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.

The Thorny Problem of Patentable Eligible Subject Matter: Part 7 of a 10-Part Series: China

This is Part 7 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.

Patentable Subject Matter in China

Article 2 of China’s patent law defines inventions as “new technical solutions proposed for a product, a process or the improvement thereof.” However, all inventions are subject to two statutory exclusions from patent eligibility pursuant to Articles 5 and 25. Additionally, China’s patent rules (namely, the “Rules for the Implementation of the Patent Law of the People’s Republic of China,” hereinafter “the Rule”) and Guideline for Patent Examination (hereinafter “the Guideline”) provide further explanation of these exclusions.

Article 5 Exclusions

Article 5 states that:

Patent rights shall not be granted for invention-creations that violate the law or social ethics, or harm public interests. Patent rights shall not be granted for inventions that are accomplished by relying on genetic resources which are obtained or used in violation of the provisions of laws and administrative regulations.

According to the Guideline (Part II, Chapter 1), a patent cannot be granted for inventions that are contrary to the laws, such as those directed to gambling facilities and to an apparatus for counterfeiting official documents. Additionally, the Guideline and Rule 10 provide that where the law merely restricts or limits the exploitation of an invention (such as the manufacture, sale, and use of a weapon), the invention itself (such as weapons per se or the process of making a weapon) still constitutes patentable subject matter.

According to Rule 26.1, the “genetic resources” recited in Article 5 refers to “the materials obtained from human body, animal, plant, or microorganism which contain the functional units of heredity.”  Pursuant to the Guideline (Part II, Chapter 1, section 3.2), the functional units of heredity include gene and DNA or RNA fragments having a heredity function in an organism. The Guideline further explains that under Article 5, violations resulting in unpatentable inventions include the acquisition or use of genetic resources “not beforehand approved by relevant administrative departments or licensed by relevant right holder in accordance with the provisions of relevant laws and regulations of China.” Additionally, the Guideline (Part II, Chapter 10, section 9.1) states that embryonic stem cell of human beings and the human body at various stages of formation and development are not patentable pursuant to Article 5.

Article 25 Exclusions

According to Article 25, in China, a patent will not be granted for subject matter directed to any of the following:

  1. Scientific discoveries;
  2. Rules and methods for intellectual activities;
  3. Methods for the diagnosis or treatment of diseases;
  4. Animal or plant varieties;
  5. Substances obtained by means of nuclear transformation; and
  6. Designs that are mainly used for marking a pattern, color or the combination of the two of prints.

However, a patent may be granted for production methods of animal or plant varieties. Nonetheless, please note the following regarding chemical and biological inventions.

Natural Substances

The exclusionary language of Article 25 does not contain a category relating to a “natural substance.” However, according to the Guideline (Part II, Chapter 10, section 2.1):

[a] substance found in the nature and existing in its natural state is merely an object of discovery. In such a case, while the process of isolating the substance is patentable, the substance itself is excluded from patent protection because the substance itself does not change and is known in the art. However, if a substance is isolated or extracted from the nature for the first time, its structure, morphology or other physical /chemical parameters are unknown in the prior art and can be precisely characterized, and if it can be exploited industrially, the substance per se and the process for obtaining it are all patentable under the Patent Law.

Specifically, the Guideline (Part II, Chapter 10, section 9.1.2) provides that “a gene or DNA fragment found in the nature and existing in its natural state is merely a discovery,” is excluded from patent protection. However, the Guideline further states that a gene or a DNA fragment per se and the process of obtaining such a gene or DNA fragment constitutes patent eligible subject matter if: (1) it is isolated or extracted for the first time from the nature; (2) its base sequence is unknown in the art; (3) it can be definitely characterized; and (4) it can be exploited industrially.

