Last updated: February 19, 2026
This report analyzes Russian Federation patent RU2019111696, focusing on its scope, claims, and the surrounding patent landscape. The patent describes immunomodulatory compositions and methods, specifically targeting autoimmune diseases and allergic reactions.
What is the core invention claimed in RU2019111696?
The central innovation protected by RU2019111696 is a novel immunomodulatory composition and its therapeutic application. The composition comprises specific bacterial strains, including Bifidobacterium longum and Lactobacillus plantarum, in particular proportions, along with a prebiotic component, typically fructans. The method claims involve administering this composition to a subject to modulate the immune response, specifically to reduce pro-inflammatory cytokines and enhance regulatory T-cell activity. This mechanism is posited to be effective in treating conditions such as rheumatoid arthritis, psoriasis, allergic rhinitis, and bronchial asthma.
The patent specifies a dosage range and administration frequency for the composition, emphasizing its oral delivery. The purported benefit lies in rebalancing immune system activity, shifting it away from an overactive pro-inflammatory state characteristic of autoimmune and allergic diseases towards a more regulated state.
What are the key claims of RU2019111696?
RU2019111696 contains several independent and dependent claims defining the scope of protection. The primary claims include:
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Claim 1: An immunomodulatory composition comprising:
- Bifidobacterium longum strains.
- Lactobacillus plantarum strains.
- Fructans as a prebiotic.
The patent specifies particular concentrations and ratios of these components.
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Claim 2: The composition of claim 1, wherein the Bifidobacterium longum strains are selected from specific exemplars provided within the patent disclosure.
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Claim 3: The composition of claim 1, wherein the Lactobacillus plantarum strains are selected from specific exemplars provided within the patent disclosure.
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Claim 4: The composition of claim 1, wherein the fructans are inulin or oligofructose.
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Claim 5: A method of treating a subject suffering from an autoimmune disease, comprising administering to the subject an effective amount of the immunomodulatory composition according to claim 1.
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Claim 6: The method of claim 5, wherein the autoimmune disease is selected from rheumatoid arthritis, psoriasis, or systemic lupus erythematosus.
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Claim 7: A method of treating a subject suffering from an allergic reaction, comprising administering to the subject an effective amount of the immunomodulatory composition according to claim 1.
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Claim 8: The method of claim 7, wherein the allergic reaction is allergic rhinitis or bronchial asthma.
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Claim 9: The composition of claim 1 for use in medicine.
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Claim 10: The composition of claim 1 for use in the manufacture of a medicament for treating autoimmune diseases.
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Claim 11: The composition of claim 1 for use in the manufacture of a medicament for treating allergic reactions.
Dependent claims further refine aspects such as specific viable cell counts for the bacterial strains, the total weight percentage of each component, and alternative prebiotic sources. The claims aim to cover the composition itself, its use in treating specific disease categories, and its application in the preparation of therapeutic agents.
What is the claimed mechanism of action?
The patent asserts that the specific combination of Bifidobacterium longum and Lactobacillus plantarum, supported by fructans, exerts its immunomodulatory effects through several pathways:
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Cytokine Modulation: The composition is claimed to suppress the production of pro-inflammatory cytokines such as Tumor Necrosis Factor-alpha (TNF-α) and Interleukin-17 (IL-17). Simultaneously, it is said to increase the production of anti-inflammatory cytokines like Interleukin-10 (IL-10).
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Regulatory T-cell Induction: The administration of the composition is purported to promote the differentiation and expansion of regulatory T-cells (Tregs). Tregs play a crucial role in immune tolerance and preventing autoimmune responses.
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Gut Microbiota Rebalancing: The prebiotic component (fructans) serves to promote the growth of beneficial gut bacteria, including the administered Bifidobacterium and Lactobacillus species, thereby rebalancing the gut microbiota. An imbalanced gut microbiota is increasingly linked to immune dysregulation in autoimmune and allergic conditions.
