The United States Court of Appeals for the Federal Circuit is deciding whether to reconsider en banc its panel decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. Numerous amici have lined up in support of rehearing. At stake is what room recent U.S. Supreme Court jurisprudence leaves for obtaining patent claims involving diagnostic innovations that use established processes.
The patent claims methods of using cell-free fetal DNA (“cffDNA”). Id. at 3. The Sequenom researchers who obtained the patent had discovered that such cffDNA could be found in a pregnant mother’s blood serum and plasma. This discovery meant that information such as the fetus’s gender, paternity, and certain genetic defects could be determined from a mother’s blood sample rather than from riskier and more invasive procedures which obtain genetic material from the placenta or the fetus. Id. at 3-4.
The claimed methods involve (1) amplifying cffDNA taken from maternal plasma or serum and (2) detecting the cffDNA inherited from the father. Id. at 3. These methods were marketed as a diagnostic test by Sequenom. Competitors Ariosa Diagnostics, Inc., Natera, Inc., and Diagnostics Center, Inc. sought declaratory judgments that their own tests did not infringe Sequenom’s patent. On cross motions for summary judgment, the district court found Sequenom’s claims ineligible under 35 U.S.C. § 101 because, “the steps of amplifying and detecting were well-understood, routine, or conventional activity in 1997, when the application . . . was filed.” Id. at 7.
The Federal Circuit’s § 101 analysis was similar. Under § 101 of the Patent Act: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor… .” However, as reaffirmed by Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014), natural phenomena, laws of nature, and abstract ideas are excepted from eligibility. Furthermore, as the Gibbons IP Law Alert has written previously, after Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) a court applying Alice must evaluate whether the claims are directed to one of those patent-ineligible concepts and, if so, whether additional elements transform the nature of the claim into patent-eligible subject matter.
On the facts presented, the Federal Circuit found that:
the asserted claims …. are directed to a multistep method that starts with cffDNA taken from a sample of maternal plasma or serum – a naturally occurring non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman. . . . The method ends with paternally inherited cffDNA, which is also a natural phenomenon. The method therefore begins and ends with a natural phenomenon. Thus, the claims are directed to matter that is naturally occurring. (Emphasis added)
Id. at 9. Not only were the beginning and end point natural phenomena, according to the Federal Circuit, but “[u]sing methods like [Polymerase Chain Reaction] to amplify and detect cffDNA was well-understood, routine, and conventional activity in 1997.” Id. at 11. The court concluded, “Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful. The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum.” Id.
Commentators and amici have criticized this decision – and implicitly the underlying Supreme Court decisions – as leaving little incentive for innovation in fields such as medical diagnostics. Most elaborate on the concerns noted by Judge Linn in his concurrence: that the Supreme Court’s ruling in Mayo seems irreconcilable with its statements in Diamond v. Diehr, 450 U.S. 175, 188 (1981), that “claims must be considered as a whole” “because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.” Under existing § 101 law a claim will likely be ineligible – regardless of how “ground-breaking” the invention or discovery; regardless of how much time and money is saved; and regardless of improvement to patient safety – if its “essence” involves a natural phenomenon.
Gibbons will continue to monitor developments in this area.