Friday, August 17, 2012

The Myriad method patent claims that failed 35 USC 101

Although claims to isolated genes were found patent-eligible under 35 USC 101 in the Myriad case, certain method claims were found patent-ineligible. For example:

1. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Ta-bles 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleo-tides corresponding to base numbers 4184-4187 of SEQ ID NO:1.
’999 patent col.161 ll.17-25 (emphases added).

AND

1. A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises [] comparing a first sequence selected from the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic altera-tion in the BRCA1 gene in said tumor sample.
’001 patent col.155 ll.2-17 (emphasis added)

*But

Claim 20 of the ’282 patent, directed to a method for screening potential cancer therapeutics via changes in cell growth rates of transformed cells, was patent eligible. Those transformed cells, like the patent-eligible cells in Chakrabarty, are not naturally occurring. Rather, they are derived by altering a cell to include a foreign gene, resulting in a man-made, transformed cell with enhanced function and utility.

20. A method for screening potential cancer therapeutics which comprises:

growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound,

determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and

comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.
’282 patent col.156 ll.13–24 (emphases added).

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