Tuesday, March 20, 2012

Medical Diagnostic Processes Not Patentable

In recent years medical companies have been getting patents on medical diagnostic techniques and processes.  In their simplest form, such a patent claims testing a patient to see if a certain disorder is present; and then reporting the result to the patient, or perhaps applying some treatment.  These patents have been controversial, since they potentially interfere with a doctor's ability to give advice to the patient, and with medical research generally.

Today the U.S. Supreme Court decided Mayo Collaborative Services v. Prometheus Laboratories, Inc.  The Court unanimously held that Prometheus was not entitled to a patent for treating a gastrointestinal disorder.  The patent covered administering a drug to a patent, testing the patent for the level of a metabolite, and increasing or decreasing the drug dose depending on the test result.  The patent apparently did not cover the drug itself, and did not cover any particular methods of administering the drug or doing the testing.

Justice Breyer's opinion held that the patent covered little more than a law of nature, which is not patentable under 35 U.S.C. §101.  The Court adopted a test of unpatentability for processes that merely "involve well-understood, routine, conventional activity":

In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field.  At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.

The opinion contained several other interesting statements:

If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.  A patent, for example, could not simply recite a law of nature and then add the instruction “apply the law.”  Einstein, we assume, could not have patented his famous law [E=mc^2] by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa).  Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float.
. . . even though rewarding with patents those who discover new laws of nature and the like might well encourage their discovery, those laws and principles, considered generally, are “the basic tools of scientific and technological work.”  Benson, supra, at 67.  And so there is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to “apply the natural law,” or otherwise forecloses more future invention than the underlying discovery could reasonably justify.
Patent protection is, after all, a two-edged sword.  On the one hand, the promise of exclusive rights provides monetary incentives that lead to creation, invention, and discovery.  On the other hand, that very exclusivity can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing arrangements.  At the same time, patent law’s general rules must govern inventive activity in many different fields of human endeavor, with the result that the practical effects of rules that reflect a general effort to balance these considerations may differ from one field to another.

This case will have broad implications for other cases.  For example, another highly publicized case involving patents on using genes to detect breast cancer is pending before the Supreme Court; next Monday the Court will likely send that case back to the lower courts for reconsideration in view of Mayo v. Prometheus.  Other cases dealing with §101 involve adding conventional things such as a computer to abstract concepts such as advertising, and those patents will be highly suspect in the future as well.

Here are discussions of the case by SCOTUSblog and the Patently-O blog.  UPDATE:  More posts by EFF, Techdirt and Michael Risch.


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