According to an article on Law360, Bristol-Myers Squibb Co. is challenging the validity of two Genetic Technologies Ltd. patents on the basis that the claimed intron sequence analysis methods recite natural phenomena that do not satisfy the patent-eligibility requirements of 35 USC § 101. This case highlights some of the questions left unanswered by the Supreme Court decisions in Prometheus and Myriad.

The Patents At Issue 

The sequence analysis method patents at issue are U.S. Patent 5,612,179 (granted in 1997 with a priority claim to 1989) and U.S. Patent 5,851,762 (granted in 1998 with a priority claim to 1990). The patents include a number of independent claims of varying scope and specificity.

The broadest claim of the ’179 patent may be claim 26:

26. A DNA analysis method for determining coding region alleles of a multi-allelic genetic locus comprising identifying sequence polymorphisms characteristic of the alleles, wherein said sequence polymorphisms characteristic of the alleles are present in a non-coding region sequence, said non-coding region sequence being not more than about two kilobases in length.

Other claims in the ’179 patent are similar to claim 1:

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.

The broadest claim of the ’762 patent may be claim 9:

9. A genomic mapping method for identifying a chromosomal region associated with a trait, comprising:

  1. obtaining genomic DNA samples from a plurality of individuals with the trait from a general population, wherein said plurality of individuals with the trait is not derived from a single family;
  2. amplifying a plurality of non-coding sequences from a series of selected chromosomal regions in each genomic DNA sample to produce a plurality of amplified DNA sequences, wherein each selected chromosomal region comprises a plurality of polymorphic non-coding regions, and said plurality of polymorphic non-coding regions defines a plurality of haplotypic patterns detectable by a selected technique for analyzing genetic variation;
  3. analyzing said plurality of amplified DNA sequences to identify the haplotype of each corresponding selected chromosomal region;
  4. determining the degree of restriction in haplotype heterogeneity at each selected chromosomal region for said plurality of individuals with the trait, as compared to said general population; and
  5. comparing the degree of haplotype heterogeneity restriction across said selected chromosomal regions to identify a subseries of adjacent selected chromosomal regions having a greater degree of haplotype heterogeneity restriction at a central selected chromosomal region in said subseries than at selected chromosomal regions at the ends of said subseries as an indication that said central selected chromosomal region is associated with the trait.

Are These Claims Eligible For Patenting? 

My initial impression of these claims is that while claim 26 of the ’179 patent may vulnerable to BMS’ challenge, the other claims present harder questions.

The only “step” recited in claim 26 is “identifying sequence polymorphisms characteristic of the alleles.” This type of claim structure may be vulnerable to being invalidated for reciting an abstract idea or only mental processes. Even if the actual steps required to carry out the “identifying” are complex and concrete, a court may focus on the claim language which sounds like a mental process.

Although the other claims recite more concrete steps, BMS asserts that they are invalid underPrometheus and Myriad because they only recite natural phenomena and conventional steps.

Taking claim 1 of the ’179 patent as an example, while “amplifying genomic DNA with a primer pair” likely was conventional at the time the patent applications were filed, it is doubtful that it was routine in the art to “amplify 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.” (Otherwise the claimed methods would not be novel.)

If the district court addresses this issue, it will have to look harder at the “well-understood, routine and conventional” rubric of the Supreme Court’s Prometheus decision, and decide the level of detail at which that test must be satisfied.