On March 21, 2016, Sequenom filed a writ of certiorari with the U.S. Supreme Court, asking the Court to provide clarification regarding the limits of 35 U.S.C §101 as it relates to patent eligibility of diagnostic tests. Sequenom’s petition presents the following question:

Whether a novel method is patent-eligible where:

(1) a researcher is the first to discover a natural phenomenon;

(2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and

(3) he thereby achieves a previously impossible result without preempting other uses of the discovery?

Petition for Writ of Certiorari at i, Sequenom, Inc., v. Ariosa Diagnostic, Inc., No. 15-1182 (March 21, 2016). The petition offers the Court the opportunity to loosen the seemingly universal prohibition against diagnostic method claims set forth in Mayo Collaborative Servs. v. Prometheus Labs., 132 S. Ct. 1289 (2012).

Sequenom is the exclusive licensee of U.S. Patent No. 6,258,540 (the ’540 patent), which claims a “method of detecting paternally inherited nucleic acid of fetal origin performed on the maternal serum or plasma sample from a pregnant female.” ’540 patent at 23:61-63. According to Sequenom, the inventors of the patented subject matter “discovered that ‘cell-free’ fetal DNA (cffDNA) was circulating in pregnant women’s plasma in surprising concentrations.” Petition at p. 2. The inventors further discovered that, by identifying paternal DNA in the maternal plasma, the fetal DNA could be identified, enabling the diagnosis of certain fetal genetic conditions. Id. This discovery is said to have “revolutionized [the] field” (id.) as previous researchers searching for noninvasive tests to detect fetal genetic material sought to “meticulously comb[ ] the cellular portion of maternal blood for fetal cells, and routinely discarded the rest of their maternal blood samples – the plasma and serum – as waste.” Id. at 1. According the Sequenom, the inventors:

[D]evised an early-prenatal genetic test whose key steps – never previously combined in this way – were to take a maternal blood sample, keep only the long discarded non-cellular fraction, amplify the cell-free DNA only they had discovered therein, and search for paternally inherited sequences whose presence or quantity indicated diagnostically relevant conditions.

Id. at p. 3. Independent claims 1 and 21 of the ’540 patent recite:

  1. 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.
  1. A method of performing a prenatal diagnosis, which method comprises the steps of:

(i)         providing a maternal blood sample;
(ii)        separating the sample into a cellular and a non-cellular fraction;
(iii)       detecting the presence of a nucleic acid of foetal origin in the non-cellular fraction according to the method of claim 1;
(iv)       providing a diagnosis based on the presence and/or quantity and/or sequence of the foetal nucleic acid.

Sequenom requests that the Court grant the petition because “[t]his is as straightforward a certiorari candidate as any patent case can be.” Petition at p. 10. Sequenom points to the fact that, in affirming the district court’s ruling that the patent is directed to patent-ineligible subject matter and denying en banc review, several Federal Circuit judges indicated that their hands were tied by the Court’s previous decision in Mayo. For example, in affirming the district court’s decision, Judge Linn wrote that he was “bound by the sweeping language of the test set out in Mayo.” Ariosa Diagnostic, Inc. v. Sequenom, Inc., 788 F.3d 1380 (Fed. Cir. 2015).[1] Sequenom argues that “[h]ere, unlike Mayo, every intuition points towards patent-eligibility. And yet the Federal Circuit felt compelled by Mayo to condemn this meritorious patent – and, a fortiori, the patents underlying an entire, vital field of American healthcare innovation.” Petition at p. 11.

According to Sequenom, this is a perfect case to provide clarification on the limits of Section 101, because:

[T]he Court can brighten the line between a method that merely adds a new discovery to what practitioners were already doing, see Mayo, 132 S. Ct. at 1299, and one that, by the Federal Circuit’s own description, “combine[s] … man-made tools … in a new way” to achieve a revolutionary result. . . . Put otherwise, this case allows the Court to emphasize that a new combination of otherwise conventional techniques is patent-eligible even if it is straightforwardly motivated by a patentee’s unique discovery of a natural law or phenomenon.

Id. at p. 12; emphasis in original. Sequenom argues that the current state of the law weakens the patent system and poses a danger to life science innovators. See, id. at p. 12 (“Right now, Section 101 doctrine lacks any discernible [sic] limits, and so no company can trust in the patent system when deciding whether to invest in bringing an invention to market. This issue has become particularly life-threatening to life-science innovators.”); id. at p. 31 (“[T]he decision below threatens to destroy the predictability and certainty the patent system needs to do its job.”)

The Federal Circuit’s displeasure with the Court’s ruling in Mayo is clear from the various opinions in this case. Mayo, together with the Court’s decision in Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), has significantly reduced the ability to obtain patentable subject matter in the life science arena. As the courts and USPTO continue to expand the scope of those rulings beyond correlations between metabolite levels and adjusting drug dosages (Mayo) and isolated DNA (Myriad), biotech and pharmaceutical companies struggle with deciding whether or not to pursue a patent or keep the invention hidden from the public as a trade secret. The dangers of this are clear; less patent protection in this space equates to less investment and ultimately less innovation. Furthermore, as patents disclose to the public how to make and use the invention, having fewer patents decreases the public’s knowledge in this space.

While clarification of the scope of Section 101 as it relates to laws of nature and abstract ideas would be extremely valuable to the biotech and pharmaceutical industry as a whole, it is yet to be seen if this case offers the best opportunity to obtain such clarity. Claim 1 recites “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.” Sequenom argues that the “combined steps were anything but ‘conventional’ because ‘convention’ was the opposite.” Petition at p. 5; emphasis added. In other words, while researchers knew how to perform these steps, they were not performing them in the same manner as the claimed methods because the material on which the steps were performed was discarded as waste. Thus, this case offers the Court the opportunity to address whether or not “a new combination of otherwise conventional techniques is patent-eligible even if it is straightforwardly motivated by a patentee’s unique discovery of a natural law or phenomenon.” Id. at p. 12. Should the court rule that this subject matter is patentable, the scope of patentability under 101 will expand greatly since the ruling in Mayo. A denial of the petition or a ruling that the claims do not recite patentable subject matter, however, will not forever foreclose patenting in this space. Rather, new strategies will need to be developed to obtain patentable subject matter. At the very least, let’s hope the Court provides clarity as to what is, rather than what is not, patentable in this area.

Ariosa has until April 20, 2016 (extendable with permission from the Court), to file a brief in opposition. As indicated by the number of amici briefs filed in the Federal Circuit, this case is sure to be closely monitored by biotech and pharmaceutical companies, associations, practitioners, professors, universities, international interests, the USPTO, and more.

[1] For further review of the lower court decisions, see https://www.ipintelligencereport.com/2015/12/08/federal-circuit-denies-en-banc-review-of-ariosa-v-sequenom/