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Many policies governing biobanks revolve around ownership and control of the materials and information in them. Those who manage biobanks may be tempted to seek the broadest legal rights possible over material and data. However, we suggest that even if ownership and control were clearly defined by the law and readily obtained by biobanks, how legal rights are used in practice matters as much or more than the rules for ownership. We draw lessons from cases in genetic testing where the use or assertion of legal rights led to preventable controversy and suboptimal outcomes. In the cases we describe, the attempt to acquire and exercise intellectual property rights antagonized and alienated stakeholders, whom we define broadly to include the donors, patients, doctors, research institutions, health care providers, governments, and citizens with an interest in research and its outcomes.1 By analogy, even if biobanks could acquire expansive and clear property rights over materials and data, biobanks that want to maintain productive relationships with stakeholders must not lose the trust of those who contribute material or others with an interest in research.
Our analogy to genetic testing is instructive for biobanks, which we define here as institutions that maintain collections of genetic material for use in research.2 Biobanks include tissue collections managed by academic institutions,3 government agencies,4 and private, nonprofit institutions5 as well as private, commercial entities.6 Some biobanks are organized as private-public partnerships.7 The lessons emerging from clinical testing of patented genes may be even more relevant for biobanks with commercial interests than for academic and nonprofit biobanks precisely because of the salience and complexity of public-private interactions.8
However, biobanks require a source for materials and data. People’s willingness to provide those materials and data depends in part on individuals’ and the public’s trust in biobanks. To build and maintain trust, researchers and research institutions must take stakeholders’ concerns into account when making important decisions.9 Biobanks would do well to consider how they will interact with those who have an interest in research and its outcomes, particularly those who provide or use tissue samples.
The laws and policies governing biobanks’ physical and intellectual property holdings differ among jurisdictions, and commentators have already described what legal rights biobanks may be able to claim over materials and data.10 Potential legal claims covering genetic and genomic material include property rights over samples,11 associated patents, and other intellectual property.12 Some rights may also attach to information in databases constructed and maintained by biobanks.13 Biobanks might also negotiate contracts with those who provide samples.14 Although we encourage biobanks to consult with stakeholders regardless of how samples and data are controlled, we focus on physical samples and associated intellectual property rights.
In the United States, case law has been especially important in discussion of what rights biobanks might have. Commentators interpret Moore v. Regents of the University of California, Washington University v. Catalona, and Greenberg v. Miami Children’s Hospital to mean that individuals who provide samples are less likely to retain ownership of samples than the institutions that collect them.15 In Moore, the court found that granting ownership rights to those who provided samples would hinder research but did not object when the researchers who obtained the samples used them in work that led to a granted patent.16 Additionally, in Washington University v. Catalona, the court relied in part on the informed consent documentation to hold that sample donors did not retain ownership in their tissue and that Washington University owned the samples.17 The Greenberg court similarly found that tissue donors had no title to the material they donated and that there was nothing legally objectionable per se about a researcher’s use of the samples to develop a diagnostic test and seek patents.18 If the facts were somewhat different, however, an American court might significantly depart from the reasoning in these cases to grant some property rights to those who provide tissue samples, and biobanks that ignore this possibility are vulnerable to future legal action should case law change. However, we do not focus on that (thus far) hypothetical scenario here. Regardless of how case law evolves, we suggest that biobanks should not use legal tools to avoid consulting stakeholders. Rather, legal tools should be part of ongoing consultation with those who provide tissue samples and use the results of research.
We illustrate our point by reviewing the history of two controversies that arose from the exercise of patent rights over genes involved in two conditions: Canavan disease and inherited breast and ovarian cancer. In both cases, using intellectual property rights to force others’ hands caused problems for the actors holding the patents. We argue that these events harmed the interests of the patent-holders as well as those seeking genetic tests. In the first case, discussed below, Miami Children’s Hospital (“MCH”) decided to patent and to impose restrictive licensing terms on genetic testing for Canavan disease without notifying the families whose tissue samples made developing the test possible. This led to controversy, ill will, and litigation.
In our second illustrative case, Myriad Genetics adopted a business model based on patenting sequences and mutations of two genes, BRCA1 and BRCA2, associated with inherited risk of breast and ovarian cancer. Myriad’s business model required initial testing in any given family to be performed at their laboratories in Salt Lake City. This model encountered resistance in the United States, but eventually prevailed. Outside the United States, however, Myriad’s business model failed in the face of public health systems already providing genetic testing services in public facilities. Myriad’s relationships with international scientists and policymakers were seriously damaged, and its foreign markets in Canada and Europe were diminished.
Both MCH and Myriad Genetics failed to consult key stakeholders and used patents to threaten them; potential collaborators became antagonists who pushed back. The result was a retreat for MCH and loss of foreign markets for Myriad.
The lessons for biobanks arise by analogy. Neither MCH nor Myriad is a biobank, and they held patents that biobanks might not hold. However, like biobanks, they needed to build trust and productive collaborations with stakeholders, especially those who provide samples and use research’s end products. Blindly asserting property rights prevented MCH and Myriad from establishing the requisite relationships. As MCH and Myriad discovered, not appreciating, engaging, and incorporating the views of powerful and important constituencies can have dire consequences. Thus, to avoid similarly undesirable outcomes, biobanks should not only consider when, whether, and how to seek and exercise legal rights, but also the rights and interests of stakeholders. They should consider bringing donor and user constituencies directly into the decision-making process in a transparent and credible way.
