Sequenom loses at CAFC
This appeal is from a grant of summary judgment of
invalidity of the asserted claims of U.S. Patent No.
6,258,540 (“the ’540 patent”). The United States District
Court for the Northern District of California found that
the asserted claims of the ’540 patent are not directed
to patent eligible subject matter and are therefore invalid
under 35 U.S.C. § 101.
For the reasons explained below, we affirm.
The invention here, commer-
cialized by Sequenom as its MaterniT21 test, created an
alternative for prenatal diagnosis of fetal DNA that
avoids the risks of widely-
samples from the fetus or placenta.
The district court also found that the
claimed processes posed a risk of preempting a natural
From a press release:
The U.S. Court of Appeals for the Federal Circuit today upheld the ruling of the United States District Court for the Northern District of California that the claims of the Company's '540 patent are not patent eligible under the patent eligibility criteria established by the Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories decision.
In a concurring opinion, Circuit Judge Richard Linn wrote that he joined the decision "only because I am bound by the sweeping language of the test set out in Mayo…." He concluded that, but for that language, "I see no reason, in policy or statute, why this breakthrough invention [as claimed in the '540 Patent] should be deemed patent ineligible."
As a practical matter, the Company believes that the ruling has little business impact, as it has been operating under the District Court's invalidity ruling since October 2013, and due to the pooling arrangement of NIPT intellectual property entered into with Illumina, Inc. in December 2014. In addition, valid and enforceable patents with claims equivalent to those of the '540 Patent are issued in Europe, Japan, Hong Kong, Canada and Australia.