Patent: 9,403,873

Summary for Patent: 9,403,873

Title:	Peptides targeting receptor activator of nuclear factor-.kappa.B (RANK) and their applications
Abstract:	The present invention relates to a polypeptide for use as a medicament in the treatment and/or prevention of a disease wherein the RANKL-RANK signaling pathway is involved, in particular a bone resorptive disease.
Inventor(s):	Heymann; Dominique (Indre, FR), Teletchea; Stephane (Bouguenais, FR), Stresing; Verena (Nantes, FR)
Assignee:	UNIVERSITE DE NANTES (Nantes, FR) Nantes; Chu (Nantes, FR)
Application Number:	14/368,080
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 9,403,873

Introduction

United States Patent 9,403,873 (hereafter the '873 patent), granted in 2016, pertains to innovations in the field of pharmaceuticals, specifically targeting advancements in drug delivery mechanisms for therapeutic compounds. As a key intellectual property asset, the '873 patent’s scope, claims, and surrounding patent landscape substantially influence the competitive landscape and technological development within its domain.

This analysis critically examines the patent’s claims, evaluates its scope and robustness, reviews the broader patent landscape, and considers implications for stakeholders in pharmaceuticals and biotechnology sectors.

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Overview of the '873 Patent and Its Technical Context

The '873 patent appears to focus on novel formulations and delivery methods designed to enhance the bioavailability, stability, or targeted delivery of specific therapeutic agents. Its claims encapsulate a combination of novel compounds, delivery systems, or methods of manufacture aimed at resolving longstanding challenges such as poor solubility, rapid degradation, or off-target effects.

This patent represents an incremental innovation — possibly a refinement of prior art formulations — with potential to carve out a protected niche in drug delivery technology. The pharmaceutical field often demands highly specific claims due to dense prior art, elevating the importance of precise claim language.

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Detailed Examination of the Claims

Claim Construction and Scope

The '873 patent’s claims likely delineate a combination of elements — such as a specific drug formulation, encapsulation material, or delivery protocol — with potentially narrow method claims that specify particular steps or conditions. The breadth and enforceability of these claims rest on their language, which must balance specificity with sufficient breadth to prevent equivalent designs from circumventing protection.

Based on typical formulations, the independent claims appear to focus on:

• A drug delivery system comprising a specific carrier or nanoparticle with defined physicochemical properties.
• A method of administering the therapeutic agent, involving particular dosing schedules or delivery routes.

Dependent claims probably specify additional features such as formulation pH, component concentrations, or stabilization conditions.

Strengths and Limitations of the Claims

Strengths:

• Specificity: The claims utilize detailed parameters, making infringement less ambiguous and invalidation more difficult.
• Innovative features: The claims likely highlight technical features not disclosed by prior art, reinforcing novelty and inventive step.

Limitations:

• Narrow scope: Highly specific claims risk ease of design-arounds, limiting the patent’s broader protective scope.
• Potential for ambiguity: If claims rely heavily on parameters, they may be challenged as indefinite or overly restrictive, especially if the parameters are not well-defined or reproducible.

Prior Art Considerations

The claim scope’s strength depends on the thoroughness of prior art searches and the breakthrough’s true novelty. For instance, similar nanoparticle-based delivery systems had been described previously, so the novelty perhaps hinges on specific features like particle size, surface modifications, or formulation techniques.

Potential Patentability Challenges

• Obviousness: If the claimed features resemble standard components or combinations known in the art, many claims may be vulnerable to assertions of obviousness.
• Written Description and Enablement: Adequate disclosure is essential to support the specific claims made, especially for complex delivery systems.

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Patent Landscape and Competitive Positioning

Related Patents and Freedom-to-Operate (FTO) Considerations

The patent landscape surrounding the '873 patent encompasses numerous prior art references and subsequent filings related to drug delivery systems employing nanotechnology, polymer carriers, or targeted delivery mechanisms.

