Myriad Genetics patents on two genes linked to breast and ovarian cancer (BRCA1 and BRCA2,) have been struck down in a US District Court ruling – Judge Sweet stating that the patents "are directed to a law of nature and were therefore improperly granted" ( Association for Molecular Biology et. al. Vs United States Patent and Trademark Office et. al.; "the Myriad decision"). This is a pivotal case for those operating in the biotech space and will shape the future of gene patenting and the developing biotechnology industry.
A case was brought against Myriad Genetics last year in relation to a suite of patents covering genes linked to detection of breast and ovarian cancer. The American Civil Liberties Union (ACLU) attorneys acting for patients, pathologists, genetic researchers and other scientists, argued that gene patents suffocated research and competition. Myriad Genetics, it was argued, has a stronghold over use of these genes, which has consequently discouraged scientists from investigating other options for breast cancer screening.
The patents cover the breast and ovarian cancer genes BRCA1 and BRCA2 and diagnostic methods using these genes to determine a person's risk of developing breast and/or ovarian cancer. Five to ten percent of breast cancers are thought to be due to mutations in these genes.
The Court invalidated composition claims relating to 1) isolated
DNA sequences containing all or a portion of the breast cancer
genes and 2) method claims relating to analysing/comparing isolated
DNA sequences to detect BRCA1 /BRCA2 mutations in a patient. In the
ruling, it was stated that
"The claims-in-suit directed to 'isolated DNA'
containing human BRCA1 /BRCA2 gene sequences reflect the
USPTO's practice of granting patents on the DNA sequences so
long as those sequence are claimed in the form of 'isolated
DNA'. This practice is premised on the view that DNA should be
treated no differently from any other chemical compound, and that
its purification from the body, using well-known techniques,
renders it patentable by transforming it into something distinctly
different in character. Many, however, including scientists in the
fields of molecular biology and genomics, have considered this
practice a 'lawyer's trick' that circumvents the
prohibitions on the direct patenting of the DNA in our bodies but
which, in practice, reaches the same result.".
In Australia, for example, a DNA sequence, microorganism or protein can be patented in its isolated form (or in a form substantially free of impurities). In particular, a gene can be claimed provided that the claim does not include the native gene (or the gene as it occurs in nature) within its scope. Whether such subject matter should be patentable is a contentious issue and is currently the subject of a Senate Inquiry in Australia, with a report expected to issue mid-June 2010. The terms of reference of the Senate Inquiry cover various questions relating to gene patents and, in particular, invites submissions from the public as to whether our laws should be revised to prohibit the patenting of genes and proteins.
The Myriad decision is not set in stone. The Court of Appeals is next to decide whether this surprising and highly controversial decision will stand. It is expected that the case will eventually reach the Supreme Court.
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