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Cancer Risk Assessment Starting a family. Why Genetic Screening and Testing? We provide resources to help educate your patients about Myriad products. We offer a comprehensive program to make genetic products accessible for more of your patients. Together, with Myriad Genetics. References Hogan et al. One example of this is the short amount of time it took Myriad to send its cease-and-desist letter to the University of Pennsylvania's GDL after Myriad obtained its major patent.

GDL ensured that this letter received significant media attention, with the accompanying message that Myriad was attempting to impede basic scientific research. In any event, Myriad disagreed with the GDL's assessment and stated that it fully supported the use of its inventions, without license or payment, by researchers actually carrying out their own research projects.

As noted earlier, Myriad took the position, enshrined in its agreement with the NCI that by supplying testing services to outside researchers, GDL was not conducting its own research and, thus, needed to obtain a license.

Although, on several occasions, Myriad representatives confirmed during media interviews 51 that the company had no intention of enforcing its patents against scientists conducting research on their own behalf, the company did not broadly publicize this however, its spokespeople did state in newspaper interviews that Myriad would not prevent scientific researchers from using the genes.

Instead, the GDL story, and general discussion in the scientific community, left researchers with the impression that Myriad would enforce its patents against them if they pursued research on the genes.

Even though news that Myriad was willing to provide a half-price testing service to those conducting research testing with funding from the NCI was widely disseminated, little was said of Myriad's willingness to permit researchers to do their own sequencing of BRCA1 and BRCA2. There are precedents of companies providing public assurances in respect of research, although in the software industry. Similarly, Myriad could have defined some uses as research and publicly assured researchers that it would not enforce against such use.

However, once such a statement is made public, it does have legal implications. To the large majority of researchers who had not been closely following Myriad's public statements, it seemed that Myriad was willing to block scientific research to turn a profit. In reaction, a number of scientists expressed concern about contributing their own research results on BRCA1 and BRCA2 to public databases for fear of providing Myriad with evidence of patent infringement.

In fact, one researcher at the University of Alberta was advised not to contribute new mutations to databases for this very reason. Following on these fears, King, Stoppa-Lyonnet and others spoke out against Myriad's patents, arguing that Myriad's aggressive stand would prevent researchers from developing improved BRCA1 and BRCA2 tests, assessing the quality of Myriad's test, and developing treatments for breast and ovarian cancer.

In fact, Myriad states that it did not even require researchers to sign a license to use these genes for research purposes. Note that this number includes articles on ethics and clinical care. Of concern to both Stoppa-Lyonnet and King was the fact that, at that time, Myriad's test did not catch all mutations in the BRCA1 and BRCA2 genes, in particular, large-scale changes in the genes called large-scale rearrangements such as deletions of gene segments or partial duplication of the gene.

The first article reporting such large-scale gene rearrangements was published in Subsequently King and her coauthors 58 studied particularly high-risk women who, despite having four or more cases of breast cancer in their families, had received a negative test result using Myriad's BRACAnalysis.

Because of this, King argued that better tests needed to be developed. She argued that, however, because Myriad held patents over the genes and the genetic tests, it could prevent others from developing more comprehensive or accurate tests. By the time, King had published her article in ; however, her critique had lost some of its force.

Myriad states that it had been working on large-scale rearrangements since and, in , introduced analyses for the most significant of these into the BRACAnalysis test.

By the summer of , it had introduced them all G. Critchfield, President, Myriad Laboratories, personal communication, Even before , Myriad readily acknowledged that its early test did not catch all large-scale rearrangements. In fact, Myriad states that, through physicians, it would inform patients who were at risk of having such a rearrangement of other laboratories providing a test that might catch them. These laboratories provided individualized testing and so could catch the rearrangements while Myriad worked at developing the high throughput rearrangement panel that it introduced in Although these other laboratories may have been technically infringing on Myriad's patent, Myriad states that it did not and had no intention of preventing these laboratories from providing this individualized testing.

Stoppa-Lyonnet and others also raised a more general concern about the implications of exclusive licensing on the training of new laboratory professionals. If only the patent holder could perform genetic tests, Stoppa-Lyonnet worried, it would be difficult to train the next generation of geneticists to perform proband testing.

