Since the 1970s when genetically-engineered bacterium capable of breaking down crude oil was held to be patentable subject-matter, much attention has been paid to the patenting of living inventions. This topic continues to elicit passionate responses. The curious case of xenobots, which are living machines assembled from frog cells, highlights some of the challenging questions living inventions pose to the patent system. The potential of xenobots is enormous, including use as a novel vehicle for intelligent drug delivery. At the same time, xenobots raise important questions regarding the patenting of living inventions.
Xenobots – Living machines that can kinematically replicate
Xenobots have recently featured in the mainstream media for being the world's first living machines and for being capable of self reproduction. Xenobots were developed by scientists at the University of Vermont, Tufts University, and the Wyss Institute for Biologically Inspired Engineering at Harvard University. Xenobots are made from frog cells (Xenopus laevis). When individual skin and heart muscle cells are removed from their native embryonic microenvironments and reassembled in a specific fashion, they self-organize into a functional morphology that exhibits distinct behaviours from the genomically specified default. In other words, the frog's skin and heart cells no longer function as skin and heart cells normally would (as individual components of a tadpole's body), but rather they become an entirely new independent organism that utilizes their unique morphological characteristics to enact tasks. For example, xenobots can exhibit coordinated locomotion via cilia present on their surface. They can navigate aqueous environments in diverse ways (including swimming and walking), heal after being damaged, show emergent group behaviors, and reproduce (by kinematical replication).
Xenobots are expected to have industrial applicability:
Given their nontoxicity and self-limiting lifespan, they could serve as a novel vehicle for intelligent drug delivery or internal surgery. If equipped to express signaling circuits and proteins for enzymatic, sensory (receptor), and mechanical deformation functions, they could seek out and digest toxic or waste products, or identify molecules of interest in environments physically inaccessible to robots. If equipped with reproductive systems (by exploiting endogenous regenerative mechanisms such as occurs in planarian fissioning), they may be capable of doing so at scale. In biomedical settings, one could envision such biobots (made from the patient's own cells) removing plaque from artery walls, identifying cancer, or settling down to differentiate or control events in locations of disease.
A research article, entitled "A cellular platform for the development of synthetic living machines", written by Xenobots' creators identifies that some relevant patent documents include U.S. provisional patent application No. 63/136,564 (for Engineered Multicellular Organisms) and international patent application No. PCT/US2021/013105, neither of which is presently available for public inspection.
Living inventions as patentable subject-matter
In Canada, the landmark decision dealing with the patenting of living inventions is Harvard College v. Canada (Commissioner of Patents). In that decision, the Supreme Court of Canada considered the validity of a patent for a genetically modified mouse with heightened susceptibility to cancer. The Court held that higher life forms such as mice, as well as plants and animals, are generally not patentable subject-matter. In contrast, lower life forms are generally considered to be statutory "manufactures" or "compositions of matter". The Canadian Intellectual Property Office ("CIPO")'s Manual of Patent Office Practice provides further guidance. In particular, the Manual provides that lower life forms (usually unicellular) include: "microscopic algae; unicellular fungi (including moulds and yeasts); bacteria; protozoa; viruses; transformed cell lines; hybridomas; and embryonic, pluripotent and multipotent stem cells." Higher life forms (usually multicellular) include: "animals, plants, mushrooms, fertilized eggs and totipotent stem cells."
Are xenobots patentable subject-matter? This question challenges the technological validity of any legal dividing line between higher life forms and lower life forms.
Xenobots blur the dividing line between higher life forms and lower life forms. Xenobots can "replicate kinematically by moving and compressing dissociated cells in their environment into functional self-copies." The individual, genetically unmodified, dissociated cells may be considered lower life forms. However, the functional self-copies of xenobots are something more. Xenobots' ability to transition between a single cell lifestyle and life as a relatively sophisticated multicellular organism challenges the line between higher and lower life forms.
Xenobots are not the only curious case; slime molds offer another interesting example of a life form that does not fit neatly into the metaphysical divide between higher and lower life forms. Slime molds are an informal category of taxonomically diverse organisms that can in some circumstances transition between a single cell lifestyle and life as a cooperative multinucleate or multicellular organism behaving in a unified manner. These characteristics have been leveraged to create living computational tools from slime molds .
So are xenobots higher life forms or lower life forms? Nature has worked to blur any clear taxonomic dividing line, which leaves the resolution of a clear legal dividing line in doubt. Xenobots are structurally akin to multicellular organisms, artificially assembled from non-genetically modified cells of fertilized embryos. In current practice, the Canadian Intellectual Property Office takes the policy position that fertilized eggs are a higher life form; however, in the Harvard Mouse decision where the Court opined that fertilized eggs are patentable compositions of matter. These disparities again highlight the challenges of basing a legal dividing line between patentable and unpatentable biological subject matter on an ill defined conception of "higher" and "lower" life forms – when that distinction is undermined by the intricate nuances of biology.
Apart from xenobots themselves, there are related aspects of more clearly patentable subject matter. The processes by which xenobots are made are likely to fall within patentable subject-matter. Further, the use of xenobots for particular purposes may be patentable subject-matter.
In addition to patentable subject-matter, xenobots raise questions about other foundational patent doctrines. For example, xenobots reflect the fact that biology is in many ways becoming more predictable in an engineering sense. Living machines (and other biological systems) can now be constructed to behave in predictable ways. This may mean that over time, there is more room for prophetic biological innovation, and correspondingly less room for non-obviousness to be grounded in 'surprising' empirical biological results. More specifically, the basis for a sound prediction of utility in Canadian patent law may be more easily found for biological subject matter than in the past, because the prophetic outcomes of some biological manipulations can be predicted with confidence. This gradual and incomplete shift in biology from empiricism to rationalism has the potential to cut the other way in patent law, restricting the scope for patentability in some cases, in the sense that the unpredictability of biological systems often underpins the non-obviousness of biological innovations. Part II of the Curious Case of Xenobots explores other challenging patent questions posed by xenobots.
As our biotechnological capabilities continue to advance, the commercial importance of protecting investments in living inventions increases, and the number and importance of patents related to living inventions will likely also increase. Questions about the impact of these innovations on our society as a whole are distinct from focused jurisprudential issues relating to patentability. Nonetheless, patent law in this field is likely to continue to be shaped by a wider discussion of the societal impacts of these technologies. The Harvard Mouse decision in Canada provides an example of patent jurisprudence intersecting with biological science in the context of public policy. Xenobots are yet another illustration that living inventions will continue to give rise to fascinating moral, ethical, and societal issues, all of which play into the ever shifting boundaries of patent law within the context of broader public engagement.