By Rachel Sachs
On Friday, the Court of Appeals for the Federal Circuit affirmed the district court’s judgment of invalidity of several claims in Sequenom’s diagnostic method patent on the grounds that they were not directed to patent-eligible subject matter under the relevant section of the Patent Act, 35 U.S.C. § 101. The case, Ariosa v. Sequenom, is important not only to those who have been following the recent back-and-forth between the Federal Circuit and Supreme Court on patent-eligible subject matter, but also to those who study medical innovation, as it implicates questions of innovation incentives and of access to an important new technology.
The case involves a technology known as non-invasive prenatal testing, or NIPT. Previously, pregnant women seeking to determine whether their fetuses possessed particular genetic abnormalities only had the option to undergo procedures, like amniocentesis, which pose a risk to the developing fetus. The scientists in this case made a startling discovery: there is a small amount of fetal DNA circulating in the pregnant woman’s plasma and serum. These portions of maternal blood samples had previously been discarded as medical waste, and the idea that genetic abnormalities could be discovered through a non-invasive procedure like a blood draw, which poses no risk to the health of the fetus, was groundbreaking. A patent on the method of detecting the fetal DNA in the mother’s serum or plasma was obtained, and Sequenom commercialized a test to practice the patent. Sequenom was soon embroiled in litigation with Ariosa and other companies which it believed were infringing its patent.
The Federal Circuit’s decision here is not very surprising. The judges simply applied the test set forth by the Supreme Court in its recent opinions in Mayo v. Prometheus and Alice Corp. v. CLS Bank: First, ask whether the claims are directed to a patent-ineligible concept. Here, they were: the existence of cell-free fetal DNA is a natural phenomenon. Second, ask whether the claims transform the natural phenomenon into a patent-eligible invention. According to the court, these claims did not. Like the method claims in Mayo and even in the Myriad case, they did not recite a particular application of the natural phenomenon, nor did they develop novel techniques for detecting the DNA.
But there are a host of interesting issues raised by this case. In the interest of space, I’ll consider just two here. First, Judge Linn filed a concurrence, recognizing that the Federal Circuit here is bound by the Supreme Court’s rulings in Mayo and Alice. But he wrote separately to express his strong disapproval with the direction the case law has taken. Judge Linn considered both prior case law and policy considerations in arguing that Sequenom’s patent is “truly meritorious” and that only the Supreme Court’s recent rulings compelled a different result. This discovery was a genuine breakthrough, and Judge Linn seems to believe that the Court has gone too far in limiting patent-eligible subject matter in recent years.
Second, this case does not resolve the question whether it is possible to craft any diagnostic method claim that will pass through the § 101 filter. At oral argument in Mayo, Justice Kagan suggested that adding a “treatment step” to the method claim in question would have changed the case, and that such a claim “clearly would have been patentable.” Sequenom’s claims, issued long before Mayo, did not include such a step and therefore did not resolve this question. A method claim involving such a step would run into other problems in a post-Akamai world (patent wonks interested in a more fulsome explanation of this issue might be interested in my recent paper, on innovation incentives in the personalized medicine context), but it might indeed be patent-eligible.
This case is surely not the last word on patent-eligibility. More and more claims are being invalidated at earlier and earlier stages of litigation, increasingly even at the motion-to-dismiss stage, and although in some cases this is surely a positive development, in others it may pose problems for innovation incentives. For instance, Judge Linn’s concurrence cited a 2013 article by Professor Becky Eisenberg, surmising that patents on new uses of old drugs may not be viable post-Mayo. The invalidation of Sequenom’s patent is the closest we’ve come to such a case, and industry may seek Congressional intervention soon.