Federal Circuit Invalidates Life Sciences Patent Under 101

By Brian J. Hubbard // June 12th, 2015

In Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 2014-1139 (June 12, 2015 Fed. Cir.), the Federal Circuit upheld a grant of summary judgment of invalidity for Sequenom’s US Pat. No. 6,258,540, based on a finding that the claims were not directed to patent eligible subject matter under 35 U.S.C. § 101.

Sequenom discovered that cell-free fetal DNA circulates in a pregnant woman’s plasma and serum.  This DNA may be amplified using PCR, and tested to determine the fetus’ gender and other characteristics, such as the presence of genetic disorders.  Previously, such genetic testing was invasive, and thus associated with risks to the fetus.  

The district court found that the patent claims were directed to applying routine processes to detect a natural phenomena.  Amicus briefs in support of Sequenom’s patent (including a brief by the Biotechnology Industry Organization (BIO)) argued that that such breakthroughs should be rewarded with patent protection as a matter of policy.  Another brief pointed out that a process, as used in § 101, expressly encompasses new uses of a known process, machine, manufacture, composition of matter, or material.

However, the Federal Circuit, applying Mayo, held the development fell short of statutory patentable subject matter. Indeed, this decision may be read as a veiled commentary on Mayo.  In a concurrence sympathetic to the patent holder, Judge Linn stated: “But for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.”


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