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 theMyriad 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.