In the long term, this would undermine the ability of laboratories to incorporate the new advances in genetics and genomics. Fueled by these concerns, several European research institutions launched opposition procedures—a mechanism through which individuals, institutions, or governments may challenge the decision of the EPO to grant a patent based on the criteria for patentability—against all of Myriad's patents granted by the EPO. Although this unofficial consortium challenged the patent before the EPO based on the criteria set out in the European Patent Convention—that the inventions lacked novelty, were not inventive, had no industrial application, or were not properly described—they also raised two policy concerns in the media.

Second, they argued that Myriad's business model did not adequately ensure that women would obtain genetic counseling and follow-up care. This is because the procedure for obtaining the test was divorced from the overall health system.

Oppositions were generally successful in limiting Myriad's patents assigned to the University of Utah around the time the opposition procedures were launched. First, instead of revoking EP , the Technical Board of Appeal restricted the patent to certain mutations of the BRCA1 gene and to diagnostic methods for their identification.

With respect to the patent over BRCA1 itself, the opposition division maintained the patent, in amended form, in January The Institut Curie raised an additional concern about Myriad's business model: that Myriad was using its patents to force patients to send their tissues to Myriad, allowing Myriad to collect annotated DNA samples that would give it an unfair advantage over potential competitors in discovering cures.

According to the Institut Curie, Myriad could effectively block the creation of any other database by threatening legal action against any other researcher who conducted research on the BRCA1 and BRCA2 genes. This would provide the company with the only viable database containing breast and ovarian cancer data, thus giving Myriad a large advantage in conducting further work in developing medicines to treat these cancers. Myriad states that it has not and has never intended to build a private mutation database.

The company's researchers have extensively contributed new mutations they discover to the Breast Cancer Information Core mutation database. Myriad states that its own interests are served when other researchers contribute mutations to the database because the knowledge produced improves the accuracy and value of Myriad's tests. Clinicians articulated similar concerns about Myriad's commercialization strategy. First, they worried that Myriad was making the test available to any person who wanted it, even if there was little clinical justification for the test e.

Genetic testing allows patients at a high risk of contracting a particular disease to preemptively take action—through measures such as diet, exercise, medications, and surgery—to prevent that disease from occurring. Moreover, genetic testing indicates the probability rather than the certainty of having a disease, and the results of the tests can be difficult not only for the average patient but also for the average doctor to interpret.

For example, a negative result does not mean that the patient will not contract the disease. It only means that the patient is not at a higher risk than average of contracting the disease. Similarly, a positive result does not necessarily mean that the patient will contract the disease; it simply means the patient is more likely to get the disease than the average person.

Tests say little about the age at which the patient may contract the disease—20 or 70 years old, for example. The psychological impact of BRCA diagnostic testing is evident when one looks at the results of a study by Lynch et al.

Based on a questionnaire, the study concluded that before BRCA testing, After mutation disclosure, Psychologically, a significantly higher percentage of carriers, regardless of their cancer status, felt guilt, compared with noncarriers without cancer, about passing a mutation to their children, worried about developing additional cancer or their children developing cancer, and were concerned about health insurance discrimination.

The key insight from the study is that in truly high-risk families, the genetic test can be quite valuable, as it reduces the number of women who have their breasts removed who do not have BRCA1 or BRCA2 mutations, a clinically significant outcome.

However, one can also infer from this study that misunderstanding genetic test results can lead not only to poor medical decisions but also to psychological harm. For example, it could lead to false reassurance among women testing negative and cause distress among women testing positive on whether to seek prophylactic treatment e. Even properly understood tests can lead to harmful psychological consequences.

Those carrying the gene may have feelings of fear, anxiety, and guilt for having passed down the gene to offspring. In addition to the psychological concern, there is a risk that those who test positive may face insurance discrimination, whereas women who would otherwise choose not to be tested will be forced to do so if they want insurance coverage.

Generally, the protocols target individuals with a significant family history of breast or ovarian cancer. Before Myriad cloned BRCA1 and BRCA2 , genetic testing was generally offered within academic medical centers and, so, was only available to families participating in research studies under the scrutiny of ethics committees. Even those private companies providing testing services at the time limited their availability.

