The Federal Circuit affirmed a lower court’s ruling that a method for performing prenatal testing was not patent-eligible based on recent Supreme Court rulings.

In 1996, two scientists discovered cell-free fetal DNA (“cffDNA”) in the portion of blood samples from pregnant women that other researchers normally discarded. Applying standard lab techniques, they developed a method for testing the samples in order to determine fetal characteristics, such as gender.

They obtained a patent for their discovery and it became the basis for a prenatal test commercialized by Sequenom, of San Deigo, as its MaterniT21 test.

The Lawsuit

Ariosa Diagnostics, of San Jose, makes its own non-invasive prenatal diagnostic test. After the company received a letter threatening it with litigation for infringing the patent, it (along with others) filed a declaratory judgement action seeking a finding that the company did not infringe.

A federal district court found that the claims of the patent were directed to the natural phenomenon of the cffDNA and were thus not patent-eligible based on recent Supreme Court decisions in Mayo and Myriad.

The Federal Circuit agreed with the district court that:

the only inventive component of the processes of the ’540 patent is to apply … well-understood, routine processes to paternally inherited cffDNA, a natural phenomenon.

Accordingly, the scientists’ discovery was not patentable.

The case is Ariosa Diagnostics Inc. et al. v. Sequenom Inc.


Interestingly, in his concurrence Circuit Judge Richard Linn said that he thought Sequenom should have been entitled to keep the patent but that he was bound by the Supreme Court precedents to rule otherwise.

He said that the case “represents the consequence—perhaps unintended” of the broad language in Mayo “in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.”

He also said that the invention at issue in the case was “nothing like” the invention at issue in Mayo.

That concurrence might be taken as an engraved invitation to Sequenom to seek review from the Supreme Court.

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Photo Attribution: “Difference DNA RNA-EN” by Difference_DNA_RNA-DE.svg: Sponk (talk)translation: Sponk (talk) – chemical structures of nucleobases by Roland1952. Licensed under CC BY-SA 3.0 via Wikimedia Commons.

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