The Thorny Problem of Patentable Eligible Subject Matter: Part 9 of a 10-Part Series: South Africa

This is Part 9 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. To view Part 8 (The Thorny Problem of Patent Eligible Subject Matter: Australia), click here.

Patentable Subject Matter in South Africa

In South Africa, patentable inventions are regulated by Section 25 of the Patents Act 57 of 1978 (Patents Act) as amended. Section 25 provides:

(1) A patent may, subject to the provisions of this section, be granted for any new invention which involves an inventive step and which is capable of being used or applied in trade or industry or agriculture.

(2) Anything which consists of –

(a) a discovery;

(b) a scientific theory;

(c) a mathematical method;

(d) a literary, dramatic, musical or artistic work or any other aesthetic creation;

(e) a scheme, rule or method for performing a mental act, playing a game or doing business;

(f) a program for a computer; or

(g) the presentation of information,

shall not be an invention for the purposes of this Act.

Additionally, Section 25(4)(a) provides that:

[a] patent shall not be granted for an invention the publication or exploitation of which would be generally expected to encourage immoral or offensive behavior.

Moreover, with respect to medical use claims, Section 25(9) provides that:

[i]n the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practiced on the human or animal body, the fact that the substance or composition forms part of the state of the art immediately before the priority date of the invention shall not prevent a patent being granted for the invention if the use of the substance or composition in any such method does not form part of the state of the art at that date.

Finally, Section 25(11) provides that:

[a]n invention of a method of treatment of the human or animal body by surgery or therapy or diagnosis practiced on the human or animal body shall be deemed not to be capable of being used or applied in trade or industry or agriculture.

It is important to note that South Africa does not have any case law under its current Patents Act concerning the subject matter eligibility of naturally occurring products. In fact, the only case that is partly relevant is a 1961 case under repealed Patents Act No. 37 of 1952. Specifically, Section 10(7) of the repealed Act provided.

[w]here a complete specification claims a new substance, the claim shall be construed as not extending to that substance when found in nature.

In the seminal case regarding this section of the repealed Act, American Cyanamid Co v Continental Ethicals (Pty) Ltd 1961 BP 301 CP, it was found that:

[i]n enacting Section 10(7) the legislature recognized that an absolute product claim is perfectly valid, notwithstanding the fact that the substance covered thereby may also be found to exist in nature. The legislature merely enacted that in such a case the scope of the claim should be restricted…In other words, if the plaintiff claims a new substance then it cannot complain of any dealing with that substance when the other party has merely found it in nature and has taken it from where he found it.

Should the South African Court of the Commissioner of Patents be faced with having to address the question of subject matter eligibility of naturally occurring products and the like, it will most likely turn to like judgments from Great Britain and the European Patent Office (EPO), since South Africa’s law closely mirrors the patent law of the United Kingdom and the European Patent Convention (EPC).

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 South African 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 claim 1: The subject matter of this claim does not contain excluded subject matter. However, the subject matter of this claim is not novel. Specifically, this claim is not patentable by virtue of the fact that stable energy-generating plasmids, which provide a hydrocarbon degradative pathway, are known.

Analysis of claim 2: The subject matter of this claim does not contain excluded subject matter. This claim is novel since the background states that Pseudomonas bacteria containing a (singular) stable energy-generating plasmid capable of degrading a single type of hydrocarbon are known. Thus, a Pseudomonas bacterium containing at least two stable energy-generating plasmids is novel. However, it will have to be shown that the inclusion of two plasmids involves an inventive step. In Diamond v. Chakrabarty, 447 U.S. 303, 305 (1980), (Chakrabarty) scientists added four plasmids to a bacterium, which enabled it to break down various components of crude oil. In the event that the facts are similar to Chakrabarty, South African courts will likely find that an inventive step is present since further inclusion of plasmids into the bacterium gave rise to certain advantages which were not obvious to a person skilled in the art.

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 claim 1: The subject matter of claim 1 is patentable and will be considered novel against the prior art described in the background. Prior to its isolation, it was (presumably) not possible to determine the exact chemical structure of amazonic acid. The background described that the leaf of Amazonian cherry, not the amazonic acid itself, displayed anti-cancerous properties. The fact that amazonic acid was the true active anti-cancerous compound was not known despite many attempts to isolate and determine the chemical composition of the active ingredient. Furthermore, since the amazonic acid has now been isolated from the leaf by the Applicant, it can further be viewed as novel in the sense that it is for the first time separate and distinct from the leaf. However, it should be noted that there is no South African guiding case law regarding whether or not mere “isolation” can impart novelty.

Analysis of claim 2: Because the subject matter of this claim is new, it constitutes patentable subject matter. The addition of a functional group will most likely also be deemed to be inventive since there is no indication in the prior art that such modification will impart hair growth properties and retain the anti-cancerous properties. Predicting the nature of chemico-physical properties of molecular entities remains one of science’s greatest challenges (See, P. Ball, Nature, 1996, 381, 684 and J Maddox, Nature, 1988, 335).

