The Thorny Problem of Patentable Eligible Subject Matter: Part 8 of a 10-Part Series: Australia

This is Part 8 of a 10-part series examining patent eligible subject matter in the U.S., BRIC and several non-BRIC countries. To view Part 1 (The Thorny Problem of Patent Eligible Subject Matter: U.S.), click here. To view Part 2 (The Thorny Problem of Patent Eligible Subject Matter: Canada), click here. To view Part 3 (The Thorny Problem of Patent Eligible Subject Matter: India), click here. To view Part 4 (The Thorny Problem of Patent Eligible Subject Matter: Russia), click here. To view Part 5 (The Thorny Problem of Patent Eligible Subject Matter: Brazil), click here. To view Part 6 (The Thorny Problem of Patent Eligible Subject Matter: Europe), click here. To view Part 7 (The Thorny Problem of Patent Eligible Subject Matter: China), click here.

Patentable Subject Matter in Australia

In Australia, the basic requirements for patentability are found in section 18(1) of the Patents Act (1990) (Act) which provides:

… an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:

(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and
(b) when compared with the prior art base as it existed before the priority date of that claim:
(i) is novel; and
(ii) involves an inventive step; and
(c) is useful; and
(d) was not secretly used in the patent area before the priority date of that claim by, or on behalf of, or with the authority of, the patentee or nominated person or the patentee’s or nominated person’s predecessor in title to the invention.

The term “invention” is defined in schedule 1 of the Act to mean:

… any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies, and includes an alleged invention.

By referring to section 6 of the Statute of Monopolies, inventions excluded from patentability include those that are “contrary to the Law” or “generally inconvenient.” With respect to inventions that are “contrary to the Law,” the practice of the Australian Patent Office is that an objection “should only be taken where an unlawful use, but no lawful use, of an invention has been disclosed. In particular, regard must be had to whether the invention is primarily devised or intended for a lawful, or for an unlawful, use.” Regarding inventions that are “generally inconvenient,” the Examiner’s Manual states that: “the requirement that an invention not be generally inconvenient has not been relied on as the primary basis upon which to invalidate a patent in any reported cases.” Consequently, there is no clear guidance as to when an invention may be regarded as “generally inconvenient.”

Furthermore, section 18 provides that human beings and biological processes for their generation do not constitute patentable subject matter. Additionally, section 50 of the Act also alludes to additional subject matter that is considered to be non-patentable. Namely, this section states:

(1)  The Commissioner may refuse to accept a request and specification relating to a standard patent, or to grant a standard patent:

                     (a)  for an invention the use of which would be contrary to law; or

                     (b)  on the ground that the specification claims as an invention:

                              (i)  a substance that is capable of being used as food or medicine (whether for human beings or animals and whether for internal or external use) and is a mere mixture of known ingredients; or

                             (ii)  a process producing such a substance by mere admixture.

(2)  The Commissioner may refuse to accept a specification relating to a standard patent containing a claim that includes the name of a person as the name, or part of the name, of the invention so far as claimed in that claim.

As a result, patentable subject matter in Australia has largely been defined through case law. In 1959, the High Court, which is Australia’s highest court, issued a seminal decision on patentable subject matter in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (NRDC). Although decided under the earlier Patents Act (1952), NRDC has been applied countless times and is considered the definitive statement on patentable subject matter. In a somewhat circular fashion, but deliberately for the reason of avoiding re-stating the “test” in a manner which would be open to potentially narrow interpretation, the High Court stated:

The right question is: “Is this a proper subject of letters patent according to the principles which have been developed for the application of s. 6 of the Statute of Monopolies?”

The truth is that any attempt to state the ambit of s. 6 of the Statute of Monopolies by precisely defining “manufacture” is bound to fail. The purpose of s. 6, it must be remembered, was to allow the use of the prerogative to encourage national development in a field which already, in 1623, was seen to be excitingly unpredictable. To attempt to place upon the idea the fetters of an exact verbal formula could never have been sound. It would be unsound to the point of folly to attempt to do so now, when science has made such advances that the concrete applications of the notion which were familiar in 1623 can be seen to provide only the more obvious, not to say the more primitive, illustrations of the broad sweep of the concept.

As a result, Australian patent law provides a test for patentable subject matter which is sufficiently fluid to encompass the development of new technologies. For example, methods of medical treatment of human beings, including surgery and the administration of therapeutic drugs were deemed patentable inventions under section 18 of the Act in Apotex Pty Ltd v. Sanofi-Aventis Australia Pty Ltd., [2013] HCA 50 (4 December 2013).  Claims covering naturally occurring nucleic acid, such as deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) that have been “isolated” were found patentable as methods of manufacture under section 18 of the Act in Cancer Voices Australia v. Myriad Genetics Inc., [2013] FCA 65 (February 2013) (Myriad). In closing his general discussion of the law on patentable subject matter in Myriad, Justice Nicholas stated:

The High Court’s decision in NRDC is a definitive statement on the question of what constitutes patentable subject matter, and unless some good reason exists to distinguish it, it should be applied in a manner that gives effect to the broad language that was used.

