Details for Patent: 11,229,661

Which drugs does patent 11,229,661 protect, and when does it expire?

Patent 11,229,661 protects LIVMARLI and is included in two NDAs.

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

Summary for Patent: 11,229,661

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:	US16/679,864
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,229,661

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Introduction

U.S. Patent 11,229,661, granted by the United States Patent and Trademark Office (USPTO), reflects significant advancements within the pharmaceutical landscape. As a key patent identifier, its scope, claims, and position within the broader patent ecosystem influence research, development, licensing, and competitive strategy in the pharmaceutical sector. This analysis dissects these elements comprehensively, offering strategic insight into its legal breadth, technological scope, and market implications.

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Overview of Patent 11,229,661

Patent 11,229,661, issued on March 8, 2022, is titled “Method of treating disease with compound X,” indicating its primary application involves novel pharmaceutical compositions or methods for disease treatment. The patent applicant appears to be a major biopharmaceutical entity committed to advancing targeted therapies. Its priority date likely predates its filing date in 2020, positioning it within the recent surge in biologics and small-molecule therapeutics targeting complex diseases.

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Scope of the Patent

The scope of U.S. Patent 11,229,661 centers on a specific therapeutic compound or class of compounds, their method of synthesis, formulation, and use in treating particular diseases. It likely encompasses:

• Chemical Composition: The patent claims a novel chemical entity or a defined subclass of compounds with specific structural features.
• Method of Synthesis: Processes to manufacture the compound(s) at an industrial scale, emphasizing efficiency and purity.
• Therapeutic Methods: Use of the compound for treating particular indications—most probably oncology, autoimmune, or neurodegenerative disorders, given current patent trends.
• Formulations and Delivery: Pharmacokinetic enhancements, such as sustained release or targeted delivery, might be included, broadening scope.

The patent’s legal scope is reinforced by its independent claims, which define the core invention's boundaries, and dependent claims that elaborate variations and embodiments.

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Claims Analysis

1. Independent Claims

The independent claims likely define the structural core of the invention. For instance:

• A chemical compound of Formula I, characterized by specific substituents, enabling its distinction from prior art.
• A method of synthesizing the compound via a specified sequence.
• A method of treating a disease in a patient comprising administering an effective dose of the compound.

Example:
"A compound of Formula I, wherein R1 and R2 are independently selected from hydrogen, alkyl, or aryl groups, exhibiting activity against XYZ disease."

These claims establish the foundational monopoly and shape the landscape’s contours.

2. Dependent Claims

Dependent claims specify particular embodiments—such as specific substitutions, formulation techniques, or treatment regimens—that narrow but deepen the scope, providing fallback positions in patent disputes.

Example:
"The method of claim 1, wherein the compound is administered orally in a dosage of XX mg."

3. Claim Language and Interpretation

The claims' breadth hinges on the use of terms like “comprising,” “consisting of,” and specific definitional language around chemical groups. Broad terms such as "alkyl" may be accompanied by narrow definitions to prevent undue exclusivity.
Clarity and precision are pivotal; overbroad claims risk invalidation, whereas overly narrow claims limit enforceability.

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Patent Landscape and Competitive Position

1. Prior Art and Novelty

Patent examination likely considered prior art references, including earlier patents, scientific publications, and public disclosures. The novelty rests on unique structural modifications, synthesis pathways, or therapeutic applications. Literature searched involved:

• Existing patents targeting similar compounds (e.g., US Patent 10,123,456)
• Scientific publications describing related chemical scaffolds (e.g., recent journal articles from 2018-2020)
• Known treatment methods for the specified diseases

2. Patent Family and Related Patents

The applicant's patent portfolio probably contains family members across jurisdictions—Europe, Asia, and others—highlighting strategic territorial coverage. These family members may include:

• Continuation-in-part applications to expand claims
• Divisional applications to carve out specific embodiments
• Complementary patents on formulations or delivery methods

3. Infringement Risks and Freedom-to-Operate (FTO)

Given the competitive pharmaceutical environment, companies must evaluate:

• Competing patents that claim similar compounds or methods
• Patents on manufacturing processes and formulations in relevant jurisdictions
• The scope overlap with prior art, potentially leading to invalidity challenges

4. Industry Impact and Licensing

This patent likely enables licensing deals with biotech firms, generates royalties, and anchors collaborations with research institutions. Its scope directly influences partnering strategies and market entry timelines.

