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Esoterix Genetic Laboratories v. Qiagen, Inc.

Representative Claim(s)

1. A method for determining an increased likelihood of pharmacological effectiveness of treatment by gefitinib or erlotinib in an individual diagnosed with non-small cell lung cancer comprising:

Obtaining DNA from a non-small cell lung cancer tumor sample from the individual; and determining the presence or absence of at least one nucleotide variance in exon 18, 19, or 21 of the epidermal growth factor receptor (EGFR) gene in the DNA, wherein the presence of at least one nucleotide variance selected from:

1) An in-frame deletion in exon 19 of the EGFR gene consisting of a deletion within codons 746 to 753 that results in amino acid changes comprising a deletion of at least amino acids leucine, arginine, and glutamic acid at position 747, 748, and 749 of SEQ ID NO:512;

2) A substitution in exon 21 that results in an amino acid change consisting of a substitution of arginine for leucine at position 858 (L858R) of SEQ ID NO:512, or a substitution in exon 21 that results in an amino acid change consisting of a substitution of glutamine for leucine at position 861 (L861Q) of SEQ ID NO:512; or

3) A substitution in exon 18 that results in an amino acid change consisting of a substitution of cysteine for glycine at position 719 (G719C) of SEQ ID NO:512 indicates an increased likelihood of pharmacological effectiveness of treatment by gefitinib or erlotinib in the individual.

Posture:

Motion to Dismiss Granted

Exception Category: Law of Nature

“Claim 1 of the ’468 Patent is directed to a law of nature, in that it describes the correlation between a naturally-occurring mutation in a cancer cell, and the likelihood that a particular type of known pharmaceutical compound will be effective in treating that type of cancer.”

Significantly More: No

“[T]he Court finds nothing ‘transformative’ in the method of Claim 1 that amounts to a novel application of the natural law, or that otherwise warrants patent protection. Individually, none of the steps comprising the method in Claim 1 is novel or transformative.”

“[T]he ‘obtaining’ step of ‘[o]btaining DNA from a non-small cell lung cancer tumor sample from the individual[,]’ is not inventive.”

“[T]he ‘determining’ step relies upon known methods of detecting genetic mutations.”

“[T]he ‘wherein’ step simply recites the natural law in question – that the presence of at least one identified genetic variance set forth in Claim 1 ‘indicates an increased likelihood of pharmacological effectiveness of treatment by gefitinib or erlotinib in the individual.’”

“[T]he method claimed in the ‘468 Patent does not fundamentally transform, or even alter, a known method of treating these cancers.  Rather, it identifies a law of nature that explains why such treatment is more effective in a certain population of patients, and tells scientists and doctors that they can ‘apply’ that law of nature by testing for the relevant gene mutations using methods well-known in the art.”