Griffith Hack succeeds in expanding types of nucleic acid-based inventions considered patentable

2 August 2018

The subject matter relating to genetic information which the Australian Patent Office will consider patentable has been expanded following submissions by Griffith Hack on behalf of a client seeking patent protection for an oligonucleotide which induces exon skipping.

The types of nucleic acid-based innovations that are considered patentable subject matter in Australia has been significantly limited in light of the High Court’s recent decision in D'Arcy v Myriad Genetics Inc [2015] HCA 35 (Myriad). 

In Myriad, the High Court held that claims to isolated nucleic acid is not a manner of manufacture, and therefore not patentable subject matter, in Australia if the substance of the invention is genetic information, and not “made” by human action.    

Submissions by Griffith Hack attorneys Amanda Stark and Malcolm Lyons have now succeeded in expanding the types of nucleic acid-based inventions that the Patent Office will consider patentable. 

In light of the High Court’s decision, the initial practice of the Patent Office has been to reject claims to isolated antisense oligonucleotides, interfering RNA (iRNA) and other inhibitory nucleic acids that contain naturally occurring nucleotide sequence, on the basis that the naturally occurring genetic information is the substance of the invention.

Some recent Patent Office decisions have broadened the Patent Office’s approach to what types of nucleic acid-based inventions it will consider patentable in light of Myriad.  In Arrowhead Research Corporation [2016] APO 70, the Delegate of the Commissioner of Patents considered claims to compositions comprising an iRNA molecule were directed to patentable subject matter.

In Cargill Incorporated v Dow AgroSciences LLC [2016] APO 43, the Delegate considered claims to a codon-optimised polynucleotide which encoded a naturally occurring polypeptide was patentable subject matter because the genetic information was “made” by human action.

Submissions by Griffith Hack attorneys Amanda Stark and Malcolm Lyons have now succeeded in expanding the types of nucleic acid-based inventions that the Patent Office will consider patentable. 

In Academisch Ziekenhuis Leiden and BioMarin Technologies B.V. [2018] APO 49 (“Academisch”), the Delegate considered claims to an exon skipping oligonucleotide for treating Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (BMD).  Individuals suffering from DMD and BMD produce an out of frame mRNA molecule that contains exon 44, but also contains a premature stop codon downstream of exon 44, which encodes a dysfunctional dystrophin.    

The claim at issue was directed to an oligonucleotide capable of inducing exon skipping of exon 44 thereby restoring the correct reading frame and producing a partially functional dystrophin. The oligonucleotide is antisense to a naturally occurring target sequence in exon 44, and comprises a locked nucleic acid (LNA).  The oligonucleotide works by hybridising to the target sequence and causing the cell to produce an mRNA in which exon 44 is deleted, causing production of partially functional dystrophin.  The LNA modification prevents degradation of the oligonucleotide in the cell and enhances binding of the oligonucleotide to the target sequence.

During examination of the application, the Examiner rejected the claim to the oligonucleotide on the basis that the genetic information of the claimed oligonucleotide alone is responsible for the hybridisation, that it is the hybridised complex that causes deletion of exon 44, not the oligonucleotide alone, and as such the substance of the claim is considered to be the genetic information in the oligonucleotide.

In view of the Examiner’s refusal to accept the application, a hearing was requested.  In light of submissions made by Griffith Hack, the Delegate found:

  1. The information embodied in the specific nucleotide sequence of the antisense oligonucleotide is not a genetic code that is ultimately translated into an expressed polypeptide, but rather is used to effect the production of an altered protein to a level not normally present in DMB and BMB patients.  The manner in which the antisense oligonucleotide is used, and the result of that use, resembles a chemical compound.
  2.  The information in the altered, but partially functional, dystrophin protein is not the same as the information embodied in the specific nucleotide sequence of the oligonucleotide.
  3. The information in the antisense oligonucleotide is not used to ascertain information about a nucleic acid sequence.
  4. The length of the oligonucleotide and the presence of LNA are structural features that are significant to the working of the invention.
  5. The informational aspect of the oligonucleotide does not outweigh its form as a chemical compound.

The Delegate concluded that the substance of the invention as claimed is an artificially made chemical compound, and is therefore a manner of manufacture.

In view of this decision, it would seem possible to obtain acceptance of claims to oligonucleotides if it can be argued that in view of the structure and use of the oligonucleotide, the oligonucleotide is more akin to a chemical compound than a source of information.