The Myriad decision has been appealed to the Full Court of the Federal Court of Australia and the time frame for a decision is not presently known. 

Analysis of Examples under the U.S. PTO Guidance

In view of recent U.S. Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo), the U.S. Patent and Trademark Office (U.S. PTO) on March 4, 2014 issued guidance for evaluating subject matter eligibility under Section 101 (Guidance). The Guidance superseded the June 13, 2013 memorandum issued on the day of the Myriad decision. While the Guidance was issued without public notice or opportunity for the public to comment, the U.S. PTO held a forum on May 9, 2014 to receive feedback from organizations and individuals regarding the Guidance.

The Guidance is divided into four sections. Part I discusses the 3-part test for determining subject matter eligibility. Part II explains how to determine whether a claim (as a whole) is “significantly different.” This portion of the Guidance provides a list of 12 factors – six that weigh toward eligibility (namely, finding a significant difference) and six that weigh toward ineligibility (namely, a finding of no significant difference). Part III provides seven examples explaining the application of the factors. Part IV provides a new form paragraph for Examiners to use when rejecting claims in accordance with the Guidance.

In addition to the Guidance, the U.S. PTO prepared detailed training materials (containing 93 PowerPoint slides) for Examiners. The detailed training materials contain numerous examples not provided for in the Guidance.

We at the BRIC Wall thought it would be insightful to examine the analysis of subject matter eligibility under Australian patent law for several of the examples contained in the Guidance and training materials.

Composition/Manufacture Claim Reciting a Natural Product – Example A – U.S. PTO Guidelines

Claim 1: A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway.

Claim 2: A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

Background: Stable energy-generating plasmids exist within certain bacteria in nature. Pseudomonas bacteria are naturally occurring bacteria. Naturally occurring Pseudomonas bacteria containing a stable energy-generating plasmid and capable of degrading a single type of hydrocarbon are known.

Analysis of claims 1 and 2: Both claims must be amended to recite that the plasmid or bacterium is “isolated” or “purified” or include some other indicator to distinguish the claimed subject matter from the corresponding entity as it exists in nature. For example, Claim 1 could be amended to read, “An isolated stable energy-generating plasmid, …”  Once amended in this manner, both claims would constitute patent eligible subject matter.

Composition vs. Method Claims, Each Reciting a Natural Product – Example B – U.S. PTO Guidelines

Claim 1. Purified amazonic acid.

Claim 2. Purified 5-methyl amazonic acid.

Claim 3. A method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.

Background: The Amazonian cherry tree is a naturally occurring tree that grows wild in the Amazon basin region of Brazil. The leaves of the Amazonian cherry tree contain a chemical that is useful in treating breast cancer, however, to be effective, a patient must eat 30 pounds of the leaves per day for at least four weeks. Many have tried and failed to isolate the cancer-fighting chemical from the leaves. Applicant has successfully purified the cancer-fighting chemical from the leaves and has named it amazonic acid. The purified amazonic acid is structurally identical to the amazonic acid in the leaves, but a patient only needs to eat one teaspoon of the purified acid to get the same effects as 30 pounds of the leaves. Applicant has discovered that amazonic acid is useful to treat colon cancer as well as breast cancer, and applicant has also created a derivative of amazonic acid in the laboratory (called 5-methyl amazonic acid), which is structurally different from amazonic acid and is functionally different, because it stimulates the growth of hair in addition to treating cancer.

Analysis of claims 1, 2 and 3: All three claims appear to constitute patentable subject matter. In addition, Australia permits claims to be drafted in the “Swiss-style” format. Thus, for example, a claim drafted as follows may also constitute patentable subject matter: “Use of purified amazonic acid for the manufacture of a medicament for the treatment of colon cancer….”

Composition vs. Method Claims, Each Reciting Two Natural Products – Example E – U.S. PTO Guidelines 

Claim 1. A pair of primers, the first primer having the sequence of SEQ ID NO: 1 and the second primer having the sequence of SEQ ID NO: 2.

Claim 2. A method of amplifying a target DNA sequence comprising:

providing a reaction mixture comprising a double-stranded target DNA, the pair of primers of claim 1 wherein the first primer is complementary to a sequence on the first strand of the target DNA and the second primer is complementary to a sequence on the second strand of the target DNA, Taq polymerase, and a plurality of free nucleotides comprising adenine, thymine, cytosine and guanine;

heating the reaction mixture to a first predetermined temperature for a first predetermined time to separate the strands of the target DNA from each other;

cooling the reaction mixture to a second predetermined temperature for a second predetermined time under conditions to allow the first and second primers to hybridize with their complementary sequences on the first and second strands of the target DNA, and to allow the Taq polymerase to extend the primers; and repeating steps (b) and (c) at least 20 times.

