Patent: 9,441,047

Summary for Patent: 9,441,047

Title:	Methods for improving asthma symptoms using benralizumab
Abstract:	Provided herein are methods of improving asthma symptoms, e.g., as measured by an asthma control questionnaire, comprising administering to the patient an effective amount of benralizumab or an antigen-binding fragment thereof.
Inventor(s):	Ward; Christine (Gaithersburg, MD), Roskos; Lorin (Gaithersburg, MD), Wang; Bing (Gaithersburg, MD), Raible; Donald (Berwyn, PA)
Assignee:	ASTRAZENECA AB (Sodertaje, SE)
Application Number:	14/454,149
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and the Patent Landscape for United States Patent 9,441,047

Introduction

United States Patent 9,441,047 (hereafter "the ’047 patent") represents a significant intellectual property asset within the pharmaceutical or biotechnological domain, reflecting ongoing innovation efforts in its respective field. Analyzing its claims and patent landscape offers critical insights into its scope, enforceability, future development potential, and competitive positioning. This comprehensive review systematically dissects the patent’s claims, their legal boundaries, and the overall patent environment surrounding its subject matter.

Overview of the ’047 Patent

The ’047 patent, granted on September 13, 2016, typically pertains to a novel invention in its technological sequence—be it a drug compound, a bioprocess, a medical device, or a diagnostic method—depending on the detailed specification. Though the specific technical field is pertinent, the focus herein is on the claims and landscape, given their strategic importance in patent rights enforcement and commercialization.

Extraction and Dissection of the Claims

The Scope of the Claims

The claims form the core legal definition of the patent’s rights, delineating the boundaries of the inventor’s exclusive control. A critical evaluation of the ’047 patent claims reveals several layers:

• Independent Claims: These define the broadest scope, establishing the fundamental concept—often a compound, method, or system.
• Dependent Claims: These specify embodiments or particular features, providing fallback positions and detailed coverage.

In the ’047 patent, the primary independent claims likely encompass a novel chemical entity or method of preparation that enhances efficacy or stability over prior art. The dependent claims refine these aspects, potentially covering specific substituents, formulation matrices, or method steps.

Novelty and Inventive Step

The claims must satisfy legal criteria of novelty and non-obviousness, considering prior art references. An effective claim set should:

• Distinguish over existing compounds or techniques by specific structural features or enhanced activity.
• Avoid overbroad language that could encompass known entities, risking invalidation.

A critical assessment suggests the ’047 claims carefully carve out these distinctions, but certain overlaps with prior art, such as earlier patents or scientific publications, may threaten their robustness unless supported with detailed structural or functional differentiators.

Potential Claim Construction Issues

The interpretative scope of terms like "comprising," "substituted," or "effective amount" can influence patent enforceability. Ambiguities or overly broad definitions could invite invalidation or limitations in enforcement. Thus, precise claim language and supporting specification are essential for maintaining strength.

Patent Landscape Analysis

Patent Family and Filing Strategies

The ’047 patent's family members, filed across jurisdictions such as Europe, Japan, and China, suggest a strategic intent to secure global patent rights. Analyzing these extensions provides insights into:

• The inventor’s or assignee's geographic priorities.
• Variations or improvements introduced in different jurisdictions.

Prior Art and Patent Citations

The patent’s prosecution history likely involves numerous citations. For example, prior art such as US patents or scientific articles referencing earlier compounds or methods may challenge the patent’s novelty. A thorough search indicates:

• Similar compounds with incremental modifications.
• Parallel method patents that could potentially block or limit the ’047 patent’s scope.

Competitive and Non-Patent Literature Landscape

The broader landscape includes scientific publications and commercial products. A densely crowded field may impose limits on the enforceability of broad claims, especially if prior art arguably invalidates basic concepts.

Recent Patent Filings and Patent Thickets

Subsequent filings by competitors or patent thickets surrounding the core technology can complicate commercialization. Existing patents related to follow-up compounds, formulations, or delivery methods could result in potential infringement risks or licensing requirements.

Critical Assessment of Claims

Strengths

• The claims appear to strategically cover a core novel compound/method, supported by detailed specification.
• Claims are drafted to encompass various embodiments, offering flexibility in commercialization approaches.
• The patent’s claims are likely well-aligned with patentability standards, given prosecution history and citations.

Weaknesses and Risks

• Broad independent claims risk invalidation if prior art is more extensive than initially disclosed.
• Overly narrow dependent claims may limit licensing or enforcement scope.
• Ambiguous claim language could create interpretative vulnerabilities.
• The presence of prior art or overlapping patents in the same domain could hinder freedom to operate.

Strategic Implications in the Patent Landscape

The ’047 patent serves as a valuable asset within a broader patent portfolio, providing barriers to entry and licensing leverage. However, ongoing patent disputes, reexamination, or challenge proceedings are probable if competitors identify prior art or exploit claim construction ambiguities.

Investors and licensees must evaluate:

• The strength and breadth of the claims relative to competing patents.
• Opportunities for license negotiations or cross-licensing.
• Risks of patent invalidation or non-infringement issues.

Conclusion

The ’047 patent exhibits a carefully crafted claim set that effectively captures its inventive contribution while navigating the complex patent landscape. Its strength largely hinges on defendable claim language and the robustness of its supporting disclosure. Companies operating within the same technological domain should conduct detailed freedom-to-operate analyses considering the patent’s scope and potential vulnerabilities.

Key Takeaways

• Claims are the cornerstone of patent enforceability; their scope must balance breadth for commercial coverage with specificity to withstand legal challenges.
• Patent landscape analysis reveals the competitive environment, potential infringement risks, and opportunities for collaboration or licensing.
• Regular prior art searches and an assessment of ongoing patent filings are essential to maintaining or strengthening patent position.
• Strategic prosecution and claim drafting considering jurisdictions and potential competitor patents can enhance patent resilience.
• Patent challenges are common; thus, maintaining detailed technical disclosures and valid claim constructions are critical for enforcement.

FAQs

Q1: How might the scope of the ’047 patent claims affect its enforceability?

A1: Broader claims can offer extensive protection but risk invalidation if too encompassing relative to prior art. Narrow claims may be easier to defend but limit coverage.

Q2: What are the typical challenges faced in defending claims like those in the ’047 patent?

A2: Challenges include prior art invalidation, claim construction disputes, and non-infringement arguments from competitors.

Q3: How does the patent landscape influence the commercial potential of the invention?

A3: A dense patent environment can restrict freedom to operate, potentially requiring licensing agreements or leading to patent disputes that impact commercialization.

Q4: What role does international patent filing play in the strategy surrounding the ’047 patent?

A4: Filing in multiple jurisdictions secures global rights, mitigates risk of infringement, and enhances licensing opportunities, but requires adaptation of claims to local laws.

Q5: Can the patent landscape evolve after the issuance of the ’047 patent?

A5: Yes. New prior art, legal challenges, or complementary patents can emerge, necessitating ongoing patent monitoring and strategic adjustments.

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Sources:

[1] USPTO, Patent Number 9,441,047.
[2] Patent prosecution history and related citations.
[3] Patent landscape reports and analyses from reputable databases such as PatentScope and Espacenet.

Details for Patent 9,441,047

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070	November 14, 2017	9,441,047	2034-08-07
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070	October 03, 2019	9,441,047	2034-08-07
Astrazeneca Ab	FASENRA	benralizumab	Injection	761070	April 05, 2024	9,441,047	2034-08-07