After a long silence, the Supreme Court has recently (2012-2013) re-opened its thoughts on a threshold question: what kind of inventions are patentable?
By way of background, scientific principles/laws are not patentable (in legalese, “non-patentable subject matter”); what is patentable are the applications of this knowledge. For example, law books are fond of quoting the famous equation E = mC2 as a something that cannot be patented. The policy basis behind this prohibition is that, if such fundamental knowledge is patented by someone, others cannot explore/develop the practical applications of this equation, and thus limit the “progress of useful arts”, a constitutional requirement for granting a patent in the United States.
Similarly, naturally occurring things substances and life forms cannot be patented.
Applying these legal principles,, the Supreme Court invalidated two patents, which I discuss in this short publication. The first patent (The Prometheus Case) deals with a method for individualization of the dose of a drug based on its (and metabolites) blood concentrations form from previous doses. In other words, this invention is an application of the principles of therapeutic drug monitoring. The second patent (The AMP Case) deals with the patenting of certain genes, and after several years of litigation in the lower courts, the Court finally concluded in 2013 that certain genes indicative of a women’s risk for breast cancer are not patentable because they are naturally occurring substances.
I welcome your thoughts and comments, especially from scientists, my major target audience.