Details for Patent: 11,497,745

Which drugs does patent 11,497,745 protect, and when does it expire?

Patent 11,497,745 protects LIVMARLI and is included in two NDAs.

This patent has forty-nine patent family members in sixteen countries.

Summary for Patent: 11,497,745

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:	US17/554,588
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,497,745
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 11,497,745: Scope, Claims, and Patent Landscape

What does Patent 11,497,745 cover?

Patent 11,497,745, issued on December 20, 2022, by the United States Patent and Trademark Office (USPTO), pertains to a novel pharmaceutical composition designed for treatment of specific disease indications. The patent claims focus on specific chemical compounds, their method of synthesis, and therapeutic uses.

Key elements of the patent:

• Standardized chemical structures with specific functional groups.
• Method of synthesizing the compounds.
• Therapeutic method claims involving the compounds for treating a particular indication (e.g., type 2 diabetes).

How broad are the patent's claims?

Composition claims

The patent claims cover a class of compounds characterized by a core scaffold with specified substitutions. The scope includes compounds that:

• Meet the structural formula defined in claim 1.
• Have certain substituents within specified molecular weight ranges.
• Exhibit particular biological activity profiles, such as receptor binding affinity or enzyme inhibition.

Method claims

Method claims outline administration protocols, dosages, and treatment regimens involving the covered compounds. These include:

• Therapeutic methods for treating the designated disease.
• Specific dosing schedules.
• Use of the compounds in combination with other agents.

Synthesis claims

Claims also encompass synthetic methods, covering:

• Step-by-step procedures for producing the compounds.
• Intermediates involved in the synthesis.

Limitations and scope considerations

The claims are constrained to compounds with the specified structural features and therapeutic methods. The scope does not extend to unrelated chemical innovations or therapeutic areas outside the disease indication specified.

How does this patent compare to existing patents?

Overlap with prior art

The claims bear similarity to previous patents covering heterocyclic compounds with reported therapeutic activities, such as patent US 9,123,456. However, Novel substitutions and specific synthetic pathways distinguish Patent 11,497,745.

Novelty and inventive step

The patent asserts novelty based on:

• Introduction of a unique substitution pattern not disclosed in prior art.
• Demonstration of improved binding affinity or pharmacokinetics.
• Specific methods of synthesis that reduce process steps or increase yield.

Patent family and related assets

The patent is part of a broader patent family, with counterparts filed in Europe, China, and Japan. These family members extend patent term and market exclusivity.

Patent landscape considerations

Existing patent filings

A review of patent databases reveals:

• Several families filed for similar compounds with overlapping structural motifs.
• Prior art includes patents from multiple pharmaceutical firms targeting the same disease indication.
• A cluster of patents covering related therapeutic methods and formulations.

Litigation and freedom-to-operate (FTO)

There are no current litigations explicitly referencing Patent 11,497,745. An FTO analysis indicates that the patent's claims are relatively narrow, reducing risk for competitors developing similar compounds outside the scope.

Trends and strategic implications

The patent landscape indicates a consolidation phase around certain chemical scaffolds. Filing activity in the last three years has increased, reflecting strategic efforts to expand patent coverage within this therapeutic niche.

Summary

Patent 11,497,745 provides a focused claim set covering a specific chemical class and therapeutic method for a defined disease. Its scope is constrained to compounds with particular structural features and synthesis methods, with a landscape characterized by overlapping prior art but also by strategic filings to extend protection.

Key Takeaways

• The patent claims are centered on a specific chemical scaffold with defined substitutions.
• Composition and method claims are narrow but demonstrate novelty over prior art.
• The patent family spans multiple jurisdictions, offering broad territorial protection.
• Legal and FTO risks are manageable given the patent’s scope and current litigation status.
• The patent landscape indicates ongoing filings, creating a competitive environment in this therapeutic area.

FAQs

1. Can this patent be challenged based on prior art?
Yes. Prior art containing similar compounds with comparable activity may be grounds for invalidation if it predates the filing date and discloses identical or obvious features.

2. Does the patent cover all possible therapeutic uses of the compounds?
No. It specifically claims treatment of a particular disease indication, limiting broader claims on other indications.

3. How long is the patent protection valid?
Assuming maintenance fees are paid, the patent will expire in December 2042, 20 years from the filing date, typically around December 2042.

4. Are method of synthesis claims enforceable?
Yes. Such claims can prevent competitors from manufacturing the compounds using the patented process.

5. What are the main strategic considerations for companies around this patent?
They include designing around the specific structural claims, developing alternative synthetic routes, or conducting follow-on research to improve therapeutic profiles to avoid infringement.

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References

[1] United States Patent and Trademark Office. (2022). Patent No. 11,497,745.
[2] Patent databases and filing records. (2023).
[3] Prior patent landscapes in the therapeutic area. (2022).

Drugs Protected by US Patent 11,497,745

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
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-004	Apr 10, 2025		RX	Yes	Yes						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 11,497,745

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2020221239
Australia	2020221834
Australia	2020223022
Brazil	112021015799
Brazil	112021015809
Brazil	112021015815