In the recent memorandum opinion, the court invalidated claim 1 of U.S. Pat. No. 5,612,179, owned by Genetic Technologies, Ltd., as “impermissibly [claiming] a natural phenomenon.” (Genetic Technologies, Ltd. v. Bristol-Myers Squibb Company, C.A. No. 12-394-LPS (D. Delaware, Oct. 30, 2014), copy of which can be found at the end of this post).
If you have been following the Mayo/Myriad/Intema trail of tears, you could probably write 98% of this opinion “from memory.” A number of aspects of this very lengthy and predictable opinion stand out, however.
The claims were directed to a method of detection of at least one coding region allele of a multi-allelic genetic locus by amplifying genomic DNA via PCR, with a primer pair that spans a non-coding region sequence. The primer pair defines a DNA sequence which is in genetic linkage with the genetic locus and contains a sufficient number of non-coding region sequence nucleotides so that PCR produces an amplified DNA sequence characteristic of said allele; “and analyzing the amplified DNA sequence to detect the allele.” The claim was based on the discovery that there can be a correlation between variations in non-coding introns and coding region alleles; that is, that SNPs in non-coding DNA regions can also be in linkage disequilibrium with SNPs in coding regions of DNA . The genotypes of two SNPS in non-coding regions and two SNPs in a coding region are correlated so that the SNPs in the non-coding region can serve as “surrogate markers’ for the SNPs in the coding region.