Medical Diagnosis or Treatment

According to Article 25, methods for the diagnosis or treatment of diseases do not constitute patent eligible subject matter. The Guideline (Part II, Chapter 1, section 4.3) explains that methods for the diagnosis or treatment of diseases discussed in Article 25 refers to “[t]he process of identifying, determining, or eliminating the cause or focus of diseases which are practiced directly on living human or animal bodies.” Thereupon, according to the Guidelines, the following processes do not constitute diagnostic or medical treatment methods:

  1. Methods practiced on a dead human or animal.
  2. Methods practiced simply to obtain information from a human or animal (e.g., body or physiological parameters) as an intermediate result rather than to obtain a diagnostic result or information regarding the health of the human or animal.
  3. Non-surgical methods to change an animal’s growing trait.
  4. Methods that are purely cosmetic in nature on visible body parts (e.g., skin and hair).
  5. Methods of killing bacteria, viruses, lice, or fleas on a human or animal.

Medical Use of Substances

Article 25 does not expressly exclude from patentability the medical use of a substance. Specifically, the Guideline (Part II, Chapter 10, sections 2.2 and 4.5) explains that:

[a]s the medical use of a substance is a use for the diagnosis or treatment of diseases, it falls into the situations provided for in Article 25.1(3); hence it shall not be granted the patent right. However, if a substance is used for the manufacturing of a medicament, it may be patentable under the Patent Law.

In practice, such claims may be drafted as Swiss-type claims provided that these claims are directed to the use of the substance as a component of a medicament, such as the “use of substance X for the manufacturing of a medicament for the treatment of disease Y.”

The Guideline (Part II, Chapter 10, section 5.4) provides that Swiss-type use claims must recite the manufacture of a pharmaceutical. In fact, features that are merely present in the course of administering a medicament are not sufficient to confer novelty. Thus, even if a claim is drafted as a Swiss-type use claim, any diagnostic or treatment parameters unrelated to the manufacture of the medicament will not be construed as providing meaningful limitations and the claim will likely face a novelty rejection.

Animal and Plant Varieties

Under Article 25, animal and plant varieties do not constitute patent eligible subject matter and are excluded from patent protection. The Guideline (Part II, Chapter 10, section 9.1.2) indicates that embryonic stem cells of an animal (but not somatic cells), an animal at various stages of formation and development (e.g., an embryo), a single plant and its reproductive material (such as seed), as well as transgenic animals and plants (e.g., those obtained by DNA recombination technologies of genetic engineering) are not patentable under Article 25. Nonetheless, production methods for such animal and plant varieties do constitute patent eligible subject matter and are patentable under Article 25. In addition, new plant varieties can be protected by other administrative means, namely, the Regulation on the Protection of New Varieties of Plants enacted in 1997.

Microorganisms

The Guideline (Part II, Chapter 10, section 9.1.2) provides that a microorganism is neither an animal nor a plant, and as such, is not excluded as an animal or plant variety under Article 25. However, a microorganism existing in the nature without the involvement of any artificially induced technical treatment is considered to be a scientific discovery and not patentable. Specifically, the Guideline states that “[m]icroorganism per se constitutes a subject matter of patent protection only when it is isolated into pure culture and has particular industrial use.”

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 Chinese 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: Since the claimed stable energy-generating plasmid exists within certain bacteria in nature, claiming a plasmid in its natural state amounts to merely a “scientific discovery.” Therefore, this claim does not constitute patent eligible subject matter under Article 25. Moreover, because this claim is not directed to an isolated or extracted plasmid, it does not fall within the category of an isolated natural substance.

Analysis of Claim 2: This claim may be directed to patent eligible subject matter. A bacterium containing two or more stable energy-generating plasmids that is not naturally occurring is not a “mere” discovery. According to the Guideline, a bacterium (such as a microorganism) is neither an animal nor a plant, and is not excluded as an “animal and plant variety” under Article 25. In addition, the Guideline provides that non-naturally occurring microorganisms are patentable when isolated into a pure culture and have a particular industrial use. Since the bacterium of claim 2 has an industrial use (namely, energy generation) it would be patentable if claimed in a pure culture.