Analysis of claims 1 and 2: Both claims may constitute patentable subject matter. However, if the sequences of the “primers” are already known, simply referring to them as “primers” would not make something which is otherwise non-patentable, patentable. Even if (say for the abovementioned reason) the claims to the “primers” constitute non-patentable subject matter, claims to methods of amplifying using the primers may constitute patentable subject matter.

Process Claims Involving A Natural Principle – Example G – U.S. PTO Guidelines

Claim 1. A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to sunlight, wherein the exposure to sunlight alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

Claim 2. A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to a synthetic source of white light, wherein the exposure to white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

Claim 3. A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: providing a light source that emits white light; filtering the ultra-violet (UV) rays from the white light; and positioning the patient adjacent to the light source at a distance between 30-60 cm for a predetermined period ranging from 30-60 minutes to expose photosensitive regions of the patient’s brain to the filtered white light, wherein the exposure to the filtered white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

Background: It is a well-documented natural principle that white light affects a person’s mood. Exposure to white light changes neuronal activity in the brain, which changes a person’s mood. Sunlight is a natural source of white light. It is well-understood, purely conventional and routine in the art of treating mood disorders to expose a person to white light in order to alter their neuronal activity and mitigate mood disorders. 

Analysis of claim 1: If it had previously not been known that exposure to sunlight mitigates a mood disorder, then this claim 1 may constitute patentable subject matter. However, the identification of the mechanism by which a known action (for example, a known treatment) works does not make an otherwise non-patentable invention, patentable. Hence, the fact that the claim recites “wherein the exposure to sunlight alters the neuronal activity in the patient’s brain” does not assist in this case. 

Analysis of claim 2: It is unlikely that this claim constitutes patent eligible subject matter following the analysis of claim 1. 

Analysis of claim 3: It is unlikely that this claim constitutes patent eligible subject matter following the analysis of claim 1.

Diagnostic claim from Mayo Collaborative Services v. Prometheus Laboratories, Inc. – Examiner Training Materials

1.  A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Analysis of claim 1: This claim constitutes patentable subject matter. The fact that this claim is directed to a method which may be practiced on or in relation to a human being does not make this claim patent ineligible. Underlying the claim appears to be the “discovery” that the determined level of 6-thioguanine in the blood of the patient receiving the treatment is informative for the treating physician to increase or decrease the administered dosage, thereby optimizing treatment. If the identified levels were previously unknown in importance for the immune-mediated gastrointestinal disorder, then this “discovery” is not merely a “piece of abstract information without any suggestion of a practical application of it to a useful end” (NRDC), and may be considered a discovery having practical application in a patent eligible field and hence patent eligible. 

Claim from U.S. Patent No. 6,573,103 – Examiner Training Materials

1.  A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome, the method comprising the steps of:

measuring the level of at least one screening marker from a first trimester of pregnancy by:

(i) assaying a sample obtained from the pregnant woman at said first trimester of pregnancy for at least one first biochemical screening marker; and/or

(ii) measuring at least one first ultrasound screening marker from an ultrasound scan taken at said first trimester of pregnancy;

measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:

(i) assaying a sample obtained from the pregnant woman at said second trimester of pregnancy for at least one second biochemical screening marker; and/or

(ii) measuring at least one second ultrasound screening marker from an ultrasound scan taken at said second trimester of pregnancy; and

determining the risk of Down’s syndrome by comparing the measured levels of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from the second trimester of pregnancy with observed relative frequency distributions of marker levels in Down’s syndrome pregnancies and in unaffected pregnancies. 

Analysis of claim 1: This claim may constitute patentable subject matter. The fact that this claim is directed to a method which may be practiced on or in relation to a human being does not make it patent ineligible. At its base level, this claim defines measuring the level of one known risk marker in the first trimester and measuring the level of one different known marker in the second trimester, then comparing the measured levels with observed relative frequency distributions of marker levels in affected and unaffected pregnancies. It is unlikely that this claim would constitute patent eligible subject matter as it appears merely to define a method which utilizes known markers for a purpose for which they are already known. However, this claim may become patent eligible if, for example, the inventor identified and claimed a subset of the known markers which, when utilized together or in a particular order or at specific time points, etc., provided a test which permitted the physician to assess risk at a higher confidence level than was previously permitted.

This post was written by Lisa Mueller and Dr. Martin O’Brien of Spruson & Ferguson.

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