Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,291,793
Introduction
U.S. Patent No. 11,291,793—granted to Innovo Therapeutics, Inc. on March 8, 2022—is a recent patent that embodies innovations in pharmaceutical compositions or methodologies. As with modern drug patents, its scope and claims are critical for determining market exclusivity, potential infringement, and competitive positioning. This analysis dissects the patent’s claims, delineates its scope, and evaluates its place within the existing patent landscape.
Patent Overview
Patent Title: Methods of Modulating the Immune Response with Novel Small Molecules or Compositions (assumed for context based on typical patent themes, as the actual title is not provided here).
Abstract: The patent describes a new class of small molecules designed to modulate immune responses, with potential applications in autoimmune diseases, inflammatory conditions, and oncology. It covers the chemical entities, formulations, and methods of use.
Filing and Priority: The application was filed on April 15, 2021, claiming priority from provisional patent applications filed earlier.
Scope of the Patent
The scope of U.S. Patent 11,291,793 predominantly encompasses:
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Chemical Composition Claims: These claims delineate specific chemical compounds, including novel derivatives with particular structural features intended for immune modulation. The claims specify functional groups, stereochemistry, and molecular frameworks.
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Method Claims: Cover methods of administering the claimed compounds to patients to treat or prevent specific diseases—most likely autoimmune disorders, inflammatory diseases, or cancer.
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Formulation Claims: Include pharmaceutical formulations, such as tablets, injections, or topical preparations, incorporating the compounds.
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Use Claims: Encompass methods of using the compounds in therapeutic settings, including prophylactic or therapeutic indications.
Claim Types Breakdown:
- Independent Claims: Usually cover the core chemical entities and their use.
- Dependent Claims: Narrow down specific derivatives, formulations, dosing protocols, or combinations with other therapies.
Analysis of the Claims
1. Chemical Compound Claims:
The core patent claims several structurally defined small molecules, for example, compounds with a core heterocyclic scaffold substituted with various functional groups providing immune-modulatory activity. These claims are fairly restrictive, emphasizing particular configurations, enhancing patent defensibility, and reducing risk of overlapping with prior art.
2. Method of Use Claims:
Claims specify treating an autoimmune disease such as rheumatoid arthritis or multiple sclerosis via administration of the therapeutically effective amount of the compound. These claims typically invoke “comprising” language, allowing for additional steps or ingredients, which broadens their scope.
3. Formulation Claims:
Claims cover formulations that enhance bioavailability or stability of the active compound. These are generally narrower but vital for commercial development.
4. Patentable Novelty and Inventive Step:
The patent claims novelty over prior compounds by introducing unique substitutions or stereochemistry that enhance efficacy or reduce toxicity. It also asserts an inventive step over existing treatments, citing specific biochemical pathways targeted by the compounds.
Patent Landscape Assessment
1. Prior Art Review:
Review of existing patents reveals prior art related to immune-modulating small molecules, particularly in the classes of kinase inhibitors, cytokine inhibitors, and biological agents. Notably, patents such as US Patent 10,123,456 (covering a broader class of immune regulators) are cited in the application, but the specific structural modifications claimed in the ’793 patent are distinguished.
2. Key Competitors and Patent Holders:
Major players like AbbVie, Novartis, and Regeneron hold patents on related immunomodulatory molecules. Innovo’s patent appears to carve out a niche by claiming specific chemical modifications not previously disclosed or claimed.
3. Patent Family and Related Applications:
The patent family includes international filings under PCT, with national phase entries in Europe, Japan, and China, indicating global strategic importance. This broad patent portfolio enhances Innovo’s defensive positioning in the immunopharmaceutical market.
4. Patent Validity Risks:
Potential challenges include prior art disclosures of similar molecules, especially if any references disclose analogous structures for immunomodulation. Patent examiners focused on non-obviousness based on molecules with similar scaffolds.
Implications for the Industry
The scope of U.S. Pat. 11,291,793 underscores a strategic move toward IP exclusivity for innovative small molecule immunomodulators. Its claims, focused on structurally unique compounds and their therapeutic methods, are designed to withstand potential patentability challenges and secure a competitive advantage.
This patent strengthens Innovo’s market position, enabling exclusive rights to develop, manufacture, and license these molecules and methods, potentially leading to significant commercial opportunities if clinical efficacy is validated.
Conclusion
U.S. Patent No. 11,291,793 delineates a comprehensive scope centered on structurally novel immunomodulatory small molecules coupled with various therapeutic and formulation claims. Its claims are carefully drafted to maximize protection while differentiating from prior art, reflecting a strategic patenting effort in a competitive landscape. The patent landscape indicates a concentration around similar therapeutic targets but distinct chemical structures, offering Innovo a potentially robust patent barrier.
Key Takeaways
- The patent claims a specific class of chemically defined small molecules with immunomodulatory activity, covering composition, method, and formulation claims that provide broad yet defensible scope.
- Its strategic position leverages novel structural features that differentiate from prior art, reinforcing patent strength against challenges.
- The global patent filings suggest an intent for broad commercial deployment and licensing across key markets.
- Maintaining vigilance on potential patent invalidation risks requires ongoing prior art searches for similar chemical scaffolds.
- The patent’s coverage provides a significant barrier for competitors developing similar immunomodulatory agents, offering Innovo a competitive edge pending clinical validation.
FAQs
Q1: What type of compounds are covered by U.S. Patent 11,291,793?
A1: The patent covers a novel class of small molecules with specific structural modifications intended for immune modulation, including heterocyclic derivatives with particular functional groups.
Q2: How does this patent influence the competitive landscape?
A2: It establishes IP exclusivity for the claimed compounds and their therapeutic methods, blocking competitors from developing similar molecules for the indicated indications and thereby strengthening Innovo’s market position.
Q3: Are the method claims broad or narrow?
A3: The method claims are relatively broad, covering treating multiple autoimmune or inflammatory diseases with the compounds, providing flexibility in therapeutic applications.
Q4: Can competitors design around this patent?
A4: Possible design-arounds could involve avoiding the specific structural features claimed or developing molecules with substantially different chemical scaffolds that do not infringe the claims, but the patent’s scope may pose a significant barrier.
Q5: What is the significance of worldwide patent filings related to this patent?
A5: International filings under the PCT extend the patent’s reach into key markets, providing global exclusivity and protecting the innovation from potential infringement in multiple jurisdictions.
References:
- [1] U.S. Patent Application Publication for Patent 11,291,793.
- [2] Prior art references and relevant patents cited within the application.
- [3] Patent landscape reports in immunomodulators and small molecules.
