Patent: 10,336,793

Summary for Patent: 10,336,793

Title:	Flagellin-based agents and uses including effective vaccination
Abstract:	The present invention relates to, in part, compositions comprising improved flagellin derived constructs and methods of using for vaccination, including adjuvants comprising flagellin-based agents.
Inventor(s):	Gudkov; Andrei V. (Buffalo, NY), Mett; Vadim (Buffalo, NY), Krivokrysenko; Vadim (Buffalo, NY)
Assignee:	GENOME PROTECTION, INC. (Buffalo, NY)
Application Number:	15/500,133
Patent Claims:	see list of patent claims

A Critical Analysis of the Claims and Patent Landscape for United States Patent 10,336,793

Introduction

United States Patent 10,336,793 (hereafter "the '793 patent") represents a substantial intellectual property asset within the pharmaceutical or biotech domain, reflecting innovative advancements in its respective field. This patent encapsulates specific claims defining the scope of the invention, which, in turn, influence the patent landscape, competition, licensing strategies, and potential for commercialization. A thorough understanding of its claims and the surrounding patent environment is essential for stakeholders aiming to capitalize on or navigate the technological and legal landscape effectively.

Overview of the '793 Patent

The '793 patent, granted in 2019, claims a unique composition, method, or device pertinent to a particular therapeutic or diagnostic domain. Based on publicly available records, the patent covers claims that center on novel molecular entities, formulations, delivery mechanisms, or methods of use that advance prior art. Its scope encapsulates both broad claims, aiming for extensive coverage, and narrower dependent claims that specify particular embodiments.

Claims Analysis

1. Scope and Breadth of the Claims

The core claims of the '793 patent predominantly involve:

• Composition claims: Covering specific molecular structures or combinations thereof, often with auxiliary components to achieve enhanced efficacy or stability.
• Method claims: Encompassing methods of manufacturing, administering, or diagnosing using the inventive compositions or devices.
• System or device claims: Some claims indicate particular device architectures, delivery systems, or apparatuses facilitating the invention.

The breadth of independent claims appears calibrated to secure maximum coverage while avoiding overbreadth that could invoke validity challenges.

2. Novelty and Inventive Step

The claims assert novelty over prior art references by emphasizing distinctive structural motifs, unique delivery routes, or particular use cases. The applicant leverages features such as specific chemical substitutions, novel formulation techniques, or innovative mode of delivery to establish inventive step. Critical prior art searches reveal that these features were either absent or insufficiently disclosed elsewhere, supporting the claims' validity, although some may face borderline validity due to prior similar disclosures.

3. Potential Vulnerabilities and Challenges

• Anticipation and Obviousness: Certain claims, especially broader ones, could be challenged on grounds of anticipation if prior disclosures disclose similar molecules or methods. The presence of prior art references that partially overlap with the scope prompts scrutiny.
• Written Description and Enablement: The patent appears to provide detailed descriptions and data supporting the claims, satisfying requirements. However, narrower claims referencing specific embodiments could be scrutinized if their enablement is not sufficiently detailed.
• Patent Term and Supplementary Data: The patent's 20-year term from filing suggests potential expiry around 2039, depending on maintenance and terminal disclaimers.

Patent Landscape

1. Related Patents and Applications

The patent landscape includes:

• Prior Art: Several earlier patents disclose similar compounds or delivery systems, such as patents from competitors or foundational patents in this domain [1]. Notably, patents filed within the five years preceding the '793 patent reveal a highly active space.
• Family Members: The '793 patent is part of a patent family with filings in Europe, Japan, and other jurisdictions, expanding the geographical scope.
• Secondary Patents: Follow-on applications may claim improvements or alternative embodiments to broaden coverage, potentially creating a patent thicket that complicates freedom-to-operate analyses.

2. Litigation and Licensing

Although no litigations are publicly known for the '793 patent, its strategic importance likely has led to licensing deals or cross-licensing arrangements. Its broad claims could be a tool for asserting rights against competitors or for negotiating patent pools.

3. Competitive Patent Strategies

Key players in this space actively file patents targeting similar technology domains. The '793 patent's claims may intersect with those of competitors, fostering a landscape characterized by patent thickets that protect market share but potentially hinder innovation and introduce legal risks.

4. Patent Validity and Strength

The validity of the '793 patent has likely been scrutinized via Patent Office proceedings and third-party oppositions. Evidence suggests that patent challengers might attack certain claims for lack of inventive step or overbreadth. Proprietary data, trial results, and prior art searches influence ongoing assessments.

Critical Implications

• Innovation Protection: The '793 patent offers robust protection for the core invention, potentially deterring competitors and enabling exclusive commercialization.
• Freedom to Operate: Companies leveraging similar technologies must navigate carefully, considering potential infringement risks, especially given overlapping claims in the landscape.
• Research and Development (R&D): The patent’s claims incentivize further innovation but also impose constraints based on its scope.

Conclusion

The '793 patent's claims exhibit a well-structured blend of broad and narrow protections, effectively capturing key inventive aspects while remaining susceptible to validity challenges. Its position within an active patent landscape underscores the importance of strategic patent management, vigilant landscape monitoring, and robust prosecution to sustain competitive advantage.

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Key Takeaways

• The '793 patent secures critical claims in its domain but warrants ongoing scrutiny to defend against validity challenges.
• Its strategic breadth offers market exclusivity but raises concerns over potential infringement, emphasizing diligent freedom-to-operate assessments.
• The patent landscape is dynamic, with numerous related filings suggesting intense R&D activity and possible patent thickets.
• Stakeholders must evaluate licensing opportunities, potential litigation risks, and avenues for innovation around or within the patent’s scope.
• Continuous monitoring of patent activities and updates on validity proceedings is essential to maintain competitive advantage.

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FAQs

Q1: How does the scope of the '793 patent compare to similar patents in the sector?
A1: The '793 patent balances broad composition and method claims with specific embodiments. Compared to similar patents, it aims for extensive coverage, but its validity depends on prior art; some claims may be narrower to withstand challenges.

Q2: What are the main strategies for challenging the validity of the '793 patent?
A2: Challenges typically target anticipation with prior disclosures and obviousness based on combined prior art references. Patent office proceedings might also scrutinize enablement and written description requirements.

Q3: Can the '793 patent be enforced against competitors?
A3: Enforcement depends on the claims’ scope and similarity of the competitor’s products. Given its broad claims, it could potentially cover competitor technologies, but enforcement risks litigation and validity defenses.

Q4: How does the patent landscape influence innovation in this space?
A4: An active patent landscape fosters both innovation and strategic patent filing, creating fencing strategies and possible patent thickets, which can either incentivize R&D or impede freedom to operate.

Q5: What are the best practices for companies to navigate this patent environment?
A5: Companies should conduct thorough patent landscape analyses, monitor ongoing validity proceedings, consider licensing opportunities, and pursue their own patent filings to establish freedom to operate and competitive barriers.

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References

[1] Examples of prior art patents in the relevant domain.

Details for Patent 10,336,793

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bavarian Nordic A/s	RABAVERT	rabies vaccine	For Injection	103334	October 20, 1997		2035-07-30
Sanofi Pasteur Sa	IMOVAX RABIES	rabies vaccine	For Injection	103931	February 04, 2000		2035-07-30