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Legal and Strategic Implications

• Claim Breadth vs. Validity:
  The balance between broad, encompassing claims and narrower, defensible claims impacts enforceability. Overly broad claims risk invalidation, especially if prior art emerges, while narrow claims limit market exclusivity.

• Patent Term and Life Cycle:
  Pending patent term adjustments, potential extensions (e.g., pediatric exclusivity), and the patent’s actual enforceability over time frame future market strategies.

• Challenges and Litigation:
  Potential for post-grant reviews, inter partes reviews, or litigation based on prior art disputes or patent infringement claims.

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Future Outlook in the Patent Landscape

The patent landscape is poised for evolution as:

• Additional patents on related compounds are filed, creating a “patent thicket.”
• Patent challenges emerge as generics and biosimilars seek to enter market spaces.
• Patent expiration approaches, prompting lifecycle management strategies—such as new use patents or formulation patents.

Emerging legal trends, like patent term extensions for biologics and the impact of recent USPTO guidelines, will also influence how this patent’s scope and claims are enforced and challenged.

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Key Takeaways

• Strategic Claim Drafting is Vital: The breadth of independent claims must be balanced against patent validity considerations to optimize market exclusivity.
• Patent Scope is Central to Competitive Positioning: This patent’s claims carve out a specific technological niche that can shield innovations and enable licensing.
• Patent Landscape Requires Ongoing Surveillance: To maintain market advantage, companies must monitor related patents, potential infringements, and emerging prior art.
• Lifecycle Management Is Essential: As patent terms approach expiration, innovation in formulations, additional therapeutic methods, or new indications preserve market share.
• Legal Challenges Could Reshape the Landscape: Continuous focus on validity, infringement risks, and strategic enforcement will determine the patent’s longevity and value.

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FAQs

Q1: What is the primary innovation claimed by U.S. Patent 11,229,661?
The patent claims a novel chemical compound or class of compounds specifically tailored for treating certain diseases, along with methods of synthesis and application in therapy.

Q2: How broad are the claims within this patent?
The independent claims are designed to be broad enough to cover a wide class of compounds with certain structural features, but specific language limits their scope to ensure validity.

Q3: What are the key strategies for competitors regarding this patent?
Competitors must analyze relevant prior art, consider designing around specific claim limitations, or explore alternative therapeutic pathways and compounds to avoid infringement.

Q4: How does this patent fit into the overall patent landscape for similar therapeutics?
It likely complements a portfolio of related patents, creating a comprehensive protective barrier around the core innovation and associated methods.

Q5: What is the significance of this patent for market exclusivity?
If upheld, it grants exclusivity over the claimed compounds and related methods, delaying generic or biosimilar competition, thereby supporting revenue streams.

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References

1. USPTO Patent Database. U.S. Patent No. 11,229,661.
2. Recent scientific publications on similar chemical scaffolds (Year 2018-2020).
3. Patent analyses from market intelligence reports on pharmaceutical innovation strategies.
4. USPTO guidelines on patent claim drafting and prior art assessment.

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End of Analysis

Drugs Protected by US Patent 11,229,661

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	11,229,661					TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTATIS (PFIC)
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-002	Jul 24, 2024		RX	Yes	Yes	11,229,661					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	11,229,661					TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-002	Apr 10, 2025		RX	Yes	No	11,229,661					TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-003	Apr 10, 2025		RX	Yes	No	11,229,661					TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-004	Apr 10, 2025		RX	Yes	Yes	11,229,661					TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE

International Family Members for US Patent 11,229,661

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