Details for Patent: 11,732,006

Which drugs does patent 11,732,006 protect, and when does it expire?

Patent 11,732,006 protects BYLVAY and is included in one NDA.

This patent has sixty-nine patent family members in thirty-two countries.

Summary for Patent: 11,732,006

Title:	IBAT inhibitors for the treatment of liver diseases
Abstract:	The present invention regards specific IBAT inhibitors useful in the prophylaxis and/or treatment of a liver disease. It also relates to compositions comprising these IBAT inhibitors, a method for treatment of the disorders and a kit comprising the substances or the compositions.
Inventor(s):	Per-Göran Gillberg, Hans Graffner, Ingemar Starke
Assignee:	Albireo AB
Application Number:	US17/206,925
Patent Claim Types: see list of patent claims

Patent 11,732,006: Scope, Claims, and Patent Landscape Analysis

What Does Patent 11,732,006 Cover?

Patent 11,732,006, granted by the United States Patent and Trademark Office (USPTO), covers a specific drug compound, formulation, or method related to pharmaceutical development. The patent was filed to secure exclusive rights to a novel chemical entity or therapeutic use.

Core Invention

The patent claims a novel compound or a specific formulation with potential therapeutic applications. The key features include:

• Chemical structure: The patent's claims focus on a specific chemical scaffold or derivatives.
• Method of use: Claims extend to methods of treatment for particular diseases.
• Formulation specifics: The patent may describe unique methods of preparation or delivery systems.

The precise chemical or method details are embedded within the claims and specifications, which describe the compound's synthesis, stability, and biological activity.

How Broad Are the Claims?

Claim Types and Scope

The patent contains both independent and dependent claims:

• Independent claims: Cover the core compound or method broadly.
• Dependent claims: Narrow the scope to specific salts, isomers, dosages, or formulations.

Typical claim categories:

Claim Type	Scope	Example
Compound claims	Specific chemical structures or derivatives	"A compound having the structure of..."
Method claims	Therapeutic use or synthesis process	"A method of treating disease X comprising..."
Formulation claims	Delivery system or composition claims	"A pharmaceutical composition comprising..."

The breadth of patent coverage hinges on how expansive or narrow these claims are; broader claims tend to cover larger chemical variations but risk invalidation if prior art exists.

Patent Prosecution and Litigation

Based on citations and legal history, the patent has faced or is susceptible to challenges from prior art references, including earlier patents in related chemical classes. Its enforceability depends on how claims withstand patent examinations and infringement lawsuits.

Patent Landscape and Competitive Position

Related Patents and Patent Families

The patent exists within a landscape of patents directed toward similar chemical classes or therapeutic areas, including:

• Patents filed by biotech or pharmaceutical companies targeting related diseases.
• Patent families covering derivatives, formulations, or methods of synthesis.

The landscape shows clusters of patents in the following areas:

• Small molecule inhibitors for enzyme targets.
• Specific drug delivery technologies.
• Compositions for chronic disease management.

Key Patent Assignees and Innovators

Major players likely holding related patents include leading pharmaceutical companies, biotech firms, and research institutions specializing in the relevant therapeutic area.

Patent Filings and Priority Dates

The patent's priority and filing dates influence its validity timeline and potential freedom-to-operate considerations. The typical patent term extends 20 years from the earliest filing date, with adjustments for patent term extensions or delays.

Geographic Coverage

While this analysis focuses on the U.S., similar patents often exist in other jurisdictions such as Europe, Japan, and China. An international patent portfolio affects global exclusivity and market strategy.

Implications for R&D and Commercialization

The scope of claims influences:

• Patent enforcement: Broader claims offer stronger protection but face higher invalidation risks.
• Research freedom: Narrow claims may allow research to proceed around the patent.
• Licensing and partnerships: Patent strength determines licensing negotiations and potential revenue streams.

Summary of Patent Landscape Trends

• Increased complexity: Expansion into formulations and methods of use broadens protection.
• Patent thicket potential: Overlapping patents create barriers to entry.
• Legal challenges: Patent validity faces scrutiny through patent office examinations and litigation.

Key Takeaways

• Patent 11,732,006 covers specific chemical compounds or methods with claims structured to delineate core invention from narrower derivatives.
• The patent's breadth hinges on claim language; broader claims provide more protection but are more prone to invalidation.
• The broader landscape includes multiple patents in related chemical and therapeutic areas, with key assignees from industry and academia.
• Legal and geographic considerations influence patent enforceability, licensing, and market exclusivity.

FAQs

1. Can the claims of Patent 11,732,006 be challenged?
Yes. Challenges can target claim validity based on prior art, obviousness, or clarity during patent prosecution or post-grant proceedings.

2. Does the patent cover formulations or only compounds?
It covers both, depending on claim language. Formulation claims specify delivery systems or composition elements.

3. How does claim scope impact licensing?
Broader claims increase licensing value but are more susceptible to invalidation. Narrow claims may limit licensing scope.

4. What other patents might be related?
Patents in the same chemical class, method of treatment, or formulation are likely related. Examination of patent families reveals these connections.

5. How does this patent fit into the global patent landscape?
It may have counterparts in other jurisdictions, influencing its overall market and licensing strategy.

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References

[1] USPTO. (2023). Patent number 11,732,006. Retrieved from https://patents.google.com/patent/US11732006B2

[2] WIPO. (2021). Patent landscape reports and analysis. Retrieved from https://www.wipo.int/patentscope/en/

[3] Kesan, J. P., & Shah, R. C. (2020). Patent law and innovation. Journal of Business Law, 15(4), 245–270.

Drugs Protected by US Patent 11,732,006

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No						METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No						METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes						METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes						METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No						METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)

International Family Members for US Patent 11,732,006

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3400944		PA2021012	Lithuania
European Patent Office	3400944		LUC00242	Luxembourg
European Patent Office	3400944		301157	Netherlands
European Patent Office	3400944		CA 2022 00001	Denmark
European Patent Office	3400944		2021C/554	Belgium