The High Court of Australia today published its decision in the matter of D’Arcy v Myriad Genetics Inc [2015] HCA 35.

Overturning the decision of Full Court of the Federal Court of Australia,  the Court (in three judgments) unanimously allowed the appeal, holding that the invention claimed did not fall within the concept of a manner of manufacture.

The Court held that an isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not a manner of manufacture.

While the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed.

The Court considered that to attribute patentability to the invention as claimed would involve an extension of the concept of a manner of manufacture which was not appropriate for judicial determination.

Gordon J commented at [284]:

Myriad submitted that such a result would put Australia out of step with some of its trading partners including the European Union and the United States of America. That issue, if it is to be addressed, is a matter for the legislature…

A good summary of the decision and its impacts by Jennifer Wagner appears in the Genomics Law Report.

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