NBCF urges further action to protect human genetic material

July 21st, 2013

Further to the US Supreme Court’s recent ruling that human genes cannot be patented, another round in the gene patent battle has emerged this month with the US-based biotechnology company, Myriad Genetics taking legal action against Ambry Genetics for patent infringement over the BRCA tests.

Last month, the US Supreme Court unanimously ruled in the long-running battle with Myriad Genetics on its patent over the test for breast and ovarian cancer genes, BRCA1 and BRCA2. The Court ruled that human genes cannot be patented but that the patent could be upheld on DNA that is synthetically produced in the laboratory, so called ‘complementary’ or cDNA.

In recent developments, Myriad Genetics announced that it is suing Ambry Genetics for patent infringement over the BRCA tests, claiming that Ambry Genetics’ recent release of a new (and considerably cheaper) genetic test for BRCA mutations relies on cDNA which Myriad Genetics upholds they still have a controlling patent over. Myriad Genetics has also demanded that Ambry Genetics cease offering their BRCA test with immediate effect, until the alleged infringement can be examined.

NBCF believes that this recent development in the US emphasises the importance of an amendment to the Australian Patents Act 1990, which would, as a minimum, clearly exclude the ability to grant patents over any human genetic material – including cDNA. NBCF will continue to work with our colleagues at Cancer Voices and Cancer Council Australia to push for such legislative change, and encourages our supporters to join us atwww.nbcf.org.au/Stories/Research/Strike-a-Balance-For-Genetic-Patent-Law.aspx.

With the significant advances in genetic technology that have occurred since Myriad Genetics first isolated the BRCA genes in the 1990s, many genetic tests (including several of those held by Myriad Genetics) now use cDNA rather than the naturally occurring form of the gene, and these tests are still patentable.

NBCF welcomed the decision by the US Supreme Court, calling it a victory for common sense as we believe this compromise should allow biotech investment in genetic testing to be protected and important research into breast cancer to continue.

Civil liberties groups, patients and doctors, many of whom brought the case against Myriad Genetics, also claimed this ruling as a victory and wanted it to pave the way for cheaper and more accessible genetic testing for BRCA genes. The decision was particularly timely given the recent focus on BRCA testing after US actor, Angelina Jolie, revealed that she had mutations in these genes, placing her at high risk of developing breast cancer.

“We are looking forward to seeing what impact these recent developments in the US will have on the Appeal hearing into BRCA testing in Australia which will be heard by the Australian Federal Court in early August 2013,” Dr Alison Butt, NBCF Director of Research Investment said.