Page 5 - Litigation

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Litigation | MONDAY, APRIL 13, 2015 | S5
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DNA sequence, and are used to initiate the process known as polymerase chain reaction whereby nucleotides are added to a growing chain of DNA. In a follow-on case related to Myriad, the District Court for the District of Utah held that claims to synthetic primers having the same sequence as human DNA were not patent eligible.10 The district court interpreted Myriad narrowly, finding that the claimed primers, although synthetically designed, were not “markedly different” from naturally occurring DNA, and that synthetic DNA is patent ineligible when it reflects the same nucleotide sequence as natural genomic DNA.11 On appeal, the Federal Circuit agreed that “[t]he primers before us are not distin- guishable from the isolated DNA found patent- ineligible in Myriad and are not similar to the cDNA found to be patent-eligible,” because they are “structurally identical to the ends of
12
DNA strands found in nature.” The Federal
Circuit cited the Supreme Court’s reason- ing from Myriad to conclude that primers are not patent eligible merely because they have been separated from other genetic material. According to the court, the func- tions of primers are also not fundamentally different, because “the naturally occurring material is used to form the first step in a chain reaction—a function that is performed because the primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence.”13
Man-Made Mutations. In a portion of Myr- iad that was not on appeal to the Supreme Court, the Federal Circuit held that a claim directed to a screening method for cancer treatment was patent eligible under §101. The claimed process at issue consisted of grow- ing host cells transformed with a mutated BRCA gene in the presence of a compound suspected of being a cancer therapeutic while maintaining some of the transformed cells apart from the potentially therapeutic com- pound, and subsequently determining the growth rate of the host cells in both groups by comparing growth rates (wherein a slower growth rate of host cells in the presence of such a compound is indicative of a cancer therapeutic).14 In holding that this claim covered patent-eligible subject matter, the Federal Circuit explained that it amounted to more than the simple application of a law of nature, since it involved the application of certain steps to transformed, man-made cells that were not the product of nature.15 Thus, these man-made cells were patent- eligible subject matter, and “once one has determined that a claimed composition of matter is patent-eligible subject matter, apply- ing various known types of procedures to it is not merely applying conventional steps to a law of nature.”
Clones. A clone is an identical genetic copy of a cell, cell part, or organism. In In re Ros- lin Institute (Edinburgh), the Federal Circuit addressed the patent eligibility of “Dolly the Sheep” and other mammals cloned using what the court described as “a breakthrough scien- tific method.” Noting that the patent claims directed to the method of cloning were not at issue, the court invalidated claims directed to clones developed from donor mammals because they shared exact genetic identity with the donor.16 The court held that natu- rally occurring organisms are not patent
eligible subject matter under both pre- and post-Myriad case law, even where the cloned species is the work of human ingenuity and not “nature’s handiwork.”
Use of Natural Materials, Biomolecules
Correlations Based on Analysis of Drug
Metabolites. In Ameritox v. Millenium Health,
the method claims at issue involved, in part,
“detecting,” “normalizing,” and “quantifying”
the amount of drug metabolites in a urine
sample.17 In denying defendant’s motion for
summary judgment, the court explained that while each of the steps in the claimed method
involved “conventional” scientific techniques,
Y
duced “a new and useful result.” In contraCMst
the “combination” of each of these steps pro-
to Mayo, in which the court found that “at MY
least the combination of those steps, were
in context obvious, already in use, or purely conventional,” the district court in Ameritox
CMY
noted that the defendant could not point to
any “reference demonstrating the existence of or even suggesting the combination of the comparative step with the additional steps of the invention.” Because nothing in the prior art suggested that such a combination was well-known, the method claim passed muster under §101 in light of Myriad and Mayo.
Correlations Based on Genetic Analysis.
A number of decisions have addressed patent claims directed to analyzing the correlations between certain conditions, including disease conditions, and the presence (or absence) of a genetic marker. The Federal Circuit in Myriad found that certain method claims at issue were patent ineligible under §101. Most of those claims involved “comparing” or “ana- lyzing” a patient’s BRCA sequence with the normal, or “wild-type,” sequence to identify the presence of cancer-predisposing muta- tions.18 The court concluded that these claims were not directed to patent-eligible subject matter because they “recite[] nothing more than the abstract mental steps necessary to” compare or analyze different nucleotide sequences.19
In PerkinElmer v. Intema, the claims were directed to specific screening methods to esti- mate the risk of fetal Down syndrome, using markers from the first and second trimesters of pregnancy.20 The claim at issue covered a multi-step method of: (1) measuring the levels of certain biological markers from both the first and second trimester of pregnancy; and (2) determining whether an increased risk of Down syndrome existed by comparing those markers.21 The court in PerkinElmer held that the claims recited patent-ineligible subject matter under §101 because the steps only instructed the user “to engage in well- understood, routine, conventional activity previously engaged in by scientists who work in the field.”
In Genetic Technologies v. Laboratory Corporation of America Holdings, the court considered a method claim drawn to predict- ing “potential sprinting, strength, or power performance” in elite athletes by “analyz- ing a sample” for the presence of a specific gene, “detecting” the presence of two specific alleles, and using those analytics to “predict” athletic performance was held invalid under §101.22 The claim was found patent ineligible, because the “analyzing,” “detect- » Page S10
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