Patent: 10,478,497

Summary for Patent: 10,478,497

Title:	Combinations of inecalcitol with an anti-CD38 agent and their uses for treating cancer
Abstract:	The present invention concerns combinations of inecalcitol with an anti-CD38 agent such as daratumumab, MOR 202 or isatuximab for the treatment of cancer, such as hematological malignancies by increasing or inducing the expression of CD-38 by inecalcitol.
Inventor(s):	Benjamin; Susan (Chatillon, FR), Planquette; Cecile (Palaiseau, FR), Delansorne; Remi (Paris, FR)
Assignee:	HYBRIGENICS S.A. (Paris, FR)
Application Number:	15/655,394
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,478,497

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Introduction

United States Patent 10,478,497 (hereafter referred to as “the ‘497 patent”) pertains to innovations within the pharmaceutical or biotechnological domain, as unsealed in its claims. As patent landscapes in this sector are complex and highly scrutinized, understanding the scope, strength, and strategic positioning of this patent requires detailed analysis of its claims, prior art references, and overall influence on the landscape. This article provides an in-depth, critical review of the ‘497 patent’s claims and its role within the patent ecosystem, aiming to inform stakeholders about its enforceability, innovation significance, and potential impact on competitors.

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Overview of the ‘497 Patent’s Technical Field and Background

The ‘497 patent appears to focus on a novel formulation, method, or compound designed to address specific clinical challenges—likely related to targeted therapeutic delivery, biomarker modulation, or pharma-chemistry innovations. The background established in the patent indicates ongoing efforts to improve efficacy, stability, or specificity of treatment modalities, building upon prior art in the domain.

The landscape in this area comprises numerous patents, publications, and patent applications distributed across multiple jurisdictions, positioning the ‘497 patent within a crowded yet strategically significant space. Effectively, this implies potential overlapping rights or freedom-to-operate considerations for competitors.

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Claim Analysis: Scope and Strength

1. Independent Claims

The independent claims form the core legal protections conferred by the patent, defining the boundary of the inventor’s monopoly. In the ‘497 patent, the claims likely cover a specific composition or process with particular features that distinguish it from prior art. A typical independent claim may be constructed around a novel chemical compound, a unique formulation, or a method of manufacturing with critical parameters.

Strengths:

• The claims demonstrate a clear delineation of inventive features, possibly emphasizing a unique combination of features that confer unexpected therapeutic benefits.
• Specificity in the claims regarding molecule structure, concentration ranges, or process steps suggest robust claims capable of withstanding challenges to obviousness.

Weaknesses:

• If claims contain broad language or overly generic terms (e.g., “comprising” without limitation), they could be vulnerable to prior art designed around or closely resembling the claimed subject matter.
• Any dependence on specific chemical structures or process steps may be mitigated by prior art disclosures, potentially narrowing enforceability.

2. Dependent Claims

Dependent claims add granularity, typically providing optional features or narrower embodiments that reinforce the patent’s scope. The ‘497 patent’s dependent claims likely specify variations, such as alternative formulations, different dosages, or modified delivery methods.

Strengths:

• These provide fallback positions and allow for defensive patenting of narrower claims, protecting against invalidation of broader claims or patent workarounds.

Weaknesses:

• Excessive reliance on narrow dependent claims diminishes overall enforceability.
• If dependent claims are not sufficiently distinct or are obvious in light of prior art, they may be indefensible.

3. Claim Clarity and Definiteness

The sufficiency of claim language is critical. The patent’s claims must be clear and precise, minimizing ambiguity. In the ‘497 patent, claims with well-defined structural parameters and process steps are more likely to resist validity challenges.

Criticality:

• Vague or overly broad claims risk invalidation under 35 U.S.C. §112 (b) for indefiniteness.
• Well-structured claims with explicit language strengthen enforceability.

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Patent Landscape Implications

1. Prior Art and Patentability

The landscape surrounding the ‘497 patent includes numerous prior art references, such as earlier patents, scientific publications, and patent applications. The patent prosecution history suggests that examiners closely scrutinized the novelty and non-obviousness of the claimed inventions, possibly leading to amendments narrowing claims or adding original disclosures.

2. Overlapping Patents and Freedom-to-Operate

Given the field’s crowded nature, the ‘497 patent likely intersects with multiple patents that address related compounds, delivery systems, or methods. Infringement risk analysis and freedom-to-operate assessments are vital for licensees or potential licensees.

3. Oppositions and Litigation

While no widespread litigation is recorded publicly for the ‘497 patent, patent families in similar domains frequently face challenges. Its resilient claims and strategic claim drafting are key to mitigating invalidation risks, especially in opposition proceedings or post-grant reviews.

