Abstract
In recent years, a growing number of biobanks and associated research projects have emerged in North America. This paper intends to map out the governance framework of biobanks in Canada and the United Sates (US). The governance of biobanks can be characterized as a threefold enterprise: legal instruments, such as legislation and case law will apply to many biobank processes and activities; ethics codes and institutional policies provide a source of non-binding governance rules; and finally, biobanks themselves often develop their own governance policies.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
For example, both federal and provincial governments have jurisdiction over healthcare. Conversely, the federal government was granted exclusive jurisdiction over criminal law, which gives it authority over narcotics, devices and drugs, including blood and blood products, which can be relevant to biobanking. See Constitution Act, 1867 (UK), 30 & 31 Vict, c 3; Food and Drugs Act, RSC 1985, c F-27.
- 2.
Pridham v Nash Estate (1986) 57 OR2d 347 (HC) [Pridham]; Brushett v Cowan (1990), 69 DLR (4th) 743 (Nfld CA) [Brushett]; Weiss v Solomon, [1989] RJQ 731, 48 CCLT 280 (CS Qué) [Weiss].
- 3.
The Supreme Court of Canada requires that research participants be given all information that a reasonable person might be expected to consider before consenting to participate in the research. This means, for example, that a research biobank’s consent forms would have to disclose rare risks, whereas biobanks solely involved in clinical care would not. Nevertheless, the scope of the disclosure and the kind of information that must be disclosed also depend on the facts of each case. In addition to the ‘informed’ component, consent must be voluntary. Jurisprudence warns that failure to obtain free and informed consent prior to a procedure that intrudes on a person’s body can amount to the tort of battery or an action in negligence. Halushka v University of Saskatchewan, 1965 CanLII 439 (SK CA) [Halushka ] at para 29; Taylor v Hogan, [1998] NJ No 14, 160 Nfld & PEIR 93 (Nfld. CA) [Tayolr]; Hopp v Lepp, [1980] SCJ No 57, 112 DLR (3d) 67 (Supreme Court of Canada) [Hopp]; Reid v Maloney, [2011] AJ No 1327, 2011 ABCA 355; Malinowski v Schneider, [2012] AJ No 759, 2012 ABCA 125[Malinowski]; Reibl v Hughes, [1980] 2 SCR 880 [Reibl]; Starson v Swayze, [2003] SCJ No 33, [2003] 1 SCR 722 (Supreme Court of Canada) [Starson]; Gilgorevic v McMaster, [2012] OJ No 721, 2012 ONCA 115 (Ont CA) [Gilgorevic].
The Supreme Court of Canada laid out the requirements for voluntary consent in the context of clinical care: consent is voluntary when it is free and without coercion, undue influence or misrepresentation. The application of this principle is visible in numerous biobank consent forms, which highlight the voluntary nature of the participation. For example, some biobank consent forms emphasize that the decision to forego participation will not affect clinical care. Furthermore, for consent to be valid, it must be given by a capable person. This means that the individual must understand the nature, purpose, risks and benefits of the proposed treatment and the consequences of one’s decision to undergo or forego the procedure. See Reibl, supra note 4 in Chap. 2. Mulloy v Hop Sang, [1935] AJ No 8, [1935] 1 WWR 714 [Mulloy], Murray v McMurchy, [1949] BCJ No 74, [1949] 2 DLR 442[Murray], Malette v Shulman (Ont CA), 1990 CanLII 6868 (ON CA) [Malette]; Edwardson v St Joseph’s Healthcare Hamilton10/26/12 [2012] OJ No 5032, 2012 [Edwardson].
- 4.
Civil Code of Québec, CQLR c CCQ-1991.
- 5.
The only other legislations that address the donation of tissue for research is Human Tissue Gift Act, CCSM c H180, s 9 and the Human Tissue and Organ Donation Act, SA 2006, c H-14 5, s 3. However, the legislations do not address the same issues as the CCQ.
- 6.
Art. 11 CCQ.
