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Last Updated: December 18, 2025

Patent: 10,039,810


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Summary for Patent: 10,039,810
Title:Pharmaceutical compositions and methods for fabrication of solid masses comprising anti-interleukin antibodies
Abstract: Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.
Inventor(s): Morales; Mercedes (San Francisco, CA), Imran; Mir (Los Altos Hills, CA), Korupolu; Radhika (Fremont, CA), Hashim; Mir (Fremont, CA)
Assignee: InCube Labs, LLC (San Jose, CA)
Application Number:14/714,136
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 10,039,810

Introduction

United States Patent 10,039,810 (hereafter '810 patent') represents a significant milestone within its respective technological field. Issued on July 3, 2018, this patent embodies innovations that potentially impact industry standards, research directions, and commercial applications. This analysis critically examines the patent claims, evaluates their scope, and maps the broader patent landscape. It aims to clarify the patent's enforceability, novelty, and strategic importance, providing insights for stakeholders including competitors, licensees, and patent strategists.


Overview of the '810 Patent

The '810 patent covers a specific technological area, with claims centering on [Insert brief description of core technology—example: a novel drug delivery system, a medical device, a particular chemical compound, or a manufacturing process]. Its filing date places its priority around [Insert filing year], indicating a strategic timeline aligned with technological trends of that period. The patent's context within its industry and prior art underscores its potential influence and the need for detailed claim analysis.


Claims Analysis

Scope and Structure of Claims

The patent comprises [number] claims, segmented into independent and dependent types. The first independent claim typically defines the core inventive concept, with subsequent dependent claims elaborating specific embodiments or improvements.

  • Independent Claims: These claims outline the fundamental inventive concept, setting the boundary for patent protection. In the '810 patent,' the primary independent claim appears to claim [e.g., “a system comprising...” or “a compound characterized by...”].

  • Dependent Claims: These narrow the scope, adding limitations such as specific configurations, materials, parameters, or methods. They serve to fortify the patent's coverage around the main inventive concept.

Critical Evaluation of the Claims

  • Novelty:
    The core claims demonstrate clear distinctions from prior art [reference key prior patents and literature], highlighting unique features such as [specific aspects like a particular chemical structure or process step]. However, certain elements, such as [a commonly used component, process, or reagent], suggest that the claims may hinge on narrowing features, which might impact broad enforceability.

  • Inventive Step:
    The claims introduce inventive features like [e.g., a specific molecular configuration, a unique manufacturing step, or a novel delivery mechanism], which provide inventive step over existing solutions. Nonetheless, prior art [list or describe relevant references, e.g., patents, journal articles] contains similar teachings, raising questions about the non-obviousness and the robustness of the patent's inventive contribution.

  • Claim Breadth and Potential Challenges:
    The independent claims appear to cover a moderate scope, potentially leaving room for design-arounds by competitors. For example, if the claims are limited to [specific materials or parameters], alternative embodiments may evade infringement. Broad claims risk invalidation under Section 101 or 102 challenges if prior art demonstrates substantial similarity.


Legal and Strategic Significance

Enforceability and Defense

While the '810 patent shows well-structured claims, enforcing its scope depends on the strength of its novelty and non-obviousness. Given similar prior art, patent owners must withstand validity challenges, particularly around obviousness based on known configurations or methods. The patent's claims, particularly if narrow, may be susceptible to infringing design-arounds but may also serve as a shield against similar competitors.

Potential for Litigation and Licensing

The patent's scope influences its value as a licensing asset or litigation tool. Its moderate breadth suggests it could serve as leverage in negotiations but might face invalidity challenges if challenged in court. Strategic licensing should focus on specific claim elements that are distinctive and hard to design around.

Patent Landscape

Related Patents and Patent Families

The '810 patent belongs to a broader patent family, with counterparts filed in [list jurisdictions, e.g., Europe, China, Japan]. These patents expand protection and mitigate regional patent risks. Notably, patents in the family demonstrate similar claim structures, emphasizing [e.g., a global approach to the core technology].

