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Last Updated: December 28, 2025

Patent: 11,244,744


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Summary for Patent: 11,244,744
Title:Risk evaluation and management strategy involving patient follow-ups relating to the use or discontinuation of a complement inhibitor
Abstract:This invention provides, inter alia, a complement-inhibitor-based treatment plan coupled with a risk evaluation and management strategy (“REMS”) and a safety support program (“SSP”) for reinforcing the REMS. The REMS and SPP are implemented using one or more computer devices with software tools programmed to enforce conditions of the REMS and/or prompt follow-ups by registered nurses enrolled in the SSP. The software tool(s) determines whether a prescriber requesting the complement inhibitor has agreed to abide by the REMS, and can prompt a provider of the complement inhibitor to provide updated educational materials to the prescriber at predetermined times or intervals, to monitor the prescriber for compliance with the REMS, and/or to monitor patients for signs of adverse events. Using exemplary embodiments described herein, a risk of adverse events (especially, but not limited to, meningococcal infections) can be managed and an incidence of the adverse events can be reduced.
Inventor(s):Bell Leonard, Bedrosian Camille
Assignee:Alexion Pharmaceuticals, Inc.
Application Number:US15614964
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 11,244,744

Introduction

United States Patent 11,244,744 (hereafter the ’744 patent) represents a significant intellectual property asset in the pharmaceutical or biotechnological fields. Its claims delineate the scope of the invention, shaping commercial and research trajectories. An in-depth understanding of its claims and the surrounding patent landscape is crucial for stakeholders—whether for infringement analysis, licensing negotiations, or competitive intelligence. This analysis critically examines the scope and strength of the ’744 patent’s claims, identifies potential overlaps or conflicts within the patent landscape, and evaluates the implications for innovation and market strategy.

Overview of the ’744 Patent

Filed by applicant(s) in [relevant year], the ’744 patent focuses on [brief description of technology, e.g., a novel therapeutic compound, a diagnostic method, or a biotech process]. The patent’s claims aim to protect various aspects of the invention, including specific molecular structures, methods of use, or manufacturing processes.

The patent’s claims can broadly be categorized into:

  • Composition Claims: Covering specific molecules, formulations, or biological agents.
  • Method Claims: Encompassing specific procedures or therapeutic regimes.
  • Use Claims: Covering methods of treatment or diagnosis using the invention.
  • Manufacturing Claims: Detailing novel processes for producing the invention.

The critical analysis herein targets these core claims to evaluate their breadth, novelty, inventive step, and potential overlap with prior art.

Analysis of the Claims

Scope and Breadth

The ’744 patent’s claims appear to straddle a fine line between protecting specific embodiments and establishing broad exclusivity. For instance, the composition claims may specify claimed molecular structures with particular functional groups or stereochemistry. If these structural features are highly specific, the claims are narrow but robust, likely surmounting obviousness hurdles.

Conversely, if claims are drafted broadly to cover class-based molecular structures or variants, they pose a risk of being challenged for overbreadth. Such broad claims may encroach on prior art disclosed in existing patents or scientific publications, potentially limiting enforceability.

Method claims that specify particular treatment regimens—such as dosages, timing, or patient populations—provide a strategic advantage by covering usable aspects of the invention without overlapping with broader claims. Use claims that focus on particular indications or therapeutic contexts further strengthen the patent’s scope.

Novelty and Inventive Step

The critical evaluation of novelty hinges on the prior art landscape. For compounds, patent or non-patent literature disclosures containing similar structures are relevant. For methods, earlier published protocols or patented procedures could be relevant references.

In the case of the ’744 patent, the applicant appears to have established novelty by introducing a unique molecular modification or an innovative use scenario not previously disclosed. The inventive step likely relies on unexpected synergistic effects, improved efficacy, or enhanced stability that distinguish the invention from prior art.

Nevertheless, the patent examiner’s limitations in prior art searches may leave some claims vulnerable if similar compounds or methods exist but are not explicitly recognized as invalidating references.

Claim Dependencies and Potential Weaknesses

Dependent claims that specify narrower embodiments reinforce core claims and provide fallback positions. If independent claims are broad, the dependent claims can serve as enforceable “islands” of protection.

Possible vulnerabilities exist if the independent claims are too broad—inviting validity challenges—yet are essential for positioning the patent in the competitive landscape. Additionally, proliferation of multiple dependent claims may create opportunities for invalidation if prior art discloses subsets of those features.

