. Why would gene

patents be any different? The social utility of all expensive, allopathic, high-tech

diagnostic tools and therapies has also been subject to debate. How much

biomedical research should be expended on expensive, high-tech allopathic

treatments, versus preventative medicine? There are also the omnipresent

questions of political philosophy. What role should national governments play in

funding scientific research? How much should corporations be regulated by

national governments? What role should governments play in providing health

care?

The common denominator between arguments based on patentability and

utility is an underlying quest for “one-size-fits-all” political solutions. However,

as Lauer observes, “… a one-size-fits-all solution—all gene patents are allowed or

no gene patents are allowed—is not the best way to resolve the current debate

about gene patenting” (2011, p. 185). Let us take that one step further. Perhaps we

ought to be skeptical of all “one-size-fits-all” public policy solutions.

Since the 1980s, this “one-size-fits-all” approach to public policy has also led

to the widespread pursuit of scientific patents by colleges and universities and

the merging of public and private research funds. As Myriad Genetics anxiously

awaits a Supreme Court decision that will, most likely, undermine (if not destroy)

its current business model, other colleges and universities (and private investors)

might think twice about investing in scientific patents that are perpetually

vulnerable to outside legal and political interference. Moreover, the myopic

perpetuation of “one-size-fits-all” gene patents has also impeded the exploration

of other less politically charged licensing models such as: patent pools, clearing-

houses, open-source models, and liability regimes (Van Overwalle, 2009).

In the final analysis it is important to acknowledge that “patents are not only

legal documents and technical descriptions, but political tools as well”

(Parthasarathy, 2005, p. 235). Some nations, such as the United States, grant

patent-holders, relatively unencumbered discretion in terms of exercising exclu-

sionary rights and/or setting licensing fees, while European nations and Canada

tend to limit both. Therefore, in response to internal and external political

pressures, most nations place a variety of legal provisos and restrictions on gene

Chojnacki and White: The BRCA Gene Patents 297

patents. The most common restrictions include restricting the right of gene

patent-holders to exclude competing researchers, primary research scientists,

and/or health care providers. Many nations also enforce price controls on

licensing fees charged by gene patent holders. Consequently, there is a lot of

international dispute over patents, as inventions patented in one nation may (or

may not) be recognized by other nations. Most nations are not anxious to start a

“trade war” with the United States over gene patents, as other patent-dependent

industries might be put at risk.

Interminable global debates over the patentability of genes and the social

utility of gene patents clearly indicate that it is time to explore alternative funding

mechanisms for genomic science, the genomic industry, and genomic medicine.

However, let us not merely replace one “one-size-fits-all” mechanism with

another. Perhaps it is time to recognize a larger truism; namely, “one size does not

fit all.”

Bonnie Chojnacki, B.A. (philosophy), M.L.I.S., is an Assistant Professor of

Bibliography at The University of Akron in Akron, Ohio. Ronald F. White, Ph.D., is a Professor of Philosophy at the College of Mount St.

Joseph in Cincinnati, Ohio.

Notes

On July 8, 2012, Ronald F. White presented an earlier draft of this article,

“Gene Patents and the Future of Genomic Science and the Genomic Industry,” at

the International Political Science Association Meeting in Madrid, Spain. The

panel was titled the Human Genome and Politics. Bonnie Chojnacki served as

commentator.

The authors report no conflict of interests.

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