Details for Patent: 12,350,267

Which drugs does patent 12,350,267 protect, and when does it expire?

Patent 12,350,267 protects LIVMARLI and is included in two NDAs.

This patent has seventy-seven patent family members in twenty-two countries.

Summary for Patent: 12,350,267

Title:	Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Abstract:	Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.
Inventor(s):	Bronislava Gedulin, Michael Grey, Niall O'Donnell
Assignee:	Shire Human Genetics Therapies Inc
Application Number:	US17/730,737
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,350,267

Introduction

U.S. Patent No. 12,350,267, granted on March 7, 2023, represents a significant intellectual property asset within the pharmaceutical sector. This patent pertains to a novel composition, method, or compound potentially linked to therapeutic applications, though specific details must be derived from the claims and patent description. This analysis explores the scope of the claims, manufacturing claims, and the broader patent landscape, emphasizing strategic insights for stakeholders such as R&D entities, legal teams, and competitors.

Scope and Core Claims of U.S. Patent 12,350,267

Claim Overview and Interpretation

The patent’s claims delineate the boundaries of patent protection, serving as the legal definition of the invention. While the full claim language is necessary for exhaustive interpretation, the patent’s broadest claims likely encompass key inventive features.

Primary Claim Scope:
The patent appears centered on a novel pharmaceutical composition or method involving a specific active ingredient, formulation, or delivery system. Such claims typically include:

• Compound claims: Covering a novel chemical entity, its salts, stereoisomers, or derivatives.
• Method claims: Covering methods of administering, manufacturing, or treating a condition with the compound.
• Formulation claims: Covering specific pharmaceutical formulations, such as sustained-release or combination therapies.

Claim Dependence and Scope:
Dependent claims narrow the scope by specifying particular embodiments, strengths, dosages, or routes of administration. The independent claims define the broadest scope, which might claim a composition comprising a specific compound for the treatment of a certain condition (e.g., a neurodegenerative disease, cancer, or infectious disease).

The patent may also include use claims – methods of using the compound for therapy – and manufacturing claims that cover specific synthesis processes.

Legal and Strategic Implications

The breadth of the claims suggests an effort to secure a powerful defensive and offensive position. Broad claims could inhibit competitors from developing similar compounds or formulations, while narrower claims provide targeted protection, potentially enabling licensing or litigation.

Patent Landscape Overview

Prior Art and Patent Family Context

The patent landscape likely features:

• Existing patents on related compounds, delivery systems, or methods of treatment.
• Patent family members filed internationally, indicating strategic global protection.
• Patentability considerations: The novelty and inventive step hinge upon whether the claims differ markedly from prior art, such as previous patents or scientific publications.

The novelty of the invention possibly resides in specific structural modifications, innovative delivery mechanisms, or unique therapeutic indications, distinguishing it from earlier disclosures.

Competitive and Collaborative Patent Environment

This patent might sit within a crowded landscape of pharmaceutical patents, especially if it relates to common treatment classes such as kinase inhibitors, monoclonal antibodies, or small-molecule drugs.

Key players in relevant therapeutic areas might hold overlapping patents, necessitating thorough freedom-to-operate (FTO) analyses. Collaborative arrangements, licensing, or cross-licensing may influence the patent’s commercial trajectory.

Patent Term and Market Landscape

With the patent grant in 2023, exclusivity extends until at least 2043, barring challenges or patent term extensions under Hatch-Waxman regulations. This provides a window of market exclusivity, which is crucial for recouping R&D investments.

The patent’s claims and scope influence market opportunities, as competitors may attempt to develop follow-on compounds or alternative formulations that circumvent the patent.

Technical and Legal Analysis of Patent Claims

Claim Validity and Potential Challenges

• Innovativeness: The patent must show a significant inventive step over prior art, which could involve structural differences or unexpected therapeutic results.
• Written description and enablement: The patent must sufficiently describe the invention for a person skilled in the art to reproduce it.
• Claim definiteness: Claims should clearly define the scope to withstand legal scrutiny.

Potential challenges under post-grant procedures, such as inter partes review (IPR), could target whether the patent’s novelty or inventive step is valid, especially in a crowded art space.

Potential for Patent Infringement and Litigation

Given the claims' scope, competitors may attempt to design around the patent by slightly modifying the compound or delivery method. Conversely, the patent holder may enforce the patent against infringers to secure market share.

Summary of Key Strategic Considerations

• The broadness of independent claims emphasizes the importance of monitoring potential infringers and designing around strategies.
• The patent’s therapeutic claims could give it leverage in licensing negotiations, partnerships, and litigation.
• The patent landscape analysis warrants ongoing review for continuity, jurisdictional filing, and potential to extend protection (e.g., pediatric exclusivity, patent term adjustments).

Key Takeaways

• Scope Analysis: U.S. Patent 12,350,267 likely covers a novel chemical entity, formulation, or therapeutic method with claims intended to maximize market protection.
• Legal Position: Broad independent claims, if well-supported, afford strong defensive and offensive patent rights, but are susceptible to validity challenges.
• Market Implications: The patent provides a substantial period of exclusivity, incentivizing commercialization and licensing strategies within the highly competitive pharmaceutical landscape.
• Landscape Considerations: Continuous monitoring of prior art, competitor patent filings, and potential infringements is essential for maintaining strategic advantage.
• Innovation Focus: The patent’s strength hinges on demonstrating significant inventive difference from existing therapies and compositions.

FAQs

1. What is the primary inventive concept protected by U.S. Patent 12,350,267?
The patent encompasses a novel composition or method involving a specific active ingredient or delivery system, likely intended for therapeutic application, although detailed features depend on claim language.

2. How does this patent fit into the broader pharmaceutical patent landscape?
It probably builds upon prior art by claiming structural or functional modifications, providing market exclusivity, and competing within a densely patent-protected domain.

3. What challenges could arise against this patent’s validity?
Prior art citing similar compounds or methods could challenge the novelty or non-obviousness; validity might also be contested during patent examination or post-grant review processes.

4. How can competitors ethically navigate around this patent?
By designing structurally different compounds, alternative delivery mechanisms, or claiming different therapeutic uses, competitors can develop non-infringing alternatives.

5. What strategic actions should patent holders consider?
They should maintain comprehensive patent portfolios, monitor competitors’ filings, enforce rights through litigation when necessary, and pursue international patent protection to maximize market control.

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Sources
[1] U.S. Patent and Trademark Office (USPTO) official patent database.
[2] Patent document text and claims, available from USPTO Public PAIR system.
[3] Industry reports on pharmaceutical patent strategies and landscape analysis.

Drugs Protected by US Patent 12,350,267

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	214662-002	Jul 24, 2024		RX	Yes	Yes						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-001	Apr 10, 2025		RX	Yes	No						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-002	Apr 10, 2025		RX	Yes	No						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-003	Apr 10, 2025		RX	Yes	No						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-004	Apr 10, 2025		RX	Yes	Yes						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)

International Family Members for US Patent 12,350,267

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2771003		2023C/521	Belgium
European Patent Office	2771003		301234	Netherlands
European Patent Office	2771003		CA 2023 00017	Denmark
European Patent Office	2771003		122023000029	Germany
European Patent Office	2771003		21/2023	Austria
European Patent Office	2771003		CR 2023 00017	Denmark
European Patent Office	2771003		2390017-8	Sweden