In recent years, the issue of patent eligible subject matter has been subject to heightened scrutiny by the U.S. Patent and Trademark Office, the Federal Circuit, and indeed, the Supreme Court. On June 12, 2015, the Federal Circuit again addressed this topic in Ariosa Diagnostics, Inc. v. Sequenom, Inc., wherein the court applied the framework set forth by the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., and reiterated the principle articulated in Association for Molecular Pathology v. Myriad Genetics, Inc., that “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.”1 Thus, the decision in Ariosa is applicable to all technologies and industries involving innovation in natural products and phenomena.
In Ariosa, the patent at issue (U.S. Patent No. 6,258,540) was directed to methods of using cell-free fetal DNA (“cffDNA”) in maternal plasma and serum. Particularly, the patent claimed methods of non-invasive prenatal diagnosis of fetal characteristics and abnormalities by amplifying paternally-inherited cffDNA from the serum or plasma sample of a pregnant woman and detecting the paternally inherited cffDNA. This patent related to the discovery of cffDNA in maternal plasma and serum, which prior to this discovery was typically discarded as medical waste. Sequenom was responsible for commercializing this claimed method, and its commercial test was regarded as a viable alternative to taking samples directly from the fetus or placenta.
The Federal Circuit considered this patent upon Sequenom’s appeal from a grant of summary judgment of invalidity. At the trial level, the United States District Court for the Northern District of California had found that the patent was directed to patent ineligible subject matter and was therefore invalid under 35 U.S.C. § 101. The Federal Circuit in Ariosa affirmed the decision of the district court using the two-step framework articulated in Mayo. Specifically, the Federal Circuit considered: 1) whether the claims are issue are directed to a patent ineligible concept (e.g., naturally occurring phenomena); and 2) whether the claims at issue contained an “inventive concept”—namely whether elements of the claims “transform[ed] the nature of the claim into a patent-eligible application.”2
Although it was acknowledged that methods can be generally patent eligible subject matter, the Federal Circuit determined from a review of the claims and written description of the patent that “[t]he method . . . begins and ends with a natural phenomenon.”3 The Federal Circuit noted that paternally inherited cffDNA in maternal blood is a natural phenomenon—it is naturally occurring and the location of the nucleic acids existed in nature before its discovery.4Moreover, the Federal Circuit found no dispute to the assertion that the inventors did not create or alter any of the genetic information encoded in the cffDNA.5 Accordingly, the Federal Circuit concluded that that the claims at issue were directed to naturally-occurring matter.6
Next, the Federal Circuit held that the claims at issue lacked an inventive concept.7 The Federal Circuit first repeated the Mayo principle that transforming patent ineligible subject matter into patent eligible subject matter requires “more than simply stat[ing] the law of nature while adding the words ‘apply it’”—it requires “additional features to ensure that the [claim] is more than a drafting effort to monopolize the [abstract idea, law of nature, or natural phenomenon].”8The Federal Circuit then cited to Parker v. Flook, stating that “[f]or process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful.”9 Using this guidance and analogizing to the facts in Mayo, the Federal Circuit in Ariosa concluded that methods like PCR to amplify and detect cffDNA were “well-understood, routine, conventional activities performed by doctors in 1997,” as evidenced by the specification, Sequenom’s own technical expert, and the prosecution history. As such, the Federal Circuit decided that the method of detecting paternally inherited cffDNA was not “new and useful.”10 Rather, the only “new and useful” subject matter recognized by the Federal Circuit was the discovery of cffDNA in maternal plasma or serum, which is a natural phenomenon.11 Holding that the method steps in the claims at issue failed to supply an inventive concept, the Federal Circuit therefore affirmed that the claims were directed to patent ineligible subject matter.12
After deciding that the claims were directed to patent ineligible subject matter, the Federal Circuit also addressed Sequenom’s arguments that the claimed methods would not preempt all uses of cffDNA. The concern with preemption is that “patent claims should not prevent the use of the basic building blocks of technology—abstract ideas, naturally occurring phenomena, and natural laws.”13As such, Sequenom argued that the claimed methods were narrow and specific, did not preempt the numerous other possible uses of cffDNA not claimed, and thus, were patent eligible under § 101. Citing to Alice Corp. v. CLS Bank International, the Federal Circuit stated that “the principle of preemption is the basis for the judicial exceptions to patentability” and thus, “questions on preemption are inherent in and resolved by the § 101 analysis.”14 Therefore, the Federal Circuit dismissed Sequenom’s preemption arguments as “fully addressed and made moot” because the claims at issue were already determined to be directed to patent ineligible subject matter.15 Furthermore, the Federal Circuit noted that “[w]hile preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility.”16
Of particular note is the concurrence prepared by Judge Richard Linn. In the concurrence, Judge Linn distinguished the methods in Ariosa from the methods in Mayo, and likened the claimed methods of Ariosa to be more within the holding in Diamond v. Diehr that “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.” Indeed, Judge Linn even concluded that the claims at issue were, in fact, new and useful.17However, Judge Linn ultimately joined with the court’s decision because he was bound by the “sweeping language of the test set out in Mayo,” in particular the “unnecessary” breadth of the second step of the Mayo framework.18
In conclusion, Ariosa is applicable not only to the biotechnology industry, but also to any industry utilizing discovery of natural phenomena. While Ariosa clarifies how the second step of the Mayo framework should be analyzed, the Federal Circuit’s application of the “inventive concept” with respect to the second step is not without dispute as evident from the concurrence by Judge Linn. Indeed, Sequenom is currently petitioning for a rehearing en banc. As such, the Federal Circuit, and possibly the Supreme Court, will have an opportunity to further address the issue of patent eligibility in the near future.