The Art and Science of Genetic Modification: Re-Engineering Patent Law and Constitutional Orthodoxies

As a lawyer interested in biotechnology, I find it difficult to restrict myself to any one of the many interconnected areas in which law and biotechnology intersect. Administrative law, constitutional law, criminal law, employment law, environmental law, evidence, family law, insurance law, intellectual property law, the law of succession, and tort law, to name but a few, all impinge on this rapidly developing technology. But since, unlike Dolly the sheep, we are, for the present, confined to what we think of as our real age and real time, it might be prudent to focus today on one area in particular, knowing that this too will involve inevitable excursions into related areas of law. Thus I am going to concentrate on intellectual property law, and in particular patents, and my emphasis today will be on medical rather than agricultural developments. Patent law illustrates several of what I perceive to be the most important legal issues arising from biotechnology. While I am attempting not to stray too far from patent law, it is, however, difficult to resist noting in passing that several individuals have paid significant fees to sign up with an organization that has purported to copyright their DNA or genetic code in order to protect their intellectual property rights to themselves for the day when others clone them without permission. Such cloning may eventually be possible from a hair removed, for instance, from a coat hanging in a cloakroom. Some potentially fascinating criminal as well as civil law issues arise in that context, not least in relation to theft, misappropriation, and trade dress or passing off, but we must save those for another day. It suffices for the moment to note that, from a website that appeared in 2001, the DNA Copyright Institute offers services including archiving clients’ genetic data (for use, for example, as evidence in DNA misappropriation actions). The “Institute” makes no claim that the company will register DNA with the Copyright Office of the Library of Congress and no direct claim that such a registration is possible. Nonetheless, it quotes from the Copyright Act and proclaims that “it should be possible for any person to establish a DNA Copyright for themselves [ sic ].” We are not, however, told how a work is created for this purpose, or when the crucial creation occurs.

We shall also see that litigation over patents on biotechnological inventions can give rise to questions of constitutional law and environmental law, as in the case of the patent on the Harvard mouse, which has been tested on constitutional grounds by the Supreme Court of Canada, and on environmental grounds by the European Patent Office. The mouse was genetically engineered to be particularly susceptible to cancer. We shall return to Harvard and its famous mice shortly.