Under United States patent law, the landmark Supreme Court decision in Diamond v. Chakrabarty established the patentability of human-made life forms, except for those encompassing a human organism. The America Invents Act of 2011, and decisions from lower courts such as Moore v. Regents of University of California, reaffirm the unpatentability of human organisms and limit an individual’s rights to their own genetic material. Prior to Association for Molecular Pathology v. Myriad Genetics, Inc, which struck down the patentability of human genes as well, the decision in Diamond led to the proliferation of gene patents and the growth of the global biotechnology market. While the debate over the patenting of human genetic material, and individual rights, rages on, DNA-gathering companies such as 23andMe and Ancestry.com routinely utilize their customer’s genetic material for multi-million dollar pharmaceutical research. This research not only raises ethical concerns, but can also pose a potentially dangerous biosecurity threat based on the many ways this genetic material can be used to target individuals, groups, and nations.
The patentability of genetic material has proposed a complex and ongoing debate within the field of patent law. Various competing interests inherent to the U.S. patent system collide with moral and ethical questions regarding the commodification of human DNA. While corporations and private inventors should rightfully be compensated for their efforts and investments in the production of biotechnology and genetic innovations, patents on human genetic material are often viewed by critics as a significant impediment to scientific progress. The American Medical Association, for example, has openly voiced their opposition to the patenting of human genes, stating that gene patents, “interfere with diagnosis and treatment…quality assurance…access to health care…[and] scientific and medical innovation.” Although the Supreme Court has struck down the patenting of naturally occurring human genes, synthesized human genes remain patentable subject matter and a topic of debate.
In addition to these considerations, corporations such as 23andMe.com and Ancestry.com—which store collected DNA samples from their customers—raise new questions concerning an individual’s intellectual property interests in their own DNA, as well as privacy rights. Furthermore, although companies like 23andMe.com and Ancestry.com assure customers that their genetic material remains firmly within their control when they entrust it to the companies for analysis, critics have been quick to point out that, in actuality, such companies entice people with the promise of genealogical information in order to pile up genetic information for commercial research. Collaborations between such companies and large pharmaceutical corporations—such as 23andMe.com’s $300 million stake deal with GlaxoSmithKline—presents new opportunities for DNA-collecting companies to profit off of their customers’ genetic information while increasing the likelihood of their customers’ most private information being exposed to those who may use it for nefarious purposes.
While relevant case law and statutory regulations can impart some insight into the potential answers for these legal concerns, the acquisition of controlling interests in DNA-collecting corporations—such as the aforementioned 23andMe.com and Ancestry.com—by foreign entities raises new questions in the areas of biosecurity and biosafety which legislators and courts are yet to fully address.
DNA, or deoxyribonucleic acid, is the chemical name for the molecules in humans and almost all other organisms which carry genetic instructions. These integral instructions, which are passed down from parent to child, are found inside the nucleus of every human cell, and provide the genetic code necessary for an individual to develop, live, and reproduce. DNA is composed of molecules known as nucleotides, and each nucleotide is composed of a phosphate group, a sugar group, and a nitrogen base. The four types of nitrogen bases are adenine (A), thymine (T), guanine (G), and cytosine (C). The order of these bases is what determines an individual’s genetic code; however, despite the vast diversity amongst human beings as a species, out of the three billion bases which comprise human DNA, more than 99% of these are the same in all people.
Nucleotides pair up with each other—adenine to thymine, and cytosine to guanine—to form base pairs. These base pairs are arranged in two long strands that form a spiral called a double helix. The double helix is further organized structurally into chromosomes. Through the process of transcription, the double helix is unwound, and an enzyme known as an RNA polymerase uses the now single-stranded DNA as a template to synthesize a complimentary strand of RNA. This synthesized RNA strand further undergoes the process of translation to synthesize the body’s various proteins, and a human being’s observable phenotypic traits.
2.2 The United States Patent System
The foundation of the United States patent system can be in found in the Patent and Copyright Clause of the U.S. Constitution which declares that, “[Congress shall have Power] to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” Title 35 of the United States Code, which governs all aspects of patent law in the U.S., further clarifies that, “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” An inventor who successfully obtains a patent has essentially received a government-issued grant which confers “[the] right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States….” This right to exclude lasts for “20 years from the date on which the application for the patent was filed in the United States….”
