Biotech company defends patent on gene mutation for breast cancer

By Dr. Ananya Mandal, MDFeb 21 2012

A US biotechnology company is defending the granting of a controversial patent over a common genetic mutation for breast cancer, rejecting accusations it amounts to the privatization of the human body.

In the first court case in Australia challenging the practice of granting patents over human genetic material, counsel for Myriad Genetics said the BRCA1 mutation - for which the company gained a patent in 1994 - qualified as an invention because the act of removing it from the body changed it “chemically, structurally and functionally”.

Myriad Genetics, based in Salt Lake City, contends in the Australian case that its screening process that includes an artificially made gene mutation mimicking the one that makes people more susceptible to breast and ovarian cancers should be eligible for a patent.

“You can’t use this to build another human being,” David Shavin, Myriad Genetics’ lawyer, told Federal Court Justice John Nicholas today in his opening statement at the start of the trial in Sydney, referring to the process and mutation. “All you can use it for is to compare” normal with mutated genes he said. David Shavin QC told the first day of the hearing in the Federal Court in Sydney yesterday that Myriad Genetics had tested “thousands and thousands” of people nearly 20 years ago to identify the location of the mutation in the genome. “What's in the isolated nucleic acid (taken out of the body) is not the same thing that's in the cell, and that, I think, is the key issue,” Mr Shavin told the court.

In 2008 a Melbourne company that holds the Australian rights for Myriad's BRCA1 mutation patent, Genetic Technologies, wrote to the eight public laboratories that were performing the test, informing them it would be asserting its patent rights and insisting on performing all future tests itself. The company later backed down, but not before a range of groups such as Cancer Council Australia raised the alarm, triggering a Senate inquiry and a parliamentary bill that sought to ban or limit the effect of such patents.

Cancer Voices Australia, a national organization representing cancer patients, and Yvonne D’Arcy, a Brisbane resident diagnosed with breast cancer, sued Myriad Genetics and Genetic Technologies Ltd. in 2010 over a patent the companies have on a gene mutation associated with an increased risk of breast and ovarian cancers.

Rebecca Gilsenan, principal lawyer representing patient group Cancer Voices, said “Patents protect inventions, not discoveries,” Rebecca Gilsenan, a partner at Maurice Blackburn Lawyers, who represents the plaintiffs, said before the trial. “No Australian court has considered the question of whether isolated human genes are patentable.”

The case is expected to last between five and eight days. The case is: Cancer Voices Australia v. Myriad Genetics. NSD643/2010. Federal Court of Australia (Sydney).