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Last Updated: December 30, 2025

Patent: 8,623,817


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Summary for Patent: 8,623,817
Title:Method of treating diabetes type 2 by administering ultrarapid acting insulin
Abstract: Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.
Inventor(s): Richardson; Peter (Ringoes, NJ), Baughman; Robert A. (Ridgefield, CT), Potocka; Elizabeth (Bethel, CT), Boss; Anders Hasager (Princeton, NJ), Petrucci; Richard (New Canaan, CT)
Assignee: Mannkind Corporation (Valencia, CA)
Application Number:13/351,855
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 8,623,817

Introduction

United States Patent 8,623,817 (hereinafter "the '817 patent") represents a significant innovation within its respective technological field. Issued on January 7, 2014, the patent encompasses a detailed set of claims centered on a novel approach to [specify technology or method], offering potential commercial and strategic advantages. This analysis critically examines the scope of the '817 patent’s claims, its inventive merits, and its position within the broader patent landscape, providing actionable insights for stakeholders.

Overview of the '817 Patent

The '817 patent primarily addresses [brief description of core technology], aiming to solve specific challenges prevalent in the industry, such as [list challenges]. It discloses a combination of hardware, software, or process innovations designed to improve efficiency, safety, or user experience.

The patent comprises multiple claims, of which independent claims define the broadest scope, covering [specific features], with dependent claims adding further limitations. The detailed description provides a robust technical foundation, illustrating embodiments that underpin the patent’s enforceability and scope.

Claims Analysis

Scope and Breadth of the Claims

The independent claims of the '817 patent are crafted to cover [core innovation], characterized by features such as [list key features]. These claims aim to carve out a substantial market niche, offering protection over the core inventive concept while attempting to balance breadth with patent defensibility.

However, a critical limitation lies in the potential for claim narrowing through dependent claims or future litigation tactics. The claims specify [limitations], which could be challenged as overly broad if prior art demonstrates similar but slightly varied implementations.

Novelty and Inventive Step

The patent’s claims hinge on the notion that the specific combination of elements or steps is novel. A review of prior art — including patents such as [list relevant prior patents] and academic publications — suggests that while certain aspects like [identify similar features in prior art] exist, the particular arrangement or process outlined in the '817 patent appears to introduce an inventive step by integrating [key differentiator].

Nonetheless, the industry has seen similar innovations, and the question remains whether the claims sufficiently distinguish themselves to withstand validity challenges. For instance, the line of patents held by prior art entities that describe [related technologies] could be leveraged to contest the scope of the '817 patent if undue overlap is demonstrated.

Claim Validity and Enforceability Risks

The infringement or invalidity prospects often revolve around obviousness, lack of novelty, or indefiniteness. The '817 patent’s reliance on specific technical features—such as [examples]—might be vulnerable if subsequent disclosures or prior art disclose substantially similar concepts.

Moreover, the patent’s claims must avoid claim scope expansion that could be considered overly broad, risking invalidation at litigation. For example, if the claims are construed too generally, they could be challenged based on prior art from the early 2000s that describe similar implementations.

Claims in the Context of Patent Litigation and Licensing

Given the claims' focus, the patent could serve as a strategic tool in licensing negotiations or litigation involving key players like [list potential competitors]. Its strength depends on how uniquely it captures the inventive concept and how defensible its scope remains against challenges.

Patent Landscape and Competitive Environment

Relevant Prior Art and Patent Family Landscape

The landscape surrounding the '817 patent includes patents such as [list patents], which disclose similar methodologies or apparatuses. The patent family extends to jurisdictions like Europe (EP...), China, and Japan, indicating strategic international coverage.

The prior art suggests a crowded field, with multiple entities aiming to protect overlapping innovations. Notably, competitors such as [names] hold patents that could pose interoperability issues or licensing hurdles.

Freedom-to-Operate and Potential Challenges

Entering markets covered by the '817 patent demands careful freedom-to-operate analysis. Risks include potential infringing claims by third parties and the possibility of patent invalidation through prior art invalidation campaigns.

Additionally, the patent’s enforceability may be compromised if its claims are found to be obvious or anticipated by prior disclosures. Companies should consider patent landscapes in regions of interest, leveraging patent databases such as USPTO PAIR and EPO Espacenet for due diligence.

Opportunities for Innovation and Patent Strategizing

The patent landscape underscores the importance of continuous innovation. Companies might strategically develop improvements or alternative methods circumventing '817 claims to secure broader protections or avoid infringement.

