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IP Alert: Method for Detecting Nucleic Acid Held Unpatentable Under Section 101

June 16, 2015

On June 12, 2015, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Court of Appeals for the Federal Circuit held that patent claims directed to a “method for detecting a paternally inherited nucleic acid of fetal origin” are invalid under section 101 for failure to state patent-eligible subject matter under the U.S. Supreme Court’s guidance in Mayo Collaborative Services v. Prometheus Laboratories, Inc

In 1996, inventors Dennis Lo and James Wainscoat discovered that maternal plasma and serum contained cell-free fetal DNA (“cffDNA”). This discovery, commercialized by Sequenom as its MaterniT21 test, allowed for fetal genetic testing without the risk of taking samples directly from a fetus or placenta. The inventors were awarded U.S. Patent 6,258,540 in 2001. Exemplary claim 1 of the ’540 patent is as follows:

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.
 
“Amplifying” and “detecting” were conventional steps in the genetic sciences as of the ’540 patent’s filing date. The dependent claims specified various means for detecting or amplifying cffDNA.
 
On summary judgment, the district court found that paternally inherited cffDNA is a natural phenomenon and held that the claims of the ’540 patent did not add enough to the natural phenomenon to make the claims patent eligible under section 101. Sequenom, the owner of the ’540 patent, appealed.
 
On appeal, the Federal Circuit affirmed. The court looked to the Mayo case for the framework for determining whether patent claims are directed to unpatentable laws of nature, natural phenomena, and abstract ideas or rather to patent-eligible applications of the same. Under Mayo, a two-part analysis is used. First, the court determines whether the claims are directed to a patent-ineligible concept, and second, the court determines whether any additional elements of the claim transform the otherwise patent-ineligible subject matter into a patent-eligible application. The second part of the analysis has been characterized by the Supreme Court as whether the claim includes some “inventive concept” in addition to the patent-ineligible material. Such an inventive concept ensures that the patent amounts to more than merely a patent upon the patent-ineligible material itself.
 
In applying Mayo to the ’540 patent, the Federal Circuit noted that the method in the claims of the ’540 patent starts with cffDNA taken from maternal plasma or serum and ends with amplified paternally inherited cffDNA. It was undisputed that both the starting and ending cffDNA are natural phenomena, so the first part of the Mayo test was met. 
 
In its analysis of the second part of the Mayo test, the Federal Circuit drew on the significant parallels between the patent at issue in Mayo and the ’540 patent. The Federal Circuit found that just as the methods for determining metabolite levels in Mayo were well known in the art, the amplification and detection steps in the ’540 patent were “well understood, routine, and conventional” activities at the time of the patent filing. As such, the court held the claims to be patent-ineligible.
 
The district court had considered the principle of preemption in finding the ’540 patent invalid. The principle of preemption holds that patent claims should not preclude the use of the basic building blocks of technology. As such, a patent claim which preempts the future use of an abstract idea, natural phenomenon, or natural law will signal that the claim is directed to ineligible subject matter. On appeal, the Federal Circuit addressed this issue, stating “[w]here a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot.” With this, the Federal Circuit obviated the need for a preemption analysis should the subject matter of the claim in question be found to include only patent-ineligible subject matter under Mayo.
 
Judge Linn filed a concurring opinion, largely lamenting language in the Mayo decision that precluded patent eligibility based on “[p]ost-solution activity that is purely conventional or obvious”—language that Judge Linn viewed as unnecessarily broad. He noted that doctors had routinely discarded maternal plasma until the ’540 invention, and stated that this invention was “truly meritorious,” but nonetheless foreclosed from patentability under Mayo. Judge Linn’s opinion may portend further judicial review of the ’540 patent, whether via en banc review or at the Supreme Court, and Fitch Even attorneys will report on any further developments in this case. In the meantime, please contact any Fitch Even partner with questions concerning this decision.
 
--Written by Fitch Even attorney Christian C. Damon 

 

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