Property law; intellectual property; patents; the concept of ‘manner of manufacture’.
Facts: Myriad Genetics Inc (Myriad) was granted a patent for an ‘isolated gene sequence’ that was part of the BRCA1 gene. If a person has specific mutations or problems with this BRCA1 gene, it is an indication that they are predisposed to breast cancer and ovarian cancer. By using the information in the ‘isolated gene sequence’, Myriad was able to test individuals for predisposition to these cancers. D’Arcy, who had twice survived cancer, challenged Myriad’s patent. She argued that the ‘isolated gene sequence’ was not an ‘invention’ that could be patented.
Issue: Was the ‘isolated gene sequence’, or the way that it was isolated from a cell, an invention for the purposes of patent law?
Decision: No, the sequence was information rather than a product. To be patentable, an invention must involve “making” something through human action. The information in the ‘isolated gene sequence’ was not “made” by human action, but was instead discerned.
Reason: The concept of “manner of manufacture” in section 18(1)(a) of the Patents Act 1990 (Cth) must be interpreted with the purpose of the legislation in mind. If an invention falls within existing case law regarding the meaning of “manner of manufacture”, then the inventor only needs to show: 1) that the invention is a product made, or a process producing an outcome as a result of human action, and 2) that the invention has economic utility. But where a new kind of patent claim is being made, then the court must consider other factors connected with the purpose of the Act.
The court held (at [28]) that, in the circumstances of this case, allowing Myriad to claim a patent over an isolated gene sequence ‘would give rise to a large new field of monopoly protection with potentially negative effects on innovation’. It could also ‘have a chilling effect’ on related research activities because the class of products as defined by the patent was potentially very broad.