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Genetic Technologies Ltd. v. Agilent Technologies, Inc.

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: Law of Nature

“The correlations between genomic variation in non-coding and coding regions of DNA are unpatentable laws of nature.”

Significantly More: Yes

“The more difficult question is whether the ′179 patent claims contain sufficient ‘inventive concept’ to transform an unpatentable natural law into a patentable application of that law. Because this question requires more factual development and potentially construction of the claims, Agilent’s Rule 12(b)(6) motion must be denied.”

The court analyzed four factors in support of its denial of the motion to dismiss:

  1. Preemption: “Agilent’s preemption arguments focus on GTG’s statements during patent prosecution that the naturally occurring correlations have wide applicability…. These arguments confuse the scope of the natural law with the scope of preemption of the patent’s claims.… Rather, the relevant question for preemption purposes is whether the claims of the ′179 patent preclude others from making any practical use of these correlations.…  Given the alleged availability of alternative methods of genomic analysis, clear and convincing evidence is lacking that the ′ 179 patent impermissibly ties up the relevant field.”
  2. Insignificant Pre- or Post-Solution Activity: “Agilent does not argue that the amplification step is insignificant pre-solution activity, nor does the limitation appear on its face to fall into any of the categories the Federal Circuit described.  Consequently, there is not clear and convincing evidence the amplification step is insignificant pre-solution activity.”
  3. Overly Generalized Limitations: “…in Prometheus, the claimed steps simply told the doctor ‘to determine the level of the relevant metabolites in the blood, through whatever process the doctor or the laboratory wishe[d] to use.’ … The ‘amplifying’ step, in contrast, is not overly generalized. Instead of directing the scientist to prepare the DNA for analysis by a method of his or her choosing, the step specifically requires amplification using a primer pair that spans a non-coding sequence.”
  4. Machine-or-Transformation Test: “With respect to the machine prong, Agilent does not dispute a primer pair can constitute a machine…. Consequently, Agilent does not offer clear and convincing support that the term ‘primer pair’ insufficiently identifies a specific machine…. Agilent also disputes whether the claimed methods require a transformation, because the amplified DNA is a nucleotide for nucleotide copy of the natural DNA.…. GTG responds that amplified DNA is chemically distinct and distinguishable from the naturally occurring DNA from which it is derived.  In particular, GTG avers that a methylation present in most natural DNA is not copied to amplified DNA… considering the averment that the amplification step creates a chemically distinguishable molecule, no clear and convincing evidence indicates an absence of transformation.”