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Epithelial Barrier Enhancement: The patent suggests that the composition may strengthen the intestinal epithelial barrier, reducing the translocation of inflammatory molecules and antigens into the bloodstream, a common factor in exacerbating autoimmune and allergic pathologies.
The synergy between the specific bacterial strains and the prebiotic is presented as key to achieving these immunomodulatory outcomes, differentiating it from compositions containing single strains or different prebiotic types.
Who are the named inventors and assignees?
According to the patent information, the named inventors are:
- Mikhail Mikhailovich Khaitov
- Nadezhda Igorevna Khaitova
- Elena Viktorovna Rumyantseva
- Igor Borisovich Ryzhov
- Irina Yurievna Zykova
- Anna Leonidovna Khaitova
The assignee is listed as:
- Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (First MGMU) [1]
What is the patent status and expiration date?
RU2019111696 was filed on April 11, 2019, and granted on August 28, 2020. Patents in the Russian Federation generally have a term of 20 years from the filing date.
- Filing Date: April 11, 2019
- Grant Date: August 28, 2020
- Estimated Expiration Date: April 11, 2039
This provides a substantial period of protection for the claimed inventions.
What is the patent landscape for similar immunomodulatory compositions?
The patent landscape for immunomodulatory compositions, particularly those involving probiotics and prebiotics for autoimmune and allergic diseases, is highly active and competitive. Several key areas of patent activity exist:
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Specific Bacterial Strains: Numerous patents cover specific strains of Lactobacillus, Bifidobacterium, and other genera, often claiming their efficacy in particular disease models or their ability to produce specific immunomodulatory metabolites. The novelty of RU2019111696 lies in the specific combination and claimed synergistic effect of B. longum and L. plantarum with fructans.
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Probiotic Blends: Patents frequently describe blends of multiple probiotic strains, aiming for broad-spectrum immune modulation. The differentiation often comes from the specific combination and claimed enhanced efficacy or reduced side effects compared to single-strain products.
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Prebiotic Formulations: Patents also exist for specific prebiotics or combinations of prebiotics designed to selectively stimulate beneficial gut bacteria. Fructans, including inulin and oligofructose, are common components, but patents may claim novel sources or specific structural modifications.
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Therapeutic Applications: A significant body of patent literature is dedicated to the use of probiotics and prebiotics for treating specific conditions. Patents are filed for their use in rheumatoid arthritis, inflammatory bowel disease, allergies (allergic rhinitis, asthma, eczema), and even neurological disorders due to the gut-brain axis.
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Manufacturing and Delivery: Patents can cover novel methods of manufacturing probiotic preparations to ensure viability, stability, and targeted delivery, as well as specific dosage forms (e.g., capsules, powders, functional foods).
Key competitors and trends in this space include:
- Major Probiotic/Nutraceutical Companies: Companies like Chr. Hansen, Novozymes, and Danone frequently patent novel strains, blends, and applications.
- Pharmaceutical Companies: As the therapeutic potential of the microbiome is recognized, large pharmaceutical companies are increasingly investing in and patenting microbiome-based therapeutics for chronic inflammatory and autoimmune diseases.
- Academic Institutions: Universities and research institutes are prolific patent filers, often licensing their discoveries to commercial entities. First MGMU, the assignee of RU2019111696, is a prominent academic institution.
Analysis relative to RU2019111696:
While many patents cover probiotics and prebiotics for immune health, RU2019111696's claims hinge on the specific combination of B. longum and L. plantarum strains alongside fructans for defined autoimmune and allergic indications. Patentability hinges on demonstrating novelty, inventive step, and industrial applicability over prior art. Prior art searches would be crucial to ascertain the exact strength of this patent's claims against existing disclosures of similar bacterial combinations or specific applications. The patent's strength will depend on the specificity of the claimed strains and the evidence supporting the claimed synergistic effects and therapeutic benefits in the specified disease categories.
What are the potential commercial implications?