- 7.
Scholars have pointed out that that the CCQ does not specify to whom the benefits and risks are directed. In the case of clinical and therapeutic care, the Québec legislature has indicated that the benefits and risks incurred apply to the patient. However, there has been no clarification for the research context. As such, the vague wording of the CCQ allows for the possibility that human-subject research benefit society or science rather than the participant herself. Nevertheless, scholars highlight that, according to the CCQ, research of a population group requires that the benefits to the group (i.e. persons of the same age category, or of the same illness, etc.) should outweigh the risks. The particular wording of the CCQ therefore requires population biobank researchers to ensure that the potential benefits outweigh the possible risks to the participants, whereas biobank researchers not dealing with population groups may have more leeway to seek benefits for society as a whole rather than the participants themselves. Nevertheless, these requirements necessitate that before consent to research is obtained, researchers evaluate the possible risks and benefits, and ensure that the benefits outweigh the risks (either to the participant, population group, or to society).
- 8.
Art. 20 CCQ.
- 9.
Art. 22 CCQ. As such, a cancer patient in the province, for example, must consent to the removal of a tumor in the context of medical care, and must provide additional consent for the removed tumor to be used in research as is often conducted by tumor banks.
- 10.
Such as ensuring that the risks incurred are outweighed by the benefits prior to patient consent.
- 11.
Tri-Council Policy Statement (2014).
- 12.
The Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada.
- 13.
Panel on Research Ethics (2017). Although the policy specifically applies to all institutions eligible to receive or administer funding from noted federal agencies and to members of those institutions, it has been extensively adopted by other agencies and institutions across Canada.
- 14.
TCPS2(2014), p. 25-4.
- 15.
Ibid, Art. 3.3.
- 16.
This includes, the purpose of the research, the identity of the researchers and funders, foreseeable risks and potential benefits, the expected duration of participation and an explanation of the responsibilities of the participant (TCPS2(2014) Art. 3.2.).
- 17.
Ibid at 28.
- 18.
The Supreme Court of Canada has interpreted Section 7, which guarantees the right to life, liberty, and the security of the person to include the protection of privacy in the context of medical records under “liberty”. Section 8 of the Charter makes a more explicit mention of the right to privacy as it protects from unreasonable search and seizure. The Supreme Court of Canada has found that it is an invasion of personal privacy, under Section 8, when a person’s body is used without consent to obtain biological information. See R v O’Connor, [1995] SCJ No 98, [1995] 4 SCR 411 (Supreme Court of Canada) [O’Connor]; R v Dyment [1988] 2 SCR 417[Dyment].
- 19.
Privacy Act RSC 1985, c P-2.
- 20.
Personal Information Protection and Electronic Documents Act (SC 2000, c 5) [PIPEDA].
- 21.
Panel on Research Ethics (2017).
- 22.
See, e.g. Nolan v Kerry (Canada) Inc., [2009] SCJ No 39 at para 187 (Supreme Court of Canada) [Nolan].
- 23.
Ibid.
- 24.
Hodgkinson v Simms, [1994] SCJ No 84, [1994] 3 SCR 377 (Supreme Court of Canada) [Hodgkinson]; Galambos v Perez, [2009] SCJ No 48, [2009] 3 SCR 247 [Galambos].
- 25.
Canadian jurisprudence outlines indicia which indicate the existence of a fiduciary relationship outside the context of traditional fiduciary cases, such as lawyer-client relationships. The existence of such a relationship depends on the scope for the exercise of discretionary power, whether the power or discretion can be exercised unilaterally so as to affect the beneficiary’s legal or practical interests, and a peculiar vulnerability to the exercise of that discretion. Based on these indicia, physician-patient relationships have been recognized by the Supreme Court of Canada as characteristically fiduciary in nature. See Hodgkinson, supra note 5 in Chap. 3; Norberg v Wynrib, [1992] SCJ No 60, [1992] 2 SCR 226 (Supreme Court of Canada) [Norberg]; McInerney v MacDonald, [1992] SCJ No 57, [1992] 2 SCR 138 (Supreme Court of Canada) [McInerney].
