Today the High Court unanimously allowed an appeal from a decision of the Full Court of the Federal Court of Australia and held that an isolated nucleic acid, coding for a mutant BRCA1 protein, was not a "patentable invention".
The question now is how this decision will be applied by the Australian Patent Office and by courts in the future when assessing patent applications or previously granted patents covering isolated nucleic acids. There is also a concern that the decision will be applied to patent applications and patents which cover other naturally occurring products, such as antibodies, polypeptides or stems cells.
The decision relates to Australian patent no. 686004 which was filed in August 1995 and has recently expired. Only the first three of a total of thirty claims were at issue in this decision. These first three claims are directed to isolated nucleic acid molecules per se and read as follows:
- An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.
- An isolated nucleic acid as claimed in claim 1 which is a DNA coding for a mutant BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ ID No: 1 one or more mutations set forth in Tables 12, 12A and 14.
- An isolated nucleic acid as claimed in claim 1 which is a DNA coding for a polymorphic BRCA1 polypeptide, said DNA containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ ID No:1 one or more polymorphisms set forth in Tables 18 and 19
Other claims of this patent that were not challenged include claims directed to:
- expression vectors
- host cells, and
- methods of diagnosis.
If the patent had not expired, these unchallenged claims would still provide Myriad with protection for the use of its BRCA1 diagnostic test for breast cancer.
Nevertheless, this decision is important because it will impact on the patentability of other Australian patents, including those already granted, which cover isolated nucleic acid molecules and potentially other naturally occurring substances.
Arriving at the Decision
In arriving at their decision Justices French, Kiefel, Bell and Keane noted that scope of claims 1 to 3 was excessively broad. In view of the variable lengths of the nucleic acid molecules that could encode BRCA1 polypeptides with the specified mutations, the claims cover a very large number of compounds with different molecular structures.
The High court differed from the Full Federal Court’s characterisation of the claimed isolated nucleic acid as a compound, rather than information. According to the High Court, to say the claims relate to a class of chemical compounds elevates “form over substance”. In their view, a sequence of nucleotides, whether genomic DNA or cDNA, should properly be described as “information”:
“ …. the information stored in the sequence of nucleotides coding for the mutated or polymorphic BRCA1 polypeptide is the same information as that contained in the DNA of the person from which the nucleic acid was isolated. It is the existence of that information which is an essential element of the invention as claimed. The product is the medium in which that information resides. That characteristic also attaches to cDNA, covered by the claims, which is synthesised but replicates a naturally occurring sequence of exons.”
Other important factors taken into account include:
- whether the invention as claimed could give rise to a large new field of monopoly protection with potentially negative effects on innovation;
- whether the invention as claimed could have a “chilling effect” on activities beyond those formally the subject of the exclusive rights granted to the patentee;
- whether to accord patentability to the invention would involve the court in assessing important and conflicting public and private interests and purposes, and
- whether to accord patentability to the class of invention as claimed would involve law-making of a kind which should be done by the legislature.
Taking these factors into account, the High Court decided that claim 1 to 3 should not qualify as patentable subject matter.
The ruling by the majority of the justices appears to be very narrowly applied and the decision was silent as to other naturally occurring substances. However it remains to be seen how it will be applied by the Patent Office and the courts in future cases.