On March 20th, 2012, the Supreme Court ruled in the case of Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., a case that has been avidly followed by those in the biotech and pharmaceutical industries.
The decision in favor of Mayo was a reversal of an earlier ruling by the Federal Circuit. The Federal Circuit ruling deemed that Mayo infringed upon the patent held by Prometheus on a test to determine thiopurine metabolite levels in the blood by releasing their own version in 2004. Since that time, the two companies have engaged in protracted, high stakes legal struggle which may have left those unfamiliar with the industry struggling to understand what all the fuss over an obscure medical procedure was about. However, the Supreme Court’s ruling in Mayo v. Prometheus is of vital importance to any inventor, individual and corporate alike. Let’s dissect it more carefully, starting with what exactly a “natural law” is in this context.
A scientifically-minded person would describe a natural law as something out of a physics textbook. A classic example would be the structure of an atom: a nucleus made out of protons and neutrons, surrounded by a cloud of electrons. This basic structure is identical for every known atom in this universe. Legally speaking, the definition of a natural law or process is somewhat broader. In the case of Mayo v. Prometheus, the Supreme Court ruled that the relationship between the amount of a particular chemical – as determined by the amount of metabolite – in the body and the actions/toxicity of that chemical is a natural law. By extension, a test that measures the amount of metabolite present in the body in order to determine the correct course of treatment merely grows from the natural law described above.
In plain English: whether or not a patient has the desired (not negative) reaction to a certain concentration of drug is both universal and natural. A test to determine the concentration of a drug in order to determine dosage just builds on that fact in a quantitative manner. Prometheus cannot patent such a test.
There are several issues with this ruling. First, any doctor will tell you that each and every patient has a different reaction to drug dosages. While there is certainly a range of doses within which many people will have approximately the same reaction, there is enough variability to make a strong case for the development of systems to customize individual dosage. Based off of this fact, it is too far reaching to say that drug reactions are natural laws. Personalized medicine relies heavily on the ability of the medical provider to precisely measure how an individual reacts to the dosage of a certain drug. If the precedent is set such that testing systems such as those developed by Mayo and Prometheus are “unpatentable”, then it stands to reason that this will strongly limit the development of personalized medicine.
Second, patents are supposed to incentivize invention by giving the inventor exclusive intellectual property rights. Whoever holds the patent for a particular invention acts as a gatekeeper; no one can make, use, sell, or distribute the invention without the patent holder’s permission. Granting a temporary monopoly to the patent holder makes the expensive and time consuming process of invention economically worthwhile. In the biotech and pharmaceutical industries, research and development costs are extremely high and it may take many years for a drug to get from the lab to the consumer. Patenting a new drug or technology is the way that companies recoup these costs.
Third, there is a valuable distinction to be made between a natural process and the observation of and action upon that process. Consider a very simplistic example of a fire burning: as the fire burns, the log turns into ash, heat, and smoke. Someone sitting next to the fire using it for warmth observes that the fuel has almost been completely consumed, so they add another log. Observation of and action upon the concentration of a drug in a patient’s body is complicated by the fact that we cannot see how much drug there is at any given moment and respond accordingly, but it is clear that the process and the observation/action are not the same.
While the Supreme Court may have been right to rule that Prometheus’s claim of patent infringement could not be upheld, it should have been primarily based on the fact that the tests were fundamentally dissimilar, not because the occurrence of a natural process and how it observed and acted upon are one and the same.
A potential positive effect of the ruling would be to discourage cases like Apple v. Samsung. As of August 2011, the combined tally of suits and countersuits had reached 19, taking place in a dozen courts, in nine countries and four continents. Although no conclusive research has been performed on the impacts this vicious legal battle has had on customers and shareholders, it certainly increases the cost of doing business for both entities. These costs are passed onto consumers. Imagine if the products produced were not cell phone and tablets, but essential medical goods and technologies, and this sort of litigation takes on new ethical dimensions. A balance needs to be struck between patents that incentivize innovation, and patents that crush competition and negatively impact consumers.
Since the Mayo v. Prometheus ruling is so recent, it is yet to be seen what material impact, if any, it will have. Many industries besides biotech and pharmaceutical develop and market products that could be said to build off of natural laws and processes. The Supreme Court has certainly set a bold precedent and it will be interesting to see how it will be both challenged and supported.