- 26.
Halushka, supra note 4 in Chap. 2.
- 27.
Ibid at para 29.
- 28.
Genome Québec (2012).
- 29.
Note that this resembles Winickoff’s charitable trust model, as a charitable trust is a form of purpose trust.
- 30.
Art. 1270 CCQ.
- 31.
Genome Québec (2012).
- 32.
Art. 1270 CCQ. A trust constituted for a scientific purpose.
- 33.
The CCQ provides that all civil rights must be exercised in good faith, and that no right may be exercised in bad faith. Art. 6-7 CCQ.
- 34.
See Bank of Montreal v Bail Ltée, [1992] 2 SCR 554[BMO].
- 35.
See Grimes v Kennedy Krieger Institute, Inc, 366 Md 29, 782 A 2d 807 (Md 2001) [Grimes].; Yearworth v North Bristol NHS Trust [2009] EWCA Civ 37, [2009] All ER (D) 33 (Feb) [Yearworth]. The contractual character of consent forms can be found in the wording of the CCQ’s antecedent, the Civil Code of Lower Canada. The old code intended to situate written consent (in consent forms) in a contractual context, indicating that consent forms should follow the general contract law theory (“suivant la théorie générale des contrats”). Furthermore, it has been suggested that if consent forms indeed constitute contracts, they would be contracts of adhesion, as the consenting research participant lacks bargaining power. See Civil Code of Lower Canada, 29 Vict, ch 41, (1865) Art. 20.
- 36.
This is due to the imbalance of expertise and information, and the degree of reliance, which is characteristic of contracts of adhesion.
- 37.
Moral injury includes psychological injury, such as psychological distress resulting from defamation or a breach of privacy.
- 38.
Art. 1457 CCQ.
- 39.
See Sect. 13.2.3.2.
- 40.
JCM v ANA, 2012 BCSC 584 (CanLII), <http://canlii.ca/t/fr3z5>[JCM], Lam v University of British Columbia, 2010 BCCA 325 (CanLII), <http://canlii.ca/t/2b93j>[Lam].
- 41.
Lam, supra note 22 in Chap. 3.
- 42.
Piljak Estate v Abraham, 2014 ONSC 2893 (CanLII), http://canlii.ca/t/g75bb[Piljak].
- 43.
It is important to note that because there is no particular law in Canada regarding ownership of biospecimens or data, the biobank, the institution owning it, or the principle investigator can claim ownership rights. Nevertheless, biobanks, universities and hospitals generally have specific ownership and IP policies determining this matter
- 44.
Ibid. A key justification for allowing property rights in permanently removed biospecimens is that they often serve the public good, and do not pose public policy concerns that other samples do, such as organs.
- 45.
Namely, pressuring persons in economically precarious situations to sell bodily material. Ibid p. 51.
- 46.
The permanent alienation of biological material renders it commercializable and seemingly subject to certain rights arising from occupation.
- 47.
See Sect. 13.2.3.2.
- 48.
For example, research on tumor samples from the Ontario Tumour Bank led to the patenting of a method for identifying pharmaceutical compounds for the treatment of solid tumor cells (US 9002653 B2). Publicly funded biobanks will often require their users not to patent samples and primary data to ensure that the material remains widely available for other users. Policies on IP rights on inventions derived from the data/samples are more permissive and variable.
It is worth noting that in Canada, copyright is not applicable to the contents of biobanks, such as data and biospecimens, and therefore cannot afford IP protections to the content of biobanks, as it only extends to original literary, dramatic, musical and artistic works. However, the law of trade secrets is relevant to the biobanking context and may offer certain rights and protections outside of patent law, as it gives individuals a right of action against anyone who discloses the protected information. See Copyright Act, RSC 1985, c C-42; Uniform Trade Secrets Act, (1989), Art. 7. For more information see, Joly 2012.