Analysis of claim 3: The claim will need to be amended since claims directed to methods of treatment of the human or animal body by surgery or therapy or of diagnosis practiced on the human or animal body are not patentable under the Patents Act. However, claims directed to a first medical use of a known (or novel) substance or composition are allowable under Section 25(9) of the Patents Act. Claims directed to a second or subsequent medical use of a known substance or composition are not allowable, unless framed in the “Swiss form.” Nonetheless, while “compound for use” claims for a second or subsequent medical use of a known compound are accepted in Europe pursuant to EPC 2000 and the recent changes to the EPO rules, such claims are not acceptable in South Africa.

Since the use of amazonic acid in the treatment of cancer is not previously known, claim 3 will need to be revised to a first medical use claim having the general structure “amazonic acid for use in the treatment of cancer.” While there is no case law in South Africa on whether or not a dosing regime is patentable, the courts are likely to follow the position of Great Britain Patent Office and/or EPO with respect to the patentability of such claims. In Great Britain, in the matter of Actavis v. Merck ([2008] EWCA Civ 444), the court stated at paragraph 29, “Research into new and better dosage regimes is clearly desirable, and there is simply no policy reason why, if a novel non-obvious regime is invented, there should not be an appropriate patent reward.” This is substantially in line with the Enlarged Board of Appeal decision in G02/08 EPO.

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 claim 1: Under the current Patents Act there is no case law concerning the subject matter eligibility of naturally occurring products. As such, subject matter eligibility will be determined from a novelty and inventiveness aspect taking into account exclusions of “method of treatment” claims. With respect to this claim, there is no indication of the extent of the prior art. As such, the claimed pair of primers are considered novel.

Analysis of claim 2: In this case, there is no indication of the extent of the prior art. As such the claimed method is considered novel.

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: The claim is not patentable pursuant to Section 25(11) of the Patents Act. While amending this claim to a first medical use claim is theoretically possible, this presents certain issues as will be discussed in more detail below. Moreover, amendment of this claim to a second medical use type claim is not readily possible.

Claim 1 can be rewritten as a first medical use claim to read as follows: “Sunshine for use in a method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, the sunshine being for exposure to the patient, wherein the exposure to sunlight alters the neuronal activity in the patient’s brain and mitigates the mood disorder.”

This rewritten claim will not be considered novel, since it is known that sunshine treats mood disorders. Moreover, this claim may be deemed as contra bones mores since it would afford the Applicant a monopoly over sunshine. As discussed previously herein, the Patents Act provides, at Section 25(4)(a) that a patent shall not be granted for an invention the publication or exploitation of which would be generally expected to encourage offensive or immoral behavior. Additionally, a “Swiss form” claim having the general structure, “Use of sunshine in the manufacture of a medicament to treat mood disorder” would not be possible since the manufactured medicament would need to comprise sunshine.

Analysis of claim 2: As with claim 1, this claim would have to be amended to a first medical use claim. Such a claim could read: “Synthetic white light for use in a method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, the synthetic white light being for exposure to the patient, wherein the exposure to white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.”

Since “it is a well-documented natural principle that white light affects a person’s mood” the mere fact that the white light is synthetic does not distinguish itself from the prior art. Therefore, this claim cannot be seen as novel.

Analysis of claim 3: The claim will also need to be amended. An amendment to a first medical use claim could read: “Filtered white light for use in a method of treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, the filtered white light being for exposure to the patient at a distance between 30-60 cm from a source of the filtered white light 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.”

There is no indication that filtered white light for use in the treatment of mood disorders is known in the prior art. Thereupon, this claim is arguably novel, however, it could be attacked for a lack of clarity, which is a ground of revocation under Section 61(f)(i) of the Patents Act. Because there is no case law regarding dosing regimens in South Africa, it is not possible to ascertain with any degree of certainty whether or not this claim will be seen as novel.

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: Because claim 1 is a method of treatment claim, it will need to be amended into an acceptable format under South African law. There is no case law regarding dosing regimens, and in such cases we shall typically follow the decisions of the United Kingdom and EPO.

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: Under South African law this claim will contravene Section 25(11) of the Patents Act and will need to be amended. The simplest amendment is to introduce the term “ex vivo” such that the claim is directed to “[a]n ex vivo method of determining whether a pregnant woman is at an increased risk of having a fetus with Down’s syndrome.” In principle, an “ex vivo” method claim will be patentable subject matter as long as the claim is novel and inventive over the prior art.

This post was written by Lisa Mueller of Michael Best and Dario Tanziani (Partner) and Charl Marais (Senior Associate) of Adams & Adams

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