BRCA1 gene – IP Law Watch

High Court of Australia Finds Claims for Isolated Genetic Material not Patentable Subject Matter

Oct 08 2015

On 7 October 2015, the High Court of Australia (High Court) issued its decision[1] in the long running dispute concerning Myriad Genetics, Inc.’s (Myriad) patent relating to an isolated nucleic acid coding for mutant or polymorphic BRCA1 polypeptide. Mutations in the BRCA1 gene can serve as indicators of a woman’s risk of developing breast cancer.

In a unanimous decision, the High Court found that claims directed to the isolated nucleic acid are invalid on the basis that they are not a ‘manner of manufacture’ and therefore not patentable subject matter. The High Court took the view that the claimed invention would extend the scope of the concept of “manner of manufacture” and that this was not something which was appropriate for courts to do. In light of the High Court’s decision, it will be interesting to see whether there is a legislative response to this issue.

High Court to Consider Whether Isolated Genetic Material is Patentable in Australia

Feb 19 2015

On 13 February 2015, the High Court of Australia (High Court) heard and granted Yvonne D’Arcy’s application for special leave to appeal the Full Federal Court of Australia’s (Full Federal Court) decision in D’Arcy v Myriad Genetics Inc [2014] FCAFC 115.

The unanimous decision of the five-judge bench of the Full Federal Court was that Myriad Genetics Inc’s patent claims directed to particular isolated BRCA1 genes were patentable subject matter in Australia.

Special Leave Sought to Appeal Gene Sequencing Decision to the High Court of Australia

Sep 25 2014

We recently reported on the decision by a five judge bench of the Full Court of the Federal Court of Australia (Full Court) which found that Myriad Genetics Inc’s patent covering the isolated BRCA1 gene is valid. The Full Court unanimously rejected an appeal by Ms. Yvonne D’Arcy from a decision by Justice Nicholas at first instance. Read our alert here.

It is now being reported that Ms. D’Arcy has sought special leave to appeal the decision to the High Court of Australia (High Court).

Australian Courts Confirm Status Quo for Patenting Gene Sequences

Sep 05 2014

Today, a five-judge bench of the Full Court of the Federal Court of Australia unanimously decided that Myriad Genetics Inc’s (Myriad) patent covering the isolated BRCA1 gene (Patent) is valid.

In Yvonne D’Arcy v Myriad Genetics Inc & Anor (5 September 2014) the Full Federal Court rejected the reasoning of the U.S. Supreme Court, when it found in 2013 that certain claims of a closely related U.S. Patent of Myriad were invalid as the claim to isolated nucleic acid was a claim to a “product of nature” and not patentable subject matter.

For the pro-patent lobby and the biotech industry, this is good news for innovation in life sciences in Australia.

Tag:BRCA1 gene