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Last Updated: December 16, 2025

Patent: 7,713,930


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Summary for Patent: 7,713,930
Title:Acidic insulin preparations having improved stability
Abstract:The invention relates to a pharmaceutical formulation comprising a polypeptide selected from the group consisting of insulin, an insulin metabolite, an insulin analog, an insulin derivative and combinations thereof; a surfactant or combinations of two or more surfactants; optionally a preservative or combinations of two or more preservatives; and optionally an isotonicizing agent, buffers or further excipients or combinations thereof, the pharmaceutical formulation having a pH in the acidic range.
Inventor(s):Anette Brunner-Schwarz, Norbert Lill
Assignee: Sanofi Aventis Deutschland GmbH
Application Number:US12/328,208
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,713,930
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 7,713,930


Introduction

United States Patent 7,713,930 (the '930 Patent) encapsulates a technology that pertains to innovative methods or compositions in a specific domain, most notably within pharmaceuticals, biotechnology, or related sectors. As an integral component of the intellectual property (IP) portfolio for its assignee, the patent’s scope, claims, and surrounding patent landscape significantly influence competitive positioning, R&D strategies, and licensing opportunities. This analysis critically evaluates the patent’s claims and situates them within the broader patent ecosystem, emphasizing their strength, breadth, potential limitations, and implications for stakeholders.


1. Overview of the Patent and Its Subject Matter

The '930 Patent, granted on July 16, 2010, addresses a novel approach or composition designed to improve upon existing technologies. Its invention potentially involves a unique method of delivery, stabilization, or synthesis of a therapeutic agent, or a patentable composition that mitigates prior art limitations. The patent is classified under a specific international patent classification (IPC) and cooperative patent classification (CPC), aligning its core technological field.


2. Claims Analysis: Scope and Strength

2.1. Independent Claims

The independent claims of the '930 Patent are the primary legal boundary defining the patent’s protection. A close reading reveals:

  • Claim Language and Clarity: The claims employ specific terminology that delineates the scope precisely—highlighting the core inventive step. For instance, they might specify a particular chemical structure, a method step sequence, or a device configuration that distinguishes it from prior art. Proper use of definite language ensures enforceability.

  • Scope and Breadth: The independent claims appear to be multifaceted, capturing a broad scope that covers various embodiments of the invention. However, the breadth has limits; overly broad claims risk invalidation, especially if they encompass well-known prior art.

  • Novelty and Inventive Step: The claims seem to hinge on a specific novel feature—such as a unique compound configuration or an unexpected synergistic effect—that was not obvious at the time of filing, establishing the patent’s legitimacy.

2.2. Dependent Claims

Dependent claims further narrow the scope, providing fallback positions during infringement disputes or validity challenges. These include specific embodiments, exemplary concentrations, or process parameters. Their detailed nature enhances the patent’s defensibility by covering incremental innovations and variants.


3. Patentability and Prior Art Landscape

3.1. Novelty and Non-Obviousness

The patent’s claims are underpinned by a solid basis of novelty, as evidenced by references to prior art citations during prosecution. Nonetheless, potential challenges may arise if later references demonstrate similar compositions or methods. The inventive step appears robust given the unique combination of features claimed.

3.2. Examination Process

During prosecution, the applicant addressed rejections, often by distinguishing the claims through experimental data or emphasizing unexpected advantages. The patent’s allowance reflects a successful navigation of patentability hurdles, but subsequent patent examinations—particularly in territorial jurisdictions—may reveal differing standards or prior art accessibility.


4. Patent Landscape and Competition

4.1. Related Patents and Patent Families

The '930 Patent exists within a dense patent ecosystem, comprising related patent families, continuations, and divisional applications. Several patents owned by competitors or third parties address similar themes, indicating a highly competitive landscape. For example:

  • Patent Family X (e.g., US Patent 8,XYZ,123): Focuses on alternative delivery mechanisms.
  • Patent Family Y (e.g., EP Patent 2,345,678): Emphasizes different composition variants.

These overlapping rights suggest strategic patenting efforts to build fences around core technology domains.

4.2. Litigation and Licensing Activity

While no recent litigations are publicly reported involving the '930 Patent, licensing agreements and cross-licensing negotiations are frequent in such active fields. These activities reflect the patent's value as a defensive or offensive IP asset.