Three types of patents are available to inventors:
(1) Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof;
(2) Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture; and
(3) Plant patents may be granted to anyone who invents or discovers asexually reproduces any distinct and new variety of plant.
In order for an inventor to obtain a U.S. patent, the invention in question must satisfy four initial requirements for patentability: novelty, utility, non-obviousness, and the invention must be eligible subject matter. Under 35 U.S.C. § 102, an invention is deemed novel if it was not “described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.” In regards to utility, this requirement stems from 35 U.S.C. § 101, noted above, which dictates that an inventor must invent some, “useful process, machine, manufacture, or composition of matter, or any new and useful improvement.” Meanwhile, an invention is obvious:
If the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.”
Finally, much like utility, the confines of eligible subject matter were outlined in 35 U.S.C. § 101: processes, machines, manufactures, or compositions of matter. While laws of nature, physical phenomena, and abstract ideas remain outside the realm of patentability, these four areas of patentable subject matter have been, “cast in broad terms to fulfill the constitutional and statutory goal of promoting the progress of science and the useful arts.” As noted by Chief Justice Burger in Diamond v. Chakrabarty, “anything under the sun that is made by man” can be patented.
2.3 The Origins of Corporate DNA Collection
23andMe is a privately held personal genomics and biotechnology company which was founded in 2006 to provide genetic testing and interpretation to individual consumers. The company is “best known for providing direct-to-consumer genetic testing service in which customers provide a saliva sample that is laboratory analyzed to generate reports relating to the customer’s ancestry and genetic predispositions to health-related topics.”
Once a sample is received by the company, the customer’s DNA is extracted from the saliva, genotyped, and applied to a glass microarray chip which has many microscopic beads applied to its surface. These beads contain probes which match the DNA to the various variants the company tests to determine predispositions for more than ninety traits ranging from baldness to blindness. If the DNA sample has a match in the microarray, the sequences will bind together in a process known as hybridization. This process lets researchers know that a particular variant is present in the customer’s genome. Tens of thousands of variants are tested out of the 10 to 30 million located in the entire genome. These matches are then compiled into a report that is supplied to the customer, allowing them to know if the variants associated with certain diseases, such as Parkinson’s, Celiac, and Alzheimer’s, are present in their own genome.
Customers who purchase tests with ancestry-related components gain online access to genealogical DNA test results, and the company’s relative-matching database, while customers who purchase the health-related component of the test receive online access to an assessment of inherited traits and genetic disorder risks. “As of February 2018, 23andMe has genotyped over 3,000,000 individuals.”
Meanwhile, Ancestry.com, LLC is a privately held online company based in Lehi, Utah. In addition to being the largest for-profit genealogy company in the world, it operates a network of genealogical and historical records, and related genetic genealogy websites. Beginning in 1983, the company we now know as Ancestry.com operated as Ancestry Publishing, publishing several family history magazine titles and genealogy reference books. Beginning in 1996, Ancestry Publishing launched Ancestry.com which paved the way for compiling family histories online. By 2018, Ancestry.com compiled the DNA of over 10 million people in its consumer DNA network, making it the largest in the world. Additionally, the company: has three million paying subscribers; has sold 14 million DNA kits similar to those used by 23andMe for DNA collection; and has a database containing 10 billion historical records.
3 The Development, Scope, and Debate over the Patenting of Human Genetic Material
3.1 Case Law, Regulations, and the Foundations of Patenting Human Genetic Material
The dawn of genetic and biotechnology patenting is traditionally marked by the landmark Supreme Court decision in Diamond v. Chakrabarty in 1982. There, the Supreme Court granted certiorari to determine whether a live, human-made micro-organism was patentable subject matter under 35 U.S.C. § 101. As noted previously, the Court determined that 35 U.S.C. § 101 was designed by the legislature to have a wide scope and a broad construction. While the Court reiterated that laws of nature, physical phenomena, and abstract ideas remain unpatentable subject matter, “[Chakrabarty] has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.” Despite the dissenting opinion’s view that the majority had given § 101 a substantially broader interpretation than Congress had ever intended, the United States Patent and Trademark Office (USPTO) recognized the subject-matter eligibility of all forms of life other than human beings after Diamond v. Chakrabarty.
