Lawful vs. Just

Another newspaper story doesn't quite get it right. Time and again I read stories like this one in the Miami Herald in which gene patents are called "lawful" or proper, or whatnot, tracing their appropriateness to either the Chakrabarty decision or the Moore decision, or both. Simply put, neither case applies to unmodified human genes, which are at the heart of the ACLU case against Myriad. Chakrabarty involved the patentability of an engineered life form, and Moore involved the patentability of a product manufactured out of material extracted from human tissue. The latter turned on the issue of a waiver signed by the patient which gave rights to research and development based on the extraction to the defendant. It did not go the the Supreme Court of the US, just that of California.

Of course, I describe the history in greater depth in my book, and there are a number of excellent books, including The Gene Wars that detail how, using these cases as their precedent, Celera sought patents from the Patent and Trademark Office for human genes discovered in the course of their parallel and private Human Genome Project. The point it, the ACLU case will be one "of first impression" as this sort of legal challenge has not yet been made. The administrative decision of a government agency, including that which allegedly narrowed the applicability of gene patents, is not strictly speaking "law":

The regulation states: "If a patent application discloses only nucleic acid molecular structure for a newly discovered gene, and no utility for the claimed isolated gene, the claimed invention is not patentable. But when the inventor also discloses how to use the purified gene isolated from its natural state, the application satisfies the ‘‘utility’’ requirement. That is, where the application discloses a specific, substantial, and credible utility for the claimed isolated and purified gene, the isolated and purified gene compositionmay be patentable"

This is not "law" because it is simply a regulation, issued as guidelines for PTO examiners, promulgated by an administrative agency. Laws are debated and passed by legislators elected by citizens, while regulations and administrative guidelines might be passed or issued by bureaucrats, either with or without review or comment by the public or elected legislators. Generally, there is a call for public comment, and none is received because so few people ever hear of proposed regs. The point is, just because this regulation or "guideline" exists, doesn't mean it is lawful. Plenty of administrative rules, regulations, and guidelines turn out to be illegal, unconstitutional, or just plain stupid. In this case, I believe this one is all three. As I argue in my book, the "isolation and purification" requirement, if applied to analogous cases, would make the Devils Tower in Wyoming patentable as soon as someone drew an arbitrary border around it, isolating it from the surrounding environment, and stating that by so doing one has developed a use which includes finding the Devils Tower on a map (or any other geographic feature, for that matter).

So, let's get this straight once and for all. The PTO has been acting without legal precedent, and without legal guidance. Determining the legality of these gene patents can be done in only two ways: through legislation specifically making it legal or illegal, or through a court decision, ultimately by the Supreme Court. Unless you're of the school of thought that says whatever the government, or God help us, its bureaucracies, does is legal per se. But I'm sure you're not.