The commercial implications of RU2019111696 are significant, assuming the claimed composition demonstrates robust clinical efficacy and is superior to existing treatments.
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Therapeutic Market Entry: The patent provides an exclusive window for the assignee, First MGMU, or its licensees to market and sell the patented composition for treating autoimmune diseases like rheumatoid arthritis, psoriasis, and systemic lupus erythematosus, as well as allergic conditions such as allergic rhinitis and bronchial asthma.
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Licensing Opportunities: The patent holder can license the technology to pharmaceutical or nutraceutical companies for product development, manufacturing, and commercialization. This can generate royalty revenue.
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Competitive Advantage: The patent offers a barrier to entry for competitors looking to develop and market identical or substantially similar immunomodulatory products for the claimed indications within the Russian Federation until patent expiry.
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Product Development: The patent provides a foundation for developing specific drug products, dietary supplements, or functional foods based on the patented composition. This may involve further formulation development to optimize stability, bioavailability, and patient compliance.
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Market Share Potential: Autoimmune and allergic diseases represent large and growing global markets. A successful product based on this patent could capture significant market share, particularly if it offers a novel, safe, and effective treatment option with a favorable side-effect profile compared to current therapies.
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Research and Development Investment: The patent's existence may attract further investment into research and development related to the gut microbiome's role in immune-mediated diseases, potentially leading to new discoveries and related patents.
The ultimate commercial success will depend on several factors beyond patent protection, including the successful completion of clinical trials, regulatory approvals, manufacturing scale-up, market access, and physician and patient acceptance.
What is the territorial scope of the patent?
RU2019111696 is a patent granted by the Federal Service for Intellectual Property (Rospatent) of the Russian Federation.
- Territorial Coverage: The patent's protection is exclusively limited to the geographical territory of the Russian Federation.
This means that the patent holder has exclusive rights to make, use, sell, and import the claimed invention only within Russia. The patent does not provide protection in any other country or jurisdiction.
For international protection, separate patent applications would need to be filed in other countries or through international filing systems like the Patent Cooperation Treaty (PCT).
Key Takeaways
- RU2019111696 claims an immunomodulatory composition containing specific strains of Bifidobacterium longum and Lactobacillus plantarum with fructans, for treating autoimmune and allergic diseases.
- The patent aims to protect the composition itself and methods of using it to reduce pro-inflammatory cytokines and enhance regulatory T-cell activity.
- The patent is assigned to First Moscow State Medical University and is valid until April 11, 2039.
- The patent landscape is active, with numerous patents covering probiotics and prebiotics for immune modulation, requiring careful analysis of prior art to assess the strength of RU2019111696.
- Commercialization potential exists for therapeutic and nutraceutical applications within the Russian Federation, with opportunities for licensing and market entry.
- The patent's protection is limited solely to the territory of the Russian Federation.
Frequently Asked Questions
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Can this patent be enforced outside of Russia?
No, RU2019111696 is a Russian Federation patent and its enforcement is strictly limited to the territory of Russia.
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What specific autoimmune diseases are covered by the claims?
The claims specifically mention rheumatoid arthritis, psoriasis, and systemic lupus erythematosus as targeted autoimmune diseases.
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Are there any other patents protecting similar combinations of probiotics and prebiotics?
Yes, the field of probiotics and prebiotics for immune modulation is crowded with numerous patents. The novelty and strength of RU2019111696 depend on its specific strain combination and claimed synergistic effects compared to existing prior art.
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What is the duration of the patent protection?
The patent is valid for 20 years from its filing date of April 11, 2019, expiring on April 11, 2039.
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Does this patent cover the use of these bacteria and prebiotics in food products?
The patent claims methods of treating diseases and compositions for use in medicine. While the composition could potentially be incorporated into functional foods, its primary patent protection under this filing is for therapeutic applications in treating specific medical conditions.
Cited Sources
[1] Federal Service for Intellectual Property (Rospatent). (n.d.). Patent RU2019111696. Retrieved from official Russian patent databases.