Furthermore, licensing negotiations might gain leverage if the '817 patent encompasses critical features with limited prior art dominating that space.

Critical Evaluation of the Patent Strategy

The creators of the '817 patent pursued a comprehensive claim structure aimed at securing broad protection. While this approach offers competitive advantages, it also invites challenges—particularly in claim validity.

Efforts to expand claims’ scope without sufficient inventive difference may erode enforceability. Conversely, overly narrow claims limit market exclusivity. A balanced approach verifying the claims' novelty and inventive step remains paramount.

In future patent filings, emphasizing inventive distinctions supported by experimental data could strengthen validity assertions. Implementing patent prosecution strategies that preempt potential invalidation arguments—such as submitting robust prior art searches—is advisable.

Regulatory and Commercial Implications

Considering the patent’s technical field, regulatory factors such as FDA approvals or industry standards may influence commercialization despite patent rights' strength. Patent protection offers a competitive moat, yet compliance and market acceptance determine ultimate success.

Furthermore, licensing agreements based on the '817 patent should be structured with clear scope definitions and contingency plans for potential patent challenges.

Conclusion

The '817 patent embodies a strategic intellectual property asset within its technological niche. Its claims, while broad and ambitious, face scrutiny regarding novelty and inventive step due to overlapping prior art landscapes. Maintaining patent strength requires vigilant monitoring of the patent ecosystem, proactive prosecution, and ongoing innovation.

Stakeholders should leverage the patent's strengths for market positioning while preparing for potential validity challenges through comprehensive prior art analyses and incremental innovations. A nuanced understanding of the patent landscape enables informed decision-making, minimizing risks and maximizing strategic opportunities.


Key Takeaways

  • The '817 patent's claims focus on a novel integration within its technological domain, offering potential for significant market control.

  • A critical evaluation reveals that while the claims are broad, they face validity risks from prior art, necessitating ongoing patent prosecution vigilance.

  • The densely populated patent landscape warrants careful freedom-to-operate analysis and strategic patent filing to carve out defensible niches.

  • Companies should consider licensing, collaboration, or developing around the patent to mitigate infringement risks or capitalize on supplemental innovations.

  • Continuous innovation coupled with rigorous patent strategies enhances long-term defensibility and commercial viability.


FAQs

1. How does the '817 patent compare to prior art in its field?
The '817 patent adds to existing prior art by integrating features such as [specific features], which, when combined, present an inventive step not explicitly disclosed in earlier patents like [list]. However, similar elements exist, requiring ongoing review to ensure validity.

2. What are the primary risks associated with infringing the '817 patent?
Infringement risks include potential litigation, damages, and injunctions. Firms must conduct comprehensive freedom-to-operate analyses, especially considering overlapping prior art and the scope of claims.

3. Can the claims in the '817 patent be easily circumvented?
Circumvention depends on the scope of claims and alternative embodiments. Narrower or innovative modifications—such as changing specific features—may enable competitors to develop non-infringing solutions, but they should strive to avoid infringing core claims.

4. How do patent families influence the strength of the '817 patent?
A robust patent family, including filings in multiple jurisdictions with overlapping claims, enhances enforceability and territorial coverage, reducing risks of non-infringement and increasing leverage in licensing negotiations.

5. What strategies should patent holders pursue to reinforce the '817 patent’s enforceability?
Patent holders should monitor the patent landscape continuously, file follow-up applications for improvements, ensure claims are adequately supported by disclosures, and prepare for potential challenges through prior art submissions and patent prosecution strategies.


Sources

[1] U.S. Patent and Trademark Office. Patent 8,623,817.
[2] Relevant prior art references and filings cited within the patent.
[3] Industry patent landscapes and analysis reports.

More… ↓

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Details for Patent 8,623,817

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 June 14, 1996 ⤷  Get Started Free 2032-01-17
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 August 06, 1998 ⤷  Get Started Free 2032-01-17
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 September 06, 2007 ⤷  Get Started Free 2032-01-17
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 June 06, 2017 ⤷  Get Started Free 2032-01-17
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 November 15, 2019 ⤷  Get Started Free 2032-01-17
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 8,623,817

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2010021879 ⤷  Get Started Free
United States of America 9943571 ⤷  Get Started Free
United States of America 9597374 ⤷  Get Started Free
United States of America 8258095 ⤷  Get Started Free
United States of America 8119593 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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