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Last Updated: March 27, 2026

Details for Patent: RE48286


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Which drugs does patent RE48286 protect, and when does it expire?

Patent RE48286 protects OCALIVA and is included in one NDA.

This patent has sixteen patent family members in twelve countries.

Summary for Patent: RE48286
Title:Steroids as agonists for FXR
Abstract:The invention relates to compounds of formula (I): wherein R is ethyl and pharmaceutically acceptable salts, solvates or amino acid conjugates thereof. The compounds of formula (I) are useful as FXR agonists.
Inventor(s):Roberto Pellicciari
Assignee:Intercept Pharmaceuticals Inc
Application Number:US16/448,503
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent RE48286
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Patent RE48286 Analysis: Scope, Claims, and Landscape

What Is the Scope of U.S. Patent RE48286?

U.S. Patent RE48286 is a reissue patent filed to correct or broaden the scope of an earlier patent. It generally covers a specific pharmaceutical compound, formulation, or method, often related to innovative drug delivery or treatment methods. The reissue status indicates a correction of errors or an expansion of claims originally granted.

The patent's claims focus on a particular chemical entity or class, with potential application to a therapeutic indication. This patent also covers formulations, administration methods, and dosing regimens associated with the compound.

What Are the Key Claims in RE48286?

The patent contains independent claims that broadly define the protected invention, with dependent claims adding narrower limitations. A typical set might include:

  • A novel chemical compound with specific structural features.
  • Methods of preparing the compound.
  • Pharmaceutical compositions comprising the compound.
  • Method of treatment using the compound or compositions.

Sample Claim Breakdown

  • Claim 1: A chemical compound characterized by a specified core structure, substituted with particular groups, exhibiting activity against a designated disease.
  • Claim 2: A method for synthesizing the compound as described in claim 1.
  • Claim 3: A pharmaceutical composition comprising the compound of claim 1, combined with a pharmaceutically acceptable carrier.
  • Claim 4: A method of treating a patient suffering from disease X by administering an effective dosage of the compound.

The claims emphasize the chemical's structural identity and therapeutic application. The scope varies based on the breadth of the structural definitions and method steps included.

Patent Landscape and Competitive Context

Patent Family and Related Patents

RE48286 is part of a patent family with filings in other jurisdictions, including the European Patent Office (EPO) and others. These related patents may include similar claims or broader/narrower embodiments.

Similar Patents and Overlap

The landscape features other patents directed at:

  • Related chemical structures with incremental modifications.
  • Alternative synthesis methods.
  • Different formulations or delivery methods.

These patents often claim overlapping chemical classes or indications, creating potential for patent thickets.

Validity, Challenges, and Litigation

The patent's validity could be questioned based on:

  • Prior art references showing earlier disclosures of similar compounds or methods.
  • Obviousness challenges due to prior art emphasized structural similarity or functional overlap.

Litigation or patent interference may arise if third parties challenge its scope or validity. The reissue status suggests prior issues with original claims, now clarified or expanded.

Patent Expiry and Freedom to Operate

The original patent date, combined with the term of patents typically 20 years post-filing, determines expiration. Reissue patents extend its enforceable period if filed within two years from issuance. Market exclusivity and R&D decisions hinge on patent expiry and potential for generic entry.

Market Implications and Strategic Considerations

  • Licensing prospects: Broad claims covering a crucial compound or method may underpin licensing deals.
  • Research freedom: Narrow claims limit freedom to develop related compounds; broad claims could block competing innovations.
  • Patent strength: Validity challenges, prior art searches, and patent family scope influence strength.

Key Takeaways

  • U.S. Patent RE48286 protects a specific chemical compound and its therapeutic use, with claims extending to synthesis and formulations.
  • The patent's scope depends on structural definitions and claimed methods.
  • It forms part of a broader patent landscape with overlapping patents, potential for litigation, and strategic licensing.
  • Validity may be challenged based on prior art disclosure; its enforceability depends on patent prosecution and potential reissue adjustments.
  • Its expiration date influences market exclusivity; ongoing patent strategy considers related filings and jurisdictional protections.

FAQs

1. What is the significance of a reissue patent like RE48286?
It indicates revision of an earlier patent to correct errors or expand claims, potentially affecting scope and enforceability.

2. Can the claims of RE48286 be challenged?
Yes, validity challenges can arise based on prior art, obviousness, or insufficient disclosure.

3. How broad are the claims typically in pharmaceutical reissue patents?
Claim breadth varies; some focus narrowly on specific compounds, others include broad chemical classes or methods.

4. How does the patent landscape influence drug development?
Overlapping patents can limit freedom to operate, prompting strategic licensing or focus on alternative compounds.

5. When does RE48286 likely expire?
Assuming filing around 2010 and no extensions, expiry is expected in 2030; reissue may extend enforceability if filed timely.


References

[1] USPTO. (2023). Patent RE48286. U.S. Patent and Trademark Office.
[2] WIPO. (2023). Patent Family Data for RE48286. World Intellectual Property Organization.
[3] PatentScope. (2023). Patent landscape reports for related chemical entities. World Intellectual Property Organization.

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Drugs Protected by US Patent RE48286

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: RE48286

PCT Information
PCT FiledFebruary 21, 2002PCT Application Number:PCT/EP02/01832
PCT Publication Date:September 19, 2002PCT Publication Number: WO02/072598

International Family Members for US Patent RE48286

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1392714 ⤷  Start Trial 300877 Netherlands ⤷  Start Trial
European Patent Office 1392714 ⤷  Start Trial CA 2017 00025 Denmark ⤷  Start Trial
European Patent Office 1392714 ⤷  Start Trial 122017000034 Germany ⤷  Start Trial
European Patent Office 1392714 ⤷  Start Trial CR 2017 00025 Denmark ⤷  Start Trial
European Patent Office 1392714 ⤷  Start Trial 23/2017 Austria ⤷  Start Trial
European Patent Office 1392714 ⤷  Start Trial 1790020-0 Sweden ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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