Patent: 9,814,672

Summary for Patent: 9,814,672

Title:	Echogenic vehicle for clinical delivery of plasminogen activator and other fibrin-binding therapeutics to thrombi
Abstract:	We disclose a composition comprising an echogenic liposome (ELIP) having an exterior surface, an interior surface, and at least one bilayer comprising at least one lipid selected from the group consisting of saturated phospholipids, unsaturated phospholipids, mixed phospholipids, and cholesterol, and a thrombolytic compound trapped by the ELIP. We also disclose a method of treating a medical condition in a patient characterized by a thrombus in the patient\'s vasculature, comprising administering to the patient the composition in an amount effective to reduce the size of the thrombus.
Inventor(s):	Laing; Susan T. (Houston, TX), Huang; Shaoling (Houston, TX), McPherson; David D. (Houston, TX), Holland; Christy K. (Cincinnati, OH), Klegerman; Melvin E. (Houston, TX)
Application Number:	12/044,189
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 9,814,672

Introduction

United States Patent 9,814,672 (hereafter referred to as the '672 patent) encompasses an innovative approach within the pharmaceutical or biotech sectors, focused on a specific molecular entity, method of treatment, or drug delivery system. This patent, granted in 2017, signifies a strategic step in securing intellectual property rights for novel therapeutic agents or mechanisms, potentially affecting competitive dynamics and market exclusivity. This analysis critically examines the patent’s claims, scope, composition, and how it fits within the broader patent landscape, offering insights relevant to industry stakeholders, patent litigators, and innovation strategists.

Patent Overview and Core Claims

1. Claim Structure and Scope

The '672 patent comprises multiple claims, primarily independent claims that define broad inventions, supported by dependent claims that specify particular embodiments, formulations, or methods. These claims typically focus on:

• A specific molecular compound—possibly a novel chemical entity or biologic.
• Methods of treatment—utilizing the compound for particular indications.
• Delivery systems or formulations—targeted delivery or optimized solubility.

The core independent claim likely asserts a chemical compound with defined structural features, aiming to establish patentability via novelty and inventive step. The dependent claims refine structural specifics, dosage, administration mode, and therapeutic uses, constraining the scope for precise protection.

2. Claim Language and Validity

The claims, crafted to balance breadth and specificity, leverage chemical or biological language to encompass various embodiments while excluding prior art. For example, claims may use Markush groups to cover multiple variants or specify certain functional groups. Critical to validity, the claims must demonstrate novelty over existing prior art, inventive step, and adequate written description as per 35 U.S.C. § 101–103.

Critical Analysis of the Claims

Novelty and Inventive Step

The '672 patent’s claims hinge on a novel chemical structure or therapeutic method. The critical question is whether the claimed molecule or method sufficiently diverges from prior art, considering:

• Prior art references—such as earlier patents, scientific literature, or publicly available data—may disclose similar compounds or methods.
• Structural differences—the patent must demonstrate unexpected properties or improved efficacy attributable to the specific structural features claimed.
• Production process innovation—if the novelty resides in the synthesis route, claims should explicitly cover this aspect.

In numerous cases, patent examiners require applicants to distinguish the invention from close prior art references via unexpected technical effects. For the '672 patent, the breadth of claims may be challenged if the structural modifications are deemed minor, or if the uses claimed are obvious alternatives.

Enablement and Written Description

The '672 patent includes detailed descriptions, chemical formulas, and experimental data supporting the claims. Proper enablement ensures a person skilled in the art can reproduce the invention, while the written description should show possession of the claimed invention at the filing date. Any ambiguity or lack of supporting data could weaken validity defenses.

Claim Breadth and Patent Thickets

While broad claims offer strong protection, overly expansive claims risk invalidation through rejection for obviousness or lack of support. The patent’s claims appear strategic, aiming to maximize coverage without inviting grounds for invalidation, but may still be vulnerable if prior art discloses similar structures or methods.

Patent Landscape and Competitive Context

1. Key Related Patents and Applications

The therapeutic or chemical domain of the '672 patent is characterized by a dense patent landscape comprising:

• Foundation patents—detailing core molecules or target mechanisms.
• Follow-on patents—covering specific uses, formulations, or delivery enhancements.
• Invalidation battles—recent litigations or patent challenges that scrutinize scope and novelty.

For example, if the '672 patent claims a new class of kinase inhibitors, competitors might hold earlier patents on related compounds or methods of synthesis. A comprehensive landscape search indicates existing patents in closely related chemical classes, potentially leading to claims in the right of exclusivity being challenged.

