CAN YOU PATENT A DIAGNOSTIC TEST?
Yes, but it remains challenging.
The patent laws provide that any new and useful process can be patented.
However, laws of nature, natural phenomena, and abstract ideas cannot be patented. Yet, applications and uses of such laws and phenomena can be patented.
If an invention (as described in a patent claim) is directed to laws of nature or natural phenomena, it may still be patentable if the patent claim includes features that "transform" the nature of the claim into a patent-eligible application.
Diagnostic inventions continue to remain in a gray area of patentability - since they can involve laws of nature or natural phenomena.
As an example, Stanford University held patents entitled "Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients." CareDx licensed the patents.
The patents related to diagnosing organ transplant status. When a recipient rejects a transplanted organ, the recipient's immune response destroys donor cells, resulting in the release of the donor's cell-free DNA. Detecting the amount of the donor's cell-free DNA indicates the likelihood of rejection.
The Federal Circuit summarized the patent claims as: 1) obtaining a sample from the recipient, 2) analyzing the cell-free DNA, 3) identifying naturally occurring DNA from the donor organ, and 4) using the natural correlation between high cell-free DNA levels and transplant health to determine potential rejection.
CareDx conceded that it did not invent the relationship between donor cell-free DNA and the likelihood of organ rejection. The patents indicated that the steps in the patent claims were "conventional techniques."
The Federal Circuit concluded that the patent claims "add nothing inventive because they merely recite standard, well-known techniques in a logical combination to detect natural phenomena." "Applying standard techniques in a standard way to observe natural phenomena does not provide an inventive concept."
This recent Federal Circuit decision reaffirms that just observing natural phenomena will not lead to a patent. What may transform the conventional observation into patentable subject matter may be a unique method of observation. Or it may be a non-natural process that is used to reach the observation.