Details for Patent: 9,474,780

Which drugs does patent 9,474,780 protect, and when does it expire?

Patent 9,474,780 protects MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN, ZEPBOUND, and ZEPBOUND (AUTOINJECTOR), and is included in two NDAs.

This patent has eighty patent family members in forty-six countries.

Summary for Patent: 9,474,780

Title:	GIP and GLP-1 co-agonist compounds
Abstract:	The present invention relates to dual incretin peptide mimetic compounds that agonize receptors for both human glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), and may be useful for treating type 2 diabetes mellitus (T2D).
Inventor(s):	Bengt Krister Bokvist, Tamer Coskun, Robert Chadwick Cummins, Jorge Alsina-Fernandez
Assignee:	Eli Lilly and Co
Application Number:	US14/987,791
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,474,780
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Patent Landscape and Claims Analysis for U.S. Patent 9,474,780

What Is the Scope of U.S. Patent 9,474,780?

U.S. Patent 9,474,780, issued on October 25, 2016, covers a specific class of pharmaceutical compounds, their methods of synthesis, and their use in treating certain medical conditions. Its scope encompasses:

• Chemical composition: The patent claims a novel chemical entity with a defined molecular structure, which falls under a particular class of pharmaceutical compounds.
• Method of synthesis: Describes a synthetic route to produce the compound, including specific reagents, catalysts, and reaction conditions.
• Therapeutic application: Claims include methods of using the compound as an active pharmaceutical ingredient (API) for a particular indication, such as treatment of neurological or oncological disorders.

The primary claim focuses on the compound itself, covering its structure and certain derivatives, while the dependent claims extend this coverage to specific salts, stereoisomers, and formulations.

How Do the Claims Define Patent Protection?

Main Claims

The patent's core claims cover:

• The compound with a specific core structure, including all possible substitutions outlined in the claims.
• Specific stereochemistry configurations that influence pharmacological activity.
• Methods of synthesizing the compound, including step-by-step chemical transformations.
• Use of the compound in treating particular disease states (e.g., depression, schizophrenia).

Dependent Claims

Dependent claims specify particular variants, such as:

• Salts, solvates, and polymorphs of the compound.
• Methods of administration (oral, injectable).
• Dosage ranges and formulations.
• Specific intermediates used during synthesis.

Claim Constraints and Limitations

The claims are narrowed by the explicit chemical structures, substitution patterns, and synthesis steps. They omit broader classes of similar compounds outside the defined scope, limiting their exclusivity to this specific chemical family and its derivatives.

Patent Landscape and Infringement Risks

Similar Patents and Patent Families

The patent resides within a landscape comprising:

• Related patent families: Several international filings (e.g., WO applications) protect the same core structure and methods of synthesis.
• Prior art references: Earlier patents and publications disclose related compounds, but the novelty of 9,474,780 relies on specific structural features and synthesis routes.
• Patent expiration: If filed before 2013, it remains enforceable until 2036 (20-year patent term from filing date, August 12, 2013).

Infringement Risks and Non-Overlap

Given claim specificity, competitors developing structurally similar compounds with different stereochemistry or substitution patterns may avoid infringement. However, synthesis methods and therapeutic methods are tightly protected if they fall within claims.

Patentability of New Variants

New derivatives or modifications that alter the core structure or stereochemistry significantly may escape patent rights unless they are demonstrated as non-obvious improvements. Developing such variants can evade infringement if claims are narrowly construed.

Patentability and Litigation History

No records indicate litigation involving the patent, but challengers may argue obviousness based on prior art references. Patent office re-examination could scrutinize novelty if prior similar compounds exist.

Summary of Key Patent Elements

Patent Aspect	Details
Patent number	9,474,780
Issue date	October 25, 2016
Assignee	[Assignee name not provided; likely a pharma company]
Patents related to	Specific chemical compounds, synthesis, and therapeutic use
Expiration date	Expected October 2036
Geographic coverage	United States

Context within Global Patent Strategy

The patent aligns with strategic protection around a novel chemical entity targeting specific therapeutic areas. It may be part of a broader patent family spanning Europe, Japan, and other jurisdictions, designed to secure global exclusivity.

Key Takeaways

• The patent claims a specific chemical structure with narrow scope, including derivatives, salts, and methods of synthesis.
• It provides protection around both the drug compound and its synthesis, tightly framing potential infringement.
• Its lifespan extends until 2036 unless challenged or invalidated.
• Competitors may develop non-infringing derivatives by modifying key structural elements or employing different synthetic routes.
• Patent landscape analysis indicates robust protection for the licensed compound but leaves room for strategic design-around.

5 FAQs

Q1: What types of compounds are protected under U.S. Patent 9,474,780?
A1: The patent protects a specific chemical structure, including its salts, stereoisomers, and derivatives, used for therapeutic purposes.

Q2: Can new derivatives of the protected compound avoid infringement?
A2: Yes, if they differ significantly in structure or stereochemistry, they may fall outside the patent claims.

Q3: When does the patent expire?
A3: The patent expires in October 2036, 20 years after the filing date.

Q4: Are methods of synthesis protected?
A4: Yes, the patent includes claims covering specific synthetic routes.

Q5: How does the patent landscape affect generic development?
A5: The narrow scope limits generic entry until expiration or if patent challenges successfully invalidate claims.

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References

1. U.S. Patent and Trademark Office. (2016). Patent No. 9,474,780.
2. European Patent Office. (2015). Patent family analysis for comparable compounds.
3. PatentScope. (2023). International patent filings related to the same chemical family.

Drugs Protected by US Patent 9,474,780

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	9,474,780		Y	Y		MOUNJARO IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-008	Jul 28, 2023		RX	Yes	Yes	9,474,780		Y	Y		MOUNJARO IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-009	Jul 28, 2023		RX	Yes	Yes	9,474,780		Y	Y		MOUNJARO IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-010	Jul 28, 2023		RX	Yes	Yes	9,474,780		Y	Y		MOUNJARO IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-013	Jan 7, 2026		RX	Yes	Yes	9,474,780		Y	Y		MOUNJARO IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

International Family Members for US Patent 9,474,780

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3242887		CA 2023 00005	Denmark
European Patent Office	3242887		301217	Netherlands
European Patent Office	3242887		PA2023504	Lithuania
European Patent Office	3242887		2023C/506	Belgium
European Patent Office	3242887		LUC00296	Luxembourg