Canavan disease is a rare but deadly neurodegenerative illness. Those with the disease typically die before adolescence and treatment is only palliative, not curative.19 Parents who have had one child with Canavan disease have a one in four chance of having another child with Canavan disease.20 Before discovery of the genetic mutations associated with Canavan disease, tests to make a diagnosis or to assess the risk of having an affected child were unreliable.21
After having two children with Canavan disease, Daniel and Deborah Greenberg of Chicago encouraged Dr. Reuben Matalon to search for the genetic basis of the disease.22 In the early to mid-1980s, they and other families with affected children, along with a nonprofit patient advocacy group (the National Tay-Sachs and Allied Diseases Association, or NTSAD), provided Dr. Matalon with tissue samples and clinical data from living and deceased children.23 Later, the Canavan Foundation, the United Leukodystrophy Foundation, and Dor Yeshorim, a Jewish organization that offers genetic testing, also contributed samples and funding.24 Dr. Matalon was recruited from Chicago to MCH, where he and fellow researchers found and sequenced the ASPA gene, which encodes a crucial enzyme that fails to function normally in individuals with Canavan disease. If a child has two mutated copies of the ASPA gene, they will develop Canavan disease, while individuals with one copy are carriers.25 By discovering the mutations associated with Canavan disease, Dr. Matalon provided the requisite information for a DNA-based test. The ASPA mutation test made it possible to make a diagnosis in affected children, to test embryos before implantation, and to identify individuals who carried one copy of a mutated ASPA gene and could have an affected child if their mate was also a carrier.26
In 1998, the American College of Obstetricians and Gynecologists (“ACOG”) recommended that, prior to conception, obstetricians and gynecologists offer Canavan genetic testing to all couples, if at least one prospective parent were of Ashkenazi Jewish descent. If both partners carried APSA mutations, then obstetricians and gynecologists should offer prenatal diagnosis.27 Within two weeks of the ACOG’s decision, MCH announced that its affiliate the Miami Children’s Hospital Research Institute (“MCHRI”) had been granted a patent on the gene and its mutations. MCH would not allow the unlicensed use of the patented genetic sequence for testing purposes.28 Having thought that Dr. Matalon’s work was their best and only hope, the families who had provided samples were stunned. As Daniel Greenberg told Lucinda Hahn of Chicago magazine, “[F]or [Dr. Matalon] to turn around and commercialize the gene, that to me is a desecration of all of the good that came out of [our children’s] lives.”29
Negotiations failed to resolve the acrimony among donors, researchers, organizations involved in testing and MCH. MCH initially proposed that it would license the patents, charge a royalty for each test, and limit how many tests academic and nonprofit laboratories could perform. The constituencies were concerned about access to testing, in particular how the proposed conditions would disrupt the arrangements on which the Ashkenazi Jewish populations most affected by Canavan disease depended for testing and screening for Canavan disease and other conditions. The Canavan Foundation, NTSAD, the National Foundation for Jewish Genetic Diseases, and the Canavan Research Fund formed the Canavan Disease Screening Consortium and approached MCH. The Foundation asked MCH to fund education and outreach and to provide financial assistance for those who could not afford the test.30 The Canavan Foundation, Dor Yeshorim, NTSAD, and three of the families that had contributed samples and data to the research eventually sued MCH, MCHRI, and Dr. Reuben Matalon on several legal grounds: lack of informed consent, breach of fiduciary duty, unjust enrichment, fraudulent concealment, conversion, and misappropriation of trade secrets.31 A judge accepted the defendants’ motion to dismiss most counts but retained the plaintiffs’ charge of unjust enrichment.32 The parties settled the suit out of court on confidential terms. According to a joint press release:
Miami Children’s Hospital will continue to license and collect royalty fees for clinical testing for the Canavan gene mutation. The Agreement also allows license-free use of the Canavan gene in research to cure Canavan disease, including in gene therapy research, genetic testing in pure research, and in mice used to research Canavan disease.33
Although MCH’s patent was never challenged per se and a judge dismissed most of the charges against it, the incident damaged the reputation of MCH and Dr. Matalon among Ashkenazi Jewish constituencies and among clinicians. Fundraising for the hospital that year cannot have benefitted from negative media coverage. In a story in the Miami Herald, for example, MCH’s chief of medical staff said, “[T]hese people [who donated materials for research] … shouldn’t be complaining.”34 Dr. Matalon remains an expert in Canavan disease, but he is also a teaching case for how a scientist-clinician who chooses to patent and license a disease gene and its mutations should not interact with stakeholders.35
Myriad Genetics, a Utah-based biotechnology company, sailed into a policy storm in 1996 when it launched a new genetic test to identify those at risk in families with mutations associated with breast and ovarian cancer. After a hotly contested race between 1990 and 1994 to identify and sequence the BRCA1 and BRCA2 genes associated with inherited risk for breast and ovarian cancer, Myriad published the sequences and mutation details in Science37 and Nature Genetics.38 Myriad eventually secured patent rights over BRCA1 and BRCA2 and diagnostic testing for mutations in these genes in the United States, Europe, Canada, Australia, Japan and New Zealand.39 However, Myriad ultimately lost most of its international markets, in large part due to failures in communication with key stakeholders.
Armed with its patents, Myriad first introduced the test for breast and ovarian cancer mutations in the United States in 1996.40 Like many other biotechnology companies, Myriad planned to secure patents and then enforce them to become the sole provider of services. In Myriad’s case, its monopoly on genetic testing would fund drug discovery and clinical trials of therapeutics, which required longer-term investments but promised potentially higher rates of return. Myriad’s larger goal was to be a leading biopharmaceutical diagnostic company that linked gene discovery to therapeutics.41
Following this business model, Myriad became the dominant provider of BRCA testing in the United States but only did so at a significant cost to its image and reputation. Commercialization of the test in the United States began with controversy. There was great distrust among the scientists involved in the fierce race to sequence the genes and even greater suspicion arose when Myriad filed a patent application for one of the genes just one day before another team published its results in the preeminent science journal, Nature.42 In addition, Myriad’s government collaborators were not initially included on the patent applications.43 Many scientists, ethicists and religious groups also opposed the idea of patenting human genes as they considered these to be non-patentable products of nature.44
Once Myriad had secured its patents, its business model caused consternation in some quarters. In order to clear the market for commercial testing, Myriad sent out cease and desist letters to laboratories it believed were performing BRCA genetic testing. Consequently, clinical researchers feared that Myriad would also seek to shut down ongoing research on BRCA1 and BRCA2. Although Myriad did not want to want to hinder research in the process of clearing the market of competing services, it gave researchers no clear signal of its intentions. The fact that the University of Pennsylvania’s laboratory received a cease-and-desist letter, and became the target of litigation, was especially troubling.45 The combination of the contentious scientific race for BRCA1 and BRCA2, Myriad’s unclear stance on permitted research, and its aggressive patent enforcement policy produced a lingering distrust of the company.46 Clinical geneticists were also concerned that Myriad was advertising its services directly to consumers, who might needlessly be tested.47
Its difficult relationships with stakeholders delayed but did not stop Myriad from clearing the American market of competitors. The story was vastly different when Myriad attempted to export its business model to Canada, Europe, and Australia. Outside the United States, Myriad identified an exclusive licensee in each country or region to market the tests. The licenses required that licensees direct proband testing, the initial full-sequence testing of a family member with breast or ovarian cancer, to Myriad’s Utah laboratory. Once the BRCA1 or 2 mutation was identified in that family, the licensee could perform or sublicense the less expensive single-mutation follow-up tests to identify other potentially affected family members. Most agreements made Myriad responsible for patent enforcement.48
In Canada, Myriad confronted a publicly funded health care system that was still developing a policy for managing diagnostic genetic testing. Armed with its Canadian patents, Myriad Genetics entered into an exclusive license agreement with MDS Laboratories.49 At the same time, using different methods, some provinces were offering or paying for BRCA1 and BRCA2 genetic tests on a research basis. The Hereditary Cancer Program at the British Columbia Cancer Agency and provincial government laboratories in Alberta, Manitoba, Ontario and Quebec, for example, offered tests to a limited number of patients. Provincial health systems tested patients with an early age of onset for the disease, a strong family history of multiple cases of cancer, or ethnic background correlating with high rates of breast and ovarian cancer. In addition to testing, provincial health systems provided genetic counseling, follow-up monitoring, and, where available, treatment. Thus, Myriad’s licensee MDS threatened to disrupt ongoing testing services and to increase costs.50
When MDS and Myriad Genetics first approached the provinces, officials in Ontario sought advice from the policy unit of the province’s Ministry of Health and Long Term Care. The policy unit took months to evaluate the options. Losing patience, Myriad sent cease and desist letters to Ontario as well as Quebec, Alberta, and British Columbia in 2001, provoking a political backlash from individuals who otherwise supported strong intellectual property rights. Provincial and then national Canadian politicians lined up to oppose Myriad. The political tension increased after Myriad brought several threatening letters to a November 2001 meeting with Ontario’s Minister of Health, Tony Clement. Paul Celluci, the United States’ Ambassador to Canada, threatened trade sanctions. United States Senator Orrin Hatch indicated he had asked the United States International Trade Representative to make Myriad’s BRCA patent case a “top priority.” The Biotechnology Industry Organization also threatened to move its upcoming annual meeting away from Toronto.51 After what it viewed as fruitless negotiations, Myriad abandoned, for the most part, the Canadian market, and most provinces continued to ignore the Myriad patents. Myriad never sued for patent infringement and the other threats never eventuated. Overall, Myriad expended substantial administrative resources, received significant negative media coverage (see below), and lost potential customers and research collaborators. Myriad could at best claim a lesson learned.52
In Europe, Myriad’s business model was only marginally more successful than it was in Canada, and Myriad’s understanding of the European policy context was no better. Part of that context was a long-standing European controversy over gene patents.53 Myriad first approached the European market at the end of October 1998. At the time, Myriad had angered European researchers by submitting a patent application for BRCA2 the day before the British researcher Mike Stratton published the gene’s sequence in Nature.54 To soothe tensions, Myriad invited researchers to its Salt Lake City laboratory to discuss licensing options. Myriad later approached one of the leading French researchers on BRCA1, Dominique Stoppa-Lyonnet of the Institut Curie, about the possibility of having the Institut Curie become Myriad’s French licensee. However, Stoppa-Lyonnet already mistrusted Myriad because of her previous concern that the company would prevent the Institut Curie from using its own internally developed BRCA test. She did not respond to Myriad’s offer and joined other French researchers and laboratories in opposing Myriad’s efforts in Europe.55
At this time, the French Ministry of Health examined diagnostic testing in France. Stoppa-Lyonnet largely set the tone of these consultations. As a result, the Ministry of Health and the Ministry of Research discussed strengthening French clinics’ position by supporting opposition proceedings at the European Patent Office against Myriad’s BRCA patents.56 The Institut Curie and two other clinics filed the petition for patent opposition.57 While the ministries offered public approval of the opposition, the government did not participate directly in it.58 However, Myriad misread the meaning of these actions. In European patent practice, opposition procedures signal a negotiating position. In this case, the opposition was a signal to Myriad that it should negotiate with French clinics to integrate smoothly BRCA1 and BRCA2 genetic testing into clinical care in France.59 Myriad misinterpreted the signal.