The GIVF also offered testing as an integrated service both counseling and laboratory analysis although GIVF's experience was limited as it only tested for three mutations. In Canada and Europe, laboratories also offered an integrated counseling and testing service. Patients were seen at clinics where they received genetic counseling. A blood sample was then sent to a laboratory affiliated with the center that would analyze the results.

Patients then received follow-up care. Individuals then made an appointment at the clinic offering the service. These clinics followed the Clinical Molecular Genetic Society's guidelines to ensure that only those individuals with a strong family history of cancer were tested. Because each regional center had administrative autonomy, there were some differences in treatment between centers.

However, the test was offered on a fairly restricted basis, and counseling was integrated into the health services provided. Recently, the United Kingdom adopted a harmonized national strategy that maintained integrated services and regulated access. Similarly, before Myriad's entrance into the field, advertising for the test was limited.

Cho et al. Myriad did not directly provide testing services to patients. Rather, it worked through referring physicians who would be responsible for screening patients, providing pretest and posttest services and test interpretation. To the clinical community, it appeared as if Myriad was only interested in selling testing services to as large an audience as possible without the types of controls recommended by professional clinical associations.

Myriad did not agree with these fears. Nevertheless, Myriad recognized that genetic counseling was an important component of the entire testing process. Initially, Myriad relied on genetic counselors and helped train them to provide this service. After it noticed that, however, the number of genetic counselors being trained in the United States was not only insufficient to meet demands but also in decline, Myriad sought to train physicians to provide counseling.

Myriad did so both by preparing its own material and by financially supporting an effort by the American Medical Association to prepare physician guides, written by representatives from the major medical societies, on how to assess patient risk for hereditary cancer syndromes.

There is little data available on genetic counseling; so, it is difficult to assess the impact of training and physician guides on the quality of counseling. Myriad states that, however, its own internal data support the conclusion that physicians are as effective at screening patients as are genetic counselors. Myriad's own educational materials 77 aimed to inform physicians about the appropriate use of genetic tests.

In , the ASCO published guidelines on when an individual should be tested 78 , 79 :. Myriad developed standards that it viewed as being in line with those of the ASCO. Myriad suggested that physicians follow a three-step process before collecting and sending a sample to Myriad: 1 obtain a medical and family history to determine whether the patient is an appropriate candidate for BRACAnalysis testing, 2 provide the patient with pretest education and counseling including a referral to the Genetic Counseling Resource Directory through which patients can obtain counseling services for a fee, and 3 obtain the patient's written informed consent for the test.

If you have not read this material, please ask your doctor for a copy and read it. Do not decide to be tested or sign this consent form until you have read the material and had the opportunity to have your questions answered to your satisfaction by your physician or other health care professionals. Persons specially trained in genetic counseling are available for you to talk to about these tests, but costs associated with this counseling may not be covered by your health insurance plan.

This warning seems to have had an effect. Clinicians' concerns only increased when Myriad experimented with direct-to-consumer advertising. Myriad launched a pilot direct-to-consumer advertising campaign in in Denver and Atlanta. Myriad conducted market research with the help of physicians to help ensure that the advertisement presented factually correct information, did not scare women, and reached the target audience of at-risk women.

The company then ran a pilot television commercial, advertised in various magazines such as Prevention , People , Atlanta Monthly , Colorado Life , and Time and in regional newspapers. As Myriad recognized that the demand for the test would far outweigh the number of clinical geneticists available, it prepared online materials and sponsored a Continuing Medical Education program for physicians before and after the launch of the advertising.

The commercials, however, never aired nation-wide because Myriad realized that there were too few trained genetic counselors to be able to deal with all the women who visited a health care professional following the advertisements. Without sufficient genetic counseling, the backlog was so long that many of these women gave up before they could visit a counselor.

Rather than expand the advertisements, Myriad decided to sponsor the training of more counselors and, later, more physicians on genetic testing. By , Myriad used the same information campaign in New York, Connecticut, Rhode Island, and Massachusetts to determine whether the bottleneck had been eliminated. Although only 15 for every 10, women seeing the advertisement would actually have a mutation in BRCA1 or BRCA2 , 82 there is no evidence that women at low risk took steps to be tested.