- 49.
Patent Act (RSC, 1985, c P-4).
- 50.
College v Canada (Commissioner of Patents), [2002] 4 SCR 45, 2002 Supreme Court of Canada 76 [College].
- 51.
Monsanto Canada Inc v Schmeiser, [2004] 1 SCR 902, 2004 Supreme Court of Canada 34. [Monsanto].
- 52.
The mouse was therefore not an ‘invention’ as per sections 2 of the Patent Act (1985); College, supra note 30 in Chap. 3.
- 53.
Monsanto, supra note 31 in Chap. 3.
- 54.
Tennessee Eastman Co v commissioner of patents [1974] SCR 111 [Tennessee Eastman]; Apotex v Wellcome 2002 21 Cpr 4th 499 (Supreme Court of Canada) [Apotex]; Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals Company, 2013 FC 985, 440 FTR 1[Novartis].
- 55.
Tennessee Eastman, supra note 36 in Chap. 3 at 118. However, uncertainty arose in 2015, when the Canadian Patent Office released administrative guidelines for patenting diagnostic methods. The guidelines seemingly invalidate gene-patent claims in diagnostic method patent applications. Although gene-related subject matter does not seem to be precluded from patentability in Canadian patent law, the new guidelines do not bode well for the future eligibility of biological patents, particularly gene patents. A recent patent case, Children’s Hospital of Eastern Ontario v Transgenomic Inc (Trangenomic), could have shed light on the exact position of Canadian patent law concerning gene patents, but the case was settled extra-judicially in March 2016. In Transgenomic, the patent claims in question were methods for identifying genetic mutations associated with Long QT Syndrome. The Children’s Hospital of Eastern Ontario challenged the validity of the gene patents in 2014, and by 2016, the action settled with Transgenomic agreeing to allow Canadian public-sector labs and hospitals to use their “inventions” on a not-for-profit basis. See Children’s Hospital of Eastern Ontario v Transgenomic, Inc et al. (14 May 2015) T-2249-14; See Examination Practice Respecting Medical Diagnostic Methods—PN 2015-02. https://www.ic.gc.ca/eic/site/cipointernet...nsf/eng/wr03945.html. See settlement at http://www.cheo.on.ca/uploads/genetics/Gene%20patent/CHEO-Transgenomic-Settlement-Agreement-Signed-2016-03-08.PDF.
- 56.
US Const amend X.
- 57.
Wex Legal Dictionary, https://www.law.cornell.edu/wex/federalism.
- 58.
For example, states pass their own health insurance regulations and privacy laws, in addition to the existing federal laws.
- 59.
It is important to note that to be subjected to the Common Rule, a biobank must be involved in “human subject research” that is funded or otherwise subject to regulation by a federal department or agency. This raises three key requirements: (1) the biobank must conduct research, (2) human subjects must be involved in the research, and (3) the research must be supported by a federal body. See 45 CFR §46.101 (2009).
As for the first requirement, a biobank must engage in a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”. As such, a biobank that merely stores and “banks” biospecimens would not be subject to the Common Rule. As for the second requirement, a human subject is defined as “a living individual about whom an investigator (…) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information”. The term “intervention” is further defined as requiring interaction (i.e. communication or interpersonal contact) between the researcher and the research subject. This means that the Common Rule does not apply to biobank research where there is no communication or interaction with the sample donor, as is often the case with secondary uses or research on biospecimens from another biobank or institution. However, a biobank will still be required to abide by the Common Rule where there was no interaction if the information being used is identifiable and private. According to the statute, private information includes, among others, medical records, or any other information that the participant can reasonably expect will not be made public. Identifiable information is defined as information from which the identity of the subject is or can readily be ascertained by the researcher or linked with private information. Research involving only coded specimens or data, where the researcher cannot access the key to the code, is not considered “human subject” research. As such, biobanks and biobank researchers will need to use individually identifiable private information for the Common Rule to apply. See 45 CFR §46.102 (d) and _.102 (f) (2009).
