Metastasizing patent claims on BRCA1

Department of Biostatistics and Bioinformatics, Duke University, Durham, NC 27705, USA.
Genomics (Impact Factor: 2.28). 03/2010; 95(5):312-4. DOI: 10.1016/j.ygeno.2010.03.003
Source: PubMed


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.

Download full-text

Full-text preview

Available from:
  • Source
    • "The ongoing patent litigation has already invalidated Myriad's broadest patent claims - to methods for detecting mutations in BRCA genes. Its claims on short DNA fragments (for example, claims 5 and 6 of US 5,747, 282) are likely also invalid [57], and these are among the only claims that would preclude diagnostic testing, other than through PCR methods, which fall under claim 16 of US Patent 5,747,282. Since PCR amplification is unlikely to be a necessary step in future multi-gene sequencing strategies, Myriad's exclusivity in BRCA genetic testing could be undermined by the plummeting cost of multi-gene deep sequencing, all-exome sequencing, and whole-genome sequencing. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Background The development of Herceptin® is welcomed as a major advance in breast cancer treatment, while Myriad's development of BRACAnalysis® is a widely used diagnostic. However useful and successful this product is, its presence in the public eye is tainted by predominantly negative press about gene patenting and business practices. Discussion While retrospection invites a sharp contrast between Genentech's triumphal narrative of scientific achievement and Myriad's public image as a controversial monopolist, a comparative history of these companies' products reveals two striking consistencies: patents and public discontent. Despite these similarities, time has reduced the narrative to that of hero versus villain: Genentech is lauded - at least for the final outcome of the Herceptin® story - as a corporate good citizen, Myriad as a ruthless mercenary. Since patents undergird both products yet the narratives are so different, the stories raise the question: why have patents taken the fall as the scapegoat in current biotechnology policy debate? Summary A widely publicized lawsuit and accompanying bad press have cast Myriad as a villain in the evolving narrative of biotechnology. While the lawsuit suggests that this villainy is attributable to Myriad's intellectual property, we suggest through a comparative case study that, at least in the Myriad case, it is not simply about the patents but also other business strategies the company chose to pursue. Patents were a necessary but not sufficient cause of controversy.
    Genome Medicine 01/2013; 5(1):8. DOI:10.1186/gm412 · 5.34 Impact Factor
  • Source

    New England Journal of Medicine 07/2010; 363(2):195-6. DOI:10.1056/NEJMc1005114 · 55.87 Impact Factor
  • Source

    The Lancet 07/2010; 376(9738):314-5. DOI:10.1016/S0140-6736(10)61150-6 · 45.22 Impact Factor
Show more