In fact, a study conducted by Kaiser Permanente 83 —a private health care provider in the United States—concluded that the advertisements worked in targeting interest among those women who were at a higher risk of having a mutation. According to the study, among those women who completed a questionnaire largely white women above the age of 45 years , the advertisements seemed to have had the effect of simply increasing patient awareness about the test and reducing confusion.

The study found that although the advertisements led to an increased demand for genetic counseling, this did not translate into an increased percentage of women for whom counseling was inappropriate or to an increased demand on physicians to provide referrals. Patients and patient groups had their own concerns over the introduction of Myriad's genetic tests for susceptibility to breast and ovarian cancer. Specifically, they were concerned that Myriad could violate patient privacy by building a database of genetic mutations containing private health information and that Myriad's practice of offering genetic tests to particular ethnic groups could give rise to discrimination.

Myriad's position was that it was not building a private genetic mutations database and thus patients had nothing to fear. For patients in the United States, test results are only reported to doctors and not directly to insurers or the government. For individuals in health plans that cover more than 50 people, insurers and health plans cannot exclude individuals based on genetic information. On the other hand, individuals not covered by such plans e.

For patients outside the United States, working through one of Myriad's partners, Myriad never receives information that could identify the patient. Instead, Myriad receives the sample under a unique code.

Only the intermediary in the patient's home country possesses identification information. Although there was active debate within the research, clinical, and, to a lesser degree, patient communities about Myriad's test, it was not until health care policymakers entered the debate that Myriad encountered serious difficulties.

Given the differences in health care systems, the debate among policymakers took on different hues in different regions. Here, we discuss the debates in the United States, Canada, Europe, Australia, and Japan and their spillover to the broader international arena.

Even before the introduction of Myriad's breast and ovarian susceptibility test in the late s, the US government had struggled with issues relating to genetic testing, particularly over quality control. Although certain government committees examined the impact of gene patents and patented diagnostic tests on health care, no legislative changes were made. Myriad encountered little opposition from the government over its commercialization strategy and was not impeded in the United States as it was in other countries.

In the s and s, genetic testing developed as genes associated with sickle cell anemia, cystic fibrosis, and Huntington disease were discovered. Although, initially, most tests were offered through hospitals, testing eventually expanded to private clinics e. The National Research Council addressed emerging practices in genetic testing in its report, Genetic Screening: Programs, Principles, and Research. By the early s, the number of genetic tests performed grew so significantly that national advisory committees began to examine them.

In , an Institute of Medicine committee recommended that genetic testing be brought under the Food and Drug Administration and that strict guidelines for genetic counseling be developed. Both of these committees similarly recommended Food and Drug Administration regulation of genetic tests. Nevertheless, none of these efforts led to any regulation. Although government and expert committees addressed quality control, little thought was given to the intersection of gene patenting and genetic tests.

The Department of Commerce strongly supported the patenting of genes with little opposition from the executive branch. In fact, the Bayh-Dole Act P. The first real opposition within government came from two bills introduced by Representative Lynn Rivers. The Bill also called for those who had used federal money to conduct their research to publicly disclose all DNA sequences within 30 days of filing a patent.

Industry strongly opposed the Bill, 91 and it never progressed. This Bill also never passed. Another push to reform the patent system came later and was a direct result of the Myriad controversy. Researchers became increasingly concerned that too many research outputs were being patented, slowing down research. This legislation, at least in its initial form, would have made it easier for individuals and companies to submit evidence to prevent the issuance of a patent and allow individuals to more easily fight an issued patent.

It would also have made it more difficult for a patent holder to stop others from using the invention until the courts had had a chance to look at the matter by limiting the availability of preliminary injunctions, adopting a first-to-file rule as opposed to the current first-to-invent rule and the requirement that all applications be published after 18 months starting from the priority date and a reinvigoration of the duty of candour.

The status of these reforms is currently uncertain. On the policy front, the NIH, the federal government agency that has funded part of virtually every major US biomedical research project at some stage, responded by drafting nonbinding guidelines on when grant recipients ought to apply for a patent over a genomic invention and the manner in which those recipients are to grant licenses over their inventions. Whenever possible, nonexclusive licensing should be pursued as a best practice.