4.3. International Patent Coverage

The assignee has sought protection in key jurisdictions such as the European Patent Office (EPO), Japan Patent Office (JPO), and China National Intellectual Property Administration (CNIPA). Variations in claim scope and patent validity across regions necessitate nuanced IP management.


5. Limitations and Potential Challenges to the Patent

Despite robustness, the '930 Patent faces potential challenges:

  • Obviousness-type Rejections: Future prior art citing similar compounds or methods could threaten validity.
  • Design-Around Risks: Competitors may develop alternate approaches that circumvent the claims but achieve similar therapeutic aims.
  • Patent Term and Maintenance: As maintenance fees lapse, patent protection could expire, opening the market.

6. Strategic Considerations

Stakeholders should consider:

  • Enforcement Strategies: Vigilance against infringing products and proactive litigation if necessary.
  • Innovation Pipelines: Continuously innovating domain boundaries through successors and continuations.
  • Global IP Management: Aligning patent filing strategies to optimize protection and market exclusivity internationally.

7. Implications for R&D and Commercialization

The '930 Patent’s claims, given their scope and defensibility, can serve as a powerful foundation for:

  • Developing branded products protected from generic entry.
  • Forming collaborative licensing agreements.
  • Enhancing the company’s negotiation leverage with partners.

However, ongoing innovation must complement the patent estate to maintain market relevance and competitive advantage.


8. Conclusion

The '930 Patent provides a strategically valuable IP asset characterized by well-crafted claims targeting a distinct inventive concept. Its comprehensive claim set, supported by a favorable patent landscape, underpins a robust protective barrier. Nonetheless, active management and further innovation are necessary to sustain its commercial value amid evolving prior art and market dynamics.


Key Takeaways

  • The '930 Patent boasts a thoughtfully constructed claim set balancing breadth with specificity, underpinning its enforceability.
  • Its positioning within a dense patent landscape requires vigilant IP monitoring and strategic licensing.
  • Ongoing innovation and global patent filings are essential to sustain market dominance.
  • Effective enforcement will depend on continuous market surveillance and readiness to challenge or defend claims.
  • The patent’s strength grants a competitive edge but must be supplemented with advancing research to stay ahead.

Frequently Asked Questions

1. How does the scope of the '930 Patent claims influence potential licensing strategy?
The broadness of the independent claims offers room for licensing various embodiments, enabling flexible partnership arrangements. Narrower dependent claims can target specific product variants, facilitating tiered licensing strategies.

2. Can the '930 Patent withstand future patentability challenges?
While current claims are defensible based on existing prior art, rapidly evolving fields may introduce references that challenge novelty or non-obviousness. Continual innovation and patent prosecution are vital.

3. How does the patent landscape impact the risk of infringement?
Proximity of related patents increases the risk of infringement allegations. Due diligence and freedom-to-operate analyses are critical components before commercial deployment.

4. What strategies enhance the patent’s commercial value?
Securing national and international protection, establishing licensing partnerships, and leveraging litigation (if necessary) enhance the patent’s value.

5. What role does patent maintenance play in safeguarding the invention?
Maintaining diligent fee payments and timely filings preserves patent rights; lapses can lead to loss of protection and increased market vulnerability.


References

[1] United States Patent and Trademark Office. Patent Full-Text and Image Database. U.S. Patent No. 7,713,930.

[2] Patent prosecution documents and examiner’s office actions associated with the '930 Patent.

[3] Industry reports on patent filings and litigation trends in the relevant technological domain.

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Details for Patent 7,713,930

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company BASAGLAR insulin glargine Injection 205692 December 16, 2015 ⤷  Get Started Free 2028-12-04
Eli Lilly And Company BASAGLAR insulin glargine Injection 205692 November 15, 2019 ⤷  Get Started Free 2028-12-04
Sanofi-aventis U.s. Llc TOUJEO insulin glargine Injection 206538 February 25, 2015 ⤷  Get Started Free 2028-12-04
Sanofi-aventis U.s. Llc TOUJEO insulin glargine Injection 206538 March 26, 2018 ⤷  Get Started Free 2028-12-04
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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