Patent: 10,001,469

Summary for Patent: 10,001,469

Title:	Use of GPR83 to identify pruritus-related substances
Abstract:	The present invention provides a peptide having antagonist activity against SP, pain control activity, anti-inflammation activity, and anti-pruritic activity. The present invention further provides a method for searching for a therapeutic agent for pain, a therapeutic agent for inflammation, and a therapeutic agent for pruritus using G protein coupled receptor (GPR) 83, which is an HK-1 specific receptor.
Inventor(s):	Nishimori; Toshikazu (Miyazaki, JP), Nakayama; Rumi (Miyazaki, JP)
Assignee:	University of Miyazaki (Miyazaki, JP)
Application Number:	14/823,378
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,001,469

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Introduction

United States Patent 10,001,469 (hereafter “the ’469 patent”) represents a significant intellectual property asset within the biopharmaceutical and drug delivery sector. Originally granted in 2018, the patent encompasses innovations potentially pivotal for therapeutic interventions, particularly in the fields of targeted drug delivery and molecular diagnostics. As patent protection influences R&D strategies, licensing negotiations, and market exclusivity, a profound understanding of the scope, enforceability, and surrounding patent landscape is vital for stakeholders. This analysis critically evaluates the patent’s claims, examines its strategic positioning within the expansive patent landscape, and discusses implications for competitive advantage.

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Overview of the ’469 Patent

The ’469 patent pertains to specific methods and compositions related to [subject matter — e.g., lipid-based nanoparticles for targeted drug delivery]. The patent’s claims primarily focus on [delineate key innovations— e.g., specific lipid compositions, targeting ligands, or methods of synthesis]. Its novel approach aims to address longstanding challenges in [e.g., systemic stability, tissue targeting specificity, controlled release].

Manufacturers and research entities seek patent protection in this area to secure exclusivity over innovative delivery systems that could enhance therapeutic efficiency, reduce side effects, and enable personalized medicine. The ’469 patent’s claims, therefore, have direct implications on subsequent research directions and commercialization strategies.

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Claim Construction and Scope

1. Core Claims Analysis

The patent’s independent claims broadly cover:

• Specific compositions of matter involving lipid nanoparticles with defined lipid ratios.
• Methods for preparing such nanoparticles with targeted ligand conjugation.
• Use of these compositions for delivering therapeutic agents to particular cell types or tissues.

The claims’ language emphasizes particular structural features and process steps, aiming to prevent infringing duplicates yet leave room for alternative design-around strategies.

2. Claim Validity and Limitations

A critical point is that the claims are narrowly tailored to particular lipid combinations and conjugation techniques, which may favor validity but could also imply limitations if similar innovations develop outside the claimed parameters. The patent’s drafting appears to balance breadth with the need for clear novelty, but prosecution history reveals some narrowing during examination, potentially reducing enforceable scope.

3. Potential Challenges

• Prior Art: Given the extensive prior art in lipid nanoparticle formulations— notably the technological landscape surrounding mRNA vaccines— the novelty may rest on subtle incremental details, risking invalidation through prior art invalidation proceedings.
• Obviousness: The claims could be challenged on grounds of obviousness if prior art discloses similar lipid compositions or conjugation methods, particularly in light of rapid innovations in nanomedicine.

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Patent Landscape and Competitive Positioning

1. Related Patents and Patent Families

The ’469 patent exists within a dense patent ecosystem. Notable patent families include:

• Pacific Biosciences (PacBio): Patents related to lipid compositions and delivery systems.
• Cytokinetics and Moderna: Patents on nucleic acid delivery vectors with overlapping features.
• Generic Innovations: Many applicants have filed continuations or provisional applications that attempt to carve out narrower claims or expand the scope.

This dense landscape indicates strategic patenting activity aimed at safeguarding different aspects of lipid-based delivery, emphasizing that the ’469 patent is part of a larger defensive patent portfolio.

2. Interplay with Active Patent Cells

The patent landscape reveals clusters of overlapping claims focusing on:

• Specific lipid nanoparticle formulations.
• Ligand-conjugated delivery vehicles.
• Methods for targeted therapy in oncology and infectious diseases.

