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The European Opposition Against the BRCA Gene Patents*

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Abstract

In 2001, the European Patent Organisation (EPO) granted 3 patents on the BRCA1 gene (EP-B-699754, EP-B-705903, EP-B-705902) to Myriad Genetics. The patents, and the option of the patent holder to strictly exert its monopoly right by requesting that all diagnostic testing be done at its laboratory in the United States, has evoked strong reactions in Europe. Several opposition procedures have been started against these patents. After oral hearings at the EPO in Munich in May 2004, the first patent was revoked due to errors contained in the initially filed sequence. At oral proceedings in January 2005, the other two patents were severely limited in scope. The discussion on inventive step on the cloning of the BRCA1 gene – other than the one that relates to the priority date – has not taken place. In other words, the EPO has not questioned the patentability of this gene per se. The author participated in the hearings in Munich and would like to give the genetic community a firsthand account of the case.

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Abbreviations

BCLC:

Breast Cancer Linkage Consortium

BMA:

British Medical Association

BRCA:

breast cancer

CRUK:

Cancer Research UK

EPC:

European Patent Convention

EPO:

European Patent Office

USPTO:

US Patent and Trademark Office

References

  1. G Matthijs D Halley K Sperling S Kølvraa R Elles D Stoppa-Lyonnet (2002) ArticleTitlePatents, monopolies on diagnostic tests: Europe’s opposition against the BRCA1 patents Am J Hum Genet 71(suppl.) 182

    Google Scholar 

  2. European Patent Convention can be consulted at http://www3.european-patent-office.org/legal/epc/index.html.

  3. JM Hall MK Lee B Newman JE Morrow LA Anderson B Huey MC. King (1990) ArticleTitleLinkage of early-onset familial breast cancer to chromosome 17q21 Science 250 1684–9 Occurrence Handle1:STN:280:By6C3c3lsVY%3D Occurrence Handle2270482

    CAS  PubMed  Google Scholar 

  4. R Wooster SL Neuhausen J Mangion Y Quirk D Ford N Collins K Nguyen S Seal T Tran D Averill et al. (1994) ArticleTitleLocalization of a breast cancer susceptibility gene, BRCA2, to chromosome 13q12–13 Science 265 2088–90 Occurrence Handle1:CAS:528:DyaK2cXmsFejsLY%3D Occurrence Handle8091231

    CAS  PubMed  Google Scholar 

  5. Y Miki J Swensen D Shattuck-Eidens PA Futreal K Harshman S Tavtigian Q Liu C Cochran LM Bennett W Ding et al. (1994) ArticleTitleA strong candidate for the breast and ovarian cancer susceptibility gene BRCA1 Science 266 66–71 Occurrence Handle1:CAS:528:DyaK2MXhtF2ns70%3D Occurrence Handle7545954

    CAS  PubMed  Google Scholar 

  6. PA Futreal Q Liu D Shattuck-Eidens C Cochran K Harshman S Tavtigian LM Bennett A Haugen-Strano J Swensen Y Miki et al. (1994) ArticleTitleBRCA1 mutations in primary breast and ovarian carcinomas Science 266 120–2 Occurrence Handle1:CAS:528:DyaK2cXmslers70%3D Occurrence Handle7939630

    CAS  PubMed  Google Scholar 

  7. R Wooster G Bignell J Lancaster S Swift S Seal J Mangion N Collins S Gregory C Gumbs G Micklem et al. (1995) ArticleTitleIdentification of the breast cancer susceptibility gene BRCA2 Nature 378 789–92 Occurrence Handle10.1038/378789a0 Occurrence Handle1:CAS:528:DyaK28XltFWi Occurrence Handle8524414

    Article  CAS  PubMed  Google Scholar 

  8. Directive 98/44/EC of the European Parliament and of the Council, 6 July 1998.

  9. Minutes of the opposition proceedings available for consultation in the Online Public File Inspection at http://ofi.epoline.org/view/GetDossier.

  10. Press release of February 1st 2005 available on www.myriad.com upon consultation on March 21st 2005.

  11. Cancer Research UK. Charities to make breast cancer (BRCA2) gene freely available across Europe. Press release, 2004. (available at http://www.cancerresearchuk.org/news/pressreleases/breastcancergene_11feb04).

  12. G Matthijs D Halley (2002) ArticleTitleEuropean-wide opposition against the breast cancer gene patents Eur J Hum Genet 10 783–5 Occurrence Handle10.1038/sj.ejhg.5200924 Occurrence Handle12461683

    Article  PubMed  Google Scholar 

  13. Nuffield Council on Bioethics. The ethics of patenting DNA, a discussion paper. (Available via http://www.nuffieldbioethics.org/publications/pp_0000000014.asp and launched on July 23, 2002).

  14. Gene patenting: a BMA discussion paper. 2001 (available at http://www.bma.org.uk/ap.nsf/Content/Gene+patenting+paper).

  15. European Patent Office. “Myriad/breast cancer” patent revoked after public hearing. Press release, 2004. (www.european-patent-office.org/news/pressrel/2004_05_18_e.htm May 18, 2004).

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Authors and Affiliations

  1. Center for Human Genetics, University of Leuven, Herestraat 49, B-3000, Leuven, Belgium

    Gert Matthijs

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  1. Gert Matthijs
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Correspondence to Gert Matthijs.

Additional information

*Proceedings of a lecture presented at the ‘Oncogenetics: Achievements and Challenges’ meeting, Montreal, 7–8 October 2004.

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Matthijs, G. The European Opposition Against the BRCA Gene Patents*. Familial Cancer 5, 95–102 (2006). https://doi.org/10.1007/s10689-005-2580-6

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  • DOI: https://doi.org/10.1007/s10689-005-2580-6

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