A number of decisions by the Australian Patent Office following the 2015 “Myriad” decision have provided further clarity in regard to what genetic material may be patentable under Australian law.
We look at the recent decisions and what this means for claims.
Background
In late 2015 the Australian High Court handed down its decision in D’Arcy v Myriad Genetics Inc [2015] HCA 35 (“Myriad”) finding that claims to naturally occurring nucleic acid molecules are, in essence, a claim to “genetic information” per se, and hence are not a “manner of manufacture” as required by Section 18(1)(a) of the Patents Act 1990, and therefore do not constitute patentable subject matter under Australian law.
The Australian Patent Office’s interpretation of the “Myriad” decision was detailed in its updated Guidelines, issued in December 2015. The Guidelines set out that it is the “substance” of the claim that will be considered as distinct from the “subject matter” described by the words of the claim. If the “substance” of the claim (including synthetic nucleic acids, if they share identical genetic information) merely replicates the genetic information of nucleic acids which exist in nature, it is not considered “made” and is therefore non-patentable subject matter.
Decisions since Myriad
The practice of the Australian Patent Office has been in a state of evolution following the “Myriad” decision in 2015. Three recent decisions by the Australian Patent Office provide further useful clarification regarding the interpretation and application of the “Myriad” decision.
In Cargill Incorporated v Dow AgroSciences LLC [2016] APO 43 (“Cargill”), the polynucleotide encoding a codon-optimized sequence for the Δ9- desaturase gene was held patentable, despite it coding for a naturally-occurring protein. The reason for this was because the process of codon-optimization resulted in the production of the protein being increased over its production from the naturally-occurring genomic sequence. Hence, it was held in this instance that the substance of the claim was sufficiently “made”. The product of the claim (i.e. increased production of Δ-9 desaturase) resulted in economic utility and therefore satisfied the requirements of a being a “manner of manufacture”.
In Arrowhead Research Corporation [2016] APO 70 (“Arrowhead”), the question to be decided was whether the compositions claimed, comprising double stranded RNA (so-called “iRNA”), satisfied the requirements of being a “manner of manufacture”. Whilst it is true that the genetic information in the iRNA is naturally-occurring genetic information, it was decided that the “substance of the claim” was the pharmaceutical composition and not “the genetic information that is contained in the composition”. The interfering RNA molecules within the pharmaceutical composition targeted and resulted in the inhibition of Syk mRNA expression. This was the result of the informational, structural and chemical content of the RNA molecules in the pharmaceutical composition and not just the genetic information of the RNA. As such, the claimed compositions were held to represent “more than genetic information alone” and resulted in economically significant products satisfying the requirements of being a manner of manufacture.
In Commonwealth Scientific and Industrial Research Organisation v BASF Plant Sciences GmbH [2016] APO 83 (“CSIRO”), the opposed application included claims to nucleic acid molecules. Claim 19 defined a single recombinant nucleic acid molecule including one or more copies of a promoter sequence and a terminator sequence and nucleic acid sequences encoding each of a polypeptide with Δ6-desaturase activity, a polypeptide with Δ5-desaturase activity, a polypeptide with Δ6-elongase activity and a polypeptide with Δ5-elongase activity. The Applicant submitted that claim 19 defined a nucleic acid which comprises “nucleic acid sequences originating from a variety of sources ‘stitched together’ into one recombinant nucleic acid molecule”. The Delegate found that there was “no reason to believe that the combination of enzyme-encoding nucleic acids and associated regulatory sequences specified in claim 19 would necessarily exist naturally in one nucleic acid molecule in any one organism”. Accordingly, while the substance of claim 19 (and claims dependent thereon) was clearly the genetic information embodied in the recombinant nucleic acid molecule, this information was concluded to be made by human action and to therefore define a “manner of manufacture”.
The decision in “CSIRO”, is also the first to cite, with approval, the Office’s earlier decision in
“Cargill”. The opposed application in “CSIRO” also included a claim to an isolated nucleic acid encoding a polypeptide with Δ5-elongase activity. The sequence was demonstrated to be a codon-optimised sequence and, consistent with “Cargill”, was therefore was deemed to be sufficiently “made”.
The “Cargill” decision was welcomed, since a codon-optimized sequence clearly differs from the naturally occurring counterpart and possesses a utility not observed for the naturally occurring counterpart, and should rightly be considered a manner of manufacture.
The impact of these decisions
Collectively, the impact of the above decisions is that claims to isolated nucleic acids which are identical to those found in nature and are construed to merely define genetic information are not patentable.
However, claims will be considered to define patentable subject matter where:
- a claim is directed to a composition comprising an isolated naturally occurring nucleic acid molecule which has structural and/or chemical elements which affect its function (cf. iRNA) and which can be construed to represent more than genetic information alone; or
- a claim defines a nucleic acid molecule which has been clearly “stitched together” from various sources or which conveys the same information to its naturally occurring counterpart but has been modified (cf. codon-optimized sequences).
In summary, it appears that the Australian Patent Office has undertaken an appropriate shift in practice to give the “Myriad” decision a more narrow interpretation than was given immediately following the decision and the issuance of the Patent Office Guidelines. This approach will be welcomed by industry.