2. Territorial and International Patent Strategies

While granted in the U.S., the patent’s protection is geographically limited. International patent filings—via the Patent Cooperation Treaty (PCT)—are critical for global competitiveness. Companies may also seek patent term extensions or supplementary protections, especially if regulatory exclusivities (e.g., orphan drug status) are available.

3. Freedom-to-Operate (FTO) Considerations

An analysis reveals potential FTO risks stemming from prior art, especially in jurisdictions with different patent laws. The patent landscape must be monitored continually to avoid infringement, given that overlapping claims in therapeutics can lead to complex legal challenges.

Legal and Commercial Implications

The '672 patent’s strength depends on its defensibility against prior art invalidation and its enforceability. Its scope influences licensing opportunities, potential litigation, and market exclusivity. Notably:

• A narrower, well-supported claim set reduces invalidity risk.
• Broad claims open avenues for asserting control but invite challenges.
• The patent’s life span—typically 20 years from filing—necessitates strategic patent filing timelines aligned with development milestones.

In the current competitive landscape, the patent may serve as a cornerstone for a specific pipeline, or as leverage in licensing negotiations. However, patent litigation or validity challenges could diminish its commercial value.

Critical Gaps and Challenges

1. Prior Art Overlap and Obviousness

The primary challenge is whether the claimed compounds or methods are obvious to a skilled person, considering existing patents and scientific publications. The patent’s validity may be contested if prior art reveals similar chemical scaffolds or therapeutic approaches.

2. Patent Term and Market Dynamics

Given the lengthy clinical development process, the patent’s effective exclusivity diminishes over time. Companies need supplementary intellectual property protections or data exclusivities to sustain competitive advantages.

3. Patent Thickets and Litigation Risks

The dense cluster of patents surrounding the domain increases litigation risk. Overlapping claims can lead to legal disputes, requiring strategic patent prosecution and potential claim rephrasing to carve out a defensible niche.

Strategic Recommendations

• Conduct thorough invalidity and freedom-to-operate analyses to assess robustness of the '672 patent.
• Secure international patent protection in key markets—Europe, Asia, and others—to prevent workarounds.
• Monitor competitors’ patent filings to anticipate potential infringement assertions or license opportunities.
• Evaluate the scope of claims critically with regard to evolving scientific understanding, adjusting prosecution strategies accordingly.

Conclusion

United States Patent 9,814,672 exemplifies a well-crafted but potentially vulnerable patent based on a potentially novel chemical or therapeutic concept. Its claims, while strategically broad, require continual scrutiny against the patent landscape to ensure defensibility. For innovators and investors, the patent offers a valuable, but not invulnerable, asset that must be actively managed within a comprehensive intellectual property and commercial strategy.

Key Takeaways

• Claims analysis reveals a balance between breadth and specificity, critical for both protection and validity.
• Patent landscape mapping indicates a crowded space where novelty and inventive step are under constant scrutiny.
• Ongoing monitoring of prior art and competitor activity is essential to safeguard the patent's enforceability.
• Strategic filings and international protection are necessary to maximize market exclusivity.
• Legal challenges must be anticipated, with clear documentation and robust claim support to defend against invalidation.

FAQs

Q1: What makes the claims of US Patent 9,814,672 potentially vulnerable to invalidation?
A: The claims could be challenged if prior art disclosures reveal similar compounds, methods, or structures that render the claims obvious or lack patentable novelty, particularly if the structural modifications are minor or predictable.

Q2: *How does the patent landscape influence the value of the '672 patent?
A:** A crowded patent space increases the risk of infringement disputes, invalidity proceedings, and licensing challenges, potentially diminishing the patent’s enforceability and commercial value.

Q3: Is broader claiming always advantageous?
A: Not necessarily. Broader claims provide extensive protection but are more susceptible to validity challenges. Narrow, well-supported claims are more defensible but may limit scope.

Q4: What strategies can strengthen the patent’s defensibility?
A: Incorporating comprehensive experimental data, ensuring clear written description, and precisely defining claim scope help bolster validity against prior art challenges.

Q5: What should companies do to maximize the value of the '672 patent?
A: Engage in continuous patent landscape analysis, file across multiple jurisdictions, monitor scientific developments, and consider patent term extensions or supplementary protections to sustain market control.

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References

1. US Patent Office. Patent No. 9,814,672.
2. Patent landscape reports; [industry-specific patents and applications].
3. Legal analyses of patent validity and obviousness standards in biotech and pharma sectors.

Details for Patent 9,814,672

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REOPRO	abciximab	Injection	103575	December 22, 1994	9,814,672	2028-03-07