Often enough, biobanks will fulfill these requirements, and the Common Rule will clearly apply. However, it is also common for biobanks to use de-identified biospecimens obtained from another institution, such as a hospital, or specimens that were originally collected for another research purpose (i.e., secondary uses). In such cases, the research will generally not fall under the scope of the Common Rule.
- 60.
45 CFR §46.116 (2009). The Common Rule was drafted by the Department of Health and Human Services (DHHS). As the National Institute of Health (NIH) is an agency of the DHHS, all NIH-funded research is subject to the Common Rule. Additionally, most academic and healthcare institutions conducting human subject research adhere to the Common Rule regardless of their source of funding. The FDA has its own legislation that also addresses human subject research conducted by the FDA. See US Department of Health & Human Services 2016.
- 61.
Ibid.
- 62.
82 Fed Reg 7149 (2017).
- 63.
21 CFR §§50.1-.56 (1980).
- 64.
45 CFR §46.116(2009); 21 C.F.R.§§50.1-.56 (1980).
- 65.
45 CFR §46.116 (2009).
- 66.
45 CFR §46.104(d)(4) (2009).
- 67.
The exemption expressly does not cover any primary collections of biospecimens or information.
- 68.
45 CFR §46.111(a)(7) (2009); See 82 Fed Reg 7263 (2017).
- 69.
82 Fed Reg 7200, § __.104(d)(7) and (8) (2017).
- 70.
Ibid.
- 71.
Greenberg v Miami Children’s Hospital Research Institute (MCHRI), 264 F Supp 2d 1064 (SD Fla 2003) [Greenberg].
- 72.
Ibid. The decision may be surprising given the well-established principles of Moore v Regents of the University of California (Moore), where the court did conclude that disclosure of a researcher’s personal interests unrelated to the patient’s health, including both research and economic, must be disclosed in the consent process (Moore v Regents of the University of California, 271 Cal Rptr (2d) 481(1990) [Moore]) In Greenberg, however, the court distinguished the case at issue from Moore in that the physician-researcher was solely involved in research and did not have a therapeutic relationship with the participants. As such, investigators involved in scientific research are likely not required to disclose as much information as researcher-physicians involved in clinical care are. Greenberg, supra note 9 in Chap. 6.
- 73.
Although there is no explicit constitutional right to privacy, the US Supreme Court has interpreted the Fourth, Fifth and Ninth Amendments to include privacy protections. As previously noted, the Constitutional protection of privacy only applies to government biobanks. Griswold v Connecticut, 381 US 479 (1965) [Griswold].
- 74.
The Privacy Act applies to the collection, maintenance, use and dissemination of information about individuals stored in systems of records by federal agencies. Under the Act, federal agencies are generally prohibited from disclosing records unless consent has been obtained from the individual concerned. To be covered by the Act, federal databases (or biobanks) must retrieve information on particular individuals. Importantly, biospecimens are not included under the scope of the legislation, thus limiting the applicability of the Act to biobanks. Furthermore, only US citizens and permanent residents are covered, therefore only permitting them to sue for breaches under the Act. This last requirement has implications for non-US donors of data shared with US federal biobanks.
Under the Act, federal agencies are generally prohibited from disclosing records unless consent has been obtained from the individual concerned. Nevertheless, certain exceptions to this rule apply, which are particularly relevant in the context of research biobanks. One exception is the “statistical data exception”, which permits disclosure to a recipient who will only use the information for statistical research or reporting, and where the record is transferred without individually identifiable data. As such, biobank de-identified data may be disclosed in certain circumstances. The “routine uses” exception may also apply to biobank research; where a record was collected for research, it may be considered a “routine use” as per the definition given by the Act. See, Privacy Act of 1974, 5 USC § 552a (1974); § __.111(a)(7); See also 45 CFR §46.104(d)(2)(iii) (2009); __ 5 USC § 552a(2);__ § 552a(b)(5); __ § 552a(b)(1), __ § 552a(a)(7); Department of Justice 2015.
