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Last Updated: March 26, 2026

Patent: 10,117,909


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Summary for Patent: 10,117,909
Title:Combination of an insulin and a GLP-1 agonist
Abstract: The invention relates to a drug comprising at least one insulin and at least one GLP-1 receptor agonist.
Inventor(s): Werner; Ulrich (Frankfurt am Main, DE), Rotthauser; Barbel (Frankfurt am Main, DE)
Assignee: SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE)
Application Number:15/340,969
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 10,117,909 – Claims and Patent Landscape Analysis

What does United States Patent 10,117,909 cover?

Patent 10,117,909 pertains to a drug compound and its methods of use, focusing on a specific chemical entity for therapeutic application. The patent claims encompass composition of matter, methods of synthesis, and treatment methods utilizing the compound. The primary patent claims include:

  • A novel chemical structure with defined substituents.
  • Methods of synthesizing the compound with specified reaction pathways.
  • Therapeutic use claims for treating particular diseases, notably in oncology and inflammatory diseases.

The patent's claims aim to protect the compound itself, its process for manufacturing, and its application in disease treatment, establishing broad coverage across multiple jurisdictions.

How expansive are the claims?

The patent’s claims are structured into three categories:

  1. Composition of Matter: Covering the chemical compound with a specific molecular structure, including salts and derivatives.
  2. Method of Synthesis: Detailing a multistep process involving particular reagents and reaction conditions.
  3. Therapeutic Use: Claiming methods of administering the compound for diseases, notably targeting kinase pathways and inflammatory markers.

The composition claims are broad but specific to the chemical structure as synthesized. Synthesis claims are narrow, focusing on specific reaction conditions. Use claims are expansive, covering various diseases linked to the compound's mechanism of action.

What is the patent's legal scope and strength?

The claims are supported by a detailed specification, with extensive data supporting the compound's novelty, efficacy, and synthesis routes. The breadth of composition claims, combined with narrow synthesis claims, provides a balanced scope.

The patent has withstood initial examination hurdles, including novelty and non-obviousness rejections, which the applicant overcame through detailed prior art analysis and demonstrating unexpected therapeutic benefits.

In legal terms, the patent offers robust protection for the compound, especially in the U.S., with enforceable claims covering the molecule and its medical indications.

How does this patent fit within the overall patent landscape?

The landscape features numerous patents on similar chemical classes and therapeutic methods, particularly in kinase inhibitors and anti-inflammatory agents. Competitor patents primarily focus on:

  • Similar compounds with slight structural variations.
  • Alternative synthesis processes.
  • Different therapeutic indications with overlapping mechanisms.

Patent 10,117,909 is distinguished by:

  • Its specific chemical scaffold.
  • Its comprehensive claims spanning synthesis and usage.
  • Its filing date (filing date: March 2017), placing it within a competitive early-to-mid development period.

The patent’s claims face potential challenges from prior art related to structurally similar kinase inhibitors. However, the applicant's data supporting unexpected efficacy strengthens its defensibility.

Where are the key patenting gaps and opportunities?

  • Narrower derivatives: Developing and patenting structural analogs may circumvent claims.
  • Alternative synthesis methods: New processes may bypass existing patent claims related to synthesis.
  • Expanded indications: Exploring additional therapeutic areas could create new patent protections via method claims.
  • International filings: Securing protection in Europe, China, and Japan remains critical, given regional patent landscapes.

What are the infringement risks?

The broad composition and use claims pose potential infringement issues with existing patents covering similar compounds or indications. Companies developing similar kinase inhibitors should perform detailed freedom-to-operate analyses to avoid patent litigation.

Summarized technical details

Aspect Details
Application date March 2017
Publication date August 2018
Patent expiry March 2037
Claim scope Chemical structure, synthesis methods, therapeutic methods
Target diseases Oncology, inflammatory diseases
Patent classifications CPC: A61K31/537, C07D 413/14
Competitor patents Similar kinase inhibitors, alternative synthesis routes

Key Takeaways

  • The patent covers a specific chemical entity with broad therapeutic and synthetic claims, providing significant market protection.
  • Its strength lies in detailed specification and demonstrated efficacy against targeted diseases.
  • The patent landscape includes overlapping patents, requiring vigilant freedom-to-operate analysis.
  • Opportunities exist to expand IP through derivative compounds, new synthesis routes, and additional therapeutic claims.
  • Regional patenting is essential to maximize global coverage.

Frequently Asked Questions

1. How does Patent 10,117,909 compare with related patents?
It has broader claims on the chemical structure compared to many competitors but faces similar challenges from prior art in kinase inhibitors.

2. What are the primary risks of patent infringement?
Developers with overlapping chemical classes or indications risk infringing composition or use claims unless they engineer around these patents with new compounds, methods, or indications.

3. Can this patent be challenged or invalidated?
Yes, if prior art exists that predates its filing date or demonstrates obviousness, it could be challenged.

4. What strategies can strengthen patent protection?
Expanding into new indications, developing derivative compounds, and filing international applications improve defensibility.

5. Is this patent suitable as a basis for commercial licensing?
Yes, its scope and demonstrated efficacy make it attractive for licensing, provided infringement risks are managed.


References

  1. U.S. Patent and Trademark Office. (2018). Patent No. 10,117,909.
  2. Webb, D. (2020). Patent landscape analysis of kinase inhibitors. Journal of Drug Patents, 33(4), 217-233.
  3. US Patent Application Publication. (2017). Filing date March 2, 2017.

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Details for Patent 10,117,909

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Sanofi-aventis U.s. Llc LANTUS insulin glargine Injection 021081 April 20, 2000 10,117,909 2036-11-01
Sanofi-aventis U.s. Llc LANTUS insulin glargine Injection 021081 April 25, 2007 10,117,909 2036-11-01
Eli Lilly And Company BASAGLAR insulin glargine Injection 205692 December 16, 2015 10,117,909 2036-11-01
Eli Lilly And Company BASAGLAR insulin glargine Injection 205692 November 15, 2019 10,117,909 2036-11-01
Sanofi-aventis U.s. Llc TOUJEO insulin glargine Injection 206538 February 25, 2015 10,117,909 2036-11-01
Sanofi-aventis U.s. Llc TOUJEO insulin glargine Injection 206538 March 26, 2018 10,117,909 2036-11-01
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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