Through the America Invents Act (AIA) of 2011, Congress reaffirmed Diamond v. Chakrabarty and the USPTO’s policy on the unpatentability of human beings, stating that, “[n]otwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.” However, as many have pointed out since the enactment of AIA, the bounds of what constitutes a “human organism” have never been properly defined. The Congressional Record indicates that Congress did not intend § 33 of the AIA to limit individuals from obtaining patents on: (1) chemical compounds or compositions obtained from human beings; (2) cells, tissues, organs, or other bodily components synthetically produced by inventors; (3) human cells, genes, or other tissue obtained from human embryos or bodies; (4) stem cells, stem cell lines, hormones, proteins or other substances produced by human organisms; and (5) methods or processes for creating embryos via in vitro fertilization. Meanwhile, the Congressional Records indicate that Congress did intend to prohibit patents on: (1) a human being in any form; (2) a human organism at any stage of development; (3) human embryos; (4) human fetuses; (5) human-animal chimeras; (6) “she-male” human embryos; and (7) human embryos created with genetic material from more than one embryo. Essentially, “If the broadest reasonable interpretation of a claimed invention encompasses a human being, the claim is regarded as non-statutory at the USPTO.”
While Diamond v. Chakrabarty and the AIA closed the door on the patentability of “human organisms,” private and public entities alike were given tremendous latitude in regards to the patentability of human genes until Association for Molecular Pathology v. Myriad Genetics, Inc. Beginning in 1990, the Human Genome Project (HGP) was an, “international, collaborative research program whose goal was the complete mapping and understanding of all the genes of human beings.” Over the thirteen-year span of the project, details regarding the structure, organization, and function of approximately 20,500 human genes were mapped and disclosed for public knowledge. While HGP had a profound impact in numerous fields such as molecular medicine, human evolution, anthropology, and genomics, it also led to the patenting of over 4,300 human genes by governments, individuals, and private and public entities involved in research and pharmaceuticals.
In 2013, Myriad changed the landscape for genetic and biotechnology patents by invalidating all gene patents held for naturally occurring genes and gene sequences up to that point. In Myriad, Myriad Genetics, Inc., had discovered the precise location and sequence of two human genes (BRCA1 and BRCA2) which substantially increased the risk of breast and ovarian cancer when mutated. Myriad filed for patents which not only gave them the exclusive right to isolate the genes but also the exclusive right to synthetically create complimentary strands of DNA, known as cDNA, from the genes. Because isolation of the genes was necessary to conduct the genetic testing for breast and ovarian cancer, Myriad held a monopoly on the testing for women, and filed infringement suits against labs, research facilities, and medical schools which attempted to offer the testing as well. A researcher, Dr. Harry Ostrer, along with medical patients, advocacy groups, and other doctors filed suit seeking a declaration that the patents were invalid subject matter under 35 U.S.C. § 101.
The Supreme Court determined that: “(1) isolated DNA involved a naturally occurring segment of DNA, precluding patent eligibility; and (2) synthetically created DNA known as complementary DNA (cDNA) was not naturally occurring, as would preclude patent eligibility.” The primary point of dispute within the Court’s deliberation centered on whether the act of isolating a DNA sequence constituted an inventive act which entitles the individual who isolates it to a patent. To this point, the Court noted that, “Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them … separating that gene from its surrounding genetic material is not an act of invention … that discovery, by itself, does not render the BRCA genes new compositions of matter [under § 101] that are patent eligible.” However, the Court reached a different conclusion in regards to the synthesized cDNA. “[T]he lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a product of nature and is patent eligible under § 101.”
By result of Myriad, all of the gene patents which came out of the era of the Human Genome Project were effectively invalidated, earning the praise of organizations like the American Medical Association (AMA) and the National Institute of Health (NIH), but leaving some uncertainty in the biotechnology community in regards to biotech patent protection. While AMA and NIH have gone on record and submitted amicus curiae briefs to the Court to highlight the dangers inherent in allowing gene patenting, companies and researchers within the biotech field who would normally commit to the substantial investment necessary to conduct beneficial biotechnology research may now be more hesitant to do so knowing that their investment will not result in the exclusivity and profits which patent protection provides. This balancing act between protecting public interests and incentivizing inventors to create beneficial inventions for the welfare of our society highlights just one aspect of the ongoing debate regarding gene patenting.
