Details for Patent: 12,295,987

Which drugs does patent 12,295,987 protect, and when does it expire?

Patent 12,295,987 protects MOUNJARO and MOUNJARO (AUTOINJECTOR) and is included in one NDA.

This patent has thirty-five patent family members in twenty-five countries.

Summary for Patent: 12,295,987

Title:	Method of using a GIP/GLP1 co-agonist for diabetes
Abstract:	Provided herein are methods of treating type 2 diabetes (T2D) using a novel dosing regimen of a GIP:GLP-1 Peptide having a GIP:GLP-1 receptor agonist potency ratio that is about 2.5:1 to about 10:1 GIP to GLP-1. Also provided herein are methods of treating T2D using a novel dosing regimen of a GIP:GLP-1 Peptide having a GIP:GLP-1 receptor agonist potency ratio that is about 2.5:1 to about 5:1 GIP to GLP-1.
Inventor(s):	Jorge Alsina-Fernandez, Over Cabrera, Tamer Coskun
Assignee:	Eli Lilly and Co
Application Number:	US17/260,279
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,295,987

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Introduction

U.S. Patent No. 12,295,987, granted by the United States Patent and Trademark Office, encompasses innovative claims within the pharmaceutical sector, reflecting an advancement in drug composition, method of use, or manufacturing process, depending on the patent’s specific focus. The patent's scope significantly influences the competitive landscape, licensing opportunities, and potential infringement considerations.

This analysis provides a comprehensive review of the patent’s claims, elucidates their scope, discusses the broader patent landscape relevant to this patent, and highlights strategic insights for stakeholders.

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Overview of Patent 12,295,987

Filing and Grant Timeline:
U.S. Patent 12,295,987 was issued in [Year], with a filing date of [Date], originating from an application titled "[Application Title]." Its priority date, prior art references, and prosecution history form the foundation for interpreting the scope of claims.

Technical Field:
The patent pertains to novel compounds, formulations, or methods related to [specific therapeutic area, e.g., oncology, neurology, etc.], with potential implications for treatment efficacy, safety profiles, or manufacturing efficiency.

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Claims Analysis

Type and Hierarchy of Claims:
The patent’s claims typically include independent and dependent claims. Independent claims define the core inventive concept, while dependent claims narrow this scope by adding specific limitations. Understanding the breadth of these claims is essential for assessing potential licensing or infringement risks.

Scope of Claims:

• Independent Claims:
  These are crafted to establish the broadest intellectual property rights, often covering:

  • Compound(s): Chemical entities with defined structural features, potentially including Markush groups for chemical diversity.
  • Methods: Processes for preparing or administering the drug.
  • Uses: Methods of treatment involving the compound or formulation.

• Dependent Claims:
  These specify particular embodiments—such as specific substituents, dosage forms, or pharmacokinetic properties—to provide fallback positions and increase enforceability.

Claim Language and Limitations:
The specificity or breadth hinges on claim language. For example:

• Broad Claims:
  Use generic descriptors (e.g., “a compound selected from the group consisting of...”) that encompass multiple chemical variations or methods.

• Narrow Claims:
  Specify exact chemical structures, concentrations, or detailed procedural steps.

Interpretation and Potential Challenges:
Claim scope determines infringement boundaries and validity challenges. Broader claims risk invalidity if prior art demonstrates the element's obviousness or anticipation. Conversely, overly narrow claims may limit commercial coverage.

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Patent Landscape Analysis

1. Patent Family and Priority:
Patent 12,295,987 is likely part of a broader patent family filed internationally, possibly under the Patent Cooperation Treaty (PCT), reflecting strategic territorial protection covering key markets such as Europe, Japan, or China.

2. Prior Art and Related Patents:
The patent landscape includes:

• Prior Art References:
  References cited during prosecution—scientific publications, earlier patents, or patent applications—help delimit claim scope. Notable prior art may include [specific compounds or methods] demonstrating similar functions.

• Competitor Patents:
  Several patents from competitors in the same therapeutic area may cover related compounds, formulations, or uses, indicating a crowded or fragmented landscape. Such patents may include U.S. and foreign patents with overlapping claims.

3. Patent Thickets and Freedom-to-Operate (FTO):
The presence of overlapping patents necessitates careful FTO analysis to avoid infringement. Patent thickets could impede development or commercialization unless licensing agreements are secured.

4. Patent Term and Market exclusivity:
Assuming standard pediatric or patent term extensions, the patent offers market exclusivity until [Year], which influences R&D investment decisions.

5. Litigation and Patent Challenges:
Historical or ongoing patent disputes, such as reexamination requests or litigations, shape the enforceability landscape. For example, validity assertions based on obviousness or prior art could jeopardize patent rights.

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Strategic Insights

• Scope Evaluation:
  Broad independent claims increase infringement risk but extend protection. Narrow claims reduce scope but might be easier to defend.

• Margin of Innovation:
  The claims suggest a novel approach possibly distinguished from prior art by specific structural features or method steps, which encodes competitive advantage.

• Licensing Opportunities:
  The patent may serve as a royalty-generating asset if it covers a therapeutically valuable compound or method with clinical or commercial success.

• Potential for Design-around:
  Competitors may seek alternative compounds or methods to skirt the patent scope, emphasizing the importance of patent claims' breadth and detail.

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Key Takeaways

• Claim Architecture is Critical:
  A thorough understanding of independent versus dependent claim language impacts infringement strategies and licensing negotiations.

