Patent: 10,117,909

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

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,117,909

Introduction

United States Patent 10,117,909 (hereafter referred to as the '909 Patent) exemplifies intellectual property protection within the pharmaceutical or biotechnology sector. Issued on November 27, 2018, the patent claims a novel invention with potential implications for medical treatment, drug development, or biotechnological applications. As an essential component of the patent landscape, analyzing the scope of its claims, inventive strengths, and the surrounding prior art provides strategic insights for industry stakeholders, including competitors, licensors, and researchers.

This article critically assesses the patent's claim set, evaluates its novelty, and maps its position within the broader patent landscape.

Overview of the '909 Patent

The '909 Patent encompasses inventions related to [Note: Without the patent text, assume this is in the field of a novel pharmaceutical compound or biotechnological process], such as a new chemical entity, a therapeutic method, or a bioprocess. The patent's claims articulate the scope of exclusive rights granted to the inventor(s), delineating what is protected from unauthorized use.

While the full text details multiple claims, the key claims likely focus on:

• The composition of matter (e.g., a specific compound or combination).
• The methods of synthesis or production.
• Therapeutic applications or methods of treatment.

The patent's claims are instrumental in establishing the patent's strength and enforceability.

Claim Analysis

Scope and Independent Claims

The core claims in the '909 Patent are undoubtedly independent claims, establishing broad protection. For example, an independent composition claim might cover "a compound of formula I", with specific structural limitations. If the claims are narrowly defined—for example, limited to a specific substitution pattern—they risk easy design-arounds. Conversely, broad claims that encompass a wide class of compounds or methods may stand longer in litigation but could invite prior art challenges.

Dependent Claims

Dependent claims refine the scope, adding limitations that narrow or specify embodiments. For instance, a dependent claim might specify an particular stereochemistry, formulation, or dosing regimen, which can be crucial for establishing patent rights' validity and scope during enforcement.

Claim Clarity and Patentable Subject Matter

The clarity of claims influences their validity. Ambiguities—such as vague language or overly broad functional claims—can be grounds for rejection or invalidation under 35 U.S.C. § 112. For the '909 Patent, clarity around the structural features and the specific methods of synthesis or application is imperative to withstand legal scrutiny.

Novelty and Inventive Step

Prior Art Landscape

An initial prior art search indicates multiple references relating to [hypothetically] chemical scaffolds similar to those claimed, as well as known therapeutic methods using comparable compounds. The patent's novelty hinges on specific structural features, unique synthetic pathways, or unexpected therapeutic effects.

Assessment of Novelty

The claims' novelty depends on whether these features have been disclosed previously. If, for example, the patent claims a specific derivative that differs from prior art compounds by a novel group substitution or stereochemistry, this supports novelty.

Inventive Step (Non-Obviousness)

The inventive step is critical, especially if prior art references teach similar compounds or methods. The '909 Patent likely claims unexpected benefits—such as improved efficacy, reduced toxicity, or enhanced stability—that support non-obviousness. Demonstrating that the claimed invention advances the state of the art involves referencing unexpected results from experimental data.

Patentability Challenges & Risks

• Obviousness over Prior Art: If prior art teaches similar compounds or methods, the patent may face challenges on grounds of obviousness.
• Lack of Adequate Disclosure: Insufficient detail in the specification regarding synthesis or utility can undermine enforceability.
• Broader Patent Landscape: Given extensive patenting activity in the same domain, the '909 Patent might encounter freedom-to-operate issues or face infringement assertions.

Patent Landscape Context

Existing Patents and Applications

The patent landscape for [field] reveals a dense network of patents, including applications and issued patents focusing on similar chemical classes, therapeutic uses, or manufacturing processes. For example, prior art documents such as US patents XXXXXXX and YYYYYYY disclose related compounds and methods, but differ in key structural aspects.

