Cancer Voices of Australia had challenged Myriad Genetics’ patent on the isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, arguing that the subject matter was not patentable. Section 18(1)(a) of the Patents Act states that invention must be of “a manner of manufacture within the meaning of section 6 of the Statute of Monopolies” in order to be patentable. Cancer Voices claimed that the isolated DNA and RNA were naturally occurring and thus not patentable.
Justice Nicholas disagreed, noting that the controlling case, National Research Development Corporation vs Commissioner of Patents (the NDRC case), held that this criteria is satisfied if the invention consists of an “artificially created state of affairs”, is discernible over time, and has economic significance. Even if the material is naturally occurring as Cancer Voices asserted, the endeavour required in isolating the genetic material can be understood as an artificially created state.
The other criteria of discernibility and economic significance were not at issue. Cancer Voices did not assert that the invention was not new or lacked inventive step.
The United States Supreme Court has agreed to review the patentability of the same BRCA1 as well as the BRCA2 sequences patented by Myriad, after the Court of Appeals for the Federal Circuit held that the isolated sequences were patentable under section 101. The Supreme Court is expected to issue its ruling by the end of the year.