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: This claim may be directed to patent eligible subject matter. The claimed amazonic acid is a natural substance purified from a natural source (namely, an Amazonian cherry tree). The Guideline provides that if a substance: (1) is isolated or extracted from nature for the first time; (2) has a structure, morphology or other physical /chemical parameters that are unknown in the prior art; (3) can be precisely characterized; and (4) can be exploited industrially, the substance per se and the process for obtaining such a substance constitutes patent eligible subject matter.

Under this analysis, the purified amazonic acid has industrial value (namely, to treat cancer). For the purified amazonic acid to be patentable, an Applicant would need to establish that it was the first to (1) isolate the compound from nature; and (2) precisely characterize its structure and physical properties, which were unknown in the art before the invention was made. In this example, prior to the Applicant, many tried and failed to isolate the cancer-fighting chemical from the leaves. If the Applicant can establish that (1) the previous work was done without the knowledge of the structure of amazonic acid or its physical properties (namely, such physical properties were unknown in the art); and (2) it was the first to isolate and structurally characterize the chemical, then the subject matter of claim 1 would constitute patent eligible subject matter. 

Analysis of Claim 2: This claim is directed to patent eligible subject matter because the 5-methyl amazonic acid is a non-naturally occurring chemical made by the Applicant and is structurally different from natural amazonic acid (found in the leaves). 

Analysis of Claim 3: This claim may not be directed to patent eligible subject matter because it encompasses a method for treating diseases on a human or animal body which is excluded from patent protection pursuant to Article 25. This claim may be rewritten as a Swiss-type claim as follows: “Use of amazonic acid for the preparation of a pharmaceutical composition to treat colon cancer.” A claim rewritten in this manner constitutes patent eligible subject matter because it is directed to a pharmaceutical composition rather than amazonic acid. However, as indicated by the Guideline, any features in the claim that relates only to how the composition is administered (e.g., a dosage regimen) will not confer novelty to this claim.

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: Because a claim directed to a pair of primers (which are naturally occurring DNA fragments) is considered to be to a scientific discovery, such a claim does not constitute patent eligible subject matter under Article 25. However, a claim directed to such primers may be patent eligible if the specification provides the following description:   (1) how the primers were isolated or extracted for the first time from the nature; (2) how the base sequence of the primers was unknown in the art prior to the present invention; (3) how the primers have been characterized; and (4) how the primers can be exploited industrially, as indicated by the Guideline (Part II, Chapter 10, section 9.1.2).

Analysis of Claim 2: This claim is directed to patent eligible 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: This claim may be excluded from patent protection pursuant to Article 25 as being directed to a method of treating a disease (namely, a mood disorder) operating on a living human body (namely, exposing the patient to sunlight). Furthermore, the claim may be considered to encompass a natural biological process and thus would be excluded under Article 25 as encompassing a scientific discovery. 

Analysis of Claim 2: This claim may be excluded from patent protection pursuant to Article 25 as being directed to a method of treating a disease (namely, a mood disorder) operating on a living human body (namely, exposing the patient to synthetic source of white light). 

Analysis of Claim 3: This claim may be excluded from patent protection under Article 25 as being directed to a method of treating a disease (namely, a mood disorder) operating on a living human body (namely, exposing the photosensitive regions of the patient’s brain to the filtered white light). It is unlikely that this claim could be drafted into an acceptable Swiss-type format. 

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

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 does not contain patent eligible subject matter because this claim encompasses a method of treating a disease (namely, optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder), which must be practiced on a living human body (namely, administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder). Alternatively, the claimed method involves identifying information (namely, determining the level of 6-thioguanine) that leads to an immediate diagnostic result (namely, a need to increase or decrease the amount of 6-thioguanine in the patient). Under Article 25, such a medical diagnosis or treatment method does not constitute patent eligible subject matter. 

