In its June 12, 2015 opinion in Ariosa Diagnostics, Inc. v.
Sequenom, Inc., the U.S. Court of Appeals for the Federal
Circuit held that Sequenom's patent directed to methods of
detecting fetal DNA in a pregnant woman's plasma or serum,
although "a positive and valuable contribution to
science," was not eligible for patent under U.S. Supreme Court
precedent. Ariosa Diagnostics, Inc. v. Sequenom, Inc.,
Case Nos. 2014-1139, 2014-1144, slip op. at 16 (Fed. Cir. June 12,
2015) ("Ariosa"). The Federal Circuit's
decision underscores the breadth of the Supreme Court's test,
originally announced in Mayo Collaborative Serv. v. Prometheus
Labs. Inc., 132 S. Ct. 1289 (2012), for distinguishing patents
that impermissibly claim laws of nature, natural phenomena, and
abstract ideas from those that claim patent-eligible applications
of those concepts.
In 1996, scientists discovered the presence of cell-free fetal DNA
("cffDNA") in maternal plasma and serum, the portion of
maternal blood others in the field had been routinely discarding as
medical waste. Ariosa, slip op. at 3. Applying certain
laboratory techniques, the scientists were able to detect the small
fraction of cffDNA that was inherited from the father, enabling
them to determine fetal genetic characteristics. The ability to
detect cffDNA in the maternal circulation revolutionized the field
of prenatal DNA testing by avoiding the clinical risks inherent in
the invasive standard-of-care tests at the time, which relied on
taking DNA samples from the fetus or placenta. Id.
Sequenom obtained an exclusive license to the first patent directed
to the discovery of cffDNA—U.S. Patent. No. 6,258,540 (the
"'540 patent"). Claim 1 of the '540 patent, the
broadest independent claim, claimed a method of "amplifying a
paternally inherited nucleic acid from the [maternal] serum or
plasma sample" and "detecting the presence of a
paternally inherited nucleic acid of fetal origin."
Id. at 4.
In 2011, Sequenom sought to enforce the '540 patent against
several competitors, including Ariosa. In response, Ariosa filed a
declaratory judgment action in the U.S. District Court for the
Northern District of California. On the parties' cross-motions
for summary judgment, the district court held that the '540
patent was invalid under §101. Id. at 7. Sequenom
appealed to the Federal Circuit. Like the district court, the
Federal Circuit applied the familiar two-step framework for
analyzing claims under §101 announced by the Supreme Court in
Mayo. Id. at 8. Under the first step, the court
must determine whether the claim at issue is directed to a
patent-ineligible concept, such as a law of nature, natural
phenomenon, or abstract idea. Id. If so, the court turns to the
second step of the Mayo test, which requires the court to
determine whether the additional elements of the claim amount to an
"inventive concept" sufficient to "'transform
the nature of the claim' into a patent-eligible
application." Id. (quoting Mayo, 132 S. Ct.
at 1298).
Applying this test to Sequenom's patent claims, the Federal
Circuit held that under step one of Mayo, the claims of
the '540 patent were "generally directed to detecting the
presence of a naturally occurring thing or a natural phenomenon,
cffDNA in maternal plasma or serum." Id. at 10.
Turning to step two, the court held that the additional steps in
each claim, such as amplifying and detecting cffDNA through
polymerase chain reaction, were all well-understood, routine, and
conventional activity at the time of filing of the '540 patent
in 1997. Id. at 11. Thus, "[t]he 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. According to the court, this was not sufficient to
satisfy the second step of the Mayo analysis, and it
affirmed the district court that the claims were invalid under
§101. Id. at 13.
The Federal Circuit did not end its discussion there. It took the
opportunity to address an important issue regarding preemption.
Sequenom had argued that because the record clearly showed that the
'540 patent did not preempt all uses of cffDNA, the claims
should be upheld. Id. at 14. The Federal Circuit
acknowledged that "the principle of preemption is the basis
for the judicial exceptions to patentability" but held that
"questions on preemption are inherent in and resolved by the
§101 analysis." Id. In other words,
"[w]here a patent's claims are deemed only to disclose
patent-ineligible subject matter under the Mayo framework,
as they are in this case, preemption concerns are fully addressed
and made moot." Id. at 14–15.
In a separate concurring opinion, Judge Linn highlighted the
consequences of the Supreme Court's test in Mayo and
expressed his concerns that the Mayo test is too sweeping.
Ariosa, concurring op. at 4–5. Judge Linn wrote that
he would have held the '540 patent valid under §101 if the
Federal Circuit were not bound by Supreme Court precedent, which
"le[ft] no room to distinguish Mayo from this
case." Id. at 3–5.
In conclusion, the Ariosa decision, including Judge
Linn's concurring opinion, is important because it underscores
the breadth of the Supreme Court's Mayo decision. It
makes clear that "[g]roundbreaking, innovative, or even
brilliant discovery does not by itself satisfy the §101
inquiry." Ariosa, slip op. at 16 (quoting Myriad
Genetics, Inc., 133 S. Ct. 2107, 2117 (2013)). And, it holds
that if a patent claim is invalid for failing Mayo's
two-part test, any preemption concerns are fully addressed and
rendered moot. Id. at 14–15.
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