Department of Biostatistics and Bioinformatics, Duke University, Durham, NC 27705, USA.
Genomics. 2010 May;95(5):312-4. doi: 10.1016/j.ygeno.2010.03.003. Epub 2010 Mar 10.
Many patents make claims on DNA sequences; some include claims on oligonucleotides related to the primary patented gene. We used bioinformatics to quantify the reach of one such claim from patent 4,747,282 on BRCA1. We find that human chromosome 1 (which does not contain BRCA1) contains over 300,000 oligonucleotides covered by this claim, and that 80% of cDNA and mRNA sequences contributed to GenBank before the patent application was filed also contain at least one claimed oligonucleotide. Any "isolated" DNA molecules that include such 15 bp nucleotide sequences would fall under the claim as granted by the US Patent and Trademark Office. Anyone making, using, selling, or importing such a molecule for any purpose within the United States would thus be infringing the claim. This claim and others like it turn out, on examination, to be surprisingly broad, and if enforced would have substantial implications for medical practice and scientific research.
许多专利对 DNA 序列提出了要求;其中一些包括与主要专利基因相关的寡核苷酸的要求。我们使用生物信息学来量化来自 BRCA1 专利 4,747,282 的一项此类权利要求的范围。我们发现,不包含 BRCA1 的人类染色体 1 包含超过 300,000 个受该权利要求保护的寡核苷酸,并且在专利申请提交之前提交给 GenBank 的 80%的 cDNA 和 mRNA 序列也至少包含一个被要求的寡核苷酸。任何包含这种 15 个碱基核苷酸序列的“分离”DNA 分子都将属于美国专利和商标局授予的权利要求范围。因此,在美国境内为任何目的制造、使用、销售或进口此类分子的任何人都将侵犯该权利要求。在审查过程中,这种权利要求和其他类似的权利要求被证明非常广泛,如果得到执行,将对医疗实践和科学研究产生重大影响。