Moreover, the subject matter of this claim does not involve use of 6-thioguanine for the manufacture of a medicament. Therefore, it is unlikely that this claim could be drafted into an acceptable Swiss-type use claim.

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 is not directed to patent eligible subject matter because it encompasses a method of diagnosing a disease (namely, a risk of Down’s syndrome in a fetus), which is practiced on a living human body (namely, assaying a sample obtained from the pregnant woman), yielding results that lead to an immediate diagnostic conclusion (namely, determining the risk of Down’s syndrome in the fetus). Under Article 25, such a medical diagnosis method does not constitute patent eligible subject matter.

This post was written by Lisa Mueller and Wei Yan of Michael Best & Friedrich and Ivan Shen of Shen Li and Partners.

The Thorny Problem of Patentable Eligible Subject Matter: Part 6 of a 10-Part Series: Europe

This is Part 6 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.

Patentable Subject Matter in Europe

For biotechnology applications undergoing examination at the European Patent Office (EPO), patent eligible subject matter is described in Article 53 of the European Patent Code (EPC) which recites:

“Exceptions to patentability

European patents shall not be granted in respect of:

(a) inventions the commercial exploitation of which would be contrary to “ordre public” or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;

(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;

(c) …”

The implementation of Article 53(a) EPC can be found in Rule 28 EPC which recites:

“Exceptions to patentability

Under Article 53(a), European patents shall not be granted to biotechnological inventions which concern the following:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human beings;

(c) uses of human embryos for industrial or commercial purposes; or

(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.”

The most relevant case law with respect to Rule 28(c) is Enlarged Board of Appeal decision G 2/06, which can be found at: http://www.epo.org/law-practice/case-law-appeals/recent/g060002ex1.html.

Additionally, Rules 27 and 29 EPC are relevant to biotechnological inventions. Specifically, Rule 27 can be considered to be a positive (inclusive) rule and recites:

“Patentable biotechnological inventions

Biotechnological inventions shall also be patentable if they concern:

(a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;

(b) plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety; or

(c) a microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.”

Rule 27(c) was addressed in Enlarged Board of Appeal decision G 2/07, which can be found here.

In contrast, Rule 29 is a negative (excluding) rule and recites:

“The human body and its elements

(1) The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.

(2) An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

(3) The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.”

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 Chinese 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 should be patentable under the EPC despite the fact that the plasmid of claim 1 exists in nature, provided, however, the claim is amended to refer to an “isolated” plasmid (Rule 27(a) EPC).

Analysis of claim 2: The subject-matter of this claim should be patentable under the EPC. In fact, it appears that the claimed bacteria are different from those existing in nature and, as a result, should be patentable.

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 this claim should be patentable under the EPC. In fact, as noted in the Guidelines for Examination in the EPO (G-II, 3.1), “if a substance found in nature can be shown to produce a technical effect, it may be patentable”. In this case, it does not appear to be necessary to amend the claim language to include the term “isolated” (as mentioned in Example A regarding the plasmid) as the claim language already contains the term “purified”.

Analysis of claim 2: The subject-matter of this claim should be patentable under the EPC. In fact, the claimed compound is different from those existing in nature and, as a result, this “artificial” compound should be patentable.

Analysis of claim 3: The subject-matter of this claim should be patentable under the EPC (provided that the claim is redrafted as a product-for-use claim, which is the currently acceptable format for 2nd medical use claims (See, Article 54(4) EPC)). In fact, a new use of a compound existing in nature is patentable. Additionally, the new use of a purified compound which, in nature, only existed in non-purified form, is patentable as well.

E. 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: The subject-matter of this claim should be patentable under the EPC, provided that the claim language is amended to include the term “isolated”. In fact, it appears that the primers are “natural products” in that the primers are part of the genome of an organism, in which case Rules 27(a) and 29(2) EPC would apply thus allowing the patenting of biological material or a part of a human body when isolated from its source.

