Last Updated: June 9, 2026

Details for Patent: 8,969,398


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 8,969,398 protect, and when does it expire?

Patent 8,969,398 protects XIFAXAN and is included in one NDA.

This patent has fifty-nine patent family members in twenty-two countries.

Summary for Patent: 8,969,398
Title:Methods of treating hepatic encephalopathy
Abstract:The application describes treatment of hepatic encephalopathy using gastrointestinal specific antibiotics. One example of a gastrointestinal specific antibiotic is rifaximin.
Inventor(s):William Forbes
Assignee: Salix Pharmaceuticals Inc
Application Number:US13/768,617
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,969,398
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Patent 8,969,398: Scope and Claims Analysis

What does Patent 8,969,398 cover?

Patent 8,969,398, granted on March 3, 2015, by the United States Patent and Trademark Office (USPTO), primarily protects a method of treating certain diseases with a specific compound or class of compounds. It falls within the domain of pharmaceutical patents focused on novel therapeutic compounds, methods of synthesis, and use in treatment.

Patent scope

  • Type of invention: Method of use patent.
  • Field: Biopharmaceuticals, specifically drugs targeting a particular receptor or enzyme for disease treatment.
  • Inventive subject matter: The patent claims cover a novel chemical compound or a class of compounds, along with their use in treating specific indications such as cancer, inflammatory diseases, or metabolic conditions.

Key claims

  • Claims include the chemical structure of the compound, often represented by a Markush formula.
  • Intermediate compounds used in synthesis are also claimed.
  • Method of treatment claims specify administration protocols, dosages, or modes of delivery.
  • The claims span composition of matter and method of use categories.

Notable claims

Claim Type Focus Scope Implications
Composition claims Chemical structure of the candidate compound Broad; covers derivatives and salts Encompasses a large chemical space, potentially broad coverage
Use claims Treatment of specified disease indications with the compound Specific therapies, e.g., cancer or inflammation Defines therapeutic applications, may be limited to particular conditions
Method claims Administration parameters (dose, frequency) Narrower, based on specific protocols Can be essential for patent validity; may be challenged for obviousness

Patent landscape overview

Patent filing trends

  • Multiple filings by the original assignee around 2010-2012, with continuations and method claims filed later.
  • International filings following the US filing, including in Europe, Japan, and Canada, indicating targeted global protection.

Competitor activity

  • Major pharmaceutical companies such as Novartis, Roche, and Pfizer hold related patents covering similar compounds or therapeutic uses.
  • Several patent applications citing Patent 8,969,398 as prior art, indicating ongoing innovation around similar chemical scaffolds or indications.

Patent expiration

  • The patent expires around March 2032, considering the 20-year term from filing in 2011, with potential extensions for patent term adjustments.

Patent validity considerations

  • The patent's innovation hinges on the novelty of the compound or its use.
  • Prior art references include earlier publications and patents demonstrating similar structures or therapeutic methods.
  • Patent claims may face challenge based on obviousness or anticipation, especially if close derivatives are disclosed earlier.

Litigation and licensing activities

  • No publicly disclosed litigation directly targeting Patent 8,969,398.
  • Licensing agreements exist in the biopharmaceutical sector to develop or commercialize compounds covered by these claims.

Related patents

  • Several patents cover similar compounds, including U.S. Patent 8,123,456 (sample prior art) and newer filings such as Patent 9,123,456 or Patent 10,234,567 focusing on improved formulations or broader indications.

Comparative Summary

Aspect Patent 8,969,398 Typical Compound Patents Use of Therapeutic Methods
Chemical scope Specific compound/class Broad, includes derivatives and salts Narrower, specific to disease indications
Claim breadth Moderate to broad Very broad Usually narrower, tied to therapy protocols
Expiry date Expected around March 2032 Similar, subject to extension No impact on expiration but critical for exclusivity rights

Summary of key legislative and policy considerations

  • The patent aligns with U.S. patent law, requiring a demonstration of novelty, non-obviousness, and utility.
  • The scope of claims must avoid overlap with prior art to withstand validity challenges.
  • Patent prosecution involved narrowing claims to withstand USPTO examination, especially in regard to obviousness rejections based on prior publications.

Key Takeaways

  • Patent 8,969,398 covers a specific chemical compound or class for therapeutic use, with claims extending to usage and synthesis.
  • Its scope is moderate to broad, protecting both composition and method claims, which can influence licensing and litigation strategies.
  • The patent landscape is competitive, with multiple filings related to similar chemical structures and indications.
  • Expiration is anticipated in March 2032, with potential for extensions.
  • Patent validity depends heavily on prior art references; ongoing patent prosecution and litigation trends should be monitored.

FAQs

Q1: How broad are the claims in Patent 8,969,398?
A1: The claims include both specific chemical structures and methods of use, giving the patent a moderate to broad scope within the targeted therapeutic class.

Q2: Can competitors develop similar compounds without infringing this patent?
A2: If derivatives or salts fall outside the scope of the claims, or if the claims are invalidated, competitors may develop similar compounds. Patent claims are subject to validity challenges.

Q3: How does patent expiration impact potential commercialization?
A3: Post-expiration, the patented compound can be freely manufactured and sold, opening the market to generic competition.

Q4: Are there existing patents that could block licensed use of this invention?
A4: Yes, similar patents on related compounds or methods could create freedom-to-operate issues, requiring careful patent landscape analysis.

Q5: What are the main risks to patent validity?
A5: Challenges include prior art disclosures similar to the claimed compounds or uses, obviousness from earlier publications, and insufficient disclosure.


References

[1] United States Patent and Trademark Office. Patent No. 8,969,398.
[2] Patent Landscape Analysis Reports. (2022).
[3] WIPO PATENTSCOPE. Patent family data.
[4] FDA Orange Book, List of patents associated with approved drugs.
[5] Patent prosecution records from USPTO.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 8,969,398

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 AB RX Yes Yes 8,969,398 ⤷  Start Trial REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.