I have written on this topic before. See my past article Patenting Medical Devices and Procedures. But the question remains. The court can not make up its mind. What is an invention that is eligible for patenting? Specifically, in regard to novel medical diagnostic techniques, the court continues to stumble over the issue of whether the technique is merely an application of “natural law”.
The situation has gotten so bad that the US Court of Appeals for the Federal Circuit has thrown up its hands and requested the Supreme Court provide some clarification. But the Supreme Court has thus far refused. Where does that leave us? It leaves us in the land of “maybe”, close to the province of “it depends”.
The case at issue is Athena v. Mayo. Athena developed a new diagnostic test that required the creation of manmade molecules to cause naturally occurring proteins to bind to the molecular marker. The occurrence of the binding demonstrated that the patient suffered from a heretofore un-diagnoseable condition.
Although not clearly stated by the Court, it is apparent that this binding action was a natural phenomenon based upon the molecular structures of the naturally occurring protein and the manmade molecule. Recall from my previous posts that it is not possible to patent a natural phenomenon or abstract idea. This is the so-called Section 101 exception.
The majority of the Court believed the invention required the natural phenomena or natural law of molecular binding to achieve its objective and utility. The dissent of the Court believed the invention was the creation of manmade molecules of a unique structure that caused the binding action, thereby allowing the detection of the protein and hence the medical malady.
Note the facts are not really in dispute, but rather it is how the facts are viewed. Thus the spin put on the facts determines whether an invention is patentable. I am not sure this is how the law should work.
Apparently the justices of the Court of Appeals for the Federal Circuit agree. They feel, however, that the past decisions of the Supreme Court have created this problem. But since we a “spinning” facts, could it be that the Court of Appeals is mis-interpreting or mis-applying the decisions of the Supreme Court?
In any event, the situation is untenable. How can the inventor know whether she has created a patentable invention if the answer is dependent where a future and unknown judge will land on a subjective matter. When is the color red red enough?
Note that this situation reinforces my previously repeated advice that it is necessary to anticipate these problems in drafting the patent application. It is not merely necessary to “teach enablement” but also to describe the invention in terms of its being patentable subject matter.
Although not all decisions can be stated as a bright line test or clear as black and white, the existing situation is now total unpredictability. If the investment of developing a method of medical diagnosis cannot be protected, what is the incentive for making the investment?
© David McEwing 2020