Patenting Breast Cancer
A brief history of the events leading up to the patenting of the BRCA1
In 1988 the UK breast
cancer study group initiated the establishment of a syndicate to search
for the genetic basis of breast cancer which over the next 2 to 3 years
evolved into the Breast Cancer Linkage Consortium BCLC) which has remained
intact to the present day. The BCLC is a European wide consortium of researchers
who have an interest in breast cancer. In addition to a series of European
groups some additional researchers in the US were also incorporated into
the consortium. Funding for the BCLC came principally from the European
Union and each member group within the consortium obtained funding from
their respective national governments. In 1990 the research group lead
by Mary-Clare King in California reported the identification of a genetic
locus on the long arm of chromosome 17 that was linked to a familial predisposition
to breast cancer.
This was the first
report that breast cancer susceptibility could be inherited. Approximately
3 years later Mary-Clare King's findings were substantially confirmed
by the BCLC and reported in the American Journal of Human Genetics (this
is one of the premier genetics journals). At the time of publication the
information gained form all groups knowledge had been accumulated that
identified a minimal region on chromosome 17 that harboured a gene which
was associated breast cancer susceptibility. In addition, it was found
that the gene (by this time termed BRCA1) was associated not only with
breast cancer families but also breast and ovarian cancer families. Through
the type of analysis performed form all families that were collected into
the BCLC it became apparent that a second breast cancer locus existed
on chromosome 13. The type of analysis performed at this stage was called
linkage analysis (linking a disease with a genetic locus). Linkage analysis
is extremely useful in refining a gene locus to under 1 million base pairs
(the entire human genome is approximately 3,000,000,000 bp). The gene
locus when refined to this size is termed an interval. The size of ~ 1
million base pairs lends itself to other strategies used in the identification
of a gene and it was at this stage the hunt for the gene within a defined
genetic interval began. Several groups searched this interval and identified
a number of potential candidate genes (and indeed one group identified
the start of the BRCA1 gene but did not realize it because when tested
in their families no mutations were identified).
All of this research
was performed on funding that was received from public funding agencies.
As the BCLC was honing in on the BRCA1 gene the newly established company
of Myriad Genetics was performing its own search for the BRCA1 gene using
the information published by the BCLC. In 1994 the BRCA1 gene was identified
and published in Science. Myriad genetics had identified the BRCA1 gene
by virtue of having as a population to study a group of women who shared
the same ethnic background where there are common mutations in the BRCA1
gene, one of which is very close to the beginning of the gene. In 1994
members of the BCLC commenced studies into identifying the BRCA2 gene.
There was a level of rivalry between Myriad Genetics representatives and
other members of the BCLC, so much so that some of the meetings were held
in camera to prevent Myriad from getting any information that may have
aided them in identifying the BRCA2 gene. In 1995 the BRCA2 gene was identified
by a British group working within the ICRF (Imperial Cancer Research Fund),
which is a charity organization supported by public donation and to some
extent government funding. Myriad Genetics is trying to get the patent
of BRCA2.
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