March 21, 2012
(Editor’s note: The Supreme Court typically hands down quite a few decisions in the month of March, some of these being quite significant. Throughout the month, we’ll be looking at some of these significant decisions as they are announced.)
Click here for the first post on Kiobel v. Royal Dutch Petroleum.
Click here for the second post on life without parole for a 14 year old.
The Supreme Court has grappled for decades with the question of what in nature can be patented.
The general rule has been that things in nature (including the laws of nature and natural phenomena) aren’t patentable, though 1980’s Diamond v. Chakrabarty created a notable exception – allowing the patenting of genetically-modified organisms.
Yesterday, the Court released its opinion in Mayo Collaborative Services v. Prometheus Laboratories, another case dealing with patents in nature.
Instead of creating another exception, a unanimous Court invalidated the two patents in question.
Given what the former patents covered, the Court would have lost a lot of credibility had it actually upheld the patents.
The patents in question were owned by Prometheus Laboratories, and they covered a process in determining the proper use of thiopurine drugs (which are used to treat autoimmune diseases).
Because patients metabolize these drugs differently, it’s difficult for doctors to determine the safe and effective dosage level for a given patient.
Enter Prometheus’s patents, which covered processes instructing a doctor on how to determine a safe dosage for a patient based on that patient’s blood test results.
In other words, the patents protected an instruction book detailing how the relationships between concentrations of certain metabolites in the blood affect the likelihood that a thiopurine drug dosage will prove ineffective or cause harm to the patient.
Yes, that does sound like it belongs in a medical journal or textbook, but apparently Prometheus believed it was patentable.
As did the Mayo Clinic (at least initially), since it had bought and used diagnostic tests based on Prometheus’s patents until it wised up and started doing its own (and then Prometheus sued, which eventually led to this decision).
In its ruling, the Court held that this correlation between the blood test results and thiopurine drug effectiveness fall into the “laws of nature” category, and is therefore not patentable.
In addition, the Court held that the processes of Prometheus’s patents are not patentable unless “they have additional features that provide practical assurance that the processes are genuine applications of those laws.”
Loosely translated from legalese: a patentable process has to be an invention in some form, unlike Prometheus’s patents’ processes, which were, as the Court noted, “well-understood, routine, conventional activity.”
The Court actually broke down the process into fairly simple terms:
(1) measure (somehow) the current level of the relevant metabolite,
(2) use particular (unpatentable) laws of nature (which the claim sets forth) to calculate the current toxicity/inefficacy limits, and
(3) reconsider the drug dosage in light of the law.
Presented as such, the process certainly doesn’t sound anything but conventional (at least to doctors, the intended audience).
As such, the Court essentially found that Prometheus was trying to “monopolize the correlations” between the patient blood test results and the appropriate thiopurine dosage.
To use an admittedly less precise analogy, this would be like someone trying to patent the correlation between the height from which a person falls and the injuries that he or she is likely to sustain.
It should go without saying that such information is within the realm of the “laws of nature” and is thus unpatentable.
Strangely enough, given the number of amicus curiae supporting Prometheus’s position, it doesn’t seem that everyone is on board with this proposition.
Instead, Prometheus and its amici contended the opposite: that discoveries of the laws of nature should be patentable.
This difference of opinion is irrelevant, though.
With the Court’s ruling in the Mayo v. Prometheus, all laws of nature, even newly discovered ones, remain beyond the scope of patent protection.