Analysis of claim 2: The subject-matter of this claim should be patentable under the EPC. The fact that what is being used to amplify the target DNA are primers that are identical to those existing in nature has no bearing on the patentability of the amplification method as such. Incidentally, for the purpose of this claim, it is not necessary to repeat the primers are “isolated”. At the same time, it may be advisable to indicate that the method is an “in vitro” method so as to avoid covering the same method if practiced in vivo (assuming that it is even possible to practice the method in vivo).

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: Even if redrafted as a product-for-use claim (i.e., the currently acceptable format for 2nd medical use claims), the subject-matter of this claim does not appear to be patentable. In fact, product-for-use claims can only relate to the use of a “product” (See, Article 53(c) EPC) and sunlight does not appear to qualify as a product (despite the fact that the EPC does not contain a definition of the term “product”). In addition, even if the redrafted product-for-use claim were patentable, it would likely be found to be anticipated by the “well-documented natural principle that white light affects a person’s mood.

Analysis of claim 2: As with claim 1, this claim would need to be redrafted as a product-for-use claim. If redrafted in such a manner, it might be argued that what is being claimed is the use of a synthetic source of white light, which synthetic source might qualify as a “product” under Article 53(c) EPC. Nevertheless, it could be argued that what exerts the treating effect is not the synthetic source of white light but the white light itself, in which case the same considerations as discussed for claim 1 would apply, namely, that the white light (whether natural or synthetic) does not appear to qualify as a “product.” In addition, as with claim 1, even if this claim is redrafted as a product-for-use claim, it would likely be found be anticipated by the “well-documented natural principle that white light affects a person’s mood”.

Analysis of claim 3: As with claims 1 and 2, this claim would also have to be redrafted as a product-for-use claim. If redrafted in such a manner, as with claim 2, it might be argued that what is being claimed is the use of the source of white light, which source might qualify as a “product” under Article 53(c) EPC. Such an argument may be more persuasive with respect to claim 3 since this claim contains the feature of “providing a light source that emits white light.” Nevertheless, as discussed with claim 2, it could be argued that what exerts the treating effect is not the source of white light but the white light itself, in which case the same considerations as discussed for claims 1 and 2 would apply, namely, that the white light (whether natural or synthetic) does not appear to qualify as a “product.” However, the redrafted product-for-use claim should not be anticipated by the “well-documented natural principle that white light affects a person’s mood” because of the additional features contained in claim 3 relating to the positioning of the patient and time of exposure.

Diagnostic Claims from Mayo

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

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

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: The subject-matter of this claim should be patentable under the EPC, provided that:

a) the step of “administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder,” which is arguably a step of a method of treatment of the human body, is deleted; and

b) as a result of the deletion mentioned under a) above, the step of “determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder” is amended to refer to a subject “that received a drug providing 6-thioguanine.

According to Article 53(c) EPC, methods of treatment of the human or animal body are excluded from patentability (namely, not patent eligible subject matter).

Claim from U.S. Patent No. 6,573,103

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: As presently drafted, the subject-matter of this claim not patentable as it relates to as a diagnostic method practiced on a human body which is excluded from patentability under Article 53(c) EPC (as also interpreted in Enlarged Board of Appeal decision G 1/04) for two reasons:

a) feature (ii) represent technical steps which are constitutive for making the diagnosis and which are necessarily applied to the human body; and

b) the last feature, as well as the preamble, represent a feature relating to the diagnosis for curative purposes.

The claim might be patentable under the EPC if feature (ii) were deleted in its entirety since this portion of the claim cannot be reworded in such a way where a relevant measurement is not made on the human body. In such case, it appears arguable that despite the fact that the claim is still directed to a diagnostic method, it would no longer be directed to a diagnostic method applied to the human body and would thus fall outside the exclusions set out decision G 1/04.

This post was written by Lisa Mueller of Michael, Best & Friedrich and Micaela Modiano and Paolo Mimo, Modiano & Partners.