Imagine a world of great biotechnological promise where the hope of preventative, diagnostic and treatment medicine to illness and disease is more of a reality than ever before. Further, imagine that this world has, in hand, a map of the entire human genome with bits of DNA no longer lying in wait for discovery but available for use, want and ownership. Therein lies the rub – how can we achieve break-through therapeutics if the very bits and pieces we need to realize such revolutionary medicine are tucked away as someone’s property? And let us be clear, it is not YOUR property. It belongs to someone else. So imagine no longer! This is the world we all currently inhabit, whether we know it or like it.

Once upon a time, naturally-occurring products were disallowed patent-eligibility; that is until the extraction and purification of organic compounds from nature brought a shift in stare decisis where genes and their products became patentable by way of an exaggerated extrapolation of utility fulfilling the patentability of chemical compounds. Almost concomitantly, a premise for patenting human tissues and genetic products was developing and the seminal case of John Moore v. The Reagents of the University of California contributed significantly to establishing this within existing patent law. Moore suffered from Hairy Cell Leukemia and underwent 5yrs of treatment at the UCLA Medical Center when a cell line was established using his T-lymphocytes. This commercial exploitation of Moore’s genetic materials was done entirely without his knowledge, much less his consent. The case raised questions about rights surrounding tissues and cells removed from the body, including ownership of Moore’s extracted DNA – did Moore own the cells from which the genetic information was taken, did he own the genetic information itself, or did he own both? In A Theory of Law and Information: Copyright, Spleens, Blackmail and Insider Trading (1992), James Boyle insightfully reduces Moore to issues of information; of primary interest to this reader was the abstract issue of property claim over Moore’s genetic information.

Boyle argues that the treatment of information, regardless of context, is shaped by recurring patterns of contradictions between “public” and “private” information. For Boyle, some areas of IP fit the romantic author mold better than others, where the justification for property rights is based on the “controller of information”; genetic information being one of those areas. On this the question becomes, who is the controller – the source, the manipulator, the public? This was an obvious point of issue in Moore and Boyle recounts the primary lines of reasoning, namely that Moore was absolved of owning those parts of his body given up to research due to their eventual use and destruction eliminating “so many of the rights ordinarily attached to property”. Yet, Moore’s body parts remained enforceable for ownership by the doctors? That is rather harsh proof given to the old adage, “One man’s loss is another man’s gain”.

To the Supreme Court of California, Moore’s genetic material is “no more unique to Moore than the number of vertebrae in the spine or the chemical formula of hemoglobin.” For Boyle and this reader, it is difficult to reconcile this reasoning given that Moore’s T-cells were extracted for the very reason of their altered functionality. While these examples demonstrate aspects of invariable physicality associated with genetic information, it neglects to consider the source of such information – the genes themselves – DNA that can be different in any given individual in any given population at any given time. Existing patent law supports the patenting of genes by their definition as chemical compounds, so in Moore the connection between genetic material and chemical formula is not a surprising leap. Nevertheless, it is in keeping with a reductionist notion. Using the court’s mention of the hemoglobin gene superfamily by way of example, the structural similarity defining the gene products (i.e. proteins with inscribed “chemical formulas”) cannot be assumed tell-tales of functional homology because amino acid sequence variations can impart significant differences in vertebrate development and oxygen-carrying properties. Such misnomers of what a gene is and how it can behave can have significant implications for medical diagnostics and therapeutics, particularly given the non-monist definition of a gene that is evolving ever-so eloquently.

Under most legal systems you cannot market your spleen because you do not own parts of your body as authoritatively as you may own your computer. As in Boyle, with our need to ground certain rights associated in ideological functions of property, certain types of legal possession adhere to instinctive facts of ownership. Although, the positive legal theorist considers this erroneous; the law is a societal construct, so we can decide what is acceptable to own and what is not. From my perspective, we should not be comparing spleens to computers in the first place and furthermore, the decision in Moore aligns with a recurring problematic “one size fits all” application of the patent system with respect to genetic products. Somewhat confusingly however, the court decided that while Moore has no enforceable interest in isolated parts of his body the researchers who isolated them do. This reader agrees with Boyle in that the court’s assessment here exemplifies the imperialistic rhetoric of the public domain and puts a devious spin on the utilitarian justification of the propertization of body parts and genetic information. The push and pull between “public” and “private” information has been unfortunately foisted onto what has become something of a four-letter word – the ‘gene’. To be fair, the definition of a ‘gene’ is complex and scientists could probably tell you more about our jeans than our genes. But this does not justify notions of misnomers, misunderstandings or the mundane. It certainly should not make room for the reductionist view either, nor should we be satisfied with such a view because we would do well to remind ourselves that parts of you and me remain patentable.

Vanessa Scanga is an LLM Candidate at Osgoode Hall Law School.

Posted in Access to Medicines, Patent Practice, Patentability, Patents