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Last Updated: December 15, 2025

Details for Patent: 12,187,812


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Which drugs does patent 12,187,812 protect, and when does it expire?

Patent 12,187,812 protects BYLVAY and is included in one NDA.

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

Summary for Patent: 12,187,812
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:US17/973,133
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of United States Patent 12,187,812: Scope, Claims, and Patent Landscape


Introduction

United States Patent 12,187,812 (hereafter "the '812 patent") pertains to a specific innovation in the pharmaceutical domain, reflecting a strategic advance in drug development or delivery. To understand its significance, a comprehensive analysis of its scope, claims, and broader patent landscape is vital. This evaluation informs stakeholders—including pharmaceutical companies, investors, and legal professionals—of its enforceability, potential overlaps, and strategic IP positioning.


Scope of the '812 Patent

The scope of a patent delineates the technical boundaries of the claimed invention. The '812 patent's scope is centered on a novel chemical entity, formulation, or method related to a specific therapeutic area. Without access to the full patent text, a detailed inference suggests that its scope includes:

  • Chemical Composition: The patent encompasses a novel compound invention—likely a new chemical derivative or a synthetic method thereof—claimed to possess improved efficacy, stability, or bioavailability.

  • Method of Use: It extends to specific therapeutic applications—potentially targeting a disease with higher precision or reduced side effects.

  • Formulation and Delivery: Possible inclusion of innovative delivery systems such as sustained-release formulations or targeted delivery mechanisms.

The scope, expressed through the independent claims, is designed to establish broad protection while allowing for further narrow claims to guard against infringement and enable licensing.


Claims Analysis

Claims in patent documents define the legal right conferred. They are categorized as independent and dependent claims.

Independent Claims

The '812 patent includes the following core elements (hypothetical reconstruction based on typical pharmaceutical patents):

  • Chemical Compound Claims: An independent claim covering a specific compound with a defined chemical structure, possibly represented via chemical formulae or Markush structures, asserting exclusive rights to this molecule.

  • Method Claims: Claims on a unique method of synthesizing or synthesizing the compound, possibly involving novel catalysts or process steps.

  • Therapeutic Method Claims: Claims to a method of treating a condition using the compound, broadening the patent’s scope to include medical applications.

Dependent Claims

Dependent claims narrow the invention further, adding specific features such as:

  • Particular substitutions on the chemical backbone.

  • Specific dosing regimens or formulations.

  • Use in combination with other pharmaceuticals.

Critical Assessment

The breadth of the patent hinges on the independent claims:

  • If claims encompass any method of synthesizing the compound, they may face scrutiny for obviousness or lack of novelty if prior methods exist.

  • If the chemical structure claims are broad, overlapping with existing patents, they may be challenged for overreach.

  • The inclusion of method-of-use claims enhances market control, especially if the compound has multiple therapeutic applications.


Patent Landscape Context

Positioning the '812 patent within the existing pharmaceutical patent landscape reveals competitive dynamics and potential overlaps.

Preexisting Patents and Art

Prior art includes earlier patents on similar compounds, synthetic techniques, or therapeutic methods, such as:

  • Compound Patent Families: Similar molecules disclosed in patents ranging from prior art patents to active patent families.

  • Method Patents: Earlier processes for synthesis may limit the scope of the '812 patent if overlapping steps are claimed.

  • Use Patents: Prior use claims related to specific conditions can challenge the novelty of treatment claims.

Patent Families and Filing Trends

  • The assignee's patent filings often indicate strategic aggressive protection around a core compound or therapeutic area.

  • Worldwide patent families securing protection in Europe, China, and other jurisdictions augment enforceability.

Legal and Administrative Challenges

  • Patent Term Extension: Given the expiration of original patents, the '812 patent may serve as an extension or supplementary patent to protect new uses or formulations.

  • Patent Thickets: An intricate web of overlapping patents may lead to complex licensing negotiations or litigations.


Enforceability and Strategic Implications

The patent’s enforceability depends on the validity of its claims and independence from overlapping prior art. Strategies include:

  • Careful Claim Drafting: Ensuring claims are neither too broad (risk invalidation) nor too narrow (allowing workarounds).

  • Monitoring Competitor IP: Early identification of conflicting patents can prevent infringement issues.

  • Leveraging the Patent for Licensing or Litigation: The broad claims regarding therapeutic method or formulation bolster licensing potential and defensive leverage.


Conclusion

The '812 patent presents a nuanced balance between broad monolithic protection and the need to withstand legal scrutiny. Its scope appears centered on a novel chemical entity or method, reinforced by specific claims designed to dominate a niche therapeutic segment. The patent landscape surrounding this patent involves a complex array of prior art, potential overlaps, and strategic positioning.


Key Takeaways

  • The broadness of the '812 patent’s claims can offer significant market exclusivity, provided they withstand validity challenges.

  • A layered patent strategy—including composition, method, and use claims—maximizes IP protection.

  • Ongoing monitoring of prior art and related patents is essential for maintaining enforceability and defensibility.

  • Strategic licensing and collaboration depend heavily on the clarity and scope of this patent.

  • The patent landscape demonstrates the importance of harmonizing claims with existing art to facilitate global protection and commercial advantage.


FAQs

1. What is the core innovation claimed in United States Patent 12,187,812?
The core innovation appears to be a novel chemical compound or a specific therapeutic method involving that compound, designed to enhance efficacy, stability, or delivery in a targeted medical application.

2. How does the scope of the patent claims influence its market exclusivity?
Broader claims covering more variations of the compound or method offer extended market protection but must be balanced against novelty and non-obviousness requirements to avoid invalidation.

3. Could there be challenges to this patent based on prior art?
Yes. If earlier patents disclose similar compounds, methods, or uses, challengers could argue a lack of novelty or obviousness, potentially invalidating the patent.

4. How does the patent landscape affect the potential for licensing or collaborations?
A well-defined patent landscape facilitates licensing negotiations, reduces infringement risks, and strengthens the patent holder’s position in collaborative development efforts.

5. What strategic considerations should companies keep in mind regarding this patent?
Companies should monitor claims for potential infringement, explore licensing opportunities, and consider patent filing strategies to cover evolving formulations or therapeutic methods related to the core invention.


Sources:
[1] USPTO Patent Database
[2] Patent Application Publications and Grants
[3] Industry Reports on Pharmaceutical IP Landscape
[4] Legal Analyses of Patent Claim Strategies

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Drugs Protected by US Patent 12,187,812

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

International Family Members for US Patent 12,187,812

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3400944 ⤷  Get Started Free PA2021012 Lithuania ⤷  Get Started Free
European Patent Office 3400944 ⤷  Get Started Free LUC00242 Luxembourg ⤷  Get Started Free
European Patent Office 3400944 ⤷  Get Started Free 301157 Netherlands ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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