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5.6.8.11 Nucleic Acids and Genetic Information

Date Published

Overview

In D’Arcy v Myriad Genetics Inc. (2015) HCA 35 (Myriad), the High Court considered whether an isolated nucleic acid is a “manner of manufacture” within the meaning of s.6 of the Statute of Monopolies.

The decision relates to Myriad’s patent [686004] for isolated nucleic acid sequences encoding a mutant or polymorphic BRCA1 polypeptide. The claimed sequences contained specified mutations or polymorphisms in BRCA1 that are indicative of susceptibility to cancer. The High Court was asked to determine whether claims 1 – 3, directed to the isolated BRCA1 nucleic acid and mutants and polymorphisms thereof, defined patent eligible subject matter (that is, a manner of manufacture).

The High Court unanimously held that claims 1 – 3 did not define a manner of manufacture. The Court found that, while formulated as claims to a product (that is, a nucleic acid molecule), the substance of the invention resides in the information embodied in the sequence of nucleotides of the molecule. The Court concluded that the information incorporated in the isolated nucleic acid sequence reproduced a relevant sequence of nucleotides existing in a human being and is therefore information that is not “made”.

The Court made clear that it was not concerned with “gene patenting” generally and did not make any finding with respect to the remaining claims of the patent directed to probes, vectors, methods of production, and methods of diagnosis.

The decision does not set out a general rule that isolated natural products or their derivatives are excluded from patentability. The majority did not engage in a debate about “products of nature” versus “artificially created products”, but found that, in a case where the substance of the claimed invention was genetic information that was not “made”, the claiming of the alleged invention as an isolated product did not confer patent eligibility. The substance was therefore outside the established bounds of patentability and extending the concept of manner of manufacture to that subject matter was not justified.

Notwithstanding the other requirements of patentability (for example, utility, novelty, and inventiveness), the key principles that determine the patentability of claims directed to nucleic acids or genetic information are:

  1. What is the substance of the claim; and
  2. Is the substance of the claim “made”?

These principles have been applied in several decisions of the Court and the Commissioner:​​​​​​​

  • Meat & Livestock Australia Limited v Cargill, Inc. (2018) FCA 51 in relation to an invention for methods of identifying cattle having useful traits using genetic information from SNPs.
  • Sequenom, Inc. v Ariosa Diagnostics, Inc. (2019) FCA 1011 regarding an invention for methods of detecting cell free DNA of fetal origin in a maternal serum or plasma sample.
  • Arrowhead Research Corporation [2016] APO 70 in relation to compositions comprising double-stranded RNA that interferes with Syk mRNA expression.
  • Cargill Incorporated v Dow AgroSciences LLC (2016) APO 43 regarding an invention for a codon-optimised delta-9 desaturase gene.
  • Academisch Ziekenhuis Leiden and BioMarin Technologies B.V. [2018] APO 49 in relation to antisense oligonucleotides for treatment of Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD) by inducing exon skipping.

What is the substance of the claim?

In determining the substance of the claim, examiners should consider the claimed invention in light of the description.

In Myriad, the Court found that the substance of the claims was genetic information, even though the claims were drafted as product claims. In determining the substance of the claim, it is important to consider the description and how the invention works as well as the claim itself. For a more detailed discussion on how to determine the substance of the invention, refer to 5.6.8.1 General Principles – Assessing Manner of Manufacture​​​​​​​.

In practice, as DNA and RNA are both carriers of genetic information, any claim to a sequence of nucleotides that reproduces genomic DNA is likely to be in substance directed to genetic information. This will be the case even when the nucleic acid claimed represents a lesser part of the full-length nucleic acid molecule, for example a fragment, primer, or interfering molecule.

In contrast, where a claim is directed to a method or process that makes use of a nucleic acid molecule, the substance of the claim will normally reside in that process for producing a particular outcome, for example, a method of diagnosis. In this situation, provided the invention as claimed has economic utility, the subject matter claimed will be a manner of manufacture.

Is the substance of the claim "made"?

The second question considered by the Court was whether the substance of the claim had been "made" or changed by human intervention.

When examiners consider the question of whether the substance of a claim is “made”, they should compare the state of affairs before the invention and as a result of the invention. When dealing with genetic information, if the claimed nucleic acid sequence conveys the same information as a sequence of nucleotides in the genome of an organism, plant or animal, the state of affairs before and after the invention is the same, and therefore the substance of the invention cannot be considered “made”. That is, the act of isolation, purification, or synthesis is not enough to confer patentability in this situation. This is the case, even when the molecule is man-made (for example, cDNA), if the genetic information in the man-made molecule is the same as that in the genome of an organism because the genetic information conveyed by the claimed molecule has not been changed and therefore cannot be considered “made” for the assessment of manner of manufacture. In Myriad, the Court found that the genetic information stored in the sequence of nucleotides coding for the mutated or polymorphic BRCA1 polypeptide is the same as that contained in the natural DNA. In addition, the existence of that information was an essential element of the invention claimed.

In contrast, where the information in a nucleic acid does not have a counterpart in the genome of an organism, plant or animal, the genetic information can be considered “made” or artificial, and therefore represents a manner of manufacture.

A nucleic acid may also provide patentable subject matter when the substance of a claim is determined to be a product and not genetic information. For example, a nucleic acid microarray is more than merely genetic information. Instead, the substance of the claim is a product which has been “made”.

Amended Reasons

Amended Reason Date Amended

Published for testing
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