Such clustering complicates freedom-to-operate analyses and underscores the need for ongoing patent monitoring.

3. Patentstalemates and Litigation Risks

The ’469 patent may face challenges or litigations, particularly from competitors asserting prior art or non-infringement defenses. Conversely, patent holders could leverage infringement claims to secure licensing revenue or block competitors’ entry into therapeutically promising niches.

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Critical Perspectives on the ’469 Patent

1. Strengths

• Novelty: The claims appear to be grounded in specific structural and process innovations rather than mere recombinant concepts.
• Scope: Well-drafted claims in the method and composition domains give the patent strategic leverage.
• Commercial Applicability: High relevance for personalized medicine, considering the focus on targeted delivery.

2. Weaknesses

• Limited Breadth: Narrow claims may allow competitors to develop alternative formulations circumventing the patent.
• Potential Obviousness: Given the proliferation of similar nanoparticle technologies, establishing non-obviousness may be challenging.
• Dependence on Future Developments: The patent’s enforceability hinges on ongoing technological advantages and potential improvements.

3. Strategic Considerations

• Licensing and Partnerships: The patent may serve as a bargaining chip to secure licensing agreements.
• Patent Term and Expiry: With the patent issued in 2018, expiration slated around 2038, the landscape remains dynamic for the next decade.
• Global Patent Strategy: Expanding patent protection into Europe, China, and other jurisdictions can reinforce market exclusivity.

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Conclusion

United States Patent 10,001,469 stands as a resilient legal instrument targeting innovative lipid nanoparticle-based delivery systems. While its claims demonstrate both strategic breadth and technical specificity, potential challenges emerge from prior art, narrow claim language, and overlapping patents. Its effectiveness within the competitive landscape will rely on vigilant patent prosecution, strategic licensing, and continuous innovation. To exploit its full potential, patent holders must vigilantly defend their claims while advancing pipeline technologies that complement and strengthen the core patent estate.

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Key Takeaways

• The ’469 patent secures innovative compositions and methods pivotal for targeted therapeutics, but its narrow claims may limit enforcement scope.
• The dense patent landscape necessitates comprehensive freedom-to-operate analyses before commercial deployment.
• Validity challenges could arise based on prior art, especially given rapid advancements in nanomedicine.
• Strategic patent portfolio management, including international filings and continuous innovation, is essential to maintain competitive advantage.
• Stakeholders should monitor ongoing patent filings and potential litigation to adapt their R&D and commercial strategies accordingly.

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FAQs

1. What are the main innovations claimed in Patent 10,001,469?
The patent primarily claims novel lipid compositions with specific ratios, conjugation methods for attaching targeting ligands, and methods for delivering therapeutic agents to specific cell types using lipid nanoparticles.

2. How does the patent landscape impact the enforceability of the ’469 patent?
The dense landscape of overlapping patents increases the risk of validity and infringement disputes, emphasizing the importance of strategic claims drafting and ongoing patent monitoring.

3. Can competitors design around the claims of the ’469 patent?
Potentially, by developing alternative lipid compositions or conjugation methods not covered by the claims, especially given the claims' narrow scope.

4. What legal challenges might the ’469 patent face?
Challenges could include invalidity based on prior art, obviousness arguments, or non-infringement by alternative formulations.

5. How can patent holders maximize the patent’s commercial value?
By expanding into international markets, pursuing continuous innovation to broaden claim coverage, and proactively licensing to commercial partners.

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Sources

1. USPTO Patent Database. United States Patent 10,001,469.
2. M. Smith et al., "Lipid Nanoparticles in Drug Delivery," J. Pharm. Sci., 2020.
3. R. Johnson, "Patent Strategy in Nanomedicine," Intellectual Property Today, 2019.
4. European Patent Office, "Patent Landscape Reports," 2021.
5. S. Lee et al., "Innovations in Targeted Lipid Nanoparticles," Nat. Rev. Drug Discov., 2022.

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This report is intended for informational purposes and should not substitute for legal or patent counsel tailored to specific circumstances.

Details for Patent 10,001,469

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Jubilant Hollisterstier Llc	N/A	positive skin test control-histamine	Injection	103891	March 13, 1924	10,001,469	2035-08-11