In light of the U.S. District Court ruling that invalidated patents related to the BRCA1 and BRCA2 genes that are held by Myriad Genetics (see previous item), the findings of a Duke University study estimating the reach of one of the claims involved are all the more instructive. The reseachers analyzed U.S. Patent No. 5,747,282 and compared a 15-mer oligonucleotide in the BRCA1 gene described by one of the patent’s claims against gene sequences in GenBank, the NIH genetic sequence database. They found that 80% of cDNA and mRNA in the database contain at least one oligonucleotide covered by the claim. Additionally, some 300,000 oligonucleotides in chromosome 1, which does not contain the BRCA1 gene, would be covered by the claim, according to the researchers, who conclude that “any ‘isolated’ DNA molecules that include such 15bp nucleotide sequences would fall under the claim as granted by the U.S. Patent and Trademark Office (USPTO). Anyone making, using, selling, or importing such a molecule for any purpose within the United States would thus be infringing the claim.”
Based on the timing of Myriad’s application for patent ‘282 and a patent application by the NIH that had previously been rejected due to the claimed 15-mer oligonucleotide being identified in existing DNA sequences, the researchers conclude that the USPTO may have erred in granting Myriad this far-reaching claim. The paper by Thomas Kepler, PhD, division chief of computational biology in Duke’s department of bioinformatics and biostatistics, attorney Colin Crossman, and Robert Cook-Deegan, MD, director of the Center for Genome Ethics, Law & Policy at the Duke Institute for Genome Sciences and Policy, was published in Genomics.
When the researchers examined the claims of the ‘282 patent, they found that one claim “seemed to us particularly broad, so we investigated it, doing simple calculations to estimate its reach, and testing our findings by direct analysis of the extent of its reach within parts of the human genome.” They concluded that certain claims, particularly claim 5, were so broad that the ‘282 patent could be enforced to cover portions of most genes in the human genome and likely most genes in nature. Claim 5 covers “an isolated DNA having at least 15 nucleotides” in the BRCA1 polypeptide — language that is essentially “a claim on any 15-mer oligonucleotide found in any such sequence,” Kepler and colleagues point out.
The USPTO granted Myriad and the University of Utah the ‘282 patent in 1998, but Myriad filed its patent application in 1995. A survey of GenBank performed by the Duke researchers showed that 568 of 713 mRNA coding sequences deposited in GenBank in 1994 contain at least one BRCA1-derived 15-mer oligonucleotide. “These findings suggest that there were already many sequences in GenBank covered by claim 5 at the time the patent application was filed,” the authors point out. “This further suggests that the claim should not have been granted, based on section 102 of the Patent Act (novelty).” In fact, a patent application by the NIH filed four years before Myriad’s ‘282 patent was rejected precisely because the patent claimed 15-mer oligonucleotides found to exist in other DNA sequences, according to the researchers.
“[We] believe the astounding breadth of the claim coupled with the fact that the DNA was already well known to researchers leaves this claim of the patent vulnerable to a court challenge,” the researchers said in a statement. Indeed, the Duke team determined that not only can Myriad’s claim be “significantly narrowed,” but that many genetic patents are similarly broad. As full-genome sequencing becomes more widespread, any kind of genomic sequencing will likely infringe such broad patents, the researchers conclude.
Source: GenomeWeb