Genetic engineering and digital technology concept.

The ‘Res Nullius’ Construction of Human Genomic Data

By Donrich Thaldar

No one domain of the law holds exclusive sway over human genomic data. Instead, genomic data have a multidimensional legal nature, meaning that multiple legal domains — including property law, privacy law, contract law, and intellectual property law — are all applicable. This opens the door for different persons to have rights originating in different legal domains with respect to the same genomic data.

To determine who has rights with respect to a particular person’s genomic data, the rules of each relevant legal domain must be applied. The application of these rules to genomic data may be relatively straightforward in some domains, but in property law — which is relevant in determining ownership of genomic data — it is often more complicated. Only a handful of jurisdictions have specifically legislated on the ownership of genomic data. In the absence of such specific legislation that provides who owns genomic data, general property law rules must be applied. (In common law legal systems, and some mixed legal systems where legislation is absent, this would entail resorting to the jurisdiction’s common law.) However, given the novelty of applying property law rules to genomic data, it is not always obvious which of the general rules would apply. In this post, I will share some of my research group’s thinking in this regard. Although our thinking is based in South African law, many of the principles are shared with other legal systems.

Let’s begin!

A helpful start is to consider the genesis of genomic data as a legal object. There is genetic information (i.e., facts about heredity) encoded in the DNA of every cell in a human body. However, in its natural form (i.e., encoded in DNA) genetic information is neither capable of human control, nor useful in conscious human activity. Accordingly, genetic information locked up in DNA does not qualify as a legal object. It is only when DNA is sequenced and genomic data are generated (i.e., when facts are collected for analysis and stored digitally), that there is something — a data instance — that is capable of human control and useful in conscious human activity, such as genomics research. It is at this point that a legal object comes into being. (And to reiterate, because we can control computer files, we can own them — they are digital property, and often quite valuable!)

How to acquire a new legal object

As genomic data are newly generated, an original mode of acquisition of ownership must apply. There are only two original modes of acquisition that are potentially relevant to genomic data, namely (a) acquisition of fruit (which would view genomic data as the fruit of DNA), and (b) acquisition of a res nullius (which would view genomic data as a res nullius — literally “nobody’s thing” — that can be acquired by whoever first takes effective control of it with the intention of being the owner).

The construction of genomic data as fruit

Can genomic data be viewed as the fruit of DNA? We suggest not. In property law theory, the fruit-bearing object is not only a necessary antecedent of the fruit — it must produce the fruit. It seems contrived to suggest that DNA produces genomic data. More aptly, DNA is being described by the genomic data. Accordingly, the construction of genomic data as the fruit of DNA does not fit well with property law theory.

Would a solution be to construct genomic data as the fruit of something other than DNA? This is an interesting possibility, but problematic, as genomic data are generated by a sequencing process that makes use of a multiplicity of distinct objects, ranging from sequencers in the lab, to cloud servers using software as a service — all of which may have different owners. By contrast, classic property law theory contemplates the fruit being produced by a singular fruit-bearing object. Also, can the objects involved in the sequencing process properly be described as themselves generating the data, analogous to an apple tree producing apples? Although much of the sequencing process is automated, the equipment and software used in the sequencing process are best conceived of as instruments in the hands of the lab technicians. Accordingly, it is doubtful whether a construction of genomic data as fruit can theoretically be sustained.

The lab technicians’ labor?

If we accept that genomic data are generated by lab technicians, can such lab technicians have a claim to owning the data based on their labor? Investment of (intellectual) labor can be a ground for the vesting of rights, but only if the product falls within one of the well-defined kinds of intellectual property (IP), such as copyright or patents. The issue with genomic data — I am referring specifically to “raw” sequence data — do not qualify for either copyright or patent protection. If a dataset is compiled with the genomic data of various individuals, such a dataset may, in certain jurisdictions, qualify for IP protection. However, this possibility in IP law does not solve the property law problem of original acquisition of ownership of a newly generated genomic data instance.

I should mention that the European Union (EU) is indeed considering creating a new right for data generators in the data that they generate. However, this new right will not include human genomic data.

The construction of genomic data as res nullius

Given that the construction of genomic data as fruit has proven to be unsustainable, and given that no other mode of original acquisition of ownership offers even the superficial possibility of being applicable to genomic data, the only remaining option is that a newly minted genomic data instance belongs to no one — it is res nullius. This construction allows for original acquisition of the genomic data instance through occupation, which requires the will to be the owner and effective control of the object. The result is quite workable: The lab technicians conducting the sequencing will be best placed to acquire ownership on behalf of their employer, as they will already be in effective control of the genomic data.

What about the data subject?

But, what about the person to whom the genomic data relates — often referred to as the “data subject” — should this person not automatically be deemed the owner of the genomic data? Well, no. Having a personal connection with an object is no legal ground for claiming any property rights in such an object. If the personal connection is of such a nature that it may reasonably impact one’s privacy, it may give rise to privacy rights in respect of the object. In the context of informational privacy, over the past decade or two, many jurisdictions have enacted data protection statues. And although some privacy rights may appear property-like, it does not mean that privacy law has been subsumed by property law. Each of these legal domains has its own distinct theoretical foundations, structures, and rules. To illustrate with an old-fashioned example: I can get an injunction against you to destroy a stockpile of pamphlets — your property!— that contains libelous statements about me. This does not mean that my dignity is my property. It simply means that different legal domains interact in a dynamic way and that rights with a basis in one legal domain of the law can, depending on the jurisdiction and the circumstances, supersede rights with a basis in another legal domain.

To conclude

The res nullius construction of genomic data is the only way to provide a sound legal-theoretical basis for the acquisition of ownership of a genomic data instance. Once such a basis is established, the rights entailed by ownership can be distributed through contract. Importantly, however, certain rights in the ownership bundle are likely to be encumbered by the data subject’s informational privacy rights. It is the task of smart technology lawyers to carefully delineate the extent of such encumberment.

dthaldar

Donrich Thaldar is a professor of law at the University of KwaZulu-Natal, Durban, where he chairs the Health Law & Ethics Research Interest Group. His research interests are reprolaw and genetics and the law. He is currently principal investigator of an NIH-funded project that investigates the legal aspects of data science in health innovation in Africa. Donrich also has a private law practice, where he specializes in strategic litigation in reprolaw. Before starting his academic career in 2017, he practiced as a litigation lawyer at the Pretoria Bar. He served as legal counsel or as amicus curiae in several landmark cases in the field of reprolaw in South Africa. Some highlights are: The first case that considered the concept ‘designer children’ (2016); the first case of posthumous conception (2018); the first case of gamete withdrawal from a comatose person (2020); and the first case about the enforceability of a sperm donor agreement (2021); and a successful legal challenge to the constitutionality of the statutory prohibition on non-medical preimplantation sex selection (2022).

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