In a decision handed down on 7 October 2015, the High Court has unanimously allowed the appeal from the decision of the Full Federal Court in D’Arcy v Myriad Genetics Inc. [2014] FCAFC 115 (see our article dated 8 September 2014).
In this surprise decision, the court held that claims 1 to 3 of the Myriad patent directed to isolated nucleic acids coding for mutant or polymorphic forms of the BRCA1 polypeptide do not meet the requirement of manner of manufacture and are therefore inherently non-patentable. In reaching this decision the court concurred with the reasoning of the U.S. Supreme Court in Association for Molecular Pathology v Myriad Genetics Inc. that the information stored in the relevant sequences is an essential feature that is not modified simply because the molecules have been isolated. The court noted that the claims in question cover a “very large, indeed unquantified” class of isolated nucleic acids bearing the requisite information, and that allowing patent protection of this class risks “a chilling effect upon legitimate innovative activity outside the formal boundaries of the monopoly”. A further factor in the decision is the court’s view that “if the claims are properly the subject of a patent, the patent could be infringed without the infringer being aware of that fact”.
The High Court decision has certainly expanded the patentable subject matter “manner of manufacture test”. However, while the majority judgment of the court doesn’t specifically address the issue of patentable subject matter with respect to naturally occurring compounds (other than nucleic acids) or artificial nucleic acids, it is hoped that the judgment will be restricted in its future application to the present fact situation; namely in relation to naturally occurring human nucleic acids.
A detailed analysis of this decision is to follow.