The United States Court of Appeals for the Federal Circuit issued its opinion reviewing a lower court’s ruling that Sequenom’s use of cell free DNA (“cfDNA”) for its tests like MaterniT21 is not patentable. Here’s how the appellate court ruled.
The lower court decision
In 2011, Sequenom was the first cfDNA laboratory to offer what was then called “non-invasive prenatal testing” or “NIPT.” In the winter months of 2011 and early 2012, Ariosa and Natera sought to bring to market their NIPT offerings, Harmony and Panorama, respectively. In response to this market competition, Sequenom sent them letters threatening claims of patent infringement.
Ariosa and Natera moved forward with offering their tests and filed lawsuits against Sequenom seeking a declaratory judgment that they were not infringing on Sequenom’s patent, referred to as the ‘540 patent. Sequenom filed counterclaims for infringement on the ‘540 patent.
The lower court ruled that Sequenom’s ‘540 patent was not, in fact, patentable. It did so in the wake of the Supreme Court issuing its decision concerning another lab, Myriad, and its testing technology for BRCA1 and BRCA2, genes associated with elevated risk for breast and ovarian cancer.
The Supreme Court ruled that because BRCA1 and BRCA2, being human genes, they were therefore naturally occurring phenomena, which are not patentable. Further, the methods used by Myriad for detecting BRCA1 and BRCA2 were not so innovative as to make those methods patentable, either.
The lower court ruled that the same applies to Sequenom’s methods for detecting cfDNA:
[T]he claims of the ‘540 patent merely apply “conventional techniques” to the newly discovered natural phenomenon of cffDNA.
The inventive concept was to take a known method and to look at [it] in place where people were–where the Federal Circuit and all the experts agree were throwing waste away to look there.
They used conventional tools to make it useful to other people.
(emphasis added). Sequenom, obviously, disagreed with the ruling and appealed to the United States Court of Appeals for the Federal Circuit. (For more on the lower court decision, see this post).
The United States Court of Appeals for the Federal Circuit Opinion
The legal analysis used by the Federal Circuit was based on another Supreme Court decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012). In Mayo, the Supreme Court established a two-step review process. The first step is whether “the claims are directed to a patent-ineligible concept.” If so, then the second step is whether there is an “‘inventive concept’–i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.”
Regarding the first step, the Federal Circuit concluded that cfDNA screening (what NIPT is now increasingly being referred to as), is directed at a patent-ineligible concept. “The Supreme Court has long held that there are certain exceptions to [what is patentable]: laws of nature, natural phenomena, and abstract ideas.” With regard to naturally occurring phenomena, those are not inventions, since they’re naturally occurring, but rather discoveries, which are not patentable. The Court noted that “[i]t is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon. … The method therefore begins and ends with a natural phenomenon.” As such, cfDNA in and of itself is not patentable.
Therefore, for Sequenom’s cfDNA screening to be patentable, it had to use such an “inventive concept” as to warrant patentability.
Leading into its analysis, the opinion states that “[a] claim that recites an abstract idea, law of nature, or natural phenomenon must include ‘additional features’ to ensure ‘that the [claim] is more than a drafting effort designed to monopolize the [abstract idea, law of nature, or natural phenomenon].” Essentially, what Sequenom otherwise would have been seeking to do with its cease-and-desist letters it sent to its competitors Ariosa and Natera, unless Sequenom’s cfDNA screening was patentable. To be patentable, “the process steps are the additional features that must be new and useful.”
The opinion considered how Sequenom had described the process used for its cfDNA screening. In the ‘540 patent, it states that “[t]he preparation of serum or plasma from the maternal blood sample is carried out by standard techniques.” In applying for the ‘540 patent, Sequenom described its methods for detecting chromosomal conditions using cfDNA as “techniques [that] are a matter of routine for one skilled in the art for the analysis of DNA.”
These admissions by Sequenom led the Federal Circuit to conclude that:
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.
The Federal Circuit addressed Sequenom’s final argument regarding the significance of cfDNA screening.
Seqeunom also notes that “the method reflects a significant human contribution in that [Drs.] Lo and Wainscoat combined and utilized man-made tools of biotechnology in a new way that revolutionized prenatal care.” We agree but note that the Supreme Court instructs that “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [patentability] inquiry. … While Drs. Lo and Wainscoat’s discovery regarding cfDNA may have been a significant contribution to the medical field, that alone does not make it patentable.
Even while this case wound its way through the lower and now appellate court, Ariosa, Natera, and an ever-increasing number of other laboratories have pressed on with offering cfDNA screening. Now with this appellate decision ruling Sequenom’s patent is invalid, it can only be expected that more laboratories will pursue offering cfDNA screening. Absent a reinterpretation by the United States Supreme Court, there will not be a claim that Sequenom can make that competitors are infringing on its “revolutionary” biotechnology.