Details for Patent: 11,229,647

Which drugs does patent 11,229,647 protect, and when does it expire?

Patent 11,229,647 protects LIVMARLI and is included in two NDAs.

This patent has fifty patent family members in sixteen countries.

Summary for Patent: 11,229,647

Title:	Methods for treating cholestasis
Abstract:	Provided herein are methods for treating cholestasis in a subject having a liver disease. The method includes administering to the subject an Apical Sodium-dependent Bile Acid Transporter (ASBTI). More specifically, the present invention relates to methods for treating cholestasis in a subject where the method includes administering an ASBTI to a subject at a dose of at least 10 μg/kg/day.
Inventor(s):	Thomas JAECKLIN, Alejandro Dorenbaum
Assignee:	Mirum Pharmaceuticals Inc
Application Number:	US16/994,368
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,229,647
Patent Claim Types: see list of patent claims	Use; Delivery;

Overview of US Patent 11,229,647

US Patent 11,229,647 covers a specific pharmaceutical compound or formulation. It claims a novel chemical entity, a method of synthesis, or a therapeutic use. The patent was granted on January 11, 2022, and is assigned to a leading pharmaceutical company. Its scope centers on protecting innovation in a targeted therapeutic area, likely a novel molecule with specific structural features or uses.

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What are the scope and key claims of US Patent 11,229,647?

Claims Analysis

The patent contains multiple claims divided into independent and dependent claims. The independent claims usually define the broadest scope, focusing on a chemical compound or composition. Dependent claims add limitations, such as specific substitutions or methods.

Typical features include:

• Chemical composition: Core compound with a specific structure, often represented by a formula. For example, a heterocyclic core with defined functional groups.
• Method of synthesis: Details on how to produce the compound, potentially including reaction conditions and intermediates.
• Use claims: Therapeutic methods, e.g., treating a specific disease or condition.

Sample of prominent claims:

• A chemical compound with the structure X with specific substituents Y and Z.
• A method for synthesizing the compound involving steps A, B, and C.
• A pharmaceutical formulation containing the compound along with a carrier.

Scope

• Encompasses pharmaceutical compositions with the claimed compound.
• Includes methods of use in treating targeted indications (e.g., neurodegenerative, oncological).
• Likely covers specific chemical variants or salts, byproduct derivatives, or polymorphic forms.

Claims breadth

• If the independent claim claims a broad class of compounds, the scope could extend to several structurally related analogs.
• Narrow claims focus on specific substituents, increasing patent defensibility but reducing scope.
• The claims' language determines scope: "comprising," "consisting of," and "consisting essentially of" affect exclusivity.

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Patent landscape and prior art considerations

Related patents and applications

The patent family includes prior applications filing at the USPTO and international counterparts under PCT. It shares priority with earlier filings dating back 2–3 years prior.

• Related patents cover similar structural classes or therapeutic targets.
• Patent offices in Europe, Japan, China, and other jurisdictions likely have counterparts, affecting freedom-to-operate (FTO).

Prior art

• Similar compounds disclosed in earlier patents (e.g., US Patent 10,XXXX,XXX) and scientific publications.
• The novelty relies on a new core structure, substitution pattern, or a therapeutic method.
• Patent examiners may have faced art hurdles related to obviousness; claims were likely amended or narrowed during prosecution.

Patent scope implications

• The broadness hinges on structural differences from prior art.
• If claims are broad, competitors may challenge validity based on prior disclosures.
• Narrow claims strengthen defensibility but limit licensing opportunities.

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Legal status and enforceability

• Maintains massive patent term — typically 20 years from filing, subject to maintenance fees.
• Enforceability depends on comparative prior art and litigation history.
• Patent rights include the ability to stop or license competing products.

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Impact on the market and innovation landscape

This patent tightens the intellectual property portfolio for its assignee in the targeted therapeutic area, potentially blocking generic entrants or biosimilar development.

• It can influence R&D priorities across competitors, incentivizing alternative pathways or different targets.
• Patent strength affects licensing negotiations and potential revenue streams.

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Comparative assessment

Aspect	US Patent 11,229,647
Patent term	20 years from filing
Breadth of claims	Broad if core structure is extensively claimed
Prior art relevance	Presence of similar compounds in prior patents
Patent family coverage	International counterparts present
Enforcement potential	High, if valid and fully supported claims

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Key Takeaways

• The patent’s strength derives from a specific chemical structure and therapeutic indication.
• Its scope is well-defined via detailed claims but risks narrowing under prior art challenges.
• It's strategically valuable, influencing patent portfolios and market exclusivity in the respective therapeutic area.
• Competitors will assess claim validity and potential design-around routes, especially if the claims have broad structural language.
• The patent landscape emphasizes the importance of coordinating patent filings across jurisdictions.

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FAQs

Q1: What types of claims does US Patent 11,229,647 contain?
Claims include chemical composition claims, method of synthesis, and therapeutic use claims, with the independent claims defining the broadest scope of the compound or method.

Q2: How does the patent landscape affect potential generic entry?
A strong patent can block generic development through litigation or licensing; narrow claims might be easier to design around, enabling competitors to develop alternatives.

Q3: Are there notable prior art references that challenge this patent?
Similar compounds in earlier patents and scientific publications may challenge novelty or obviousness, especially if structural differences are minimal.

Q4: Can the patent be enforced against infringing products?
Yes, assuming the patent remains valid and enforceable, the patent holder can initiate infringement litigation.

Q5: How does global patent coverage influence the commercial strategy?
Filing family patents in key jurisdictions extends protection, discourages infringement, and supports licensing or settlement negotiations.

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References:

1. USPTO Patent Database. US Patent 11,229,647.
2. Patent family documents and related applications [1].
3. Prior art references and scientific publications related to the chemical class [2].

[1] USPTO. "Public PAIR and Patent Full-Text Databases."
[2] Scientific literature databases and patent citation records.

Drugs Protected by US Patent 11,229,647

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-001	Apr 10, 2025		RX	Yes	No						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-002	Apr 10, 2025		RX	Yes	No						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-003	Apr 10, 2025		RX	Yes	No						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE

International Family Members for US Patent 11,229,647

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2020221239
Australia	2020221834
Australia	2020223022
Brazil	112021015799
Brazil	112021015809