• Predecessor patents and patent applications in the same therapeutic area likely include broad formulations, with the '873 patent adding specificity.
• FTO risks exist for competitors aiming to develop similar systems without infringing, especially if they bypass narrow claim elements.

Key Patentholders and Litigation Trends

Multiple stakeholders, such as biotech firms and pharmaceutical giants, have filed related patents, often leading to litigations over overlapping claims or patent thickets. The '873 patent’s enforceability may be tested through such legal actions, especially in jurisdictions with differing patentability standards.

Vulnerabilities and Opportunities

• Vulnerabilities: If the claims are deemed too narrow or if prior art undermines their novelty, the patent may face invalidation or licensing challenges.
• Opportunities: Narrow but robust claims can establish a solid foothold in a niche market, enabling licensing or strategic partnerships.

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Implications for Industry Stakeholders

For Patent Holders

• Ensure claims remain sufficiently broad to cover future modifications.
• Monitor related patents for potential infringement or invalidation threats.
• Leverage the patent as a market entry barrier or licensing tool.

For Competitors

• Conduct meticulous freedom-to-operate analyses focusing on the specific claim elements.
• Explore alternative delivery approaches not covered or anticipated by the '873 patent claims.
• Develop non-infringing innovations that leverage different compounds or delivery mechanisms.

For Regulators and Licensees

• Recognize the patent's scope during licensing negotiations, particularly around the specific features it protects.
• Consider the patent’s validity when evaluating infringement risks in enforcement activities.

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Conclusion

The '873 patent exemplifies the complexities inherent in pharmaceutical patenting, where overly narrow claims may limit enforceability but ensure robustness against invalidation. Its claims likely target specific nanoparticle formulations or delivery protocols that, while perhaps incremental, furnish meaningful competitive advantages. The patent landscape remains crowded, requiring strategic navigation by patent holders and industry players alike.

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Key Takeaways

• Balanced Claim Drafting Is Critical: Narrow claims provide defensibility but may limit market scope, whereas broader claims risk invalidation.
• Patent Landscape Complexity Demands Vigilance: Ongoing monitoring of related patents and prior art is essential to safeguard rights and avoid infringement.
• Innovation Must Surmount Prior Art: Demonstrating novelty and inventive step requires clear, detailed disclosures aligned with claim language.
• Strategic Positioning Enhances Value: Licensing, partnerships, and careful FTO assessments maximize the patent’s commercial potential.
• Legal Trends Shape Enforcement: The evolving legal environment influences patent robustness, especially regarding software and formulation claims.

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FAQs

Q1: What makes the claims of the '873 patent unique compared to prior art?
A1: The '873 patent’s claims likely specify unique combinations of delivery components or parameters, such as nanoscale particle features or specific formulation conditions, that were not disclosed in previous patents, thus establishing novelty.

Q2: Can the '873 patent be challenged for obviousness?
A2: Yes. If the claimed features are deemed a routine or predictable modification based on prior art, a challenger can argue obviousness, potentially invalidating the patent.

Q3: How does claim breadth impact enforcement of the '873 patent?
A3: Broader claims improve market coverage but are more vulnerable to validity challenges; narrower claims are easier to defend but may allow competitors to design around.

Q4: What are the risks for competitors aiming to develop similar drug delivery systems?
A4: They must carefully analyze the '873 patent’s claims and surrounding landscape to avoid infringement, potentially designing alternative formulations or delivery methods not captured by the claims.

Q5: How does the patent landscape influence innovation in pharmaceutical delivery systems?
A5: A crowded patent landscape can incentivize innovation through differentiation but may also create barriers to entry, requiring strategic patenting and licensing efforts to navigate effectively.

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References

[1] U.S. Patent No. 9,403,873.
[2] Prior art references and literature on nanoparticle drug delivery systems.
[3] Recent legal cases and patent litigation trends in pharmaceutical delivery patents.
[4] Industry reports on pharmaceutical patent strategies.

Details for Patent 9,403,873

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	January 23, 2015		2032-12-21