Federal Circuit Invalidates Patent Claims to Methods for Noninvasive Prenatal Testing of Fetal DNA
The recognition that fetal DNA could be recovered from maternal serum launched the development of non-invasive prenatal testing (NIPT) using cell free fetal DNA (“cffDNA”). NIPT testing can be used to identify chromosomal abnormalities or other genetic aberrations, and it offers an alternative to the invasive techniques of amniocentesis or chorionic villi sampling, both of which carry some risk to the fetus. Sequenom, Inc. holds the rights to the foundational U.S. Patent No. 6,258,540. Sequenom
sued Ariosa Diagnostics, Inc. (formerly Aria) and several other genetic
testing companies for infringement of the patent based on their
offerings of NIPT tests. Claim 1 of the patent is as follows:
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.
In Ariosa v. Sequenom (2015), the Federal Circuit has just ruled that the patent claims to methods for detecting and recovering the fetal DNA are invalid for lack of patentable subject matter (35 U.S.C. § 101). This patent case follows a sequence of recent Supreme Court decisions, AMP v. Myriad (2013) and Mayo v. Prometheus (2012) (Mayo) that each invalidated patent claims in the life sciences for a lack of patentable subject mater. At the trial court in 2013, the judge had granted summary judgment to Ariosa, ruling that the patent claims impermissibly claimed a natural phenomenon and thereby preempted other uses of the natural subject matter, an outcome in conflict with Supreme Court dictates. The Federal Circuit has just affirmed that lower court decision, relying on the analytic framework from Mayo to dissect the patent claims. The court summarized the Mayo test:
First, we determine whether the claims at issue are directed to a patent-ineligible concept. If the answer is yes, then we next consider the elements of each claim both individually and “as an ordered combination” to determine whether additional elements “transform the nature of the claim” into a patent-eligible application.
The court notes that the presence of fetal DNA in maternal serum is a patent-ineligible natural phenomenon (step 1) and then goes on to step 2, where it considers whether the other elements of the patent claim (detecting, amplifying) operate to transform the unpatentable natural phenomenon, deciding that they do not:
Thus, in this case, appending routine, conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept. Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art. The claims of the ’540 patent at issue in this appeal are not directed to patent eligible subject matter and are therefore, invalid.
Judge Linn filed a concurrence, but made it clear that he did so because Mayo demanded the application of a fairly unforgiving test, and without that standard, he did regard the Sequenom method claim to be patentable:
But for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.
Thus, the Federal Circuit has reinforced an analytic approach to the patentable subject matter question of method claims that applies the Mayo framework. Mayo requires that if a patent claim reads on a natural phenomenon, all of the surrounding elements of the claim are analyzed separately to determine if they supply an “inventive concept.” This claim dissection does appear to conflict with a well-known maxim from Diamond v. Diehr (1981), and antecedent to Mayo, that patent claims need to be evaluated as a whole, not as set of constituent parts:
In determining the eligibility of respondents' claimed process for patent protection under § 101, their claims must be considered as a whole.
Ariosa can be added to a line of life science patent cases that are struggling with several issues: how to precisely identify when a natural phenomenon or law of nature is present in a patent claim; and how to evaluate the eligibility of a patent claim that embeds natural subject matter but does not preempt that use.
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