One week after filing the opposition proceedings, the French Minister of Health called a meeting with Myriad. Myriad failed to understand that the French government had no control over the clinics and offered the government licenses for French public laboratories to conduct testing. After elections in June 2002, a Gaullist government replaced the previous Socialist one. Myriad received no further word and interpreted the silence as an unwillingness to negotiate.60
Myriad’s situation in Europe is unclear. The opposition proceedings substantially reduced the scope of Myriad’s patents. However, the European Patent Office’s Board of Appeals announced in November 2008 that it had restored some of Myriad’s patent claims. The exact scope of the restored claims will only be determined when the Board releases its formal decision.61 Myriad must also contend with changes to European states’ laws that were passed partly in response to the debate over BRCA1 and BRCA2 testing. Both France and Belgium approved laws that listed diagnostic use as a criterion for government compulsory licensing authority.62 Neither the European Patent Office nor future legislatures can alter the ill will that many European governments, scientists, and doctors feel toward Myriad. This ill will translates into lost European business for Myriad.
As biobanks consider the consequences of aggressive legal tactics, they should note how the media’s coverage of Myriad Genetic correlated with the company’s international difficulties. Media coverage both shapes and reflects public opinion. Media accounts bear directly on the public trust that is so crucial to biobanks’ long-term viability. Media coverage also plays a role in framing social controversies, such as the ones that erupted over genetically modified food and stem cell research.63 In the case of Myriad, especially in Canada, political opposition to Myriad’s gene patents was widely covered. The negative publicity continued as the company interacted with the government, found itself in a hostile policy environment, and saw its interactions with its customers sour. The public relations disaster that Myriad faced is relevant for biobanks.64 Like Myriad, a biobank could become the target of negative publicity, which in turn could reduce public trust in the biobank and lead to fewer people being willing to provide tissue samples.
To understand our concerns, biobanks should recall the early 2000s, when the Myriad controversy was at its peak. The North American and European public was already skeptical of biotechnology’s risks and benefits and generally opposed to patenting human genes. According to many lay people’s intuition, genes are natural parts of the human body and thus not “inventions” that patents should protect.65 Even among some scientists, patenting genes is a dubious practice. As biology Professor Jonathan King told The New York Times, “The notion that some company has a monopoly on my genes is like claiming ownership of the sea.”66 By aggressively asserting its right to patent and control BRCA testing, Myriad became the poster child for gene patenting controversies.67
While it is difficult to gauge the exact impact of media coverage on policymakers and politicians, there was certainly a correlation between the policy responses to Myriad and both the extent and tone of concurrent media coverage.68 Early stories in the United States about the Myriad BRCA patents focused on the dispute between Myriad and NIH researchers, who had not initially been included as inventors.69 Negative coverage spilled over to Europe as nongovernmental and patient organizations lined up to lobby the European Parliament, and to oppose Myriad’s patent claims at the European Patent Office (and then the Board of Appeals). The peak coverage occurred in 2001, when Myriad obtained its European patents for BRCA1 and BRCA2 in Europe and initiated enforcement actions in Canada.70 Canadian officials grabbed headlines by pushing back against Myriad. At first, the media presented the MDS-Myriad business relationship as a way for Canadians to increase their access to testing services.71 Coverage of Australia and the UK also highlighted local licensees,72 and coverage in Utah in the United States included more positive comments about Myriad than elsewhere because of the company’s local affiliation.73 The fact that Myriad received some positive coverage suggests that the negative shift was not inevitable; Myriad might have worked with local companies and regulators to build relationships and gain trust. However, once Myriad presented Canadian provincial leaders with aggressive cease and desist letters and threatened the Ontario Minister of Health, the coverage’s tone became overwhelmingly negative. Ontario’s Premier and Health Minister both demonized Myriad as the destroyer of Canada’s public health system.74 A 2002 telephone survey of 1,200 randomly selected Canadians found that “46% … said there are likely more risks than benefits to allowing such [biotechnology] patenting, up from 37% in 2000.”75 The lasting effects of GTG’s play for the Australian market are unknown, but media coverage has thus far been negative.76
The lesson for biobanks is that patent enforcement against disease constituencies or against public health authorities is likely to be highly unpopular and self-destructive when those groups both influence public opinion and control the purse-strings. Biobanks will likely receive negative media coverage if they antagonize potential partners. Negative coverage will translate into a damaged reputation, lost potential for participation and donations, and foregone research and business opportunities.
American universities’ experience in technology transfer provides both negative and positive examples for biobanks. One strikingly negative example of how the ill-considered use of legal tools can backfire is Columbia University’s experience in attempting to extend its patents on the co-transformation technology used to produce many protein therapeutics.77 Two years after its initial patents expired in 2000, Columbia was granted another patent. The university demanded that businesses that had been paying royalties for the 2000 patent also pay royalties for the new patent.78 The affected companies sued,79 and the Public Patent Foundation petitioned for a re-examination of the patent.80 The procedure forced Columbia to sign a covenant not to enforce the 2002 patent’s claims, and created an embarrassing public record.81 Other university-owned patents, including the University of Wisconsin’s human embryonic stem cell patents,82 Harvard and MIT’s NF-kB pathway patent,83 University of Rochester’s patent on inhibition of the COX-2 pathway,84 and Johns Hopkins University’s purified stem cell patent,85 have led to controversy or litigation that has threatened the universities’ beneficent images and consumed financial resources that could have otherwise supported research.
