United States: Sequenom Throws Diagnositc Method Patents At The Mercy Of The Supreme Court

It comes as no surprise that Sequenom has filed a petition for certiorari to the Supreme Court, asking the Court to review the Federal Circuit decision that upheld the district court decision that held its diagnostic method claims invalid for failing to satisfy the patent eligibility requirements of 35 USC § 101. With no relief from Congress on the horizon, this filing puts at least the near-term future of diagnostic method patents at the mercy of the Supreme Court. Will the Court agree that its § 101 jurisprudence has been taken too far, or will it decide that diagnostic methods really cannot be patented?

The Invention At Issue

The opening page of Sequenom's petition describes the invention at issue as follows:

In 1996, two doctors discovered cell-free fetal DNA (cffDNA) circulating in maternal plasma. They used that discovery to invent a test for detecting fetal genetic conditions in early pregnancy that avoided dangerous, invasive techniques. Their patent teaches technicians to take a maternal blood sample, keep the non-cellular portion (which was "previously discarded as medical waste"), amplify the genetic material within (which they alone knew about), and identify paternally inherited sequences as a means of distinguishing fetal and maternal DNA. Notably, this method does not preempt other demonstrated uses of cffDNA.

To the extent Sequenom focuses on a specific claim, it discusses claim 21 of U.S. Patent No. 6,258,540:

21. 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 non-cellular fraction;
(iii) detecting the presence of nucleic acid of fetal origin in the non-cellular fraction according to the method of claim 1 [that is, by (i) amplifying and (ii) detecting paternally inherited nucleic acids, and];
(iv) providing a diagnosis based on the presence and/or quantity and/or sequence of the fetal nucleic acid.

The Question Presented

Sequenom's brief sets forth the following question presented for review:

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?

An Alternative § 101 Analysis

In its petition, Sequenom argues that the Federal Circuit decision (which you can read about here) "has dangerously overextended Mayo." Sequenom urges the Court to clarify that "Mayo does not prohibit claiming new methods assembled by combining previously known techniques even when [or just because?] those methods are motivated by or incorporate new insights into nature and its laws" (emphasis added). Rather, according to Sequenom, Mayo only "prohibits taking a series of steps 'already engaged in by the scientific community' and claiming them for oneself by merely adding new knowledge of a natural law."

Sequenom also urges the Court to "take this unique opportunity to reiterate the centrality of preemption to Section 101 analysis" (emphasis added). On that point, Sequenom states:

Section 101 ... forecloses claims that preempt essentially all uses of a natural phenomenon—not claims foreclosing only particular methods of using them that the inventor has disclosed.

Sequenom emphasizes that the Court should grant its petition because the issue raised is "vitally important," for at least these reasons:

  • First is the overwhelming support of trustworthy amici. Twelve different briefs supported rehearing below and more are expected here.
  • Second, the decision below threatens to destroy the predictability and certainty the patent system needs to do its job.
  • Finally, the decision below places the United States out of step with the international community regarding the patent-eligibility of biomedical methods—perhaps even breaching our treaty obligations. Other authorities, including the European Patent Office, have bars on patenting natural laws.

Sequenom expands on the second point as follows:

At a minimum, the biomedical community is now adrift in determining whether or not patents will ever be available in these or related fields. And that's essentially the ballgame, because once you must seriously question the availability of patent protection, you cannot: (1) confidently invest in research; (2) confidently invest in clinical validation and commercialization of existing patents; or (3) confidently predict that it is better to disclose your discoveries through the patent system than it is to keep them a trade secret.

It is likely that these themes will be echoed in amicus briefs.

Waiting For Mercy

The Supreme Court should decide whether to grant Sequenom's petition for certiorari by the end of its current term in June 2016. If it takes up the case, it should issue a decision on the merits by the end of its next term, in June 2017. To paraphrase Sequenom, hopefully the bottom won't fall out of life-science innovation by then.

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