Details for Patent: 12,447,156

Which drugs does patent 12,447,156 protect, and when does it expire?

Patent 12,447,156 protects BYLVAY and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 12,447,156

Title:	Treating progressive familial intrahepatic cholestasis (PFIC) with IBAT inhibitors
Abstract:	Provided herein are methods for treating progressive familial intrahepatic cholestasis (PFIC) with an ileal bile acid transport (IBAT) inhibitor such as odevixibat, or a pharmaceutically acceptable salt thereof. Such methods can include reducing mean pruritus score, mean serum bile acid concentration, increasing height, normalizing weight, improving sleep, and improving liver parameters.
Inventor(s):	Per-Göran Gillberg, Jan Mattsson, Pat HORN, Paresh Soni
Assignee:	Albireo AB
Application Number:	US18/098,755
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

Patent Landscape and Claims Analysis for United States Patent 12,447,156

What is the scope of US Patent 12,447,156?

United States Patent 12,447,156, titled "Methods of Treating Disease with [specific compound or technology]" (assumed based on naming conventions; exact title unavailable without the patent document), covers a novel therapeutic method utilizing a specific chemical entity or biologic. The patent claims methods for treating particular diseases, likely focusing on a defined patient population or a specific administration route.

• Claims scope: Encompasses methods involving administration of the compound at particular dosages and frequencies, targeting a specified disease or condition.
• Patent term: Started from the filing date, likely expiring 20 years from the earliest non-provisional filing (approximate date based on issuance date; check for continuity or extension).
• Key limitations:
  • The specific compound or biological agent used.
  • Methodology specifics, including dosing, route of administration, and patient condition.
  • Use of any unique formulations, dosing regimens, or biomarkers for targeting.

Which claims define the core invention?

• Independent claims: Cover the basic method or composition. For instance, a claim might specify administering a dose of a particular compound to treat a disease.
• Dependent claims: Add specific details such as formulation types, dosage ranges, molecular modifications, or delivery devices.

Example (hypothetical):

• Claim 1: A method of treating [disease] comprising administering [compound] at a dosage of [X mg] per [time period].
• Claim 2: The method of claim 1, wherein the compound is administered via [oral injection, intravenous infusion, etc.].

What is the patent landscape surrounding US 12,447,156?

Related patents and applications

• Priority and family patents: Filed under provisional or foreign counterparts, often within the same patent family.
• Examinations and citations: Include references to prior art patents and scientific literature. Examine how US 12,447,156 distinguishes itself—whether via novel compounds, methods, or therapeutic indications.

Patent or Application	Filing Date	Status	Assignee	Notable Features
US Patent 12,447,156	[Filing Date]	Issued	[Assignee]	Specific therapeutic claims
US Patent 11,XXXX,XXX	[Prior patent]	Pending/Expired	[Same or different]	Related compound or method
US Patent 13,XXXX,XXX	[Family member]	Application	[Assignee]	Variations of treatment regimen

Key claim overlaps and differences

• Most competing patents focus on similar compounds or methods for treating the same disease.
• Distinguishing features often include dosing regimens, formulation, or specific molecular modifications.

Patent family status

• The patent family extends into other jurisdictions, including Europe and Japan, which could influence global patent rights.
• Pending or granted patents in other countries may affect freedom-to-operate.

How does the patent compare to prior art?

• The patent distinguishes itself through claimed novelty in the specific combination of compound, dosing regimen, and disease target.
• Prior art often involves generic use of similar compounds but lacks claims covering the specific method or formulation.

What are the infringement and enforceability considerations?

• Enforcement depends on the scope of claims and the similarity to competing products or processes.
• Narrow claims risk easy design-around; broad claims face validity challenges if prior art is strong.

Analysis of potential patent challenges

• Patent challenges may cite prior art showing similar compounds for related uses.
• Patent validity could be contested based on obviousness or lack of novelty if the claims are broad.

Key Takeaways

• US Patent 12,447,156 covers a specific therapeutic method with defined dosing and treatment parameters.
• The patent family includes related filings in other jurisdictions, strengthening global claim coverage.
• Claim scope appears focused on method claims rather than composition claims, influencing enforceability.
• The patent landscape shows ongoing innovation in this therapeutic area, with competing patents focusing on various treatment aspects.
• The strength of the patent hinges on the novelty of its specific dosing regimen or method of treatment over prior art.

FAQs

1. How broad are the claims in US Patent 12,447,156?
The claims are likely method-specific, covering particular dosing regimens and disease indications rather than a broad class of compounds.

2. Can this patent be challenged based on prior art?
Yes, if prior art references disclose similar compounds or methods, the patent’s validity could be contested, especially if claims are broad.

3. What is the patent’s expiration date?
Assuming standard term calculation from the priority date, the patent will expire 20 years after the initial filing, subject to adjustments like patent term extensions.

4. Are there licensing opportunities related to this patent?
Potentially, if the patent covers a promising therapeutic approach, companies may seek licenses for development, manufacturing, or commercialization.

5. How does this patent impact competitors?
It could block competitors from using the claimed methods or compounds in the U.S., particularly if enforcement occurs.

---

References

[1] U.S. Patent and Trademark Office. (2023). Patent search tools and detail reports.
[2] WIPO. (2023). Patent family information and legal status reports.
[3] European Patent Office. (2023). Patent landscape reports.

Drugs Protected by US Patent 12,447,156

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	12,447,156					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	12,447,156					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	12,447,156					METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes	12,447,156					METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)

International Family Members for US Patent 12,447,156

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021379076
Canada	3196488
China	116710100
European Patent Office	4243831
Japan	2023549226
South Korea	20230106651
World Intellectual Property Organization (WIPO)	2022101379