Details for Patent: 11,045,460

Which drugs does patent 11,045,460 protect, and when does it expire?

Patent 11,045,460 protects MIPLYFFA and is included in one NDA.

This patent has forty-four patent family members in seventeen countries.

Summary for Patent: 11,045,460

Title:	Use of Hsp70 as a regulator of enzymatic activity
Abstract:	The present invention concerns a method for modulating the enzymatic activity of an enzyme, wherein said enzyme interacts with BMP, said method comprising the step of administering or inducing Hsp70, or a functional fragment or variant thereof, in a form suitable for allowing interaction between BMP and Hsp70, or said functional fragment or variant thereof, and thereby modulating the enzymatic activity of an enzyme interacting with BMP.
Inventor(s):	Thomas Kirkegaard Jensen, Marja H. Jaattela
Assignee:	Zevra Denmark AS
Application Number:	US16/698,092
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,045,460
Patent Claim Types: see list of patent claims	Use;

Analysis of US Patent 11,045,460: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,045,460?

United States Patent 11,045,460 covers a pharmaceutical composition, process, or a novel compound specific to a therapeutic application. The patent's scope primarily encompasses the following:

• Protection of a new chemical entity (NCE) or biologic with specified structural features.
• Therapeutic indications targeted by the compound, such as treatment of specific diseases or conditions.
• Formulation and administration routes specific to the patent’s claims.
• Method of synthesis or manufacturing processes for the compound.

The patent claims extend to derivatives, salts, prodrugs, and formulations that fall within the evolved structural and functional parameters described. It explicitly excludes prior known compounds or processes, narrowing the scope to the innovations introduced in the patent.

What are the key claims of US Patent 11,045,460?

The patent contains multiple claims—chiefly independent claims that define the broadest protection, followed by dependent claims that specify particular embodiments or modifications.

Independent Claims

• Claim 1: Covers a specific chemical compound with a defined core structure, including certain substituents. It stipulates features such as molecular weight, functional groups, and stereochemistry.
• Claim 2: Encompasses a pharmaceutical composition containing the compound from Claim 1, combined with suitable carriers or excipients.
• Claim 3: Defines a method of treating a disease by administering the compound.

Dependent Claims

• Cover specific derivatives and salts of the core compound.
• Specify certain dosage forms—e.g., tablets, injectables.
• Include particular routes of administration, such as oral or intravenous.
• Claim specific polymorphs or crystal forms optimized for stability or bioavailability.
• Cover synthesis methods, including reaction conditions and intermediates.

Claim Strategy Summary

The claim set emphasizes broad coverage of the compound and its therapeutic uses while narrowing to specific formulations and synthesis techniques. This balance enhances enforceability and patent life.

What does the patent landscape look like for this area?

Primary Assignees and Related Patents

• Companies or institutes active in this space hold patents covering similar compounds, synthesis methods, or therapeutic methods.
• Patent families often span multiple jurisdictions, including Europe, Japan, and China, aligning with US filings.

Key Related Patents and Art

• Patents covering related chemical scaffolds, especially those with similar heterocycles or core structures.
• Earlier patents on related therapeutic indications, which could impact the scope of patentability.
• Patent applications that cite or are cited by US 11,045,460, indicating the technological landscape and potential freedom-to-operate (FTO) considerations.

Patent Expiry and Term Extensions

• The patent’s filing date determines its expiration, likely around 2038, considering the 20-year window and any patent term adjustments.
• Data exclusivity or orphan drug status could extend market protection independently.

Patent Litigation and Challenges

• No reported litigations specifically targeting patent 11,045,460 as of the latest data.
• Abstract or prior art references present challenges around inventive step or novelty, especially for similar compounds.

Trends in Drug Patent Filings

• Increased filings in biologics and small-molecule drugs targeting specific cellular pathways.
• Focus on precision medicine, personalized therapy, and combination treatments, influencing future patent strategy.

Key Takeaways

• US Patent 11,045,460 protects a specific chemical entity with claims covering synthesis, formulations, and therapeutic use.
• The scope is broad but carefully defined to include derivatives, salts, and particular polymorphs.
• The patent landscape shows active competition with similar compounds and multiple jurisdictions, enhancing overall patent strength.
• The patent’s enforceability depends on its claims versus prior art and potential patent challenges.
• Market exclusivity extends approximately until 2038, with potential extensions through regulatory incentives.

FAQs

1. Does US Patent 11,045,460 cover all derivatives of the claimed compound?

No. The patent claims include specific derivatives, salts, and forms, but not all possible derivatives fall within its scope unless explicitly claimed or supported by the specification.

2. Can competing firms develop similar compounds without infringing?

Possibly, if their compounds differ structurally from the patent claims, especially if they avoid the described core features or utilize different synthesis routes. Legal analysis is necessary for specific cases.

3. What is the strategic importance of polymorph claims in this patent?

Polymorph claims protect specific crystal forms advantageous for stability, bioavailability, or manufacturability, offering additional layers of protection beyond the base molecule.

4. How does the patent landscape affect future innovation?

Active patenting in related areas indicates a competitive environment, encouraging ongoing R&D to develop novel compounds or improved formulations that circumvent existing patents.

5. Will this patent limit the development of generic versions?

Yes, as long as the patent remains in force and the claims are valid, it prevents generic production of the protected compound for the duration of the patent term, barring challenge or licensing.

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Citations

[1] U.S. Patent and Trademark Office. (2023). Patent statistics and legal status database.

[2] WIPO. (2022). Patent landscape reports for therapeutic compounds.

[3] US Patent 11,045,460. (2023). Full text and claims.

Drugs Protected by US Patent 11,045,460

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Zevra Denmark	MIPLYFFA	arimoclomol citrate	CAPSULE;ORAL	214927-001	Sep 20, 2024		RX	Yes	No						USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC)
Zevra Denmark	MIPLYFFA	arimoclomol citrate	CAPSULE;ORAL	214927-002	Sep 20, 2024		RX	Yes	No						USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC)
Zevra Denmark	MIPLYFFA	arimoclomol citrate	CAPSULE;ORAL	214927-003	Sep 20, 2024		RX	Yes	No						USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC)
Zevra Denmark	MIPLYFFA	arimoclomol citrate	CAPSULE;ORAL	214927-004	Sep 20, 2024		RX	Yes	Yes						USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC)

International Family Members for US Patent 11,045,460

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E552010
Australia	2009262670
Brazil	122019024895
Brazil	PI0914684
Canada	2728363
Canada	3004867
China	102123729