A nonexclusive licensing approach favors and facilitates making broad enabling technologies and research uses of inventions widely available and accessible to the scientific community. When a genomic invention represents a component part or background to a commercial development, nonexclusive freedom-to-operate licensing may provide an appropriate and sufficient complement to existing exclusive IP rights. In those cases where exclusive licensing is necessary to encourage research and development by private partners, best practices dictate that exclusive licenses should be appropriately tailored to ensure expeditious development of as many aspects of the technology as possible.

Specific indications, fields of use, and territories should be limited to be commensurate with the abilities and commitment of licensees to bring the technology to market expeditiously. As part of this initiative, the NIH also sponsored several studies to provide an empirical understanding of the scope and impact of university gene patents.

For example, Pressman et al. More recently, the Secretary's Advisory Committee on Genetics, Health, and Society, which advises the Secretary of Health and Human Services on a broad range of ethical, legal, clinical, and social issues arising from the development and use of genetic and genomic technologies, issued a report on February 10, , based on substantial evidence, that found that gene patents were not an important incentive to develop and make available genetic tests.

March 29, 09 Civ. The basis of the decision was that Myriad's claims to isolated human genes are unpatentable products of nature and that the diagnostic testing claims cannot be patented because they are mere mental processes. We will discuss both these arguments in Part V, but it is extremely likely that the United States Court of Appeals for the Federal Circuit will overturn the District Court on the issue of patenting human genes.

The question of whether the diagnostic test claims are valid is less clear. Unlike most research tools or manufacturing methods, diagnostic tests often must go through the regulatory approval process and, so, may warrant exclusive licensing when the costs of test development, approval, or diffusion require substantial investment of capital.

Nevertheless, licensing of diagnostic tests based on broadly applicable genomics or proteomics methods should strive to preserve sufficient flexibility to permit testing for multiple indications i. Exclusive licensing of a single gene for a diagnostic may be counterproductive in multigene pathology where only a panel of genes can yield an adequate diagnosis, unless the licensee has access to the other genes of the panel …[when] no alternative testing strategy is available for a given indication, consideration should be given to means of ensuring reasonable access for patients and shielding individual health care providers from the risk of suit for patent infringement.

Despite these efforts, given the private nature of health care insurance in the United States and the preference of limited government regulation, the US government did little to limit Myriad's ability to commercialize tests in accordance with the company's commercialization strategy.

The same cannot be said of other governments, especially those with public health care systems. Outside the United States, Myriad sought to find an intermediary in each region—in Europe, Canada, and Japan—with which it could enter into a licensing agreement.

As was the case with its US licensees, Myriad wanted to reserve proband testing for itself at its Salt Lake City facility but was willing to permit local licensees to conduct follow-on testing. Recall that, in the late s, Myriad believed that this would roughly split revenue between itself and its licensee.

Myriad approached a mixture of private and public sector actors to act as its local licensee depending on what it knew of each country and the organization of its health care system.

Myriad's choice of partner, particularly in Canada, led to difficulty. As we will later discuss, the situation in Australia was slightly different in that GTG was pursuing Myriad for patent infringement, thus forcing Myriad to enter into an agreement. In internationalizing its US commercialization strategy, Myriad failed to account for important policy debates occurring within national health departments and research institutions.

In particular, the international policy community was struggling with how to ensure the appropriate introduction of new genetic technologies into health care systems and whether and to what extent these technologies should be patented.

The overarching question facing policymakers, particularly those in publicly funded health care systems, was how to administer new genetic tests to both ensure access for those who needed them while ensuring universal coverage. Myriad walked into this policy debate largely unaware that it was going on and with little knowledge or, according to press reports, 99 sympathy for public health care systems.

In so doing, Myriad placed itself squarely in the eye of a policy storm. In Canada, jurisdiction over patents and health care is split not only between the federal and provincial governments but also between different federal departments. The Canadian federal government possesses specific powers to enact and administer patent law and implicit power over health and industrial policy—through its ability to spend money— whereas provincial governments actually manage and pay for the public health care system.

