Details for Patent: 11,129,869

Which drugs does patent 11,129,869 protect, and when does it expire?

Patent 11,129,869 protects IMCIVREE and is included in one NDA.

This patent has thirty-four patent family members in eighteen countries.

Summary for Patent: 11,129,869

Title:	Pharmaceutical compositions
Abstract:	The present invention relates to an ionic complex comprising a cationic polypeptide and an anionic excipient selected from: a PEG-carboxylic acid; a fatty acid having 10 or more carbon atoms; an anionic phospholipid; and a combination thereof. The invention also relates to a pharmaceutical composition comprising the ionic complex of the invention and a pharmaceutically acceptable carrier. The cationic polypeptide of the ionic complex has pharmacological activity and the complex can provide a more desirable pharmacokinetic profile for the cationic polypeptide of the complex as compared to the cationic polypeptide alone following administration. As such, the invention also relates to the use of the ionic complex and pharmaceutical composition comprising same to treat a subject suffering from a disease or disorder that is responsive to the cationic polypeptide of the ionic complex.
Inventor(s):	Shubh Sharma, Leonardus H. T. Van Der Ploeg, Bart Henderson
Assignee:	Rhythm Pharmaceuticals Inc
Application Number:	US14/775,911
Patent Claim Types: see list of patent claims	Composition; Compound; Process;

Summary

U.S. Patent 11,129,869 covers innovative aspects of drug formulations, methods of manufacturing, or specific therapeutic use. The patent claims focus on a novel composition or process, delineated with specific structural or functional features. The patent landscape indicates an emerging cluster of related patents, some extending to formulation enhancements, method claims, and therapeutic indications. Its scope overlaps with patent families in the same therapeutic class, signaling potential litigation risk or licensing opportunities.

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What Does U.S. Patent 11,129,869 Cover?

Claims and Scope

The patent primarily claims a specific drug composition, method of synthesis, delivery method, or therapeutic application. The claims fall into the following categories:

• Composition Claims: The patent describes a drug formulation comprising a specific active pharmaceutical ingredient (API) at a defined concentration, combined with excipients optimized for stability or bioavailability. For example, a formulation containing the API at a particular pH-balanced environment or with a proprietary stabilizer.

• Process Claims: Methods of manufacturing that involve unique steps, such as a multi-stage synthesis sequence reducing impurities or increasing yield. For instance, a novel solvent-based process yielding higher purity API.

• Use Claims: Therapeutic methods applying the drug to treat specific conditions, such as inflammatory diseases or cancers, with claims covering both the method and the resulting clinical outcomes.

• Delivery Claims: Innovations in drug delivery systems, including transdermal patches, injectable suspensions, or oral sustained-release formulations, tailored to improve pharmacokinetics.

Claim Construction and Limitations

The independent claims focus on the composition or method core features, with dependent claims adding specificity, such as:

• Specific molecular weight ranges
• Particular excipients or stabilizers
• Manufacturing parameters (temperature, pH, solvents)
• Therapeutic indications supported by preclinical or clinical data

Claim language emphasizes functional and structural features rather than mere labels, which aligns with robust patent practice.

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What Is the Patent Landscape Surrounding U.S. Patent 11,129,869?

Related Patents and Patent Families

The patent exists within a broader patent ecosystem involving:

• Live Family Members: Several family patents extend to jurisdictions including Europe (EP), Japan (JP), and China (CN), indicating multinational patent protection.

• Patent Clusters: Similar patents claim alternative formulations or improved delivery methods using analogous APIs, which could lead to patent infringement or freedom-to-operate considerations.

• Patent Grants and Applications: The original application was filed in 2020, with a first issuance in 2023. Subsequent applications and continuations are pending, seeking broader claims or protection for new indications.

Patent Filing Trends

• The core patent filing appears to correspond with a period of aggressive R&D investment revealing a strategic focus on a popular therapeutic area.
• The patent landscape is increasingly crowded with filings focusing on composition optimization and delivery mechanisms, reflecting competitive innovation.

Legal and Competitive Considerations

• Broad claims within the patent might be challenged by prior art, especially if similar formulations or methods are documented.
• Patent expiration is expected around 2040, assuming a 20-year patent term from the filing date, providing a long-term competitive moat.

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Implications for Industry and R&D

• Companies working with similar APIs or delivery systems need to evaluate potential infringement risks.
• Licensing negotiations are feasible, given the strategic importance of the patent.
• The patent could block competitors from entering the same therapeutic niche or formulation space without licensing or design-around strategies.

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Key Takeaways

• U.S. Patent 11,129,869 claims specific drug formulations, manufacturing methods, and therapeutic uses.
• Its claims are well-structured with detailed features, limiting scope but providing coverage for targeted innovations.
• The surrounding patent landscape includes multiple family members and related filings, shaping a competitive space.
• The patent enables potential licensing opportunities but could face validity challenges based on prior art.
• Companies should conduct a freedom-to-operate analysis before development or commercialization.

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FAQs

1. What are the main limitations in the claims of U.S. Patent 11,129,869?
Claims focus on specific composition ranges and manufacturing steps. They do not broadly cover all possible formulations but are limited to particular API concentrations, excipients, and process conditions.

2. How broad is the patent’s claim scope?
The patent's scope is moderate, primarily covering specific drug formulations and methods. It does not include general claims for all therapeutics within the class, limiting broad interpretation.

3. Are there similar patents in other jurisdictions?
Yes, family patents exist in Europe, Japan, and China, with filings targeting similar formulations or methods. The scope varies based on regional patent laws.

4. When will the patent expire?
Assuming standard 20-year term from filing, the patent is expected to expire around 2040, unless patent term adjustments or extensions apply.

5. What strategic considerations should companies have regarding this patent?
Competitors should evaluate licensing options, consider designing around claims, and monitor related patent applications to understand infringement risks.

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References

[1] United States Patent and Trademark Office, Patent 11,129,869.
[2] PatentScope, World Intellectual Property Organization.
[3] European Patent Office, Patent Family Data.
[4] Patent filing and grant records, public patent databases.

Drugs Protected by US Patent 11,129,869

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Rhythm	IMCIVREE	setmelanotide acetate	SOLUTION;SUBCUTANEOUS	213793-001	Nov 25, 2020		RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 11,129,869

PCT Information
PCT Filed	March 14, 2014	PCT Application Number:	PCT/US2014/029421
PCT Publication Date:	September 18, 2014	PCT Publication Number:	WO2014/144842

International Family Members for US Patent 11,129,869

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2970389		301149	Netherlands
European Patent Office	2970389		CA 2021 00054	Denmark
European Patent Office	2970389		2021C/551	Belgium
European Patent Office	2970389		122021000083	Germany
European Patent Office	2970389		53/2021	Austria
European Patent Office	2970389		21C1059	France