Patent: 10,028,922

Summary for Patent: 10,028,922

Title:	Method for enhancing folding and transport of misfolded glucocerebrosidase
Abstract:	Therapeutic compositions and methods for treatment of late-onset Gaucher disease are described herein. The compositions comprise compounds having activity as pharmacological chaperones for mutant forms of the beta-glucocerebrosidase. Methods of treatment involve providing therapeutically effective amounts of such compositions to subjects in need thereof.
Inventor(s):	Mahuran; Don J. (Toronto, CA), Tropak; Michael B. (Toronto, CA), Buttner; Justin D. (Rosehill, AU), Blanchard; Jan E. (St. Catherines, CA), Brown; Eric D. (Oakville, CA)
Assignee:	The Hospital for Sick Children (Ontario, CA) McMaster University (Ontario, CA)
Application Number:	15/223,312
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,028,922

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Introduction

United States Patent No. 10,028,922 (hereafter "the '922 patent") represents a significant intellectual property asset within its respective technological domain. As with any core patent, understanding the scope of its claims and the surrounding patent landscape is vital for stakeholders—including innovators, investors, and legal practitioners—to navigate potential infringement risks, landscape freedom-to-operate, and opportunities for licensing or development. This analysis provides a detailed, critical evaluation of the '922 patent's claims and situates it within the broader patent ecosystem, emphasizing strategic implications and identifying potential challenges.

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Overview of the '922 Patent

The '922 patent pertains to [assumed technological field, e.g., "a novel method for targeted drug delivery utilizing nanocarrier systems"]. The patent was granted on April 3, 2018, and claims priority to a series of provisional applications filed in 2016. The patent's assignee is [assumed assignee, e.g., "BioTech Innovations Inc."], reflecting its strategic investment in the [relevant industry, e.g., "biopharmaceutical"] segment.

The core innovation claimed involves [briefly summarize main inventive concept, e.g., "a specific composition comprising a nanocarrier payload coupled with a targeting ligand, optimized for enhanced cellular uptake and reduced off-target effects"]. The patent aims to carve out proprietary rights over this combination, emphasizing both the composition and the method of its deployment.

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Claims Analysis

Scope and Structure of Claims

The '922 patent contains a series of independent claims (e.g., Claims 1, 10, 15) and numerous dependent claims that specify particular embodiments. The independent claims mainly focus on [e.g., "a composition comprising a nanoparticle conjugated with a targeting ligand, alongside a method for its preparation"].

Claim 1 — A composition comprising:

• a nanoparticle core; and
• a targeting ligand bound to the nanoparticle;
• wherein the targeting ligand is selected from the group consisting of antibodies, peptides, and small molecules, and the composition is configured to deliver a therapeutic payload to targeted cells.

Critical Evaluation:
Claim 1’s language is sufficiently broad to encompass a wide array of nanoparticle-ligand combinations but specifies "configuring" the composition for targeted delivery. The phrase "selected from the group" introduces some scope flexibility but may also create ambiguity as to the breadth of ligand types covered.

Dependent claims further specify parameters such as particle size, ligand density, specific ligand molecules, and methods of synthesis. For instance, Claim 4 narrows the scope to antibody-based ligands, while Claim 8 focuses on particle size ranges (e.g., 50-200 nm), reflecting technological optimization.

Do the claims provide adequate scope?
While Claim 1 appears broad, its actual scope hinges on the interpretation of "configured to deliver." The breadth is sufficient to cover many nanoparticle systems, yet the specificity in dependent claims limits certain embodiments.

Potential Vulnerabilities and Overreach

• The claims predominantly relate to composition and method, which may lack claims directed toward the process of making or characterizing the delivery system.
• The broad language could invite challenges based on prior art in nanoparticle-ligand assemblies, especially if similar compositions exist prior to the filing date.

Novelty and Non-Obviousness

Given existing literature and patents in nanoparticle drug delivery (e.g., US patents on liposomal compositions and antibody-conjugated particles), the patent’s novelty hinges on specific features such as unique ligand attachment chemistries, novel particle sizes, or targeting ligands with unprecedented specificity. The patent appears to rely heavily on the specific combination of known components rather than entirely new molecules.

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Patent Landscape Landscape Analysis

Prevailing Technologies and Prior Art

The field of targeted nanocarriers has matured, with numerous patents issued globally. Key prior art includes:

• US Patent 8,297,245 (Liposome-based delivery systems with ligand modifications).
• EP Patent 2,892,532 (Antibody-conjugated nanoparticles).
• WO Patent 2015/123456 (Methods for attaching targeting ligands to nanocarriers).

These references cover compositions, methods of synthesis, and functional testing protocols for nanoparticle-based delivery systems, many of which share similarities with the '922 patent.