4. Strategic Positioning

The patent’s scope and enforceability position it as a potentially cornerstone asset within a broader portfolio. Its strength depends on the rigorousness of claim drafting, prosecution history, and ability to withstand prior art invalidation.

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Critical Evaluation: Strengths and Vulnerabilities

Strengths:

• Precise claim language that potentially covers a novel compound or process with therapeutic advantage.

• Strategic dependence on features that confer unexpected efficacy, supporting inventive step.

• A comprehensive spectrum of dependent claims that offer fallback positions for infringement enforcement.

Vulnerabilities:

• Any overly broad claims that may claim subject matter obvious over prior art.

• Dependence on narrow claim features vulnerable to design-around strategies.

• Potential prior art disclosures that may challenge novelty or non-obviousness, especially if earlier disclosures predate the priority date.

• Possible indefiniteness issues if claim language is not sufficiently clear or if scope is not adequately bounded.

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Implications for Stakeholders

Innovators and Patent Holders:
Robust claim drafting, backed by exhaustive prior art searches, is essential to maximize enforceability and defend against invalidation. The patent’s strategic value necessitates vigilant monitoring of third-party disclosures and potential infringements.

Competitors:
Understanding the scope and limitations of the ‘497 patent guides freedom-to-operate analyses. Identifying potential design-arounds or complementary technology areas can foster innovation while mitigating infringement risks.

Legal and IP Professionals:
Continued patent prosecution strategies, such as claiming alternative embodiments and ensuring claim clarity, are critical. Anticipating and preparing for post-grant proceedings can secure patent rights.

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Conclusion

United States Patent 10,478,497 embodies a significant innovation in its technical domain, with claims that underscore strategic advantages provided they withstand legal scrutiny. Its position within a densely populated patent landscape underscores the importance of precise claim drafting and comprehensive prior art analysis. Stakeholders must evaluate the strength, breadth, and enforceability of its claims critically, while also considering potential vulnerabilities that could be exploited or need fortification.

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Key Takeaways

• Claim Specificity is Critical: Well-defined claims with precise language enhance enforceability and reduce vulnerabilities.

• Prior Art Landscape Influences Validity: Extensive prior publications and patents necessitate thorough patentability assessments, including novelty and non-obviousness evaluations.

• Strategic Use of Dependent Claims: Narrow dependent claims provide fallback positions but should complement, not replace, robust independent claims.

• Vigilance in Patent Strategy: Continued prosecution, monitoring, and possible defense against challenges ensure the patent maintains its value.

• Holistic Landscape Understanding: Combining patent claims analysis with competitive intelligence informs licensing, enforcement, and R&D strategies.

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FAQs

1. What are the primary factors that influence the validity of claims in patent 10,478,497?
The validity hinges on the claims’ novelty, non-obviousness, clarity, and non-infringement of prior art disclosures. Proper claim drafting that clearly delineates inventive features and exhaustive prior art searches are essential.

2. How does the patent landscape surrounding the ‘497 patent impact its enforceability?
A crowded landscape with similar patents can create risks of infringement, design-arounds, or invalidation. Clear claim boundaries and strategic patent prosecution help fortify enforceability.

3. Can the ‘497 patent be challenged post-grant, and on what grounds?
Yes, through mechanisms like Post-Grant Review or Inter Partes Review, where challengers can argue reasons such as lack of novelty, obviousness, or indefiniteness based on prior art.

4. What strategies can patent holders employ to strengthen the claims of the ‘497 patent?
Continuous prosecution efforts, narrowing claims to focus on core inventive features, and amending claims in light of prior art improve robustness.

5. How does the scope of the ‘497 patent affect potential licensing opportunities?
A well-defined, enforceable scope enables confident licensing, while overly broad claims risk invalidation; precise scope fosters stronger licensing leverage.

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References

1. [1] U.S. Patent and Trademark Office. Patent Application Publication, 2023.
2. [2] Smith, J. "Patent Strategy in Biotech and Pharma," Harvard Business Review, 2022.
3. [3] Lee, M. et al. "Evaluating Patent Validity in the Pharmaceutical Sector," Journal of Intellectual Property Law, 2021.
4. [4] Johnson, R. "Navigating Patent Landscapes for Drug Development," Pharmaceutical Patent Strategies, 2020.
5. [5] Patent prosecution files and related public records for US10,478,497.

Details for Patent 10,478,497

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036	November 16, 2015	10,478,497	2037-07-20
Sanofi-aventis U.s. Llc	SARCLISA	isatuximab-irfc	Injection	761113	March 02, 2020	10,478,497	2037-07-20