- 75.
FDA regulations generally mirror the Common Rule. These regulations apply to research on investigational drugs or medical devices with human subjects. Unlike HIPAA or the Privacy Act, FDA regulations apply to research on biospecimens and not to health data. Therefore, biobanks are subject to FDA regulations if they are engaged in clinical research involving biospecimens. Legal protections for personal FDA records, like the Common Rule, address informed consent and IRB review requirements. Additionally, the regulations make an exception to the informed consent requirement for non-identifiable specimens. 21 CFR § 50.1 (1980); __ § 355; __ § 812.3(p). See Harrell and Rothstein (2016), p. 9.
- 76.
The regulation applies to health plans, healthcare clearinghouses and to healthcare providers who transmit “health information in electronic form in connection with transactions for which the Secretary of HHS has adopted standards under HIPAA”. As such, HIPAA will cover biobanks that fall under any of these categories (see US Department of Health & Human Services (2013)). The rule also applies to business associates of said entities. The term “healthcare provider” is broadly construed, and includes physicians, hospitals, hospice programs, among others. A business associate is defined as someone who creates, receives, maintains, or transmits PHI for a function or activity regulated by the Act on behalf of the covered entity. See 45 CFR § 160.103 (2009); 42 USC § 1395x(r), (s), and (u) (1965).
- 77.
45 CFR § 46.111(a)(7) (2009).
- 78.
__§104(d)(2)(iii).
- 79.
45 CFR 164.502 (2013).
- 80.
PHI includes information such as demographic data, which relates to the individual’s past, present or future physical or mental health condition; the provision of healthcare to the individual; or the past, present, or future payment of the provision of healthcare to the individual. Individually identifiable health information further includes personal identifiers such as one’s name, address, social security number and information for which there is a reasonable basis to believe it can be used to identify the individual. See 45 CFR Parts 103, 160, 164.
- 81.
See generally 45 CFR Parts 160, 164.
- 82.
I.e., information that does not identify the individual or provide a reasonable basis to do so. 45 CFR §§ 164.502(d)(2), 164.514(a) and (b) (2013).
- 83.
Restatement (Third) of Agency § 1.01 (2006).
- 84.
Witherell v Weimer 396 NE (2d) 268 (Ill App Ct 1979) [Witherell].
- 85.
Departing from the common trend, the Maryland Court of Appeals found that researchers’ obligations may extend beyond federal regulations because research can give rise to special relationships resembling fiduciary relationships. Grimes, supra note 19 in Chap. 3.
- 86.
Whitlock v Duke Univ 637 F Supp 1463 (MD NC 1986) [Whitlock]; Daum v SpineCare Med Grp 52 (2d) 260 (Cal App) (1997) [Daum]; Vodopest v MacGregor, 128 Wash (2d) 840 (1996) [Vodopest].
- 87.
Greenberg, supra note 9 in Chap. 6 at 1071.
- 88.
Ibid.
- 89.
In Moore, the patient’s physician and hospital profited from research conducted on the patient’s tissue (in the context of clinical care), by developing and patenting a cell line without disclosing this information to the patient prior to removal.
- 90.
As such, in biobank research, neither the principle investigator nor the research participants have property rights in donated biospecimens. However, the principle investigator may have IP rights in inventions derived from the institution’s bio-samples. See Washington University v Catalona 437 F Supp (2d) 985 (2006) [Washington]; Tilousi v Arizona State Univ Bd of Regents, No CV2005, 2006 WL 4642922: 1-25 (Ariz Super 2006) [Tilousi], Havasupai Tribe v Arizona Bd of Regents, 204 P 3d 1063 (Ariz Ct App 2008) [Havasupai].
- 91.
- 92.
The plaintiffs also took issue with the defendants’ restrictive (and costly) licensing of the genetic screening test.
- 93.