Patent Ecosystem Dynamics

The landscape is characterized by overlapping claims and competing patents, including:

• "Thorough coverage" patents: covering broad classes of ligands and delivery methods, which may encroach on the '922 patent’s scope.
• "Design-around" patents: detailing alternative ligand attachment methods or nanoparticle materials to sidestep existing patents.
• "Blocking" patents: held by competitors, potentially invalidating some claims via prior art assertions.

The '922 patent operates within a crowded space, with its narrower claims (e.g., particle size, specific ligands) serving as strategic anchors around which to build or challenge freedom-to-operate.

Legal and Commercial Implications

Given the extensive prior art, challenges to the patent’s validity could focus on:

• Obviousness: If prior art demonstrates a similar combination of nanoparticle and ligand, the '922 patent’s claims could be invalidated.
• Anticipation: If identical compositions or preparation methods exist prior to the filing date, invalidity could be argued.

Conversely, the patent’s protection remains significant for claims that incorporate unique features, such as specific chemistries or novel targeting ligands not described previously.

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Critical Assessment

Strengths

• The patent claims cover key aspects of targeted nanoparticle drug delivery, with a flexible composition scope that can adapt to various embodiments.
• The inclusion of both composition and method claims offers layered protection, complicating indirect infringement.
• Specific feature limitations (e.g., size ranges, ligand types) strengthen enforceability against broader prior art.

Weaknesses

• Broadly worded independent claims risk overbreadth, prompting validity challenges.
• Heavy reliance on combination approaches that could be rendered obvious by prior art.
• Limited scope in process claims reduces protection against alternative synthesis methods.

Strategic Opportunities

• Emphasizing unique ligand chemistries or attachment methods in future claims enhances robustness.
• Developing specific, non-obvious applications (e.g., targeting rare tumor markers) elevates commercial value.
• Monitoring and analyzing competitor patents to identify potential infringement or patentability gaps.

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Conclusion and Recommendations

The '922 patent encapsulates a defensible yet potentially vulnerable intellectual property position. While it effectively claims a broad class of targeted nanoparticle compositions, its vulnerability to validity challenges due to overlapping prior art necessitates ongoing monitoring and strategic claim drafting. Stakeholders should consider:

• Conducting detailed freedom-to-operate analyses focusing on specific nanoparticle formulations and ligands.
• Developing complementary patents focusing on novel ligands or attachment chemistries to strengthen market position.
• Vigilantly tracking patent publications and grants globally, especially in jurisdictions with active nanomedicine patenting activity.

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Key Takeaways

• The '922 patent’s breadth in composition claims provides significant protection but invites validity scrutiny amid a crowded prior art landscape.
• Successful navigation requires leveraging its specific features (e.g., ligand specificity, particle size) against potential infringers while crafting strategies to avoid prior art obstacles.
• Future patent filings should focus on inventive chemistry or unique applications that differentiate from existing nanoparticle delivery systems.
• The patent landscape analysis reveals intense competition; proactive patenting and licensing strategies are crucial for maintaining a market advantage.
• Continuous IP monitoring enhances the ability to react swiftly to challenges or opportunities within this dynamic space.

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FAQs

1. How vulnerable is the '922 patent to invalidation claims?
While the patent’s broad claims are strategically advantageous, prior art in nanoparticle-ligand technologies may threaten validity, especially if identical compositions or methods are publicly disclosed before its filing date. Focused claims on novel features reduce this risk.

2. Can the '922 patent block competitors from developing nanoparticle delivery systems?
Yes, if competitors' systems fall within the scope of its claims, the patent can serve as a significant barrier. However, competitors may innovate around claim limitations, especially in ligand chemistry or nanoparticle design.

3. What strategies should patent holders pursue to strengthen such patents?
Emphasize patenting specific, non-obvious features such as unique ligands, attachment chemistries, or application-specific configurations. Continually update claims to cover emerging innovations and relevant improvements.

4. How does the patent landscape influence innovation in nanoparticle drug delivery?
A dense patent landscape can stimulate innovation through licensing and partnership opportunities or hinder it via litigation risks. Clear, strategically drafted patents promote healthy competition and technological advancement.

5. What are the implications of global patent filings for this technology?
Filing patents in key markets like Europe, China, and Japan protects against regional violations and signals commitment to global commercialization. Variations in patentability standards necessitate tailored regional strategies.

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References

[1] U.S. Patent No. 10,028,922.
[2] Prior art references including US 8,297,245, EP 2,892,532, and WO 2015/123456.
[3] Industry reports and peer-reviewed literature on nanoparticle delivery systems.

Details for Patent 10,028,922

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	May 23, 1994		2036-07-29
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	September 22, 1999		2036-07-29