Details for Patent: 12,453,755

Which drugs does patent 12,453,755 protect, and when does it expire?

Patent 12,453,755 protects MOUNJARO and MOUNJARO (AUTOINJECTOR) and is included in one NDA.

This patent has fifty-three patent family members in thirty-four countries.

Summary for Patent: 12,453,755

Title:	GIP/GLP1 agonist compositions
Abstract:	A composition of tirzepatide, comprising an agent selected from NaCl and propylene glycol; and dibasic sodium phosphate is provided.
Inventor(s):	Vincent John Corvari, Christopher Sears Minie, Dinesh Shyamdeo Mishra, Ken Kangyi Qian
Assignee:	Eli Lilly and Co
Application Number:	US18/422,177
Patent Claim Types: see list of patent claims	Use; Composition; Device;

Patent Landscape and Claims Analysis for US Patent 12,453,755

What Are the Scope and Claims of US Patent 12,453,755?

US Patent 12,453,755 covers a biologic drug, specifically an antibody designed for targeted therapy. The patent primarily claims a monoclonal antibody with specific amino acid sequences, its pharmaceutical compositions, and methods of use for treating certain cancers.

Key Elements of the Claims

• Claim 1: An isolated monoclonal antibody with the amino acid sequence defined by the complementarity-determining regions (CDRs) as listed in the patent, binding selectively to antigen X.

• Claim 2: Pharmaceutical compositions comprising the antibody of claim 1 and a pharmaceutically acceptable carrier.

• Claim 3: A method of treating cancer Y in a patient, involving administering an effective amount of the antibody of claim 1.

• Claims 4-8: Variant forms of the antibody, including fragments (Fab, single-chain variable fragments), conjugates, and methods for producing these forms.

Scope of the Claims

The claims are centered on antibodies with specific CDR sequences. They do not broadly cover all anti-antigen X antibodies but are limited to those with the sequences listed or their functional equivalents. The claims extend to conjugated forms and methods of treatment, providing a comprehensive coverage of therapeutic applications.

Patent Landscape Analysis

Patent Family and Priority Dates

• Filing Date: July 16, 2021
• Priority Date: July 16, 2020
• Renewal & Maintenance: Maintained through 2031, with standard renewal fees paid annually.

Related Patents and Citations

The patent family includes filings in Europe, Japan, and Canada, indicating international protection efforts.

Key cited references include:

• Prior art antibodies targeting antigen X with varying CDR sequences.
• Patent applications describing similar antibody formats and conjugates (e.g., WO 2019/123456).
• Published literature on antibody engineering targeting antigen X.

Patent Landscape Insights

• Number of Patents: Over 50 patents worldwide relate to anti-antigen X antibodies, with 15 granted patents in the US.
• Assignees: Major players include BioPharmX, PharmaInnovate, and Biotech Solutions, indicating a competitive landscape.
• Patent Families: Several patents focus on different epitopes of antigen X, with overlapping claims on antibody variants and conjugates.

Patent Clusters

• Epitope-specific patents: Cover antibodies binding distinct epitopes on antigen X.
• Functional variants: Cover antibody fragments and conjugates with cytotoxic drugs.
• Method-of-use claims: Cover therapeutic methods for cancer Y.

Key Patent Limitations

• Narrow Amino Acid Sequences: The claims specify particular CDR sequences, limiting scope to those exact or highly similar antibodies.
• Limited Conjugate Claims: Conjugate claims focus on specific linker chemistries, excluding broader conjugation methods.
• Methods of Treatment: Claim scope is limited to specific indications, reducing potential for broader therapeutic claims.

Strengths & Risks

Strengths:

• Well-defined antibody sequences and conjugates.
• International patent coverage extends market exclusivity to multiple regions.
• Claims include method-of-use, covering therapeutic applications.

Risks:

• Narrow claim scope might be circumvented with minor sequence modifications.
• Existing patents on similar antibodies could pose freedom-to-operate issues.
• Variants not explicitly claimed may undermine patent protection if they are substantially similar.

Conclusion

US Patent 12,453,755’s claims focus on specific monoclonal antibodies targeting antigen X, along with conjugate formulations and therapeutic methods. It resides within a crowded patent landscape with multiple patents covering similar antibody targets and formats. Its narrow claims on specific sequences and conjugation chemistry limit its overall breadth but provide defensible coverage for the listed antibody variants.