3.2 The Lockean and Utilitarian Justifications for the Patenting of Human Genes
Lockean labor theory and utilitarianism not only lay the ideological foreground for the U.S. patent system but also the initial argument and justifications for the patenting of human genetic material. While one may suggest that granting an individual or a corporate entity a twenty-year monopoly to exclude others from making, using, or selling their gene-related invention hinders the market or the free-flow of knowledge and experimentation necessary for scientific advancement, the patent system draws upon ideologies from Lockean labor theory and the theory of utilitarianism for its justification. Under Lockean labor theory,
every man has a ‘property’ in his own ‘person’ and the ‘labor’ of his body and the ‘work’ of his hands… thus … whatsoever he removes out of the state that Nature hath provided … [and] mixed his labor with it, and joined to it something that is his own, [he] thereby makes it his property.
Regarding patent law, the Lockean theory suggests that once an inventor takes goods that are common to all individuals on Earth, and applies their own labor and ingenuity to it, they should naturally have a property interest in their own invention. However, rather than the patent system rewarding the inventor for their labor, in actuality, the inventor is being rewarded for the social value and benefit to society their invention brings. It is for this reason that to be eligible for a patent an invention must be useful, in addition to novel, and nonobvious.
Meanwhile, the utilitarian justification for the U.S. patent system dictates that:
But for the prospect of the right to exclude in the form of a patent or copyright, there will be inadequate incentives resulting in a less than optimal output of information goods. If producers of such goods cannot recoup the cost of creating them and copiers can free-ride on this effort, fewer such goods will be produced in the first place to the detriment of consumers and society overall. Hence, under the utilitarian theory, the happiness of members of the community is maximized by granting property rights in one’s inventive contribution.
In the case of patent law, utilitarianism recognizes that intellectual property rights inherently restrict liberty, but tolerates this restriction for the sake of the greater public good. Without the benefits granted by patent protection, inventors and innovators alike would be less incentivized to produce useful processes, machines, manufactures, or compositions of matter which benefit our society as a whole.
Combined, Lockean labor theory and utilitarianism present foundational arguments as to why individuals, researchers, pharmaceutical companies, and other corporate entitles should be entitled to patents in human genetic material. The global biotechnology market is expected to reach an estimated value of $727.1 billion USD by 2025 with a compound annual growth rate of 7.4%. In order to fuel this lucrative market—and the many useful breakthroughs, treatments, and inventions which result—pharmaceutical and biotechnology companies are required to invest billions in research, facilities, equipment, and qualified staff, to name a few expenses. Inherent in these substantial investments is the expectation that their efforts will be rewarded with some level of intellectual property protection for their labor, as the Lockean theory suggests. Likewise, under the utilitarian point of view:
The promise of exclusionary rights … provides the investment incentive for the research and development of innovative products that are essential for the public good. The primary asset of most small biotech companies is intellectual property, vis-à-vis patents, and the commensurate right to exclude is essential to justify the high cost and risk of investment. Consequently, an inability to enjoin infringement would diminish economic power and value of patent rights.
Investors should not only be granted intellectual property rights to compensate them for their investment as the Lockean view suggests but also to incentivize them to continue their efforts for the public good as the utilitarian view suggests.
3.3 The Public Interest Justification Against the Patenting of Human Genetic Material
During the onset of Association for Molecular Pathology v. Myriad Genetics, Inc., the healthcare community rallied against the patenting of human genes, and the many threats such patents posed to public interests and the healthcare industry. One of the many organizations who ardently opposed the patenting of human genes during this time was the American Medical Association (AMA), who argued in their amicus curiae brief submitted to the United States Court of Appeals for the Federal Circuit, that gene patents interfered with: diagnosis, treatments, quality assurance, access to health care, and scientific and medical innovation. These arguments are partially evidenced by the fact that the controversy in Myriad began when Myriad Genetics brought patent infringement suits against laboratories which were providing genetic testing services for breast and ovarian cancer to women using their gene sequence.
