iThis is Part 4 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 Patentable Eligible Subject Matter: U.S.), click here. To view Part 2 (The Thorny Problem of Patentable Eligible Subject Matter: Canada), click here. To view Part 3 (The Thorny Problem of Patentable Eligible Subject Matter: India), click here.
Patentable Subject Matter in Russia
The national patent legislation in the Russian Federation became fully consistent with the provisions of TRIPS and other international treaties as of January 1, 2008, the effective date of the Civil Code of the Russian Federation (Civil Code). As a result, Russian’s patent law has been harmonized with other international patent laws, including, primarily, the European Patent Convention, particularly with regard to patent protection of pharmaceutical and biotechnological inventions.
According to article 1350(1) of the Civil Code, an invention is entitled to legal protection if it satisfies the requirements of patentability, namely, if the invention is “new, involves an inventive step and is industrially applicable”. Accordingly, patentable subject matter is defined broadly to include:
A technical solution in any area, relating to a product (for instance a device, substance, microorganism strain, cell culture of plants or animals) or method (process of affecting a material object using material means) (Article 1350(1) of the Civil Code).
It is important to note that some inventions (such as those claiming the treatment of humans and animals by surgery or therapy, as well as diagnostic methods employed on humans and animals) may be patentable in the Russian Federation, even though such inventions may not be patentable in other jurisdictions (such as in the European Patent Office). Nonetheless, not all inventions are patentable in the Russian Federation. Specifically, subject matter not considered to be patentable includes:
1. Discoveries, as well as scientific theories and mathematical methods, proposals concerning solely the outward appearance of manufactured articles and intended to satisfy aesthetic requirements, rules and methods of games, intellectual or business activities, computer software or ideas on presentation of information (Article 1350(5) of the Civil Code);
2. Plant and animal varieties, and biological methods for producing them, excluding microbiological methods and products produced by microbiological methods or topographies of integrated circuits (Article 1350(6) of the Civil Code); and
3. Methods for the cloning of humans, methods for modifying genetic integrity of human germ line cells, use of human embryos for industrial and commercial purposes, other solutions contradicting societal interests or principles of humanity and morality (Article 1350(4) of the Civil Code).
According to item 3) above, stem cells derived from human embryos and any products produced from such stem cells do not constitute patent eligible subject matter; however, stem cells derived from other tissues (such as, for example, from adipose tissue) constitute patent eligible subject matter.
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 Russian 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: A p”lasmid” constitutes patent eligible subject matter in the Russian Federation even if the plasmid exists in nature. Under Russian practice, a plasmid as recited in claim 1 would not be accepted and this claim should be revised to further recite the structural elements of the plasmid (such as its encoding and regulatory sequences, the assemblage of such sequences, etc.).
However, if it is not possible to characterize the plasmid by its structural elements but only by its functional features (such as by reciting that the plasmid provides a hydrocarbon degradative pathway), an Applicant will need to deposit the plasmid in a recognized depositary and provide the deposit number in the specification and claims.
Analysis of claim 2: A bacterium constitutes patent eligible subject matter in the Russian Federation even if it is isolated from the natural environment. Under Russian practice, the description of the bacterium recited in claim 2 would not be accepted and should be further revised to recite the structural elements of the plasmid (such as its encoding and regulatory sequences, the assemblage of such sequences, etc.) which can be replaced by reference to claim 1 (assuming claim 1 recites such structural elements).
As with claim 1, if it is not possible to characterize the bacterium by its structural elements but only by its functional features (such as providing a hydrocarbon degradative pathway), an Applicant will need to deposit the bacterium in a recognized depositary and provide the deposit number in the specification and claims.
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: Purified amazonic acid constitutes patent eligible subject matter in the Russian Federation even if it is derived from the natural environment. However, claims directed to amazonic acid must further recite the structure of amazonic acid (such as its chemical structure). If the chemical structure has not been established or is unknown, then the amazonic acid can be characterized by other specific features distinguishing the claimed substance from others known in the prior art (such as, for example, by features of a method for producing the substance).
Analysis of claim 2: Any derivatives of amazonic acids also constitute patent eligible subject matter. As discussed above, this claim must recite the structure of any such derivatives (as discussed above in connection with claim 1).
Analysis of claim 3: A method of treatment constitutes patent eligible subject matter in the Russian Federation. A method of treatment using an isolated active agent also constitutes patent eligible subject matter.
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: In principle, a pair of primers constitutes patent eligible subject matter in the Russian Federation (the primers are considered to be a kit). However, if the target DNA is known in the prior art, claims directed to a pair primers may be rejected as lacking inventive step because designing primers to a known nucleic acid sequence will likely be considered to be a routine technique for a skilled artisan.
Analysis of claim 2: This claim constitutes patent eligible subject matter in the Russian Federation. However, as discussed above in connection with claim 1, inventive step objections may be raised if the target DNA is known in the prior art.
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: Claim 1 constitutes patent eligible subject matter in the Russian Federation. However, this claim most likely will be rejected as lacking inventive step in view of well-documented principle that white light affects a person’s mood.
Analysis of claim 2: Claim 2 constitutes patent eligible subject matter in the Russian Federation. However, this claim may have similar inventive step issues as claim 1.
Analysis of claim 3: Claim 3 constitutes patent eligible subject matter in the Russian Federation. The additional elements included in this claim compared to claims 1 and 2 increase the likelihood of this claim being recognized as involving inventive step.
Additionally, it should be noted that only the method of treatment type claim format would be allowable for this type of invention in the Russian Federation. It is not possible to secure protection for this type of invention using Swiss-type or German-type claims.
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 type of claim directed to a method of optimizing therapeutic efficacy constitutes patent eligible subject matter in the Russian Federation.
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: Diagnostic methods constitute patent eligible subject matter in the Russian Federation. However, this claim may be rejected as being too broad and indefinite because the screening markers are not defined in the claim. Additionally, an inventive step rejection may be raised if the screening markers and their use in diagnosing Down’s syndrome were known in the prior art.