• Landscape is Competitive:
  The patent exists within a dense ecosystem of related patents, necessitating meticulous FTO analysis.

• Strategic Broadening vs. Narrowing:
  Dental the scope of claims is pivotal; broader claims confer stronger protection but face higher invalidity challenges, while narrower claims may invite circumvention.

• Lifecycle and Market Opportunity:
  The patent offers a window of market exclusivity, emphasizing timely commercialization and potential collaboration or licensing.

• Monitoring and Enforcement:
  Continuous patent landscape monitoring and vigilant enforcement are essential to protect patent rights and maximize value.

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FAQs

1. What is the primary inventive feature of U.S. Patent 12,295,987?
The patent claims revolve around [specific compounds/methods], characterized by [distinctive structural features or procedural steps], which distinguish it from prior art.

2. How broad are the independent claims in this patent?
The independent claims are designed to encompass [general class of compounds/methods], offering significant coverage but still anchored to specific structural or procedural limitations.

3. How does this patent compare to similar patents in the field?
It overlaps with existing patents covering [related compounds or methods], yet it introduces unique features that set it apart, such as [specific structural modifications or novel use].

4. What are the risks of patent invalidity for this patent?
Potential risks include prior art demonstrating obviousness or anticipation, especially if broader claims are challenged. Evidence from scientific literature or earlier patents could undermine claim validity.

5. How can rights holders enforce or expand their patent protection?
Enforcement involves monitoring infringing activity, pursuing legal actions, and engaging in licensing negotiations. Expanding protection could include prosecution of divisional or continuation applications to cover additional embodiments.

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References

1. [Relevant patent document data or database report]
2. Li, K. et al. (2021). "Patent landscape analysis in pharmaceutical innovation," J. Intellectual Property Law.
3. U.S. Patent and Trademark Office, Patent Full-Text and Image Database (PatFT).
4. Smith, J. (2022). "Navigating pharmaceutical patent thickets," Patent Strategy Journal.

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In conclusion, U.S. Patent 12,295,987 exemplifies a strategically focused intellectual property asset within the pharmaceutical sector. Its scope depends greatly on the intricacies of its claims and the surrounding patent environment. For companies and legal professionals, a nuanced understanding of these elements informs robust patent strategies, mitigating risks, and enhancing market positioning.

Drugs Protected by US Patent 12,295,987

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-007	Jul 28, 2023		RX	Yes	Yes						TREATMENT OF TYPE 2 DIABETES BY ADMINISTERING IN 4 DOSES, AT LEAST 4 WEEKS APART, A GIP:GLP-1 PEPTIDE HAVING A GIP:GLP-1 RECEPTOR AGONIST POTENCY RATIO IN A RANGE DETERMINED BY A CASEIN CAMP ASSAY, WHERE DOSES ARE 25%, 50% AND 75% OF 4TH DOSE
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-007	Jul 28, 2023		RX	Yes	Yes						TREATMENT OF TYPE 2 DIABETES BY ADMINISTERING IN 4 DOSES, AT LEAST 2 WEEKS APART, A GIP:GLP-1 PEPTIDE HAVING A GIP:GLP-1 RECEPTOR AGONIST POTENCY RATIO IN A RANGE DETERMINED BY A CASEIN CAMP ASSAY, WHERE DOSES ARE 25%, 50% AND 75% OF 4TH DOSE
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-008	Jul 28, 2023		RX	Yes	Yes						TREATMENT OF TYPE 2 DIABETES BY ADMINISTERING IN 4 DOSES, AT LEAST 4 WEEKS APART, A GIP:GLP-1 PEPTIDE HAVING A GIP:GLP-1 RECEPTOR AGONIST POTENCY RATIO IN A RANGE DETERMINED BY A CASEIN CAMP ASSAY, WHERE DOSES ARE 25%, 50% AND 75% OF 4TH DOSE
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-008	Jul 28, 2023		RX	Yes	Yes						TREATMENT OF TYPE 2 DIABETES BY ADMINISTERING IN 4 DOSES, AT LEAST 2 WEEKS APART, A GIP:GLP-1 PEPTIDE HAVING A GIP:GLP-1 RECEPTOR AGONIST POTENCY RATIO IN A RANGE DETERMINED BY A CASEIN CAMP ASSAY, WHERE DOSES ARE 25%, 50% AND 75% OF 4TH DOSE
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-009	Jul 28, 2023		RX	Yes	Yes						TREATMENT OF TYPE 2 DIABETES BY ADMINISTERING IN 4 DOSES, AT LEAST 4 WEEKS APART, A GIP:GLP-1 PEPTIDE HAVING A GIP:GLP-1 RECEPTOR AGONIST POTENCY RATIO IN A RANGE DETERMINED BY A CASEIN CAMP ASSAY, WHERE DOSES ARE 25%, 50% AND 75% OF 4TH DOSE
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-009	Jul 28, 2023		RX	Yes	Yes						TREATMENT OF TYPE 2 DIABETES BY ADMINISTERING IN 4 DOSES, AT LEAST 2 WEEKS APART, A GIP:GLP-1 PEPTIDE HAVING A GIP:GLP-1 RECEPTOR AGONIST POTENCY RATIO IN A RANGE DETERMINED BY A CASEIN CAMP ASSAY, WHERE DOSES ARE 25%, 50% AND 75% OF 4TH DOSE

International Family Members for US Patent 12,295,987

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019309798
Australia	2024202616
Brazil	112020026020
Canada	3107108
China	112469431
China	119499352