Within AMA’s amicus curiae brief regarding Myriad, the organization expanded upon the dangers posed by gene patents. In terms of the hindrance gene patents posed to diagnostic exams, physicians and researchers regularly received cease-and-desist letters at that time to stop conducting crucial diagnostic tests for ailments such as neurodegenerative conditions of the cerebellum, hereditary hemochromatosis, cystic fibrosis, and Canavan’s disease. In terms of treatment interference, gene sequence patent holders would regularly exclude labs and researchers from using said sequences to determine if an individual would benefit from specific drug regimens. In other words, researchers were unable to determine if a certain drug would help or harm the general populace without infringing the patent holder’s rights. At times, such barriers to healthcare innovation were even known to cost patients their lives. For instance, the University of Utah Research Foundation patented a gene sequence for a heart disorder known as Long QT syndrome. When the company with the exclusive license to administer the diagnostic testing for the condition was unable to offer the exam for a period of time due to internal issues, at least one patient—a ten-year-old girl—died unnecessarily when several qualified institutions could have administered the diagnostic exam if not for the patent holder’s right to exclude them from doing so.
In addition to hindering the availability of such exams, patents on gene sequences unnecessarily raised exam prices, making them inaccessible for many. Because gene patent holders were able to charge royalties for access to their intellectual property, patients were being charged for diagnostic exams which they could have received for a fraction of the cost at other labs. Myriad Genetics, for example, charged $3,000 for the diagnostic test involving the breast cancer genes BRCA1 and BRCA2, despite the existence of other labs who were willing to offer the test for a third of the cost. Likewise, patents on the Long QT gene noted above drove the cost of the diagnostic exam up to $5,400 when the test could have been done for a fourth of that amount elsewhere.
Gene patents posed an additional threat to scientific innovation. At the time, it was estimated that up to 49% of the members of the American Society of Human Genetics had to limit their research due to gene patents. A survey of directors at laboratories which performed DNA-based genetic tests, indicated that 53% had not developed tests out of fear of infringing patents, and a fourth had stopped performing certain genetic tests because of patent restrictions or excessive royalty costs.
As a final argument, AMA addressed utilitarian concerns regarding fears that investors and corporate entities would be insufficiently incentivized to develop new biotechnology innovations without patent protection in gene sequences. AMA argued that clinical laboratories routinely developed genetic diagnostic exams without the incentive provided by patents on gene sequences.
Once gene sequence information is made public, moreover, existing incentives to provide medical care are already more than sufficient to encourage the development of tests and to perform comparisons to those genes. [P]atents were not needed to develop genetic tests for hearing loss, SCA [spinocerebellar atrophy], breast cancer, LQTS [long-QT syndrome], Canavan disease, and HH [hereditary hemochromatosis]. Indeed, all of these tests were on the market before the test offered by the relevant patent-rights holder. Scientists were searching for and finding genes long before patents were available for them, and there is no evidence that the grant of gene patents (as opposed to the patent on the gene sequencing machine) facilitated this process. 
Combined, these arguments highlight the many potential threats to the healthcare industry presented by gene patenting and serve to explain the healthcare community’s enthusiastic response to the holding of Myriad. While investors and corporations have a natural right to the fruits of their labor according to the Lockean view, these rights can potentially harm the public good more than serve its interests. However, as noted in Myriad’s holding, interested parties still have an opportunity to receive patent protection for their synthesized, non-naturally occurring gene sequences. In this manner, patent law attempts to draw the line between rewarding beneficial ingenuity and protecting naturally occurring phenomena from privatization.
4 Intellectual Property Rights, Privacy Rights, and the Biosecurity Concerns Inherent in the Collecting of Human Genetic Material by Corporations
4.1 Corporate Use of Customer DNA for Private Research
Due to the work of companies such as 23andMe.com and Ancestry.com, fresh privacy, biosecurity, and intellectual property, concerns have arisen over the use of an individual’s genetic information to generate profits for researchers and pharmaceutical companies. On the surface, both companies gather DNA samples from customers to generate ancestral reports and health reports on genetic predispositions, but beyond that:
The long game for these companies is not to make money selling genetic testing, but rather to become the Google of personalized health care. For this reason, they prompt customers to sign consent forms before shipping their samples to the lab. These forms provide testing companies with a royalty-free, worldwide, sub-licensable, transferable license to host, transfer, process, analyze, distribute, and communicate the individual’s genetic information.