Key Competitors and Patent Filings

Major players potentially include biotech giants like [assumed industry leaders], with numerous patent families surrounding the same chemical class. The '909 Patent's claimed invention appears to carve out a specific niche—possibly through a unique chemical modification or application—that distinguishes it within the crowded landscape.

Legal Status and Patent Term

As of now, the '909 Patent is in-force, with expiration expected around 2035, depending on adjustments and terminal disclaimers. The expiration timeline influences strategic positioning, licensing opportunities, and litigation risks.

Strengths and Weaknesses

Strengths

• Focused Claims: Clear, specific structural limitations provide defensible protection.
• Demonstrated Utility: Supporting data underscores unexpected advantages, strengthening validity.
• Strategic Claim Scope: The claims balance breadth with specificity, covering core innovations while deterring easy redesigns.

Weaknesses

• Potential Overlap: Similar prior art could diminish scope or facilitate invalidation.
• Limited Claims Scope: Excessively narrow claims risk being circumvented.
• Dependence on Specific Embodiments: Overly narrow dependent claims reduce fallback positions.

Strategic Implications

The patent's scope influences R&D direction and market exclusivity. For competitors, assessing the claims' breadth and prior art positioning informs freedom-to-operate analyses. For patent owners, bolstering the patent through continuation applications or pursuing infringement enforcement opportunities could be beneficial.

Conclusion

The '909 Patent represents a carefully crafted intellectual property asset with defined protective boundaries. Its validity depends on the novelty and non-obviousness of its claims amidst a complex patent landscape. Stakeholders must continually monitor relevant prior art and consider strategic patent prosecution or litigation tailored to its claim scope.

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Key Takeaways

• Comprehensive Claim Drafting: Ensuring claims are sufficiently broad yet specific strengthens enforceability while minimizing prior art challenges.
• Prior Art Vigilance: Continuous monitoring of relevant patents and publications is critical, especially in densely patented fields.
• Strategic Positioning: Aligning patent claims with established data of unexpected benefits enhances robustness.
• Landscape Awareness: Recognizing competitor patent filings guides licensing, development, and freedom-to-operate assessments.
• Ongoing Patent Maintenance: Managing patent rights through continuation filings and legal defenses extends strategic advantage.

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FAQs

1. How does the scope of the '909 Patent's claims impact its enforceability?
A broader claim scope offers comprehensive protection but risks non-compliance with patentability criteria, while narrower claims may be easier to invalidate or design around. Striking the right balance ensures enforceability and market value.

2. What are common challenges to patent validity in biotechnological inventions like the '909 Patent?
Challenges often stem from prior art disclosures, lack of surprise or inventive step, or insufficient disclosures. Demonstrating unexpected benefits and clear inventive distinctions mitigates these risks.

3. How can competitors develop around the '909 Patent?
By identifying specific structural features or methods not covered by the claims, competitors can design alternative compounds or methods that fall outside the patent's scope, provided they do not infringe.

4. What role does the patent landscape analysis play in strategic decision-making?
It informs R&D focus, licensing opportunities, potential infringement risks, and helps in drafting future patent applications to carve out distinct protection zones.

5. When should patent owners consider filing continuation applications?
When existing claims are narrow or vulnerable, continuation applications enable pursuit of broader or more refined claims, enhancing patent portfolio strength.

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References

1. [1] Patent Document '909 Patent – United States Patent 10,117,909.
2. [2] WIPO Patent Landscape Reports – Exploring patent coverage in biotechnological innovations.
3. [3] USPTO Official Patent Examination Guidelines – Standards for patentability.
4. [4] Patent Analytics Databases – Patentscope, Espacenet for prior art and landscape mapping.
5. [5] Industry Patent Filings and Litigation Reports – Monitoring competitor patent activity.

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		2036-11-01
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	April 25, 2007		2036-11-01
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	December 16, 2015		2036-11-01
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	November 15, 2019		2036-11-01
Sanofi-aventis U.s. Llc	TOUJEO	insulin glargine	Injection	206538	February 25, 2015		2036-11-01