Bottom line: Although the following patent case relating to eligibility of patent protection is set within the medical diagnostic realm, it may potentially be applicable to other technological areas. Diagnostic tests for detecting a biomarker and merely amplifying that biomarker using well-known techniques are ineligible for patent protection if the biomarker is a naturally occurring substance, as held in Ariosa Diagnostic, Inc. v. Sequenom, Inc. (Fed. Cir. 2015). However, the Federal Circuit hinted that extracting the naturally occurring substance out of a biological substance that was not known to contain the naturally occurring substance may be eligible for patent protection.
In this case, the Ariosa patent was directed to a method for detecting a small fraction of paternally inherited cell-free fetal DNA (“cffDNA”) in maternal plasma and serum to determine fetal characteristics (e.g., birth defects and gender). In particular, a diagnostic test was conducted on maternal plasma to look for cffDNA then culture the cells to amplify them, and then analyze the amplified material to determine fetal characteristics based on the level of cffDNA. This new method was truly revolutionary since maternal plasma was previously discarded and considered biological waste. No one would have thought to test maternal plasma for any useful biomarker until the inventors of the patent at issue did so. Nevertheless, this “invention” was held to be not eligible for patent protection.
Once the inventors discovered cffDNA in maternal plasma, they used a conventional, well-understood and routine method of amplifying and detecting cffDNA. The preparation and amplification of DNA sequencing in plasma or serum were well understood, routine, conventional activities performed by doctors since 1997. The patent specification also admits that the preparation of the plasma was done with standard techniques.
In invalidating the patent, the Federal Circuit focused its analysis on the claims at issue. They stated several times that a claim that begins and ends with the naturally occurring phenomenon (i.e., cffDNA) is not eligible for patent protection. A review of Claim 1 shows what the Federal Circuit means by stating that the claimed invention began and ended with the naturally occurring phenomenon (i.e., cffDNA).
Claim 1 reads:
1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises:
amplifying a paternally inherited nucleic acid from the serum or plasma sample and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
The claimed method takes naturally occurring paternally inherited nucleic acid (i.e., cffDNA), amplifies it then detects it. The naturally occurring cffDNA is not altered in any way. The claimed invention begins and ends with the same naturally occurring phenomenon, specifically, cffDNA and applies known methods to amplify the naturally occurring phenomenon.
At the end of the majority’s opinion, the Federal Circuit addresses the patent owner’s argument that the method should be eligible for patent protection because no one was previously using the plasma or serum of pregnant mothers to amplify and detect paternally-inherited cffDNA. In response, the Federal Circuit focused on the claims once again. They stated that “even if so, this is not the invention claimed by the ‘540 patent.” (emphasis added). In this way, the court hinted that this might be a way to obtain patent protection.
Claim 1 above assumes that the claimed diagnostic method starts after the paternally inherited nucleic acid is provided. Thereafter, the paternally inherited nucleic acid is amplified and detected. However, if the claims also recited the steps of extracting maternal plasma or serum from a pregnant mother then this may have been a sufficient basis to find for eligibility for patent protection. To put the situation differently, could a method of extracting oil out of a region having a particular characteristic previously thought to contain NO oil be eligible for patent protection? We won’t know except for future litigation.
Although this case was directed to diagnostic tests for biological treatment, this case could be applied to other technical arts that use diagnostic testing. However, at this point, the cases involving eligibility for patent protection have been predominantly limited to the biological and software arts, and we haven’t seen much spill over into the mechanical arts.
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