Sequenom Comments On U.S. Court Of Appeals For The Federal Circuit Decision On '540 Patent
SAN DIEGO, Dec. 2, 2015
SAN DIEGO, Dec. 2, 2015 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company committed to enabling healthier lives through the development of innovative products and services, today issued a statement on the decision by the U.S. Court of Appeals for the Federal Circuit on the Company's U.S. Patent No. 6,258,540 ("'540 Patent").
The U.S. Court of Appeals for the Federal Circuit today announced that it denied Sequenom's petition for en banc re-hearing of the Court's earlier decision upholding the ruling of the United States District Court for the Northern District of California that the claims of Sequenom'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. This result was not unexpected given the earlier ruling by a three-judge panel of the Court of Appeals that said it was "bound by the sweeping language of the test set out in Mayo." However, denial of the petition was considered as a necessary first step to having the case potentially heard on appeal by the Supreme Court of the United States.
In concurring opinions, three Circuit Judges expressed concern that the current interpretation of the Mayo decision may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena. However, the Judges stated that despite the claims reciting "innovative and practical uses" for circulating, cell-free fetal DNA, they are bound by the language of Mayo, and any further guidance must come from the Supreme Court, not the U.S. Court of Appeals for the Federal Circuit. In a dissenting opinion, Circuit Judge Newman expressed her view that "the new diagnostic method here is novel and unforeseen, and is of profound public benefit" and stated: "I agree with my colleagues that this case is wrongly decided. However, I do not share their view that this incorrect decision is required by Supreme Court precedent."
As previously stated, as a practical matter, Sequenom 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.
Sequenom understands that patent eligibility under 35 U.S.C. section 101 is an emerging and complex set of issues and is considering a further appeal to the Supreme Court of the United States.
That was our last chance for a Hail Mary pass in the final minutes of the game.
Now we are just going to have to slog through the eternally gloomy tunnel with management, and no noticeable light at the end of the tunnel. Pffft!