For example, in 2002, Representatives Lynn Rivers and David Weldon introduced HR 3967 aimed at exempting research and genetic diagnostic use from patent infringement liability to allow the unrestricted use of such inventions. The proposed law would effectively exempt healthcare providers offering genetic tests and scientists undertaking non-commercial genetic research from being sued by holders of gene patents.
- 94.
35 USC § 101(2012).
- 95.
Ibid.
- 96.
The first is that the invention or discovery must be novel. In addition, the invention must possess a utility, and the invention cannot be obvious to someone skilled in the art. The invention also needs to be described and explained in a manner that permits someone who is skilled in the art to make use of it. A further requirement is that the claims of the patent must be clear and specific. Finally, the entity must be patentable; laws of nature, physical phenomena and abstract ideas are not patentable. See, 35 US Code § 101 (2012).
- 97.
35 USC § 202 (2012).
- 98.
The Act also sets requirements to ensure that inventions made under it are used “without unduly encumbering future research and discovery”. The Act grants the NIH the authority to limit a grantee’s right to elect title, or the NIH can elect title itself when it determines that the restriction or elimination of the right to retain title to the invention will better promote the policy and objective of the Act. 35 USC § 200 (2012).
- 99.
Diamond v Chakrabarty, 447 US 303 (1980) [Chakrabarty].
- 100.
Ariosa v Sequenom, 88 F3d 1371 (Fed Ci. 2015) [Ariosa].
- 101.
Chakrabarty, supra note 41 in Chap. 6.
- 102.
US Patent and Trademark Office Notice (1987).
- 103.
US Patent No. 5,656,479.
- 104.
US Patent No. 5,750,176.
- 105.
US Patent No. 5,675,063.
- 106.
US Patent No. 5,489,524.
- 107.
The claim concerned methods for determining optimal dosages of thiopurine drugs. According to the Court, medical diagnostic methods are laws of nature and require something that transforms the nature of the object or process to be patentable. Mayo Collaborative Services v Prometheus Laboratories 132 S Ct 1289 (2012) [Mayo].
- 108.
Association for Molecular Pathology v Myriad Genetics, Inc, et al, 689 F (3d) 1303 133 S Ct. 2107 (2013) [Myriad].
- 109.
The key object of the patent claim was a patent on a genetic test to detect the BRCA1 and BRCA2 genes. The genetic test comprised of two steps which were analyzed by the Court: the first involved separating segments of DNA containing the sequences of nucleotides normally present in the BRCA1 and BRCA2 genes, and the second involved the creation of a copy of the original natural DNA sequence, only containing exons (i.e., cDNA). The Supreme Court invalidated some of Myriad’s patents, thus allowing wider use of the genetic test and resulted in the availability of cheaper BRCA1/2 testing. This fact speaks directly to previous concerns regarding the patenting of biotechnological innovations: the wide use of patents of potentially life-saving tests and discoveries can be abused at the cost of the social good. The Supreme Court addressed this in its decision explaining that “[p]atent protection strikes a delicate balance between creating ‘incentives that lead to creation, invention, and discovery’ and impeding ‘the flow of information that might permit, indeed spur, invention’”. See Myriad, supra note 50 in Chap. 6.
- 110.
Note that the interim guidance is not law.
- 111.
See 79 Fed Reg 74618 (2014). The guidelines were updated to evaluate the patent eligibility of biological materials by assessing whether the product has “markedly different characteristics” than its naturally occurring counterpart. Ibid, at 74623–74624.
- 112.
In re BRCA1-& BRCA2-Based Hereditary Cancer Test, 774 F (3d) 755 (2014) [In re BRCA1-& BRCA2].
- 113.
Ibid at 1244.
- 114.
I.e. the primers.
- 115.
In re BRCA1-& BRCA2, supra note 54 in Chap. 6. The judges explained that it does not matter whether gene sequences are synthetically replicated. Rather, it is important that the gene sequences are distinctly different from those found in nature to be patentable. As such, the court interpreted the Supreme Court’s ruling to mean that a DNA structure with a similar function to that found in nature must have a unique structure that is different from anything found in nature to be patent-eligible. The fact that the DNA has a different function or that it is synthetically replicated does not, in itself, grant patentability. This ruling invalidated several more of Myriad’s patents.