On the other hand, Stanford University and others have shown biobanks how technology transfer can benefit institutions and society. At the individual, institutional level, Stanford University’s licensing of production methods for recombinant DNA illustrates the advantages of collaborative strategies that include legal elements.86 During patent prosecution, Stanford allowed public access to its application material. Before enforcing its patent, Stanford met with potential licensees to discuss what licensing terms would be seen as reasonable. When Stanford could have attempted to extend the duration of its patent protection, it decided that its relationships with licensees were more important and declined to try to extend patent protection.87 By the time the patents expired, Stanford and the University of California system earned $255 million in licensing revenues without seeking licenses from academic researchers. More importantly, recombinant DNA contributed to more than 2,400 products that in turn helped treat heart and lung disease as well as HIV-AIDS.88 At a national level, by releasing policy recommendations that apply to licensing genetic diagnostic technologies, the Association of American Medical Colleges and top universities including Harvard University, the Massachusetts Institute of Technology, and Stanford University have promoted broad dissemination of and access to research tools.89
Biobanks have legal, practical, and moral obligations that require productive relationships with the individuals and communities that provide and use samples. Some of those obligations may overlap. American biobanks may be bound by the Common Rule, which requires informed consent for research involving more than minimum risk to subjects (among other stipulations).90 American biobanks may also have to comply with the Health Insurance Portability and Accountability Act and the subsequently adopted Privacy Rules, which are meant to protect the privacy of medical records.91 Outside the United States, the Tri-Council Policy Statement requires Canadian researchers to obtain “free and informed” consent from participants and to obtain approval from research ethics boards,92 and the Convention on Human Rights and Biomedicine also requires researchers in affected European countries to obtain “free and informed consent” from research participants.93 Other intergovernmental and non-governmental organizations have adopted additional guidelines.94 These regulations are valuable in that they emphasize obtaining research participants’ informed consent, but mere compliance with regulations is insufficient for an institution’s long-term success.95 The Nuremberg Code and the Declaration of Helsinki’s prohibition of “the inhumane exploitation of individuals in research,” of course, remains a bedrock of bioethics and research ethics.96
The success of biobanks fundamentally depends on their earning the trust and good will of stakeholders. Being trustworthy in the public’s eye means respecting the rights and interests of those who use and provide tissue samples.97 Disputes with constituency groups of affected individuals, their families, or advocates for a cure undermine trust and give rise to negative publicity. A significant body of research has shown that when public sector researchers and institutions pursue commercial gain, public trust of researchers, institutions, and the research itself significantly diminishes.98 As exemplified by the stories of Myriad and MCH, patenting gene sequences and then seeking what others see as exorbitant and restrictive licensing deals can lead outsiders to doubt an organization’s commitment to the public good.
Biobanks’ most obvious and practical need is access to samples, which may come from individuals with diseases or advocacy groups that can assist in collection. As MCH discovered, if individuals or groups feel that their contributions to research and commercialization are not recognized, they lose trust in researchers and institutions. MCH may have believed it was less dependent on cooperation from tissue donors once its researchers found the gene. A similar decision to ignore donors’ concerns could cripple a biobank that continually collects new samples. This is especially so because the constituencies of many biobanks are much broader than a single disease group and support a much broader base of researchers and research programs.99 Alienated constituencies are unlikely to provide samples. Moreover, biobanks have a moral obligation to honor the autonomy of donors, meaning donors cannot be treated simply as the objects of research.100 If biobanks are to meet both practical and moral obligations, they must engage research participants when making policy decisions.
As Myriad Genetics learned, engaging those who use the results of research is also important. Having legal rights is very different from using them to force scientists, health care systems, and governments to accept a company’s business model. Leaving researchers uncertain of permitted activity, using the law to clear the market for a technology that potentially conflicts with social values, and not consulting with governments about how to employ a technology are all counter-productive strategies. If interactions between research institutions are to be more fruitful, the different parties involved must listen to and incorporate different concerns into institutional policies and actions.101 Indeed, meaningful consultation with other research institutions, individual researchers, governments, and health care systems is as important as meaningful consultation with patient groups.
One way for biobanks to build cooperative, productive relationships is to systematically involve affected individuals, researchers and advocacy groups in decision making regarding data and materials throughout the research process, rather than limiting donor participation to obtaining informed consent. This emphasis on including stakeholders is part of a much broader policy discussion on making research with public resources transparent, accountable, and democratic.102 Indeed, it is generally recognized that a plurality of views should inform and guide research and institutional policies.103 Biobanks have the opportunity to structure their consultative practices to ensure stakeholders’ views are given real weight in decision-making. The relevant stakeholders can thus be given a meaningful say in matters of ownership, regulation, uses, benefits, and risks, which in other contexts is often sadly lacking.104
The Canavan and BRCA stories are negative examples, but there are also stories in which advocacy groups have been at the table along with research institutions to discuss how to patent and license genes. The University of Michigan, Hospital for Sick Children (Toronto) and University of Toronto, for example, consulted with the Cystic Fibrosis Foundation during discussions on patenting and licensing genetic tests for cystic fibrosis.105 The broadly licensed patents covering genetic testing for cystic fibrosis are now a source of royalties for the research institutions, but they do not appear to have limited clinical access to testing or research.106 In fact, the frequent critic of gene patents, Dr. Debra Leonard, has praised the licensing arrangements for cystic fibrosis.107
Research into Huntington’s Disease has had similar success in incorporating multiple stakeholders. When making decisions about patenting and licensing of its patent portfolio for Huntington’s disease, Massachusetts General Hospital consulted with the Huntington Disease Consortium. The Consortium includes scientists and families who contributed to the research leading to discovery of the affected gene and protein. According to the National Research Council, Massachusetts General Hospital “has not exerted its own patent rights or licensed the patents to others for financial gain.”108 Like the genetic test for cystic fibrosis, the genetic test for Huntington’s disease was quickly integrated into clinical care and seen as a feather in the sponsoring institution’s cap.109 Clearly, discussions of medical research provide a chance for constituency groups to have a positive influence.
In addition to cases where research institutions have collaborated with constituency groups, there are cases where constituency groups have organized their own research programs. The constituency group PXE (pseudoxanthoma elasticum, an inherited disorder) International has provided a model for advocate-organized research by working with other disease-focused groups to establish a sample collection and oversee its use. PXE International typically uses legally binding agreements with researchers to manage intellectual property rights in research. In fact, one of PXE International’s founders is a co-inventor on a key patent and thus represents other affected individuals when deciding how to distribute research benefits.110 Other foundations such as the Michael J. Fox Foundation fund researchers on the condition that they must share data and materials and focus on producing clinical benefits.111 Although this model may not work in all cases, it shows that patients or advocates can have a much more significant role in research than merely consenting to donate tissue.
Undoubtedly one reason that public controversy did not erupt in these cases was that the relevant constituencies were welcomed to the table when decisions affecting them were being made. The success stories above are also notable because they do not include benefit sharing in a financial sense but do include researchers applying for patents. There is nothing mutually exclusive about researchers filing patents applications and institutions subsequently ensuring access to patented technologies to those who provided the requisite material. Questions about allowing access to technology and commercial development cannot be answered with boilerplate protocols, but they can (and should) be discussed early during research. As the Canavan and Myriad controversies and the success stories of CF and Huntington disease illustrate, consultation with affected constituencies and respect for research participants’ interests leads to better outcomes than antagonistic use of legal rights.
Genome-wide association studies as well as large-scale population studies present new challenges to participation models developed for relatively small groups.112 More technological complexity and larger collection size, however, do not dilute the core message from our stories and positive examples. Improving public consultation and using trust models offer biobanks ways to build positive relationships with stakeholders.
Large-scale biobanks face the same basic issue that smaller-scale biobanks face and our stories of Myriad and MCH highlight: fully engaged constituencies support and accelerate research, but alienated constituencies can sour public opinion and reduce research participation. The practical and moral need for public support is even greater for population-wide biobanks that involve a very large number of samples; such biobanks require broader consultation than previous collections.113 Controversy about large-scale genetic studies in Iceland, for example, led 20,000 out of 270,000 eligible people to opt out of research participation. About half of the adult population of Iceland is currently represented in the database, but the database’s future is now uncertain.114 Ruling on a suit against the government, Iceland’s highest court struck down as unconstitutional the Government of Iceland’s agreement with a private company deCODE to construct a database of the entire population.115 According to the court, the authorizing legislation did not sufficiently protect the constitutional right to privacy from harm through the release of a deceased relative’s health information.116 Because deCODE and Iceland’s government did not adequately address these concerns much earlier in the process, despite public criticism,117 useful research that might have been modified to match the public’s views is now stymied.118 Other biobanks should see that obtaining government approval for a socially significant project is not the same as earning wide-spread public support.