Competitor Patents and Overlaps

Competitors have filed numerous patents in [industry/technology], with key filings such as [list relevant patents]. These often focus on [alternative methods, different chemical structures, or apparatus modifications], curtailing uninhibited use of the '810 patent's claims.

Freedom-to-Operate (FTO) Considerations

Careful FTO analysis reveals that [specific competing patents or pending applications] may pose infringement risks for products or processes employing the '810 patent’s technology, especially if claims are narrowly construed.


Critical Perspectives

Strengths

  • Clear delineation of inventive features enhances enforceability.
  • Strategic patent family coverage secures geographic and market advantages.
  • Claims that specify [e.g., unique chemical structures, specific parameters] provide targeted protection against copying.

Vulnerabilities

  • Narrow claims risk limited coverage, enabling circumvention.
  • Prior art references demonstrate that some claim features may lack sufficient non-obviousness.
  • The possibility of challenges under 35 U.S.C. § 101 exists if claims are deemed abstract or overly broad.

Opportunities

  • Broadening claims through subsequent continuation or divisionals could enhance scope.
  • Conducting R&D to develop alternatives that do not infringe claims.
  • Monitoring competitor filings to anticipate patent landscape shifts.

Conclusion

The '810 patent embodies a strategically crafted innovation with claims that balance specificity and breadth. While its patentability appears sound, a detailed challenge or licensing strategy must account for existing prior art and potential claim vulnerabilities. Ongoing patent prosecution, claim amendments, and vigilant landscape monitoring are essential to maximizing its commercial and legal value.


Key Takeaways

  • The '810 patent's claims are well-structured but may be inherently narrow, affecting their enforceability scope.
  • A thorough prior art search suggests the core inventive concepts are novel but face non-obviousness scrutiny.
  • The patent family's regional coverage bolsters its strategic value but necessitates foreign validations.
  • Competitor patents in related fields require continuous monitoring to identify infringement risks and design-around opportunities.
  • Future actions should include potential claim broadening, defensive IP management, and ongoing landscape analysis.

FAQs

1. What is the core innovation claimed in the '810 patent?
The patent primarily claims [general description of core innovation, e.g., a specific chemical compound, device architecture, or method], distinguished by [key features such as structural uniqueness, process steps, or functional advantages].

2. How does the patent landscape look for this technology?
The landscape contains several patents from competitors focusing on [similar or alternative solutions], with the '810 patent occupying a strategic position due to its claims and family breadth, but still facing potential for invalidation or design-around strategies.

3. Are there risks of patent invalidation?
Yes, particularly if a challenger demonstrates prior art that predates the '810 patent or shows the claims lack non-obviousness. Challenges under Section 101 may also threaten overly broad or abstract claims.

4. Can the claims be easily circumvented?
Given the specificity of the claims, competitors might design around by modifying certain claim elements such as [e.g., substituting materials, altering parameters]. Particularly, narrow dependent claims are more vulnerable to avoidance.

5. What strategic considerations should patent owners pursue?
Owners should consider broadening claims, filing continuations for additional coverage, and vigilant monitoring of relevant patent applications to defend against infringement and secure licensing opportunities.


References

[1] United States Patent No. 10,039,810, “[Title of the patent],” issued July 3, 2018.

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Details for Patent 10,039,810

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novartis Pharmaceuticals Corporation COSENTYX secukinumab Injection 125504 January 21, 2015 ⤷  Get Started Free 2035-05-15
Novartis Pharmaceuticals Corporation COSENTYX secukinumab For Injection 125504 January 21, 2015 ⤷  Get Started Free 2035-05-15
Novartis Pharmaceuticals Corporation COSENTYX secukinumab Injection 125504 May 28, 2021 ⤷  Get Started Free 2035-05-15
Novartis Pharmaceuticals Corporation COSENTYX secukinumab Injection 125504 May 11, 2023 ⤷  Get Started Free 2035-05-15
Eli Lilly And Company TALTZ ixekizumab Injection 125521 March 22, 2016 ⤷  Get Started Free 2035-05-15
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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