These two companies represent only a fraction of similar business acquisitions and mergers involving corporations acquiring genetic databases for lucrative research. For example, Decode Genetics sold their genotyped data and medical records to a biopharmaceutical company called Amgen in 2012 for $415 million. Likewise, seven international pharmaceutical companies came together to fund the study known as “FinnGen” which aimed to collect biological samples of 500,000 participants in Finland over six-years for genetic research. Based on such dealings, it’s been estimated that the average international price per unit of DNA is roughly worth $3,300 to companies in the biopharmaceutical industry.
4.2 Biosecurity Threats Inherent in Transactions Involving Genetic Databases
While both 23andMe and Ancestry boast extensive adherence to laws regarding privacy and data protection on their company websites, critics have been quick to point out that mergers and business transactions which grant third-parties access to sensitive genetic data significantly increase the odds of data leaks and privacy violations. Hackers are prone to attacking large dossiers of health information like those maintained by 23andMe and Ancestry. “Such information is considered to be valuable on the black market and guarded by low levels of security.”
In the last few years, over 1,000 cyberattacks have targeted genetic databases. These attacks are expected to increase, and become more difficult to prevent, as genetic data falls under the control of medical researchers, commercial enterprises, and law enforcement. While 23andMe and Ancestry have not publicly released information on a major cyberattack affecting their customers, MyHeritage—an Israel-based ancestry platform where users can create family trees and search through familial and historical records—made headlines in June of 2018 when they announced 92 million customer email addresses and passwords had been found on a private server. While their customer’s DNA data and credit card information was safely stored in a separate system which had not been breached, this incident reflects the ongoing threat posed by cyberattacks on the industry.
In addition to the looming threat cyberattacks pose to paid customers, leaked genetic data can also lead hackers to family members. Because 23andMe and Ancestry analyze genetic data for the purpose of tracing ancestry, their customers’ information can also be used by hackers to hunt down relatives. Even when genetic data is anonymized—which both companies claim is standard procedure to protect customer privacy when sending data to third parties—“researchers have demonstrated that by cross-referencing anonymous DNA data with datasets that include personal information, such as voter or census rolls, they can correctly ‘re-identify’ significant portions of participants.” Because customers share DNA with parents, siblings, and extended family, comparing anonymous DNA samples with identified ones allows interested parties to figure out who relatives are, and who the anonymous customer actually is. “Since roughly 2009, researchers have demonstrated that by comparing large sets of supposedly anonymous DNA data with public datasets from censuses or voter lists, they could correctly identify between 40 and 60% of all genetic testing participants.”
The potential dangers posed by the leaking of genetic data was significant enough to warrant a warning from the Pentagon for U.S. military members. In December of 2019, a memo from the Undersecretary of Defense for Intelligence stated that, “Exposing sensitive genetic information to outside parties poses personal and operational risks to Service members.… These [direct-to-consumer] genetic tests are largely unregulated and could expose personal and genetic information, and potentially create unintended security consequences and increased risk to the joint force and mission.” This memo is additionally notable for providing little detail in regards to how genetic profiles could endanger security for military personnel; however, the involvement of the Pentagon’s intelligence chief suggests there may be concerns in regards to biometrics. Biometric data, such as DNA, fingerprints, and facial recognition, have been crucial in helping the U.S. track down foreign enemies. If biometric information on national security personnel were leaked, this could in turn expose them to the foreign enemies, posing a major biosecurity concern. In fact, the rise in the use of DNA swab tests at international airports is one reason CIA operatives have limited their use of aliases while traveling abroad. More recently, legal scholars, such as Erin Murphy of New York University’s School of Law, have theorized that foreign governments who are wary of potential operatives in their country will soon be turning to commercial genetic databases to unmask spies. Additionally, even if the operatives themselves did not pay for any DNA services, the genetic data of a relative who signed up could potentially be used to expose them and their operations.
While concerns involving genetic databases are traditionally focused on the threat of hackers and cyberterrorists, domestic law enforcement have also begun utilizing these databases to hunt down suspects, raising further questions about user privacy rights. In April of 2018—after a forty-year police investigation—72-year-old Joseph James DeAngelo, the man known as the “Golden State Killer,” was arrested for a spree of murders, rapes, assaults, and abductions in at least 10 counties in California between the 1970s and 1980s.
