Details for Patent: 8,518,949

Which drugs does patent 8,518,949 protect, and when does it expire?

Patent 8,518,949 protects XIFAXAN and is included in one NDA.

This patent has thirty-four patent family members in twenty-six countries.

Summary for Patent: 8,518,949

Title:	Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Abstract:	Crystalline polymorphous forms of the rifaximin (INN) antibiotic named rifaximin δ and rifaximin ε useful in the production of medicinal preparations containing rifaximin for oral and topical use and obtained by means of a crystallization process carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by addition of water at a determinate temperature and for a determinate period of time, followed by a drying carried out under controlled conditions until reaching a settled water content in the end product, are the object of the invention.
Inventor(s):	Giuseppe Claudio Viscomi, Manuela Campana, Donatella Confortini, Maria Miriam Barbanti, Dario Braga
Assignee:	Alfasigma SpA
Application Number:	US13/488,345
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,518,949
Patent Claim Types: see list of patent claims	Use; Compound; Formulation; Process; Composition; Dosage form;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,518,949

Introduction

U.S. Patent 8,518,949 (hereafter referred to as the '949 patent) pertains to innovative developments within the pharmaceutical landscape. Issued by the United States Patent and Trademark Office (USPTO) on August 27, 2013, the patent primarily covers novel methodologies, compositions, or uses related to therapeutic agents. This analysis offers a comprehensive examination of the patent’s scope, its claims, and the broader patent landscape in this domain, providing insight for industry stakeholders, legal professionals, and strategic decision-makers.

Scope of the Patent

The '949 patent’s scope hinges centrally on its claims, which delineate the legal boundaries and proprietary rights granted to the inventors. As is customary in pharmaceutical patents, the scope typically encompasses specific chemical compounds, formulations, methods of synthesis, or therapeutic applications thereof.

Core Focus
The patent appears to target [specific class of drugs or therapeutic area], aiming to address unmet medical needs or improve upon existing therapeutics. The scope covers:

• Novel compounds or derivatives: Chemical entities with unique structural features.
• Pharmaceutical formulations: Methods for preparing stable, bioavailable, or targeted delivery systems.
• Therapeutic applications: Indications or treatment protocols utilizing the compounds.

The initial broad claims aim to establish fundamental rights, with subsequent narrower claims refining and protecting specific embodiments.

Detailed Analysis of the Claims

Examining the independent claims, which define the core scope, reveals whether the patent provides broad monopoly rights or is narrowly tailored.

Claim Structure and Claim Types

• Independent Claims:
  Generally, cover the main inventive concept. For the '949 patent, they likely claim:

  • Chemical compounds: Such as a specific chemical structure with defined functional groups.
  • Methods of synthesis: Procedures for preparing the compound.
  • Therapeutic methods: Use of the compound for treating particular diseases.

• Dependent Claims:
  Specify particular embodiments or variants, such as specific substituents, forms, formulations, or dosing regimens.

Scope Analysis

• Chemical Scope:
  The claims encompass a particular chemical structure, perhaps a genus of compounds with certain functional group variations, thus offering potential coverage over a class of therapeutics.

• Methodological Scope:
  The patent includes claims on methods for synthesizing the compounds, indicating coverage over manufacturing processes.

• Use Scope:
  Therapeutic use claims specify particular indications, for example, treating certain cancers or neurological disorders.

Claim Language and Limitations

The scope’s breadth depends on the claims’ terminology and limitations. Words like “comprising,” “consisting of,” or “consisting essentially of” influence open or closed claim scope:

• "Comprising" indicates an open claim, allowing for additional components.
• "Consisting of" imposes a closed claim, excluding other elements.

Furthermore, the specificity of structural parameters (e.g., particular substituents, stereochemistry) affects how broad or narrow the patent’s rights are.

Potential Challenges

• Obviousness or Prior Art:
  If prior art discloses similar structures, the claims’ scope might be vulnerable unless sufficiently inventive.

• Claim Construction:
  Courts may interpret broad claims narrowly if ambiguity exists, impacting enforceability.

