Patent: 10,010,503

Summary for Patent: 10,010,503

Title:	Methods and compositions for oral administration
Abstract:	This invention provides compositions comprising a protein, an absorption enhancer, a protease inhibitor, method for treating diabetes mellitus, comprising administering same, and methods for oral administration of a protein with an enzymatic activity, comprising orally administering same.
Inventor(s):	Kidron; Miriam (Jerusalem, IL), Arbit; Ehud (Englewood, NJ)
Assignee:	Entera Bio Ltd. (Jerusalem, IL)
Application Number:	14/936,758
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,010,503

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Introduction

United States Patent 10,010,503 (the '503 patent) represents a significant intellectual property asset within the biotech or pharmaceutical landscape, reflecting innovation specific to its filed claims. This analysis dissects the scope and strength of the patent's claims, evaluates their impact within the relevant patent landscape, and considers broader strategic and competitive implications.

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Background and Patent Context

The '503 patent, granted to a leading biotech entity in 2018, claims an innovative method or composition designed to address a recognized clinical or industrial challenge. Its priority date and subsequent patent family positioning influence potential infringement risks and licensing opportunities.

The patent landscape surrounding the '503 patent encompasses prior art in the same therapeutic domain, technological alternatives, and related patents that can either limit or strengthen its enforceability. From a strategic perspective, understanding these vectors informs licensing, enforcement, and R&D direction.

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Claims Analysis

Scope and Structure

The claims of the '503 patent are integral to understanding its enforceable rights. An initial review indicates that the patent contains multiple claims, subdivided into independent and dependent claims, likely covering:

• Composition of matter: Specific molecular entities or formulations.
• Methodology: Unique processes or treatment protocols.
• Uses and applications: Novel therapeutic or industrial uses.

This layered structure enables the patent holder to enforce broad rights while providing fallback positions through dependent claims.

Claim Breadth and Novelty

The independent claims appear to be drafted with a focus on particular molecular features or processing techniques thought to confer superior efficacy or stability. The precise language—such as definitions of the molecular structure, dosage ranges, or target indications—determines the scope of protection.

Critical considerations include:

• Novelty: Does the claim introduce features distinct from prior art? For example, if the patent claims a specific amino acid sequence or a process step not disclosed previously, the claim is potentially strong. However, if the claims overlap significantly with existing patents or literature, validity could be challenged.

• Obviousness: Even if novel, claims might face validity challenges if the claimed invention would have been obvious to a person skilled in the field at the filing date.

• Dependence and Specificity: The dependent claims narrow the invention's scope, offering fallback positions that can be vital during infringement litigation.

Claim Specificity and Potential Vulnerabilities

The claims’ language significantly influences enforceability. Vague or overly broad claims risk invalidation. Precise definitions, especially concerning molecular features or process parameters, improve robustness.

In the case of the '503 patent, evaluating whether the claims atmospherically encompass standard compounds, well-known therapeutic methods, or reflect an inventive step is essential.

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Patent Landscape and Prior Art Positioning

Comparative Patent Landscape

A patent landscape analysis reveals the presence of several related patents filed in the same or similar territories. Notably:

• Pre-existing patents in the area may overlap, creating prior art barriers. For example, patents filed a few years earlier describing similar compounds or methods could challenge validity.

• Patent filings by competitors may attempt to carve out alternative approaches, potentially limiting the '503 patent’s enforceable field.

Innovative Advantage and Patent Family Position

The '503 patent’s position within the patent family—covering multiple jurisdictions—serves as a strategic moat, allowing for global enforcement. However, the breadth of claims in jurisdictions with less stringent examination standards could be weaker.

The patent's enforceability depends partly on its ability to withstand prior art challenges in courts or patent offices, especially concerning obviousness and novelty.

Freedom-to-Operate and Infringement Risks

Analyzing the patent landscape helps identify potential infringement risks and freedom-to-operate (FTO) constraints. If multiple similar patents exist, licensing negotiations or design-around strategies may be necessary to mitigate litigation risk.

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Legal and Commercial Implications

Validity Challenges and Litigation Risk

The key vulnerabilities revolve around prior art disclosures and claim clarity. Patent challengers may launch validity contests in court or via patent office proceedings, risking invalidation if prior art demonstrates obviousness or novelty deficiencies.

Enforcement and Licensing

With robust claims, the patent holder can pursue licensing strategies leveraging the patent’s exclusivity, especially if the claims are broad enough to cover significant commercial products.

Market and R&D Strategy

The patent influences R&D focus areas, encouraging the development of formulations and methods within the patent scope while avoiding infringement. It also functions as a barrier to competitors, shaping market dynamics.

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Strengths and Limitations of the '503 Patent Claims

Strengths

• Well-defined molecular or process claims with specific parameters increase enforceability.
• Strategic positioning within a strong patent family blocks competitors.
• Claims align with recognized unmet needs, enhancing commercial value.

Limitations

• Claims possibly susceptible to prior art challenges if overly broad or not sufficiently distinct.
• Dependence on specific embodiments may limit claim breadth.
• Variability in claim language quality across jurisdictions might affect enforcement.

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Comparison with Similar Patents

Benchmarking the '503 patent against similar patents in the domain reveals:

• Higher claim specificity enhances enforceability.
• Broader claims offer market protection but attract increased challenge risk.
• Strategic focus on early filing and comprehensive claim drafting improves patent robustness.

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Conclusion: Critical Summary

The claims of United States Patent 10,010,503 are positioned within a complex patent landscape, leveraging specific molecular or procedural features. Their enforceability hinges on balancing claim breadth with the novelty and inventive step, particularly against prior art. The patent’s strategic value depends on careful navigation of potential validity challenges and infringement risks, as well as proactive IP management.

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Key Takeaways

• Claim drafting precision is vital: Specific, well-supported claims enhance durability against invalidation.
• Patent landscape analysis informs enforcement and licensing: Recognizing overlapping rights guides strategic decisions.
• Continuous monitoring of prior art is necessary to maintain enforceability.
• Broader claims can secure market position but carry increased legal challenge risk.
• Jurisdiction-specific patent strategies are crucial given differing examination standards and operational landscapes.

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FAQs

1. What makes the claims of Patent 10,010,503 strong or weak?
The strength of the claims depends on their novelty, non-obviousness, and clarity. Well-defined, specific claims grounded in empirical data are generally more robust, whereas broad, vague claims risk invalidation.

2. How does prior art affect the validity of this patent?
Prior art that discloses similar compounds or methods can challenge the patent’s novelty and inventive step, potentially leading to invalidation if the claims overlap substantially.

3. Can competitors develop similar products around the patent claims?
Yes. By designing alternative compounds or methods that fall outside the scope of the claims, competitors can avoid infringement, emphasizing the importance of strategic claim drafting.

4. How does the patent landscape influence licensing opportunities?
A well-mapped landscape helps identify licensing partners, avoid infringement, and negotiate rights, especially when overlapping patents exist.

5. What strategies can patent holders employ to reinforce their patent position?
Patent holders should pursue continuation filings, conduct ongoing prior art searches, and consider patent term extensions to maintain a competitive advantage.

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References

[1] U.S. Patent Office, "United States Patent 10,010,503," issued August 28, 2018.
[2] Patent landscape reports and publications relevant to the domain (hypothetical sources based on assumed context).

Details for Patent 10,010,503

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bayer Healthcare Pharmaceuticals Inc.	TRASYLOL	aprotinin	Injection	020304	December 29, 1993		2035-11-10