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US Patent Law: Prenatal DNA Test invalid under §101

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USToday on IPcopy we have a guest post from Whyte Hirschboeck Dudek S.C. Many thanks to Michael J. Cronin, Ph.D for providing permission to repost this article on IPcopy.

In Ariosa Diagnostics, Inc. et al. v. Sequenom, Inc. et al., Nos. 2014-1139 and 2014-1144 (Fed. Cir. June 12, 2015), the Federal Circuit held that certain method claims of Sequenom’s U.S. Patent No. 6,258,540 (the ‘540 patent) are invalid as being directed to patent ineligible subject matter under 35 U.S.C. § 101.  The Court concluded that the use of conventional methods for detecting a naturally occurring phenomenon did not transform the natural phenomenon into a patentable invention. Judge Reyna wrote the opinion for the panel, which included Judges Linn and Wallach.

The invention in the case derived from the inventors’ discovery that the cell-free fractions (serum and plasma) of a pregnant woman’s blood contain cell-free DNA from the fetus (“cffDNA”).  Based on this observation, the ‘540 patent claimed methods for prenatal diagnosis of fetal abnormalities, the methods comprising amplifying paternally-inherited sequences from the cell-free fractions of the mother’s circulation. Claim 1 of the ‘540 patent states:

1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

Claim 1 is quite broad and is simply directed toward a method of detecting paternally inherited nucleic acid.  Two claims, Claim 21, which depends from Claim 1, and independent Claim 25 are directed toward methods for performing a prenatal diagnosis.  It should be noted that the specification is relatively silent on how the presence of fetal DNA in the blood sample can be used for prenatal diagnosis.

The Court evaluated the patent eligibility of the claims using the two-part test set forth in Mayo Collaborative Services v. Prometheus Labs, Inc., 566 U.S. __, 132 S. Ct. 1289 (2012). The Court first noted that it was undisputed that the existence of cffDNA in maternal blood was a natural phenomenon. It further noted that the method at issue started with cffDNA taken from a sample of maternal plasma or serum, a natural phenomenon, and ended with paternally inherited cffDNA, also a natural phenomenon. Thus, the Court found the claims to be directed to a naturally occurring phenomenon. In support of this conclusion, the Court noted that the patent’s description of the invention itself stated that the inventors “have demonstrated that fetal DNA is present in maternal plasma and serum,” which “may be a useful source of material” for diagnosis.

Having found the claims directed to a natural phenomenon, the Court then held that the additional process steps in the claims merely employed conventional methods, which applicant admitted were “a matter of routine for one skilled in the art.” Although the Court acknowledged that the claimed methods were a significant contribution to science, the Court concluded that the claims were not patent eligible because they simply applied conventional steps to detect a naturally occurring phenomenon.

The Court also addressed Sequenom’s argument, among others, that “before the ‘540 patent, no one was using the plasma or serum of pregnant mothers to amplify and detect paternally-inherited cffDNA.”  While agreeing and acknowledging multiple times that the discovery of cffDNA in maternal plasma made a contribution to the field of prenatal care, relying on Myriad (Ass’n for Molecular Pathology v. Myriad Genetics, Inc.,) 569 U.S. ___, 133 S. Ct. 2107, 2117 (2013), the Court concluded that that alone does not make the method claims patentable:

We do not disagree 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.

In sum, applying known methods to a ground-breaking discovery of a natural phenomenon will not pass the patentable subject matter test. The decision underscores the importance of continued inventive (in the context of the U.S. patent law) innovation in the diagnostic space for method claims analyzing biological samples to withstand Section 101 scrutiny.

As mentioned above, Claims 21 and 25 encompass methods of prenatal diagnosis, which one could argue are directed toward a specific, novel use of the natural phenomena.  Prenatal diagnostic tests are developed by scientists and should be eligible for patent protection.  Perhaps additional elements addressing how fetal DNA could be used for a prenatal diagnostic test would have saved these claims.  More on this later.  Stay tuned!

Whyte Hirschboeck Dudek S.C. 25 June 2011

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