Judge Stark of the U.S. District Court for the District of Delaware granted defendants’ motion to dismiss Genetic Technologies, Ltd.’s patent infringement suit with regard to claim 1 of U.S. Patent 5,612,179 on the basis that the claimed sequence analysis method is invalid under 35 USC § 101 because it merely applies conventional methods to a natural phenomenon. Judge Stark’s opinion draws on recent Supreme Court and Federal Circuit decisions, and shines a light on the difficulties biotechnology patents can face under Mayo, Myriad and Alice. If this case is appealed to the Federal Circuit, will it find that Judge Stark when astray in the analysis that led to the finding of ineligibility?

The Patents At Issue

Genetic Technoligies, Ltd. had asserted two patents relating to intron sequence analysis methods against multiple defendants including Bristol-Meyers Squibb Co. and Meriall LLC: U.S. 5,612,179 and U.S. 5,851,762.

The district court granted the motion to dismiss with regard to the ’179 patent. The court’s analysis focused on claim 1:

1. A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:

  1. amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and
  2. analyzing the amplified DNA sequence to detect the allele.

The district court denied the motion to dismiss without prejudice with regard to the ’762 patent, because the parties only had provided a “limited analysis” of that patent, which recites a 10-step method.

The Burden of Proof

The district court turned to the Federal Circuit’s 2013 decision in Ultramercial, Inc. v. Hulu, LLC, for the appropriate burden of proof, even though the Ultramercial decision was vacated by the Supreme Court.

The … Federal Circuit has stated that to grant dismissal of a patent infringement suit at the pleading stage for lack of patentable subject matter, “the only plausible reading of the patent must be that there is clear and convincing evidence of ineligibility.”

According to the court, “the Federal Circuit made clear in Ultramercial that it will be ‘rare’ that patent ineligibility is evident at the pleading stage such that a patent suit can be dismissed on this basis … the instant matter presents such a rare case.”

The Legal Principles Applied By The District Court

The district court began its analysis with this statement of the holding of Mayo v. Prometheus:

A claim is unpatentable if it merely informs a relevant audience about certain laws of nature, even newly-discovered ones, and any additional steps collectively consist only of well-understood, routine, conventional activity already engaged in by the scientific community.

The court also cited the Supreme Court’s decision in Alice Corp. v. CLS Bank for “reiterating that courts are to apply the two-step framework set out in Mayo“:

A court first determines “whether the claims at issue are directed to one of those patent-ineligible concepts.” …. If so, a court then “consider[s] the elements of each claim both individually and as ‘an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” …. At this second step, courts examine whether “a process that focuses upon the use of a natural law also contain[ s] other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.”

The district court cited the Federal Circuit decision in buySAFE, Inc. v. Google, Inc., for the proposition that “if ‘”the additional elements” do not supply an “inventive concept” in the physical realm of things and acts—a “new and useful application” of the ineligible matter in the physical realm—that ensures that the patent is on something “significantly more than” the ineligible matter itself,’ the claim is outside the scope of § 101.”

The Patent Subject Matter Eligibility Analysis

Turning to claim 1 of the ’179 patent, the district court made the following findings:

The Claim Recites A Natural Phenomenon: The correlations between variations in non-coding regions of DNA – formerly known as “junk DNA” – and variations in coding regions of DNA – specifically, alleles – are natural phenomena. A correlation that preexists in the human body is an unpatentable phenomenon.

The Claim’s Additional Steps Do Not Give Rise to an “Inventive Concept”: The asserted claim recites a series of steps to manifest the natural law – that is, to detect the natural correlations between coding and noncoding sequences. The added steps used to discern these correlations consist only of routine and conventional techniques. The patent specification states this outright ….

The court also noted that because the claim “stops” “once the correlation is detected,” it does not recite a specific application of the natural phenomenon.

The district court rejected GTG’s arguments that the claim recites “unconventional methods” because they recite the use of a primer pair with a novel property, e.g., a primer pair that “spans an intron sequence and defines a DNA sequence in genetic linkage with an allele to be detected.” In so doing, the court cited Mayo for the proposition that “when ‘the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field,’ the subject matter is ineligible without more.” (emphasis added in district court opinion). According to the district court:

Mayo requires that the additional steps be viewed apart from the natural law. Otherwise, whenever a natural law is newly discovered, any “additional step” – no matter how routine or conventional in that field – could be tacked onto it and become patent eligible by virtue of the fact it takes advantage of the naturally occurring phenomenon.

Digging further into the claims, the court stated:

The primer pair must define a DNA sequence that has enough non-coding region sequence nucleotides in “genetic linkage” with the allele such that when amplified, the sequence is characteristic of the allele. In short, the DNA sequence must contain the correlation. The limitation sets forth a condition that is inherently required in order to implement the natural law and, therefore, does nothing to impart an “inventive concept.”

(emphasis added)

The district court also rejected GTG’s arguments that the claim should be found eligible under the machine-or-transformation test. The court noted that the “claims do not tie amplification to a ‘particular machine,’” and so cannot be eligible on that basis. With regard to “transformation,” the court disagreed that the fact that the amplified DNA was “man-made” carries any weight where the claim does not recite any features of the amplified DNA that distinguish it from naturally occurring DNA. The court cited the Federal Circuit decision in In re Roslin Institute for the proposition that unclaimed differences do not support patent eligibility.

Thus, the court granted the motion to dismiss as to the ‘179 patent.

Where Did Judge Stark Go Astray?

If the Federal Circuit disagrees with this decision, where will it find that Judge Stark went astray?

In finding that “the DNA sequence must contain the correlation,” did Judge Stark confound the natural phenomenon at issue—the fact that a non-coding region can be correlated with an allele—with physical structures relevant to a specific application of the phenomenon—a primer pair useful for amplifying non-coding region DNA to detect a coding region allele?

Did Judge Stark lose sight of the method as a whole? Is a method for detecting a coding region allele by amplifying genomic DNA using the recited (novel) primer pair a specific application of the natural phenomenon that should be patent eligible under Mayo?

In dismissing GTG’s “transformation” arguments, did Judge Stark confuse the principles to be applied when the claimed subject matter is a product, as it was in Myriad and Roslin, with principles to be applied when the claimed subject matter is a method that involves the manipulation and transformation of a product?

Judge Stark worries that a liberal application of the machine or transformation test would “eviscerate the holding in Mayo” but did he forget the Supreme Court’s warning in Myriad that an overly broad application of the judicially-created patent subject matter eligibility exceptions to will “eviscerate patent law”?