Eligibility of Isolated Nucleic Acid: Australian and U.S. Standards

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Author(s) Greg Peterson

Patent 213 Blog

Eligibility of Isolated Nucleic Acid: Australian and U.S. StandardsThis is the second of a two-part series comparing Australian and U.S. law and will focus on patent eligibility of an isolated nucleic acid sequence.

Are the patent eligibility standards for isolated nucleic acid molecules becoming more or less consistent around the world? The United States and Australia have weighed in on this topic, and the results, while sharing certain philosophical underpinnings, are not identical.

The subject of patent eligibility for natural phenomenon has been a major topic of judicial decisions over the last several years. Of particular interest has been the patentability of isolated, naturally occurring nucleic acid sequences. The Myriad Genetics decisions over the past several years are a good example of how the courts and patent offices around the world view this issue.

Myriad Genetics discovered certain isolated nucleic acid sequences coding for certain variations in the BRCA1 BRCA2 genes. The variations were determined to provide early markers for a woman’s risk of developing breast cancer as well as other types of cancer. Myriad filed patent applications claiming, among other things, the isolated nucleic acid sequences, probes and primers and methods of using these sequences.

The U.S. Approach

In 2013, the U.S. Supreme Court held that claims relating to naturally occurring, isolated DNA sequences were patent-ineligible as the DNA was naturally occurring and thus a natural phenomenon. The Court placed emphasis on the lack of creation or alteration of the claimed DNA and the fact that the isolated DNA contained the same “information” when isolated as it did in nature. Following this rational, the Court held that claims directed to cDNA were patentable since introns were removed (the DNA was altered).

The Federal Circuit also found that claims to primers were also patent ineligible under § 101 in In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation. The court reasoned that the primers contain the “identical sequence of the BRCA sequence directly opposite to the strand which they are designed to bind” and therefore fall under the Supreme Court’s logic in Myriad. Certain method claims using the primers were also held patent-ineligible under the Supreme Court’s decision in Mayo v. Prometheus.

The Australian Approach

The Myriad patent estate has also been the subject of litigation in Australia. On October 7, 2015, the Australian High Court, decided D’Arcy v Myriad Genetics, Inc.  and unanimously held that isolated nucleic acids are not patentable inventions. The Myriad patent at issue was Australian Patent 686004.The decision reasoned that the substance of the invention was the information embodied in the sequence of nucleotides and such information was an inherent part of the molecule. The decision further stated that nothing was made/created/modified by the inventors. As such, the High Court’s decision mirrors the logic of the U.S. Supreme Court in many regards.

IP Australia subsequently published a proposed practice document in response to the decision in which IP Australia narrowly construed the High Court’s ruling. IP Australia departed significantly from the concepts expressed initially when the Final Guidelines were released in December 2015. The Final Guidelines emphasize analysis of the claims according to a four-part analysis:

  1. What is the substance of the claim (not merely its form)?
  2. Has the substance of the claim been “made” or changed by man, or is it “artificial?”
  3. Does the invention have economic utility?
  4. Does the invention as claimed represent a new class of claim?

In terms of whether the substance of the claim was “made” by man, the Final Guidelines consider a comparison of the “state of affairs before the invention and the state of affairs as a result of the invention.” Relevant factors listed by IP Australia include: i) was substance of the claim “made/created/modified” by human action; ii) physical differences between the claimed subject matter and the subject matter in its natural state; iii) labor required to produce the claimed subject matter;  iv) mere replication from the natural state is not enough to confer eligibility; and v) isolation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product.

IP Australia applied these concepts to exclude the following isolated nucleic acid molecules from patentability: i) DNA or RNA; ii) human or non-human; and iii) coding or non-coding. IP Australia reasoned that such isolated nucleic acid “can only be considered as a claim to genetic information that is not made” emphasizing the importance of made or changed by man requirement.

IP Australia further stated that the following subject matter are excluded when they “merely replicate the genetic information of a naturally occurring organism:” i) cDNA and synthetic nucleic acids; ii) probes and primers; and iii) isolated interfering/inhibitory nucleic acids. Such subject matter may be patent eligible where the utility/novelty of the invention relates to genetic information that has been made by human intervention (for example, a man-made chimeric nucleic acid that does not occur in nature). The Final Guidelines conclude that other types of subject matter are patent eligible when they result in a “new or useful effect.” Specifically listed are pharmaceuticals and other chemical substances, recombinant or isolated proteins, and methods of treatment.


Therefore, while the U.S. and Australia share some common thinking about the patentability of isolated nucleic acids, IP Australia has taken an arguably stricter view of what types of isolated nucleic acid are patentable. Specifically, cDNA, while patentable in the U.S., does not appear to be patentable in Australia absent specific modification. Future decisions will likely center around the amount of modification required to remove the subject matter from the ineligibility trap and whether superior utility of an isolated nucleic acid will be enough for patent eligibility.