Public skepticism toward biobanks is neither confined to Iceland nor immutable in the face of substantive public engagement. As Caulfield and Ries note, depending on exactly what questions are asked, respondents in many countries are wary of allowing researchers to access material through tissue collections. Biobanks do not have compelling reasons to think that they have widespread support for all possible research.119 However, population-based biobanks can garner support and trust if they seek the public’s input and treat it as valuable throughout the research process. Genome Canada provides an excellent example of how to involve the public in science policy. Genome Canada involved the public in discussions of how to manage a hypothetical large-scale biobank.120 In public workshops, lay participants were given information on biobanks.121 They then discussed their concerns in small groups where non-scientists’ views were solicited and treated as seriously as scientists’ views. Subsequently, participants’ views were shared with government agencies and reported in academic literature.122 Although the sessions did generate specific ideas on how to manage property, the more important point for biobanks is that the public could question a biobank’s basic goals, suggest how it could serve societal goals, and know that academics seriously considered their ideas.
One legal framework that we encourage biobanks to consider is the fiduciary trust. In this arrangement, a person who provides tissue also provides the biobank with title to the tissue. The biobank becomes a trustee with a fiduciary duty to use the tissues for the sake of a named beneficiary, which can be the general public.123 Trusts may be especially suited to accommodate the needs of large-scale biobanks because a biobanks organized as a trust can accept heightened ethical obligations toward those who provide samples and dedicate the benefits of research to the public.124 Although there may be specific instances where sharing financial benefits with tissue donors is possible and advisable, we are wary of limiting the discussion of organizing biobanks to how to distribute financial gain. Having access to the medical advances that come out of biobanks, and having a say in what advances researchers pursue, may well be more important benefits than monetary compensation. A biobank organized as a trust would not necessarily prevent researchers from being granted patents on work done with the biobank’s samples. The trust structure could also allow early and open discussion of how research would benefit the public;125 discussion of intellectual property policies could and should be part of those discussions. How exactly a biobank uses the trust model is less important than how well it reflects on the model’s consequences for other stakeholders and how sincerely it seeks those stakeholders’ views.
Recent requirements about data-sharing from the National Institutes of Health in the United States and similar bodies elsewhere, as well as computational advances in analyzing DNA data, may complicate biobanks’ efforts to give donors a say in disposing of data and materials.126 Laws governing privacy and protection of human subjects may also come into play.127 However, biobanks can manage concerns about privacy and anonymity by, among other methods, honestly describing what privacy and anonymity they can promise to participants.128 Biobanks (and stakeholders) can also contribute to policy discussions on data-sharing requirements. Biobanks should enter research collaborations only after they have discussed the ramifications with stakeholders, including public representatives. If biobanks are organized so that they consider the views of outside stakeholders, including representatives of those who provide tissue, then stakeholders will have a say in how biobanks deal with bureaucratic requirements. That collaboration is more important than any specific response to regulations.
However biobanks decide to use legal options, they should be particularly wary of policies that might exclude important constituencies from the research and commercialization process. Instead of using property and intellectual property as fences, biobanks can work with others to open the gates and alter the research landscape. Biobanks should license the use of their data and materials and use legal norms as part of a broader strategy to communicate with potential partners and pursue common goals beneficial to the research institution, industrial partners, and the public.
Biobanks have become increasingly pertinent to research ethics and policy as scientists study ever larger populations and more kinds of tissue with technologies that can process material and data more quickly. Biobanks are critical for innovation in the genomic, medical, agricultural, and even energy sectors. Biobank managers will have to decide how their legal strategies will navigate social, economic, and political constraints. If biobanks approach those constraints thinking that their property rights can be used purely for the gain of the research institution or the investigators who control it, biobanks could easily flounder as Myriad and MCH did. On the other hand, if instead of antagonizing potential partners with legal maneuvers, they actively engage stakeholders and bring them to the table to help decide how samples and information are used, and use the law to enhance collaborations, then biobanks can advance both research and their own interests.
The authors thank Timothy Caulfield (Faculty of Law & School of Public Health, Health Law Institute, University of Alberta), Subhashini Chandrasekharan (Duke Institute for Genome Sciences and Policy), and Lauren Dame (Duke Institute for Genome Sciences and Policy; Duke University School of Law) for reviewing all or portions of previous drafts and directing the authors toward references.
CH, RCD, SC, and LD gratefully acknowledge the support of the National Human Genome Research Institute and the Department of Energy (CEER Grant P50 HG003391, Duke University, Center of Excellence for ELSI Research). RG gratefully acknowledges the support of the Social Sciences and Humanities Research Council.
1For a listing of the different stakeholders in genomic research and discussion of how their interests overlap, see Morris W. Foster & Richard R. Sharp, Share and Share Alike: Deciding How to Distribute the Scientific and Social Benefits of Genomic Data, 8 Nature Rev. Genetics 633, 634–35 (2007).
2For a summary of how various kinds of tissue collections are defined, and the implications of different terminologies, see A. Cambon-Thomsen, E. Rial-Sebbag, & B.M. Knoppers, Trends in Ethical and Legal Frameworks for the Use of Human Biobanks, 30 Eur. Respiratory J. 373, 375–76 (2007). For a summary of tissue collections in the US, see Elisa Eiseman & Susanne B. Haga, Handbook of Human Tissue Sources: A National Resource of Human Tissue Samples 144–159 (1999). For a review of biobanks in Iceland, the U.K., Sweden, and Estonia, see generally Susanne B. Haga & Laura M. Beskow, Ethical, Legal, and Social Implications of Biobanks for Genetic Research, 60 Advances in Genetics 505 (2008) (reviewing ethical, legal, and social issues connected to tissue collections and provides background information on biobanks in Iceland, the U.K., Sweden, and Estonia as they relate to those issues).
3See Eiseman & Haga, supra note 2, at 46–67.
4See id. at 14–46.
5See id. at 67–77.
6See id. at 66–67.
7For an example of how the UK Biobank is organized as a public-private partnership, see David E. Winickoff, Partnership in the U.K. Biobank: A Third Way for Genomic Property, 35 J. L., Med. & Ethics 440, 441 (2007).
8See Subhashini Chandrasekharan, Noah C. Perin, Ilse R. Wiechers, & Robert Cook-Deegan, Public-Private Interactions in Genomic Medicine: Research and Development, in Genomic and Personalized Medicine 434, 435 (Huntington F. Willard & Georffrey S. Ginsburg eds., 2009). See also Cambon-Thomsen, Rial-Sebbag, & Knoppers, supra note 2, at 379.
9See Mairi Levitt & Sue Weldon, A Well Placed Trust?: Public Perceptions of the Governance of DNA Databases, 15 Critical Pub. Health 311, 319–20 (2005).
10For a review of relevant case law in the United States and alternative legal arrangements relevant to many countries, see generally Jasper Bovenberg, Whose Tissue Is It Anyway?, 23 Nature Biotechnology 929 (2005).
11See Jasper A. Bovenberg, Property Rights in Blood, Genes and Data: Naturally Yours? 118–23 (2006).
12See Robert Cook-Deegan, Gene Patents, in From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns 69, 69–70 (Mary Crowley ed., 2008).
13For an explanation of how the European Union’s Database Directive could provide legal protection for collections of genetic and genomic data, see generally Jasper A. Bovenberg, Should Companies Set Up Databases in Europe?, 18 Nature Biotechnology 907 (2000).
14See Bovenberg, supra note 10, at 931–32.