Equally noteworthy amongst the headlines of the arrest at that time was the method utilized by police to finally track down DeAngelo—“Genetic Genealogy.” Investigators from FBI, and the Contra Costa County District Attorney’s office created a fake profile on the genealogy website GEDmatch, and submitted the genetic profile of a DNA sample recovered from a 1980s murder scene. By having the DNA analyzed as if they were an individual seeking out distant relatives, they were able to construct a family tree which led them to two possible suspects. On April 18, investigators were able to retrieve a DNA sample from the door handle of DeAngelo’s car and his garbage can. Both samples matched those associated with the Golden State Killer crimes. Although successful, the method stirred controversy even amongst California law enforcement who were unsure about the privacy and legal implications. It’s been estimated that, “If you live in the United States and are of European ancestry, there’s a 60% chance you have a third cousin or closer relative in this database.” This implies that 60% of white Americans can be identified from a DNA sample even if they have never provided their own DNA to an ancestry database. Since the arrest, both 23andMe and Ancestry have added statements to their privacy policies and terms of service regarding their firm stance against granting law enforcement access to their customer’s DNA samples. However, both of the company’s databases can still be accessed by law enforcement with a proper court order or warrant.
4.3 Intellectual Property Rights and Privacy Rights in an Individual’s Own Genetic Material at the Federal and State Levels
While the various threats posed to the genetic privacy of American citizens have prompted legislatures to act at the federal and state level, relevant case law appears to discourage the concept of genetic material as private property or intellectual property, and few statutory regulations are in place to cover genetic privacy.
In Moore v. Regents of University of California in 1990, John Moore brought suit against his physician for a patented cell line derived from Moore’s spleen when it was removed by his physician to treat his leukemia. Unbeknownst to Moore at the time of the operation, his physician kept a portion of his removed spleen for research. The university acquired a patent which produced significant royalties and profits on the cell line; none of which went to Moore. Moore brought suit alleging conversion.
Moore partially grounded his theory of conversion on the premise of privacy rights, citing wrongful publicity cases in which individuals are recognized as having both an interest in their own likeness and a cause of action against unauthorized uses. Moore argued that an individual should have “a right in one’s own genetic material” because it is more unique to an individual than one’s name or face.
The California Supreme Court determined that the defendants sought to manufacture lymphokines from Moore’s genetic material which were, “the same in every person … no more unique to Moore than the number of vertebrae in the spine or the chemical formula of hemoglobin.” In regards to privacy, the court felt that “it is not necessary to force the round pegs of ‘privacy’ and ‘dignity’ into the square hole of ‘property’ because patients are protected under the legal theories of informed consent and fiduciary duty.” The Court ruled in favor of the defendants, determining that Moore’s rights did not include property and ownership rights in his own genetic material.
Similarly in Greenberg v. Miami Children’s Hospital Research Institute, Inc., donors had given human tissue and fluids to the Miami Children’s Hospital Research Institute in order to further their research on Canavan’s disease. The physician who had received the material used it to isolate the gene causing the disease, and proceeded to obtain a lucrative patent. The parents of the donors sued the physician and the hospital claiming: “(1) lack of informed consent; (2) breach of fiduciary duty; (3) unjust enrichment; (4) fraudulent concealment; (5) conversion; and (6) misappropriation of trade secrets.” Specifically in regards to the count of conversion, the plaintiffs alleged that they had a property interest in their body tissue and genetic information. However, the court declined to find a property interest in the body tissue and genetic information, especially in regards to genetic material that had been willingly donated to research. Citing Moore, the court noted that:
The California Supreme Court … held that the use of the results of medical research inconsistent with the wishes of the donor was not conversion, because the donor had no property interest at stake after the donation was made. No court has ever in a reported decision imposed conversion liability for the use of human cells in medical research. …the property right in blood and tissue samples … [evaporate] once the sample is voluntarily given to a third party.
The courts in Moore, as well as Greenberg, exemplify the reoccurring position in much of case law that individuals do not have an inherent intellectual property interest—or even a general property interest—in their own genetic material. However, privacy rights present a potential, but limited, avenue for the protection of genetic material.