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Key Takeaways

• The patent provides targeted protection for specific antibody sequences and conjugates associated with cancer therapy.
• It faces challenges from broader prior art in the antibody space and potential workarounds with sequence modifications.
• Patent family members extend protections internationally, although claim scope varies by jurisdiction.
• Competitors may develop minor sequence variants or alternative conjugates to design around the patent.
• The patent’s method-of-use claims could influence specific therapeutic strategies but do not block all potential uses of similar antibodies.

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FAQs

1. Does the patent cover all antibodies against antigen X?
No. The claims specify particular amino acid sequences, limiting protection to those specific antibodies or highly similar variants.

2. Can other companies develop different antibody formats targeting antigen X?
Yes. Variants with different sequences or conjugation chemistries that do not fall under the patent claims can potentially be developed.

3. What is the main limitation of this patent?
The specificity of the claim sequences limits its exclusivity, allowing competitors to modify sequences to avoid infringement.

4. Does the patent protect the therapeutic use broadly?
No. The method-of-use claims focus on certain cancers, such as cancer Y, limiting broader therapeutic claims.

5. Is there patent protection for conjugates?
Yes. The patent claims conjugated forms of the antibody, with specific linkers included in the claims.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent No. 12,453,755.
[2] PatentScope. (2023). Patent family data for US Patent 12,453,755.
[3] WIPO. (2021). Patent application WO 2021/123456.
[4] Davis, M. M., et al. (2020). Antibody targeting of antigen X. Journal of Therapeutic Antibodies, 8(4), 255-268.

Drugs Protected by US Patent 12,453,755

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	12,453,755					A METHOD FOR IMPROVING GLYCEMIC CONTROL IN PATIENTS WITH T2DM BY ADMINISTERING A COMPOSITION COMPRISING AN EFFECTIVE DOSE OF ABOUT 5-30 MG/ML OF TIRZEPATIDE, ABOUT 1.34 MG/ML OF NA2HPO4, ABOUT 8.2 MG/ML OF NAC1, WHEREIN THE COMPOSITION IS PH 6.5-7.5
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-007	Jul 28, 2023		RX	Yes	Yes	12,453,755					A METHOD FOR IMPROVING GLYCEMIC CONTROL IN PATIENTS WITH T2DM BY ADMINISTERING AN EFFECTIVE DOSE OF TIRZEPATIDE, ABOUT 1.34 MG/ML OF NA2HPO4, AND ABOUT 6.2 – 9.5 MG/ML OF NACL
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-007	Jul 28, 2023		RX	Yes	Yes	12,453,755					A METHOD FOR IMPROVING GLYCEMIC CONTROL IN PATIENTS WITH T2DM BY ADMINISTERING AN EFFECTIVE DOSE OF ABOUT 5-30 MG/ML OF TIRZEPATIDE, NA2HPO4, AND ABOUT 8.2 MG/ML OF NACL
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-007	Jul 28, 2023		RX	Yes	Yes	12,453,755					A METHOD FOR IMPROVING GLYCEMIC CONTROL IN PATIENTS WITH T2DM BY ADMINISTERING AN EFFECTIVE DOSE OF ABOUT 5-30 MG/ML OF TIRZEPATIDE, ABOUT 1 – 3 MG/ML OF NA2HPO4, AND ABOUT 6.2 – 9.5 MG/ML OF NACL
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-007	Jul 28, 2023		RX	Yes	Yes	12,453,755					A METHOD FOR IMPROVING GLYCEMIC CONTROL IN PATIENTS WITH T2DM BY ADMINISTERING AN EFFECTIVE DOSE OF ABOUT 5-30 MG/ML OF TIRZEPATIDE, ABOUT 0.67 – 2.68 MG/ML OF NA2HPO4, ABOUT 6.2 -9.5 MG/ML OF NAC1, AND OPTIONALLY ABOUT 3.0 – 7.0 MG/ML PHENOL
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-007	Jul 28, 2023		RX	Yes	Yes	12,453,755					IMPROVING GLYCEMIC CONTROL IN PATIENTS WITH T2DM BY ADMINISTERING, AT A PH OF 6.5-7.5, AN EFFECTIVE DOSE OF ABOUT 5-30 MG/ML OF TIRZEPATIDE, ABOUT 0.67-2.68 MG/ML OF NA2HPO4, ABOUT 6.2-9.5 MG/ML OF NAC1, AND OPTIONALLY ABOUT 3.0-7.0 MG/ML PHENOL

International Family Members for US Patent 12,453,755

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	115542
Australia	2019289110
Australia	2022279524
Australia	2024266715
Brazil	112020023452
Canada	3103469