Abstract
The scope and eligibility of patents for genetic sequences have been debated for decades, but a critical case regarding gene patents (Association of Molecular Pathologists v. Myriad Genetics) is now reaching the US Supreme Court. Recent court rulings have supported the assertion that such patents can provide intellectual property rights on sequences as small as 15 nucleotides (15mers), but an analysis of all current US patent claims and the human genome presented here shows that 15mer sequences from all human genes match at least one other gene. The average gene matches 364 other genes as 15mers; the breast-cancer-associated gene BRCA1 has 15mers matching at least 689 other genes. Longer sequences (1,000 bp) still showed extensive cross-gene matches. Furthermore, 15mer-length claims from bovine and other animal patents could also claim as much as 84% of the genes in the human genome. In addition, when we expanded our analysis to full-length patent claims on DNA from all US patents to date, we found that 41% of the genes in the human genome have been claimed. Thus, current patents for both short and long nucleotide sequences are extraordinarily non-specific and create an uncertain, problematic liability for genomic medicine, especially in regard to targeted re-sequencing and other sequence diagnostic assays.
Highlights
Gene patents are a class of intellectual property that give the patentee rights to the specific sequences in the claims of a patent, providing the exclusive right to make, use, sell, and import a molecule consisting of a claimed sequence
We used the same alignment criteria to examine the uniqueness of the entire human genome, and we found that 99.999% of 15mers in the human genome are repeated at least twice
These data confirm the findings of previous studies that showed little sequence specificity for small k-mers in the human genome [1315], but our data show for the first time that this global non-specificity of 15mers and longer k-mers impacts all gene patents, including those on BRCA1 and those claiming non-coding areas of the genome
Summary
Gene patents are a class of intellectual property that give the patentee rights to the specific sequences in the claims of a patent, providing the exclusive right to make, use, sell, and import a molecule consisting of a claimed sequence. Some DNA patents are for a very specific series of nucleotides (such as 5’-ATGCGACGGATCGATC-3’) or an exact chemical structure (such as a DNA molecule modified with a fluorescent probe), but diagnostic DNAbased patents have broader claims [5]. These patents are used to find mutations in various disease-related genes, and the specified DNA sequence as well as any other similar sequence are often covered within the patent claim. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO: (the BRCA1 gene). An isolated DNA having at least 15 nucleotides of the DNA of claim 2
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