High Court Ruling Rejects Patent on Breast Cancer Gene

After losing a federal court challenge, Yvonne D’Arcy went to Australia’s highest court to continue her fight against a US-based biotech company. The BRCA1 gene, which the Myriad Genetics has a patent over, is associated with an increased risk of ovarian and hereditary breast cancers. The lawyers representing Darcy argued that even where it gets isolated from the body, the gene will remain unpatentable since the genetic material is a product of nature. They contended that allowing biotech companies to own patents over human genes could allow them to charge exorbitant rates and stifle cancer research for patients who wish to be tested for the BRCA1 mutation.

Therefore, the high court found in an unanimous decision on Wednesday that this was not a “patentable invention” since BRCA1 protein, coded by an isolated nucleic acid, had specific variations from the norm that are indicative of susceptibility to ovarian cancer and breast cancer. The ruling made by Australia’s highest court ended a long battle over whether companies can own the rights to genetic material by ruling that the gene mutation linked to cancer cannot be patented. Hence, the ruling is a win for Yvonne D’Arcy, a 69-year-old Queensland breast cancer survivor who challenged the ownership of BRCA1 gene mutation by Myriad Genetics.

Earlier, Darcy’s appeal against a judge’s finding that the invention was classified within the concept of a “manner of manufacture” had been dismissed by the federal court. However, the high court disagreed with the federal court’s decision of dismissing Ms Darcy’s appeal. The judges said that while the invention was the existence of the information stored in the sequences that were relevant and that was an essential element of the invention though the invention claimed might be, in a formal sense or a product of human action. After a long legal battle, Darcy said that she was “ecstatic” at the High Court’s decision. She also said that taking on such a biotech corporation had been like a David and Goliath match-up to her. “I’m only a little person – but it’s not the size of the dog in the fight, it’s the size of the fight in the dog,” she said.

On the other hand, Ms Darcy said that a few people were able to afford the testing until the decision was arrived at by the High Court. At least now people can afford the cost of the testing and it should now come down. She said that this was not only her win but also a win for all those people who do have the genetic footprint. Also, she said that they were now forearmed and forewarned. As a matter of fact, D’Arcy’s one cervical cancer diagnosis and two breast cancer diagnoses are hormonally and not genetically based. She said that despite the psychological toll of continuing legal procedures, she never considered ditching her claim, because she knew she was in the right although her opponents seemed motivated purely by their commercial bottom line.