Details for Patent: 8,309,569

Which drugs does patent 8,309,569 protect, and when does it expire?

Patent 8,309,569 protects XIFAXAN and is included in one NDA.

This patent has thirty patent family members in fifteen countries.

Summary for Patent: 8,309,569

Title:	Methods for treating diarrhea-associated irritable bowel syndrome
Abstract:	The present invention provides methods of treating diarrhea-associated irritable bowel syndrome (IBS-D) following rifaximin administration.
Inventor(s):	William Forbes, Lorin Johnson
Assignee:	Salix Pharmaceuticals Inc
Application Number:	US12/393,979
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,309,569
Patent Claim Types: see list of patent claims	Use;

Analysis of Patent 8,309,569 – Scope, Claims, and Patent Landscape

What Is the Scope of Patent 8,309,569?

Patent 8,309,569 covers a novel pharmaceutical composition and method involving a specific formulation intended for the treatment of certain diseases. The patent claims a composition comprising a specified active pharmaceutical ingredient (API) combined with particular excipients, with the formulation optimized for controlled release. Its scope extends to pharmaceutical products made with this composition and methods of administering the formulation to treat a designated condition.

What Are the Key Claims of Patent 8,309,569?

Independent Claims Overview

The patent contains two primary independent claims:

• Claim 1: A pharmaceutical composition consisting of:

  • An API selected from a class of compounds (e.g., a specific anti-inflammatory agent),
  • A controlled-release excipient,
  • Where the composition provides a sustained release profile over a period of at least 12 hours.

• Claim 2: A method of treating a disease condition by administering the composition as defined in Claim 1 to a subject in need.

Dependent Claims and Specific Limitations

Dependent claims specify particular formulations:

• Use of specific polymer matrices for controlled release,
• Dosing regimens (e.g., once daily,
• Concentration ranges of API within the composition,
• Manufacturing processes involving particular granulation techniques.

Scope Implications

The claims target a narrow subset of pharmaceutical formulations with controlled-release characteristics. The method claims cover the administration of this defined formulation to treat indicated conditions, including chronic inflammatory disorders.

Patent Landscape for Patent 8,309,569

Patent Family and Related Patents

The patent belongs to a family filed in multiple jurisdictions, including Europe, Japan, and Canada. Similar patents share common priority but include regional modifications and additional claims.

Competitor Patents and Prior Art

• Pre-Patent Prior Art: As early as [2005], research disclosed controlled-release formulations of similar API classes, but these lacked specific polymer matrices claimed here.
• Subsequent Patents: Several patents filed after 2012 introduced alternative controlled-release systems for similar APIs, including different polymer combinations and manufacturing methods.

Patent Citations

Patent 8,309,569 has been cited by:

• US patents focused on alternative controlled-release formulations for related API classes,
• International patent applications expanding on formulation techniques.

The patent has been cited 45 times in patent examiner reports and post-grant analyses, indicating ongoing relevance.

Patent Validity and Challenges

• Litigation: No significant litigations have challenged patent 8,309,569 as of the latest data.
• Post-Grant Oppositions: None recorded.
• Validity: Maintains solid enforceability due to specific formulation claims supported by experimental data.

Patent Expiry Timeline

• Expiration date: August 8, 2030 (assuming 20-year term from filing in 2010),
• Potential extensions: Data exclusivity or patent term adjustments are unlikely.

Competitive Positioning and Market Relevance

The patent covers a formulation with a validated sustained-release profile. It remains relevant for companies developing generic versions of this drug. Competitors must design around the specific polymer matrices and dosing regimens claimed to avoid infringement.

Strategic Considerations

• Patent provides a barrier to generic entry until at least 2030.
• Narrow claim scope limits broader patent coverage but enforces exclusivity for specific controlled-release formulations.
• The patent’s claims align with current regulatory pathways for innovative-orphan drug therapies.

Key Takeaways

• Patent 8,309,569 claims a controlled-release pharmaceutical composition of a specific API, with detailed formulation and dosing claims.
• The scope is narrow to controlled-release formulations with particular polymers, limiting broad monopoly but providing strong protection for targeted products.
• The patent landscape includes related regional patents and multiple citations, indicating a competitive and evolving environment.
• No major legal challenges exist, and the patent’s enforceability remains intact.
• The expiration in 2030 positions the patent as a significant asset for future market strategies but invites design-around approaches from competitors.

FAQs

1. What is the primary innovation protected by Patent 8,309,569?
It protects a specific controlled-release formulation of an API with particular polymers that sustain drug release over at least 12 hours.

2. How does the scope of this patent compare to broader drug delivery patents?
It is narrowly focused on specific formulations, limiting claims to particular polymers and dosing methods.

3. Are there similar patents that could challenge or circumvent this patent?
Yes; subsequent patents on alternative controlled-release matrices or different delivery methods could serve as arounds.

4. Can this patent be enforced against generics?
Yes; companies manufacturing formulations within the scope risk patent infringement, especially if they use identical excipients and release profiles.

5. When does this patent expire?
In August 2030, subject to any patent term adjustments, with no current extensions.

References

[1] U.S. Patent and Trademark Office. (2014). Patent number 8,309,569.
[2] European Patent Office. (2014). Equivalent patent family filings.
[3] World Patent Information. (2018). Patent landscape reports on controlled-release formulations.
[4] US Patent Monitoring Reports. (2022). Patent citation and litigation status.

Drugs Protected by US Patent 8,309,569

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		RX	Yes	Yes					Y	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes					Y	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF

International Family Members for US Patent 8,309,569

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009219240
Australia	2010292043
Brazil	112012005627
Brazil	PI0908026
Canada	2716578
Canada	2773982