15See, e.g., Radhika Rao, Genes and Spleens: Property, Contract, or Privacy Rights in the Human Body?, 35 J. L., Med. & Ethics 371, 372 (2007). See, e.g., Karen J. Maschke, Biobanks: DNA and Research, in From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns 11, 12 (Mary Crowley ed., 2008).
16Moore v. Regents of the University of California, 793 P.2d 479, 494–96 (Cal. 1990).
17Washington University v. Catalona, 437 F. Supp. 2d 985, 1002 (E.D. Missouri 2006).
18Greenberg v. Miami Children’s Hospital, 264 F. Supp. 2d 1064, 1077 (S.D. Fla. 2003).
19See John R. Moffett, Brian Ross, PEETHAMBARAN Arun, Chikkarthur N. Madhavarao, Aryan M.A. Namboodiri, N-Acetylaspartate in the CNS: From Neurodiagnostics to Neurobiology, 81 Prog. in Neurobiology 89, 105 (2007).
20Canavan disease is caused by a recessive mutation of the ASPA gene. A child inherits one copy of its genes from its father and one copy of its genes from its mother. According to the laws of Mendelian inheritance, an individual has two copies of the ASPA gene. If an individual has one normal copy and one mutant copy, then he or she is known as a carrier because they may have a child with Canavan disease. If a carrier has a child with another carrier, then there is a ¼ chance that the child will have 2 normal copies of the gene, a ½ chance that the child will be a carrier and a ¼ chance that the child will have 2 mutant copies of the gene, meaning that the child will be born with Canavan disease. See Jon F. Merz, Discoveries: Are There Limits on What May Be Patented?, in Who Owns Life? 99, 102 (Arthur Caplan, David Magus, Glenn McGee eds., 2002). See also Online Mendelian Inheritance in Man: Canavan Disease, http://www.ncbi.nlm.nih.gov/entrez/dispomim.cgi?id=271900. (2008).
21See Alessandra Colaianni, Subhashini Chandrasekharan, Robert Cook-Deegan, Impact of Patents and Licensing Practices on Access to Genetic Testing and Carrier Screening for Tay-Sacs and Canavan Disease 5 (2009), available at http://oba.od.nih.gov/oba/SACGHS/Appendix%201%20SACGHS%20Patents%20Consultation%20Draft%20Compendium%20of%20Case%20Studies.pdf.
22Id. at 5. See also Lucinda Hahn, Owning a Piece of Jonathan, Chicago, May 2003, at 83–87, 104–06.
23See Merz, supra note 20, at 102.
24Id. at 109–10.
25See id. at 102. See also Rajinder Kaul, Guang P. Gao, Maria Aloya, Kuppareddi Balamurugan, Arlene Petrosky, Kimberlee Michals, Reuben Matalon, Canavan Disease: Mutations Among Jewish and Non-Jewish Patients, 55 Am. J. Hum. Genetics 34, 39 (1994).
26Reuben Matalon, Kimberlee Michals, & Rajinder Kaul, Canavan Disease: From Spongy Degeneration to Molecular Analysis, 127 J. Pediatrics 511, 515 (1995).
27See ACOG Committee Opinion, Screening for Canavan Disease, No. 212, (November 1998), Committee on Genetics. American College of Obstetricians and Gynecologists, 65 Int’l J. Gynecology & Obstretrics 91, 92 (1999).
28See Merz, supra note 20, at 103. For an example of the cease and desist letter, see Deborah G. Leonard, Patent and Licensing Fundamentals and the Nature of the Access Problem (June 27, 2006), http://oba.od.nih.gov/oba/SACGHS/meetings/June2006/Leonard3.pdf.
29See Hahn, supra note 22, at 83–87, 104–06.
30See Merz, supra note 20, at 103–06.
31Greenberg v. Miami Children’s Hospital, 264 F. Supp. 2d at 1068. See also Mary R. Anderlik & Mark A. Rothstein, Canavan Decision Favors Researchers Over Families, 31 J. L., Med. & Ethics 450, 451–53 (2003).
32Greenberg v. Miami Children’s Hospital, 264 F. Supp. 2d at 1068.
33See Canavan Foundation Press Release Sept. 29, 2003, http://canavanfoundation.org/news/09-03_miami.php.
34Quoted in Merz, supra note 20, at 110.
35The Canavan case was used at Fordham Law School’s course “Technology and Human Rights” in 2002. See Eliot Marshall, Genetic Testing: Famlies Sue Hospital, Scientist for Control of Canavan Gene, (2002), http://www.fordham.edu/law/faculty/patterson/tech&hr/. At the Decade of ELSI Research Conference, Jon F. Merz of the University of Pennsylvania used the story as a case example of how not to conduct research. See The Canavan Case: Bargaining for Benefit and the Financial Windfalls of Genetic Discovery (2001), http://www.bioethics.upenn.edu/prog/ethicsgenes/pdf/merz_ELSI_Session_III.pdf. One of the authors (Robert Cook-Deegan) has used the case in Duke University’s “Responsible Genomics” class since 2003. Matalon is featured in a teaching casebook. See Karen A. Greif & Jon F. Merz, Current Controversies in the Biological Sciences: Case Studies of Policy Challenges from New Technologies 69–76 (2007). The story is also the subject of a comparative case study for the Secretary’s Advisory Committee on Genetics, Health and Society. See Colaianni et al., supra note 21, at 5–8, 14–17.
36The account that follows is based largely on E. Richard Gold & Julia Carbone, Myriad Genetics: In the Eyes of the Policy Storm (September 9, 2008), available at SSRN: http://ssrn.com/abstract=1260098.
37See Yoshio Miki et al., A Strong Candidate for the Breast and Ovarian Cancer Susceptibility Gene BRCA1, 266 Science 66, 67 (1994).
38See S.V. Tavtigian et al., The Complete BRCA2 Gene and Mutations in Chromosome 13q-Linked Kindreds. 12 Nature Genetics 333, 335 (1996).
39See Gold & Carbone, supra note 36, at 10–12.
40See id. at 9.
42See generally Richard Wooster et al., Identification of the Breast Cancer Susceptibility Gene BRCA2, 378 Nature 789 (1995)(describing the location and sequence of BRCA2 and mutations in it). For a description of the dispute within the scientific community, see generally Eliot Marshall, The Battle Over BRCA1 Goes to Court; BRCA2 May Be Next, 278 Science 1874 (1997).
43See Rachel Nowak, NIH in Danger of Losing Out on BRCA1 Patent, 266 Science 209, 209 (1994).
44See Baruch Brody, Intellectual Property and Biotechnology: The European Debate, 17 Kennedy Inst. of Ethics J. 69, 80–81 (2007).
45See Gold & Carbone, supra note 36, at 13.
46Id. at 35–36. See also Robert Cook-Deegan, Christopher deRienzo, Julia Carbone, Subhashini Chandrasekharan, Christopher Heaney, & Christopher Conover, Impact of Patents and Licensing Practices on Access to Genetic Testing for Inherited Susceptibility to Cancer: Comparing Breast and Ovarian Cancers to Colon Cancers, 25–26 (2009), available at http://oba.od.nih.gov/oba/SACGHS/Appendix%201%20SACGHS%20Patents%20Consultation%20Draft%20Compendium%20of%20Case%20Studies.pdf.
47See Gold & Carbone, supra note 36, at 15.
48Id. at 11–2.
49According to this agreement, Myriad would conduct proband sequencing in Utah and leave it to MDS to arrange for individual mutation testing within its own network. See id. at 11.
50Id. at 22.
51None of these threats was carried out, despite Ontario’s refusal to back down. No trade sanctions were imposed or even seriously discussed, and the BIO meeting took place in Toronto in June 2002. See id. at 24–25.