Patent Landscape

The patent landscape surrounding the '949 patent features a complex web of related patents, applications, and patent families.

Related Patent Families

• Primary Innovations:
  Other patents filed by the same assignee or inventors might cover related compounds or formulations, indicating a strategic IP portfolio.

• Blocking Patents:
  Competitors may hold patents on similar compounds or methods, necessitating careful freedom-to-operate analyses.

Competitive Environment

• Patent Applications:
  Multiple applications around similar compounds can lead to patent thickets, complicating licensing and commercialization.

• Examination and Litigation:
  The strength of the '949 patent during prosecution and enforcement depends on its claims, prior art considerations, and patentability arguments.

Legal Status and Maintenance

The patent remains enforceable unless challenged or expired (the term calculated from the patent’s filing date, generally 20 years). Maintenance fees and legal challenges impact its strength and market value.

Geographical Patent Coverage

While the focus here is U.S. rights, similar patents may exist in jurisdictions like Europe, Japan, or China, impacting global commercialization strategies. International patent families should be analyzed for opportunities and risks.

Implications for Stakeholders

• Pharmaceutical Companies:
  The scope and robustness influence R&D investment, licensing potential, and potential infringement risks.

• Patent Strategists:
  Opportunities for filing continuations or workarounds hinge on the patent’s claims and overall landscape.

• Legal Professionals:
  Enforcement, validity challenges, and licensing negotiations depend heavily on the detailed claim language and prior art.

Conclusion

The '949 patent comprises a strategically significant intellectual property right in the pharmaceutical domain, with claims that likely balance broad coverage of chemical entities and therapeutic applications with narrow, inventive specifics. Its scope defines the boundaries of proprietary rights, which are challenged and shaped within a dynamic patent landscape marked by related filings and potential overlaps.

Lack of detailed claim text limits precise interpretation in this overview, emphasizing the importance of reviewing the claims in their entirety for definitive legal and business decisions. Nonetheless, the analysis underscores the critical role of claim language precision, patent family breadth, and landscape navigation in maximizing competitive advantages.

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Key Takeaways

• The '949 patent's scope hinges on both chemical and therapeutic claims, providing potentially broad protection if drafted strategically.
• Precise claim language, especially regarding structural features and methods, determines enforcement strength and vulnerability.
• Navigating the patent landscape requires assessing related patents, potential patent thickets, and international counterpart filings.
• Continuous monitoring for legal challenges or expiration is essential to maintaining market exclusivity.
• Strategic patent filings, including continuations and divisional applications, can extend protection and clarify rights.

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Frequently Asked Questions (FAQs)

1. What is the main inventive aspect of U.S. Patent 8,518,949?
   The patent's core inventive contribution pertains to specific chemical structures, formulations, or therapeutic methods, designed to differentiate it from prior art.

2. Can the scope of the claims be broadened after patent issuance?
   Yes, through filings such as continuation or continuation-in-part applications, which can seek to cover additional embodiments or broader claims.

3. How does the patent landscape influence the enforceability of this patent?
   A landscape with overlapping patents or prior art can create challenges in enforcement, potentially leading to invalidity defenses or licensing negotiations.

4. Are method of use claims typical in pharmaceutical patents like this?
   Yes, method of use claims are common and can extend patent protection even if compound claims are narrow, especially when targeting specific therapeutic indications.

5. What strategic considerations should companies keep in mind regarding this patent?
   Companies should analyze its scope for potential licensing, monitor related patents for competition, and consider global patent protections to secure market position.

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References

[1] United States Patent and Trademark Office, Patent Search Database.
[2] Known prior art and related patent applications based on publicly available patent family data.

Drugs Protected by US Patent 8,518,949

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	021361-001	May 25, 2004		RX	Yes	Yes			Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 8,518,949

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	05004695	Mar 03, 2005

International Family Members for US Patent 8,518,949

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006222312
Brazil	PI0608073
Canada	2594789
China	1900077
Denmark	1698630
European Patent Office	1698630