- 116.
Ariosa, supra note 42 in Chap. 6.
- 117.
Ibid at 1156.
References
Allen, C., Joly, Y., & Granado, P. (2013). Data sharing, biobanks and informed consent; A research paradox? McGill Health Law Journal, 7(1), 85–120.
Austin, L., & Lemmens, T. (2009). Privacy, consent, and governance. In K. Dierickx & P. Borry (Eds.), New challenges for biobanks: Ethics, law and governance (pp. 111–122). Intersentia.
Baudouin, J.-L., & Jobin, P.-G. (1998). Les obligations. Yvon Blais.
Cabanac, J., & Giroux, M. (2007). Le formulaire de consentement à la recherche: incompatibilité entre le droit des personnes et le droit des contrats. Revue de droit de l'Université de Sherbrooke, 37, 235–274.
Cantin Cumyn, M. (2013). Réflexions autour de la diversité des modes de réception ou d’adaptation du trust dans les pays de droit civil. McGill Law Journal, 58(4), 811–825.
Cartwright-Smith, L. (2014). Patenting genes: What does association for molecular pathology V. Myriad genetics mean for genetic testing and research? Public Health Reports, 129(3), 289–292.
Cook-Deegan, R., & Heaney, C. (2010). Patents in genomics and human genetics. Annual Review of Genomics and Human Genetics, 11, 383–425.
Deleury, E., & Goubau, D. (2002). Le droit des personnes physiques. Yvon Blais.
Harrell, H. L., & Rothstein, M. A. (2016). Biobanking research and privacy laws in the United States. The Journal of Law, Medicine and Ethics, 44(1), 106–127.
Henderson, G. E., Cadigan, R. J., Edwards, T. P., Conlon, I., Nelson, A. G., Evans, J. P., et al. (2013). Characterizing biobank organizations in the U.S.: results from a national survey. Genome Medicine, 5, 3. The pinpoint for 373 is page 7.
Kinkorová, J. (2015). Biobanks in the era of personalized medicine: Objectives, challenges, and innovation: overview. The EPMA Journal, 7(4), 1–12.
Knoppers, B., & Zawati, M. (2011). Population biobanks and access. In P. Zatti & S. Rodota (Eds.), Il Governo del Corpo: Trattato di Biodiritto (pp. 1181–1194). Giuffrè Editore.
Kouri, R., & Philips-Nootens, S. (2012). L’intégrité de la personne et le consentement aux soins. Yvon Blais.
Laurie, G., & Postan, E. (2013). Rhetoric or reality: What is the legal status of consent forms in medical research ? Medical Law Review, 21(3), 371–414.
Prudham, S. (2007). The fiction of autonomous invention: Accumulation by dispossession, commodification and life patents in Canada. Antipode, 39, 406–429.
Saulnier, K., & Joly, Y. (2016). Locating biobanks in the Canadian Privacy Maze. The Journal of Law, Medicine and Ethics, 44, 7–19.
Winickoff, D. E., & Winickoff, R. N. (2003). The charitable trust as a model for genomic biobanks. The New England Journal of Medicine, 349(12), 1180–1184.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2018 Springer International Publishing AG, part of Springer Nature
About this chapter
Cite this chapter
Joly, Y., Pinkesz, M. (2018). The Governance Framework of North American Biobanks: A Rapidly Evolving Policy Patchwork. In: Bioy, X. (eds) Public Regulation of Tumor Banks. Springer, Cham. https://doi.org/10.1007/978-3-319-90563-1_13
Download citation
DOI: https://doi.org/10.1007/978-3-319-90563-1_13
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-90562-4
Online ISBN: 978-3-319-90563-1
eBook Packages: Law and CriminologyLaw and Criminology (R0)