52Id. at 22–29.
53Id. at 29. For a discussion of the debate, see generally Quirin Schiermeier, Germany Gives Green Light to Gene Patents, 407 Nature 934 (2000). See generally Brody, supra note 44 (describing the European debate over moral and ethical implications of gene patenting, and how the European Patent Organization and the European Union were involved in the debate).
54See generally Wooster et al., supra note 42 (describing the location and sequence of BRCA2 and mutations in it). See generally Marshall, supra note 42 (describing the scientific community’s reaction to Myriad’s patent application). See also Shobita Parthasarathy, Building Genetic Medicine: Technology, Breast Cancer, and the Comparative Politics Of Health Care 186 (2007).
55See Gold & Carbone, supra note 36, at 30.
56An opposition procedure is an administrative means to challenge a patent through a tribunal at the EPO. An opposition procedure must be launched within 9 months after the patent is granted. It addresses the concerns of those that challenge the validity of the patent. Under such an opposition procedure, the administrative tribunal can uphold, invalidate or modify an issued patent. See id. at 30.
57See Ministère délégué à l’Enseignement supérieur et à la Recherche, Press Release (Sept. 7, 2001), http://126.96.36.199/discours/2001/myriad2.htm. See also Ministère délégué à la santé “Contestation des brevets de la société Myriads genetics sur le dépistage du cancer du sein,” Press Release (Sept. 6, 2001), http://188.8.131.52/discours/2001/myriad.htm.
58On October 9, 2001, the Assistance Publique–Hôpitaux de Paris, the authority administering Parisian hospitals, and the Institut Gustave Roussy, another clinical laboratory, joined the Institut Curie’s opposition. Once launched, other groups joined in such as groups from the Netherlands and Belgium that included individuals, research institutes, and associations of human geneticists. See Gold & Carbone, supra note 36, at 31.
59See id. at 30.
60Id. at 31.
61See Technical Board of Appeal Maintains Two ‘Myriad/Breast Cancer’ Patents in Limited Form (Nov. 19, 2008), http://www.epo.org/topics/news/2008/20081119.html.
62For the change in France’s compulsory licensing scheme, see Gold & Carbone, supra note 36, at 3. For changes to Belgian law, see Geertrui Van Overwalle, The Implementation of the Biotechnology Directive in Belgium and its After-Effects. The Introduction of a New Research Exemption and a Compulsory Licence for Public Health, 37 International Review of Intellectual Property and Competition Law 889, 908–18 (2006).
63See Toby A. Ten Eyck & Melissa Williment, The National Media and Things Genetic, 25 Science Communication 129, 145–47 (2003). See also Leonie A. Marks, Nicholas Kalaitzandonakes, Lee Wilkins, & Ludmila Zakharova, Mass Media Framing of Biotechnology News, 16 Pub. Understanding of Science 183, 199 (2007). See also Matthew C. Nisbet & Bruce V. Lewenstein, Biotechnology and the American Media: The Policy Process and the Elite Press, 1970 to 1999, 23 Science Comm. 359, 386 (2002).
64The Massachusetts-based Framingham heart study provides an example of how potential research using a large tissue collection can be stymied by public concerns. The Framingham Heart Study has lasted for fifty-two years and resulted in medical and genetic data from 10,000 individuals. When a researcher established a new company that would create a database with that data and sell exclusive access to pharmaceutical companies, individuals who had participated in the study were concerned about the loss of privacy and commercialization of the research. The National Heart, Lung, and Blood Institute also opposed the fact that the business model used exclusive access to government-funded data to generate profits. The company no longer exists. A biobanks that antagonizes individuals who provide tissues or government agencies could experience a similar outcome. See Ronald Rosenberg, Questions Still Linger on Heart Study: Access Private Industry’s Right to Use Publicly Funded Data For Profit Remains at Issue, Boston Globe, February 21, 2001, at D4.
65See Rebecca S. Eisenberg, How Can You Patent Genes? in Who Owns Life? 117, 117 (Arthur Caplan, David Magus, Glenn McGee eds., 2002). Michael Crichton exemplified a layperson’s reaction to patenting genes in an op-ed in the New York Times. See Michael Crichton, Patenting Life, N.Y. Times, Feb. 13, 2007, at A23.
66See Andrew Pollack, Is Everything for Sale? Patenting a Human Gene As if It Were an Invention, N.Y. Times, June 28, 2000, at C1.
67See Timothy Caulfield, Tania Bubela, & C. J. Murdoch, Myriad and the Mass Media: The Covering of a Gene Patent Controversy, 9 Genetics in Med. 850, 853 (2007).
68Id. at 854.
69Id. at 851.
70Id. at 854.
71Id. at 851.
72Id. at 851.
73Id. at 852.
74See Gold & Carbone, supra note 36, at 25–26.
75See Public Opinion Research Into Biotechnology Issues (Dec. 9, 2002), http://www.biostrategy.gc.ca/CMFiles/Wave7_ExecSumE49RXH-922004-8099.pdf.
76See Leo Shanahan, Call to Act on Breast Cancer Test, The Age, Oct. 28, 2008, available at http://www.theage.com.au/national/call-to-act-on-breast-cancer-test-20081027-59th.html; see also Siobhain Ryan, Competition Watchdog ACCC Investigates Genetic Technologies Over Cancer Test Monopoly, The Australian, Oct. 17, 2008, available at http://www.theaustralian.news.com.au/story/0,25197,24508810-23289,00.html; When Law Is Patent Nonsense, The Sydney Morning Herald, Oct. 25, 2008, available at http://www.smh.com.au/news/specials/science/when-law-is-patent-nonsense/2008/10/24/1224351544031.html; Company Seeks to Monopolise Breast Cancer Test, ABC News, Oct. 23, 2008, available at http://www.abc.net.au/news/stories/2008/10/23/2399406.htm.
77Recent Developments: Columbia, Co-Transformation, Commercialization & Controversy, 17 H. J. Law & Tech. 584, 594–98 (2004).
78Id. at 598.
79Id. at 599.
80See Public Patent Foundation, PubPat Scores Another Victory: Columbia University Abandons Assertion of Challenged Cotransformation Patent, http://www.pubpat.org/Axel_Patent_Abandoned.htm (2004).
82See Jeanne F. Loring & Cathryn Campbell, Intellectual Property and Human Embryonic Stem Cell Research, 311 Science 1716, 1717 (2006).
83Ariad v. Eli Lilly, 529 F. Supp. 2d 106, 112–14 (D. Mass 2007).
84University Of Rochester v. G.D. Searle & Co., 358 F.3d 916, 917–19 (Fed. Cir. 2004).
85Johns Hopkins University v. CellPro, 152 F.3d 1342, 1347–53 (Fed. Cir. 1998).
86See Maryann P. Feldman, Alessandra Colaianni,& Connie Kang Liu, Lessons from the Commercialization of the Cohen-Boyer Patents: The Stanford University Licensing Program, in Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices 1797, 1806 (Anatole Krattiger & Richard T. Mahoney eds., 2007), available at http://www.iphandbook.org/handbook/resources_and_tools/Publications/links/ipHandbook%20Volume%202.pdf.
87Id. at 1797–98.
88Id. at 1797, 1806.
89See California Institute of Technology et al., In the Public Interest: Nine Points to Consider in Licensing University Technology 1, http://news-service.stanford.edu/news/2007/march7/gifs/whitepaper.pdf (2007).
90See Robert F. Weir & Robert S. Olick, The Stored Tissue Issue 129–46 (2004).
91Id. at 146–47, 180–81.
92Id. at 115–19.
93Id. at 114.
94See Haga & Beskow, supra note 2, at 509.