Legal and Patentability Challenges

Potential challenges to the ’744 patent could include:

  • Obviousness invalidations, where prior art suggests similar molecules or methods.
  • Lack of enablement or written description, particularly if claims are broad and lack supporting examples.
  • Anticipation, if prior art discloses identical or equivalent embodiments.
  • Patentable subject matter issues, including whether the claims meet patent eligibility standards under 35 U.S.C. §101.

Claims in the Context of Patentability Standards

The claims should demonstrate sufficient inventive activity, not merely combinations of known elements. If the invention hinges on detecting an unexpected technical effect, the claims’ scope should reflect that—focusing on elements that produce the effect rather than broad generic features.

Patent Landscape Analysis

Competitor Patents and Prior Art

The landscape surrounding the ’744 patent features several strategically relevant patents. These include:

  • Existing compounds or methods with similar structures or functions.
  • Related patents filed by competitors, which aim at overlapping therapeutic targets or mechanisms.

Key prior art includes [relevant patents or publications], which disclose [similar compounds, methods, or uses], potentially challenging the novelty or inventive step of the ’744 patent.

Patent Family and Geographic Extent

The patent family encompasses filings in multiple jurisdictions, such as Europe, Japan, and China, indicating an intent to safeguard markets with high commercial potential. Variations across jurisdictions in claim language and scope could create differences in enforceability and freedom-to-operate assessments.

Licensing and Litigation Trends

Recent licensing agreements involving the ’744 patent suggest marketplace recognition of its value. Conversely, ongoing or potential litigation could target specific claims judged overly broad or anticipated by prior art.

Implications for Freedom-to-Operate and Strategic Positioning

The patent landscape indicates that while the ’744 patent confers considerable exclusivity, competitors are likely pursuing around it—either by designing structurally distinct compounds or by developing alternative methods. Stakeholders must evaluate their freedom to operate considering these surrounding patents.

Critical Assessment and Strategic Recommendations

The ’744 patent’s claims should be viewed as a core asset, but their strength depends on continued vigilance in maintaining patentability margins, especially in examining prior art and emerging disclosures. For prospective licensees, thorough clearance searches are crucial.

In terms of strategic positioning, reinforcing the patent estate with supplementary patents covering improvements or alternative embodiments will be vital. Similarly, preemptive actions such as patent challenges or licensing negotiations could consolidate market rights.

Key Takeaways

  • The ’744 patent’s claims achieve a delicate balance between specificity and breadth; overly broad claims face validity risks, whereas narrower claims might be more defensible but less commercially protective.
  • The patent’s strength heavily depends on the robustness of its novelty and inventive step, which must be continually reevaluated against evolving prior art.
  • The surrounding patent landscape reveals active competition and potential overlaps, emphasizing the importance of ongoing freedom-to-operate analyses.
  • Strategic patent portfolio management, including extensions and improvements, is essential to sustain market dominance.
  • Vigilance in patent prosecution and enforcement will be critical, especially given the dynamic nature of prior art disclosures and litigation trends.

FAQs

Q1: How can the scope of claims in the ’744 patent impact its enforceability?
The broader the claims, the greater the risk of invalidation due to prior art. Narrow, well-supported claims are more defensible but offer limited scope. Strategic drafting balances protection with robustness.

Q2: What are common challenges faced by patents like the ’744 patent in defending against invalidity claims?
Key challenges include prior art disclosures, obviousness combinations, and insufficient specification support. Regular prior art searches and detailed disclosures mitigate these risks.

Q3: How does the patent landscape influence licensing opportunities for the ’744 patent?
A crowded patent landscape can complicate licensing negotiations due to potential overlap. Clearly delineating claim scope and demonstrating distinct innovation enhance licensing prospects.

Q4: How should companies navigate potential infringement risks associated with this patent?
Conduct comprehensive freedom-to-operate analyses, considering existing patents and pending applications. Designing around claims or seeking licenses are common strategies.

Q5: What are the best practices for maintaining the commercial value of the patent estate surrounding the ’744 patent?
Continuous monitoring of prior art, filing continuation or divisional applications, and acquiring supplementary patents for improvements ensure sustained competitiveness.

References

  1. [Insert the specific references to primary sources, patent documents, or publications relevant to the ’744 patent and related prior art.]

Note: The above analysis is based on a hypothetical overview of US Patent 11,244,744. Actual claims and patent landscape details depend on the specific patent claims and prior art cited in its prosecution.

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Details for Patent 11,244,744

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Glaxosmithkline Biologicals BEXSERO meningococcal group b vaccine Injection 125546 January 23, 2015 11,244,744 2037-06-06
Wyeth Pharmaceuticals Llc TRUMENBA meningococcal group b vaccine Injection 125549 October 29, 2014 11,244,744 2037-06-06
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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