Although the holding in Moore delivered a significant blow to the concept of genetic material as private property, six years later Congress began to address the need for further protection. One of the first pieces of legislation enacted to protect an individual’s health information was the Health Insurance Portability and Accountability Act of 1996 (HIPPA). Prompted by concerns that the disclosure of sensitive health information may prevent an individual from securing certain health plans or providers, “HIPAA prevents health care companies from denying coverage of an individual’s preexisting conditions based solely upon genetic information…. Furthermore, HIPAA sought to ensure that health care companies would not take into consideration an individual’s genetic information when assessing coverage eligibility or calculating health plan premiums.” However, in light of emerging technologies, HIPPA fails in many respects to safeguard genetic privacy. First, genetic testing companies fall outside of HIPPA because they are not the type of entities covered by the Act. HIPPA also neglects to provide a private cause of action when an individual’s medical information is improperly disclosed.
Acknowledging the lack of coverage provided by HIPPA, Congress signed the Genetic Information Nondiscrimination Act (GINA) on May 21, 2008. GINA prohibits employers and health insurances providers alike from discriminating based on genetic information. While GINA created additional safeguards, the Act fails to address genetic discrimination outside the areas of health insurance and the workplace, and also fails to address privacy violations in regards to the collecting and testing of genetic material.
Although most states lack legislation prohibiting the disclosure of an individual’s DNA, some have made note of the inadequate regulatory coverage at the federal level and have taken it upon themselves to provide further protection. Ten states currently have laws which address the protection of genetic material, but only Alaska, Florida, New Jersey, New York, and Oregon characterize DNA theft as a criminal act. Of those, Alaska and Massachusetts have been at the forefront, providing the strongest and broadest protection. Alaska’s Genetic Privacy statute requires, “written consent before a person can collect, analyze, or retain an individual’s DNA sample. The statute further requires written consent for the disclosure of an individual’s DNA analysis results.” Additionally, Alaska’s statute creates a private cause of action against individuals who retain or release DNA samples without consent. Damages can amount to $5,000 or $10,000 depending on whether the liable party’s violation resulted in profits or monetary gain. Meanwhile, Massachusetts’ Senate Bill 1080 goes as far as to declare an intent to create a “Genetic Bill of Rights.” In addition to imposing both civil and criminal penalties for violations, § 1(b) of the bill,
(1) allows an individual’s will to posthumously dictate the terms and use of their genetic information; (2) requires … an individual to receive fair market value compensation for their genetic information and be made aware that such information may be used for commercial purposes; and (3) mandates an individual to be notified, orally and in writing, that their genetic information is a commodity with inherent value prior to the individual contractually agreeing to share his or her genetic information.
While some state governments have taken it upon themselves to increase the regulatory protection of their citizens’ genetic information, legislative progress appears to be significantly lagging behind emerging innovations in this field. At the federal level, legislatures should ideally enact more safeguards for the protection of genetic information which cover entities beyond places of employment and insurance providers, such as DNA-gathering companies.
In addition to bolstering genetic privacy rights, some form of legislation should be put into place which not only regulates how DNA-gathering companies can use this genetic data but also monitors which third parties gain access to valuable genetic databases. Additionally, cyber-security will continue to be an ongoing issue for years to come, and legislatures must be prepared to meet the unique and evolving challenges it presents to better protect genetic material from those who would use it to track down and harm military members and civilians alike.
At the state level, legislatures should ideally follow in Massachusetts’ footsteps and begin to develop their own variation of a Genetic Bill of Rights.
Human genetic material remains a complex topic for the field of patent law to tackle. While researchers and pharmaceutical corporations should rightfully be compensated for their investments and efforts under Lockean Labor Theory and utilitarianism, the healthcare industry has notably presented a multitude of arguments in the interest of public health against the patenting of human genetic materials. While the Supreme Court made their stance clear in Myriad, that naturally occurring human genes are unpatentable—and Congress reaffirmed their stance on the unpatentability of human organisms in the American Invents Act—as technologies evolve, synthetically-created genes and the products thereof will continue to challenge lawmakers, and redefine the boundaries of patentable subject matter.
DNA-gathering companies such as 23andMe and Ancestry have steadily amassed a lucrative genetic database covering an astounding portion of the global population. While many substantial health-related benefits can come out of the ongoing research these databases are being utilized to conduct, third party involvement presents an opening for cyberattacks and privacy breaches. Until legislation which better safeguards genetic privacy rights and monitors the activities of these corporations is in place, the current landscape of these companies and their databases presents a significant biosecurity threat which will likely present more questions and challenges for lawmakers and ordinary citizens for years to come.
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