95It may be that some of the measures we suggest would require re-contacting participants or obtaining new informed consent. Such interactions with research participants should only occur after a researcher consults with a biobank’s ethics review board and governance structure. As new biobanks are organized, such issues should be discussed before research begins. See Timothy Caulfield et al., Research Ethics Recommendations for Whole-Genome Research: Consensus Statement, 6 PLOS Biology 430, 432 (2008). Neither re-contacting participants nor obtaining new informed consent would preclude simultaneous consultation with stakeholders to assure that new form of research have broad public support, and treating informed consent as an ongoing process could increase people’s trust in research without causing unacceptable harm. See Weir & Olick, supra note 90, at 231–32. Admittedly, re-contacting participants is a contentious issue, as is the question of how much information has to be provided to constitute informed consent. Not all commentators agree on what kind of consent is appropriate for participants in genomic research. For further discussion of current debates, see Thomsen, Rial-Sebbag, & Knoppers, supra note 2, at 376 (2007). For now, an acceptably prudent policy would be re-contact in the context of a governance framework that makes a biobanks accountable to stakeholders. See Caulfield et al., supra note 955, at 432.
96See Cambon-Thomsen, Rial-Sebbag, & Knoppers, supra note 2, at 376 (2007).
97See Timothy Caulfield & Nola M. Ries, Public Opinion, Consent and Population Genetic Biobanks, in Genomics and Public Health: Legal and Socio-Ethical Perspectives, 183, 191–92 (Bartha Maria Knoppers ed., 2007). Those who provide tissue samples may have altruistic intentions, but they also expect some benefit to patients to come out of their action. See Foster & Sharp, supra note 1, at 636.
98See, e.g., Christine R. Critchley, Public Opinion and Trust in Scientists: The Role of the Research Context, and the Perceived Motivation of Stem Cell Researchers, 17 Public Understanding Sci. 309, 321–22 (2008). See, e.g., United Kingdom Research Councils, UK Public Attitudes to Science, 2008: A Survey 30 (2008), available at http://www.rcuk.ac.uk/cmsweb/downloads/rcuk/scisoc/pas08.pdf.
99See Foster & Sharp, supra note 1, at 636.
100See Cambon-Thomsen, Rial-Sebbag, & Knoppers, supra note 2, at 376.
101The International Expert Group on Biotechnology, Innovation and Intellectual Property, Toward a New Era of Intellectual Property: From Confrontation to Negotiation 27 (2008), available at http://www.theinnovationpartnership.org/en/ieg/report/data/ieg/documents/report/TIP_Report_E.pdf.
102See James Wilsdon & Rebecca Willis, See-through Science: Why Public Engagement Needs to Move Upstream 21–22 (2004), available at http://www.demos.co.uk/files/Seethroughsciencefinal.pdf.
103See Edna F. Einsiedel, Public Engagement and Dialogue: A Research Review, in Handbook of Public Communication on Science and Technology 173, 173–74 (Massimiano Bucchi & Brian Trench eds., 2008).
104See Brian Wynne, Public Engagement as a Means of Restoring Public Trust in Science – Hitting the Notes, but Missing the Music?, 9 Community Genetics 211, 214 (2006). See also Wilsdon & Willis, supra note 103, at 17 (2004). See also Tee Rogers-Hayden & Nick Pidgeon, Moving Engagement “Upstream”? Nanotechnologies and the Royal Society and Royal Academy of Engineering’s Inquiry, 16 Public Understanding Sci. 345, 347 (2007).
105See Subhashini Chandrasekharan, Christopher Heaney, Tamara James, Chris Conover, & Robert Cook-Deegan, Impact of Gene Patents and Licensing Practices on Access to Genetic Testing for Cystic Fibrosis, 5–9 (2009), available at http://oba.od.nih.gov/oba/SACGHS/Appendix%201%20SACGHS%20Patents%20Consultation%20Draft%20Compendium%20of%20Case%20Studies.pdf.
106Id. at 20–21.
107See Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) Meeting Transcript, 7 (June 26–27, 2006), http://oba.od.nih.gov/oba/SACGHS/meetings/June2006/transcripts/Patents_Licensing-Leonard.pdf.
108See Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation, National Research Council, Reaping The Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health, 65–67, at 67 (Stephen A. Merrill and & Anne-Marie Mazza, eds., 2006).
109Id. at 67.
110See Sharon F. Terry, Patrick F. Terry, Katherine A. Rauen, Jouni Uitto, & Lionel G Bercovitch, Advocacy Groups as Research Organizations: The PXE International Example, 8 NATURE REV. GENETICS 157, 161 (2007). See also Genetic Alliance Biobank, Executive Summary, Press Release, June 9, 2008, http://www.biobank.org/CMFiles/Executive_Summary_June_200838MCH-6242008-8690.pdf.
111See Joe Nocera, Taking Science Personally, N.Y. TIMES, Nov. 11, 2008, at F1.
112For a review of issues that large-scale population studies raise, see generally Cambon-Thomsen, Rial-Sebbag, & Knoppers, supra note 2. For a discussion of what questions genomic research raises for governance, consent, withdrawal from research, return of results, and public data release, see generally Caulfield et al., supra note 95.
113For more on the importance of broad consultation when making research and health care decisions such as access to genetic testing that affect an entire population, see Bryn Williams-Jones & Michael M. Burgess, Social Contract Theory and Just Decision Making: Lessons from Genetic Testing for the BRCA Mutations, 14 Kennedy Inst. Ethics J. 115, 131–32 (2004).
114See Caulfield & Ries, supra note 95, at 191.
115See Alison Abbott, Icelandic Database Shelved as Court Judges Privacy in Peril, 429 Nature 118, 118 (2004).
116See Ragnhildur Guomundsdottir v. The State of Iceland, 151 Icelandic Supreme Court 5 (2003), http://www.epic.org/privacy/genetic/iceland_decision.pdf.
117See generally Bogi Andersen & Einar Arnason, Iceland’s Database is Ethically Questionable, 318 BMJ 1565 (1999) (charging that the legislation authorizing the database had not been subjected to meaningful review by an independent ethics body, that acceptable consent was not obtained, that participants are not anonymous, and that the public did not sufficiently understand the project for it to proceed).
118See David E. Winickoff, Letter: Health-Information Altruists, 354 New Eng. J. Med. 530, 531 (2006).
119See Caulfield & Ries, supra note 95, at 184–86.
120See Michael Burgess, Kieran O’Dohert & David Secko, Biobanking in British Columbia: Discussions of the Future of Personalized Medicine Through Deliberative Public Engagement, 5 Personalized Med. 285, 292 (2008). See also Samantha MacLean & Michael M. Burgess, Biobanks: Informing the Public Through Expert and Stakeholder Presentations, 16 Health L. Rev. 6, 7 (2008).
121See Burgess, O’Dohert & Secko, supra note 120, at 290.
122Id. at 292–94.
123For an example of how biobanks could organize themselves as charitable trusts and thus allow for greater input from those who provide materials, see David E. Winickoff & Richard N. Winickoff, The Charitable Trust as a Model for Genomic Biobanks, 349 New Eng. J. Med. 1180, 1182–83 (2003). See Karen Gottlieb, Human Biological Samples and the Laws of Property: The Trust as a Model for Biological Repositories, in Stored Tissue Samples: Ethical, Legal, and Public Policy Implications, 182, 192–95 (1998).
124Id. at 192–93.
125See Winickoff & Winickoff, supra note 123, at 1182.
126See Caulfield et al., supra note 95, at 434, 435 notes 30–32.
127See Weir & Olick, supra note 90, at 146–47, 180–81.
128See Caulfield et al., supra note 95, at 431–42.