Subject-Matter Analysis – ARIOSA DIAGNOSTICS, INC., et al. v. SEQUENOM, INC., et al.

In 1996, Drs. Dennis Lo and James Wainscoat discovered cell-free fetal DNA (“cffDNA”) which is a kind of DNA that circulates freely in the blood stream of pregnant women. In 2001, Drs. Lo and Wainscoat obtained the ’540 patent, which relates to this discovery. The invention, commercialized by Sequenom as its MaterniT21 test, created an alternative for prenatal diagnosis of fetal DNA. However, the patent does not claim cffDNA. Instead, the ’540 patent claims certain methods of using cffDNA.

Natera, Inc. manufactures and sells the Non-Invasive Paternity Test, which is intended to confirm the paternity or non-paternity of a gestating fetus from genetic information in fetal DNA available in the blood of the pregnant female. Diagnostics Center, Inc. is a licensee of Natera.

Each of these firms filed separate declaratory judgment actions alleging that they did not infringe upon the ’540 patent.

The district court found that “there was a substantial question over whether the subject matter of the asserted claims was directed to eligible subject matter.” Sequenom appealed and the Federal Circuit remanded and held that the district court erred in certain respects.

Parties then filed for motions for summary judgment regarding invalidility under section 101. The district court held that “the claims of the ’540 patent were directed to the natural phenomenon of paternally inherited cffDNA, and that the claims did not add enough to the natural phenomenon to make the claims patent eligible under § 101.” Sequenom appealed.

Federal Circuit followed these steps in order to determine whether claims of ‘540 patent is patent-ineliginle concept:

1) if subject matter is patent eligible, and

2) whether the claim contains an inventive concept sufficient to “transform” the claimed naturally occurring phenomenon into a patent eligible application.

In the first step, the court stated that the claims of the ’540 patent are method claims and methods are patent eligible subject matter. In the second step, the court held that “the practice of the method claims does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention.”

Because the method steps were well-understood, and easy to follow, the court specified that “the method of detecting paternally inherited cffDNA is not new and useful, the 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.” The court also concluded that appending well-understood, routine steps to a “natural phenomenon” which is specified generally is not enough to be an “inventive concept”.

In addition, Federal Circuit indicated that “while preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility. In this case, Sequenom’s attempt to limit the breadth of the claims by showing alternative uses of cffDNA outside of the scope of the claims does not change the conclusion that the claims are directed to patent ineligible subject matter.”

Federal Circuit, then remarked that “detecting cffDNA in maternal plasma or serum that before was discarded as waste material is a positive and valuable contribution to science. But even such valuable contributions can fall short of statutory patentable subject matter, as it does here.”

For the above reasons, the court affirmed the district court’s decision, stating that the patent is invalid under Section 101.

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