P-4 the Patent Act and of industrial policy regarding biotechnology, while, at the provincial level, ministries of health are in charge of spending approximately half of provincial budgets on health care services. There is also a Federal ministry, Health Canada, mandated with national harmonization of health policy, through its administration of the Canada Health Act R.

C-6 , as well as several health agencies such as the Public Health Agency of Canada. Although it may not have expected to obtain such broad protection over the diagnostic field, the CIPO granted its claims.

There seems to have been some sense that the validity of the Canadian patents was uncertain given their breadth. Nevertheless, Myriad took the patents as they came. Before Myriad's arrival in Canada, provincial government policymakers responsible for their respective provincial health care systems were studying the new genetic technologies and their promises.

In the late s, press reports suggested that genetic tests would soon be available for a large number of significant diseases, that new gene-based therapies were around the corner, and that genetic tests could be used to better determine which medication would work best on which patient.

For example, the Hereditary Cancer Program at the British Columbia Cancer Agency and provincial government laboratories in several other provinces—Alberta, Manitoba, Ontario, and Quebec—offered tests to a limited number of patients. All of these institutions provided not only testing but also genetic counseling, follow-up monitoring, and, where available, treatment. Testing services already existed, and policymakers had started to examine the implications of new genetic technologies.

From their point of view, Myriad and its business strategy were disrupting a system, not just introducing a new test. For example, in Ontario, Canada's largest province with the largest health care budget, testing was available through Cancer Care Ontario's research protocol to those who met strict high-risk criteria to determine the utility of the tests.

Where these histories pointed to a risk of hereditary breast or ovarian cancer, the patient was given a protein truncation test PTT at independent laboratories. Although a patient who did not produce full-length proteins definitely had a genetic problem, patients producing full-length proteins might still harbor a harmful genetic mutation that the PTT test would not identify.

Where the patient failed to produce full proteins under the PTT or where the patient's medical or family history pointed to a high risk even if the patient produced full-length proteins , the patient would be offered the DNA-based test. At least one study indicated that the use of multiple factors, including PTT, provided the most cost-effective form of diagnosis. After the test, the physician or genetic counselor would meet with the patient to discuss the patient's risk of contracting breast and ovarian cancer and possible therapies and lifestyle changes the patient might wish to contemplate.

MDS, the only Canadian-based private laboratory that provided services across the country, approached Myriad to be its Canadian licensee. MDS had operated in the United States and, in particular, Utah and, so, was working in the same circles as was Myriad. MDS provided a suite of diagnostic and other testing services in Canada, primarily through the public health care system.

The majority of MDS's revenues derived from payments made by provincial health care systems, particularly that of Ontario. Nevertheless, MDS identified the introduction of new technologies into the Canadian health care system as a strategic goal.

In particular, as no breast and ovarian cancer genetic testing was available through the public health system in Ontario until April , MDS saw an opportunity to enter into the genetic testing market. This was a role that the private sector had long provided. However, by the end of the s, private sector participation in Canadian health care became complex and symbolically potent.

The core of the Canadian public health system—physician and hospital services—is publicly financed and managed through the provinces but is generally privately delivered.

The Canada Health Act R. C-6 , which governs the role of the federal government in financing health care, requires that the federal government transfer funds to the provinces in which certain rules are maintained that, notably, accessibility be maintained for all Canadians and through a ban on private financing.

For the most part, however, this type of privatization has proceeded, and private delivery of many publicly funded services e. As a result of cutbacks through the s, MDS believed that governments were slow to approve the introduction of new tests under provincial health plans. MDS thought it could fill this gap by providing new tests directly to individual patients outside the health systems on a private basis.

MDS saw itself as supplementing the core public health care system, rather than competing against it, as it was providing services that the public systems did not cover. This was a critical distinction, as MDS in no way wished to enter into a confrontational relationship with public health care administrators. In furtherance of its goal, MDS developed partnerships with hospitals and regional health centers to provide testing services.

Myriad and MDS entered into a 3-year agreement in under which MDS would be responsible for marketing the test in Canada and shipping samples to Myriad for sequencing in the United States.

At that time, MDS did not have the expertise to conduct the tests in Canada. Briefs thomsonreuters. Quote and financial data from Refinitiv. Fund performance data provided by Lipper.

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