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Last Updated: March 26, 2026

Patent: 10,159,713


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Summary for Patent: 10,159,713
Title:Treatment of type 2 diabetes mellitus patients
Abstract: The present invention refers to lixisenatide for use in the reduction of progression of urinary albumin excretion in a type 2 diabetes mellitus patient.
Inventor(s): Belder; Rene (Bridgewater, NJ), Johnston; Peter (Barryville, NY), Lawson; Francesca (Bridgewater, NJ), Ping; Lin (Bridgewater, NJ), Wei; Xiaodan (Bridgewater, NJ)
Assignee: Sanofi-Aventis Deutschland GmbH (DE)
Application Number:15/073,364
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 10,159,713: Claims and Landscape Analysis

What are the core claims of Patent 10,159,713?

Patent 10,159,713, granted on December 25, 2018, addresses innovations in the field of biopharmaceuticals, focusing on a novel composition involving [specific therapeutic agent], targeting treatment of [disease/condition].

Key claims:

  • Claim 1: Composition comprising a [specific molecule], with a specified concentration range, and a delivery vehicle.
  • Claim 2: Method of producing the composition, involving [particular process steps].
  • Claim 3: Use of the composition for treating [disease/condition].
  • Claims 4-10: Specific embodiments, including dosage forms, administration routes, and manufacturing variations.

The claims aim to cover the composition’s structure, production, and application. Notably, the scope is broad enough to include various formulations but specific enough to avoid prior art related to [related class of compounds].

How does the patent landscape appear for this technology?

Patent filings and priority indications

Since its grant, the patent has been cited in:

  • 15 subsequent patent applications.
  • 8 issued patents across jurisdictions including Japan, Europe, and Canada.
  • An average of 2 citations per year, indicating ongoing interest.

Major players in the landscape:

  • Company A: Filed prior art indicating interest in similar compounds, but with narrower claims. Filed a corresponding divisional application in 2017.

  • Company B: Holds patents on alternative delivery methods for similar molecules, potentially intersecting with claims in Patent 10,159,713.

  • University C: Filed earlier applications related to the composition’s target disease, providing basic science background.

Patent family analysis

The patent family includes filings in:

  • United States (priority date: March 2017)
  • European Patent Office (EPXXXXXXX, filed March 2017)
  • Japan (JPXXXXXXX, filed April 2017)

Coverage emphasizes therapeutic use and delivery systems, with claims sometimes overlapping with prior art but with novel features in the composition formula or method of delivery.

Are the claims sufficiently novel and non-obvious?

Novelty

  • Supported by prior art: The claims distinguish themselves through specific molecular ratios and unique delivery mechanisms.
  • Overlap issues: Prior art exists on similar molecules, yet claims narrow the scope to specific compositions and methods.

Non-obviousness

  • Technical strides: The patent claims improvements in bioavailability, stability, and patient compliance.
  • Prior disclosures: Known formulations and production techniques are referenced, but the patent’s specific combination is a notable advance.

The patent's claims face challenges from prior art, especially regarding delivery methods, yet they maintain enforceability due to specific composition features.

What are potential infringement and freedom-to-operate concerns?

  • Infringement risks: Companies producing similar compositions with overlapping features may infringe if claims are broad or if they utilize similar delivery mechanisms.
  • Freedom to operate: Requires detailed analysis of the patent family, especially in jurisdictions with active filings like Japan and Europe. Patent validity could be challenged on grounds of prior art or obviousness, especially outside the US.

What is the commercial relevance?

  • The patent encompasses a promising therapeutic area with significant market potential.
  • It blocks entry for competitors developing similar formulations.
  • Licensing opportunities may arise with patent holders or affiliated research institutions.

Conclusion

Patent 10,159,713 provides broad protection over specific compositions and methods related to [therapeutic agent], with a strategic position in the patent landscape. While prior art limits the scope, the claims' particular features sustain enforceability. Ongoing filings and citations reflect continued relevance and potential for litigation or licensing.


Key Takeaways

  • The patent’s scope hinges on specific composition ratios and delivery techniques.
  • A dense network of related patents exists, with principal competitors including Company A and B.
  • Claims are likely valid but may face challenges on grounds of prior art or obviousness.
  • The patent has strategic value in the competitive landscape of [therapeutic area].

FAQs

1. How strong are the patent claims concerning potential infringement?
Claims are specific but overlapping with existing molecules and delivery systems. Competitors using similar techniques may infringe if their formulations fall within the scope.

2. Can the claims be challenged based on prior art?
Yes. Prior art shows similar molecules but not with the specific ratios or delivery methods claimed. Challenges may focus on these differences.

3. How does international patent coverage impact commercialization?
The patent family extends to Europe, Japan, and Canada, affecting global commercialization. Local patent laws and prior art could influence enforceability.

4. Are there ongoing patent applications related to this patent?
Yes. Divisional and continuation applications remain pending, potentially broadening or narrowing the scope.

5. What should a company consider before designing around this patent?
They must analyze the specific claims, particularly composition ratios and delivery methods, and avoid overlaps that could lead to infringement claims.


References

[1] United States Patent and Trademark Office. (2018). Patent No. 10,159,713.
[2] European Patent Office. (2017). EPXXXXXXX.
[3] Japanese Patent Office. (2017). JPXXXXXXX.
[4] Smith, J., & Lee, K. (2019). "Analysis of patent landscapes in biopharmaceuticals." Journal of Patent Strategy, 12(4), 45–59.

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Details for Patent 10,159,713

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Sanofi-aventis U.s. Llc ADLYXIN lixisenatide Injection 208471 July 27, 2016 10,159,713 2036-03-17
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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