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Genetic Technologies Ltd. v. Bristol-Myers Squibb Company

Representative Claim(s)

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

a) 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

b) analyzing the amplified DNA sequence to detect the allele.

 

Posture:

Motion to Dismiss

Exception Category: 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…. just as the relationship at issue in Mayo was entirely a consequence of the body’s natural processes for metabolizing thiopurine, so too is the correlation here (between variations in the non-coding regions and allele presence in the coding regions) a consequence of the naturally occurring linkages in the DNA sequence.”

Significantly More: No

“The asserted claim recites a series of steps to manifest the natural law—that is, to detect the natural correlations between coding and non-coding sequences.  The added steps used to discern these correlations consist only of routine and conventional techniques.  The patent specification states this outright, making this one of the (perhaps rare) occasions in which further factual development and claim construction are not necessary and invalidity can properly be determined at the 12(b)(6) stage.”

“As with the ‘administering’ and ‘determining’ steps in Mayo, the ‘amplifying’ step here tells scientists to engage in ‘well-understood, routine, conventional activity previously engaged in’ by those in the field.  Mayo, 132 S.Ct. at 1298.  According to the patent itself, all of the techniques it discloses for DNA amplification, including PCR analysis, were previously well known methods.”

The court also rejected Plaintiff’s arguments that claim 1 was patent-eligible for because it satisfied the machine-or-transformation (“MoT”) test in three ways.  The court initially noted that the MoT test is not the touchstone of patentability, but merely a clue.  Next, the court addressed each MoT ground raise by Plaintiff:

  1. (Machine) The claims recite amplification, which requires a machine: Citing the Supreme Court’s Bilski decision (among others), the court stated, “With regard to GTG’s argument that the claims require use of a machine to amplify the DNA, the asserted claims do not tie amplification to a ‘particular machine’ and, therefore, do not meet the machine or transformation test on these grounds.”
  2. (Machine) The recited primers are tools themselves: Stating that, “Even if primers could be characterized as machines, GTG’s argument cannot prevail,” the court held that use of primers in the amplification of DNA was well-known in the art.
  3. (Transformation) The amplified DNA is man-made, and lacks methylation found in naturally-occurring DNA: “GTG’s attempt to liken amplified DNA to cDNA contradicts the reasoning of Myriad and related Federal Circuit precedent, which focus on what the claims recite rather than unclaimed chemical differences identified post-hoc during litigation.”  The court noted that in Myriad, an isolated DNA molecule was not patent-eligible, even though the DNA molecule in that case was not strictly naturally-occurring since “isolated” necessarily meant that chemical bonds were broken to free the DNA molecule from its naturally-occurring state.  “Therefore, although amplification is carried out in a laboratory by a human, it is a replication of the native DNA sequence, resulting in a mirror image of the naturally-occurring genetic information. The claims do not depend on the altered methylation. The chemical changes that may indeed occur during amplification are unrelated to the claimed method and, therefore, do not impose a meaningful limitation.”