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.
Appeal from the United States District Court for the District of Delaware. The district court found that claims 1-25 and 33-36 of the ’179 patent were ineligible for patenting under 35 U.S.C. § 101 and granted Merial and Bristol-Myers Squibb’s motion to dismiss for failure to state a claim.
Claim is directed toward law of nature, a patent-ineligible concept, and the physical steps of DNA amplification and analysis of amplified DNA to provide the user with a sequence of non-coding region do not provide an inventive concept necessary to render the claim patent-eligible.
Exception Category: Law of Nature
“Claim 1 is directed to the relationship between non-coding and coding sequences in linkage disequilibrium and the tendency of such non-coding DNA sequences to be representative of the linked coding sequences – a law of nature.”
“The claim is directed to a natural law—the principle that certain non-coding and coding sequences are in linkage disequilibrium with one another.”
Significantly More: No
“The first claimed step of ‘amplifying’ genomic DNA with a primer pair was indisputably well known, routine, and conventional in the field of molecular biology as of 1989, when the first precursor application to the ‘179 patent was filed.”
“The second physical implementation step, ‘analyzing’ amplified DNA to provide a user with information about the amplified DNA, including its sequence, was also clearly well known, routine, and conventional at the time the ‘179 patent was filed.”
“Thus the physical steps of DNA amplification and analysis of the amplified DNA to provide a user with the sequence of the non-coding region do not, individually or in combination, provide sufficient inventive concept to render claim 1 patent eligible.”
“To be sure, it seems to be true, as GTG alleges, that at the time the ’179 patent was filed, no one was ‘using the non-coding sequence as a surrogate marker for the coding region allele.’ . . . But the novelty of looking to non-coding DNA to detect a coding region allele of interest resides in the novelty of the newly discovered natural law of linkage disequilibrium between coding and non-coding regions and adds little more than a restatement of the natural law itself.”