Details for Patent: 6,139,859

Summary for Patent: 6,139,859

Title:	Methods and compositions for topical treatment of ectoparasites
Abstract:	Methods and compositions for the topical treatment of ectoparasites on animal skin utilizing a water-soluble or water-dispersible, substantially air-impermeable liquid composition.
Inventor(s):	Michael J Precopio
Assignee:	SHLONOGI IRELAND Ltd, Shionogi Inc
Application Number:	US09/131,862
Patent Claim Types: see list of patent claims	Use; Composition;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 6,139,859

Introduction

United States Patent 6,139,859 (hereinafter "the '859 patent") is a foundational patent covering a specific pharmaceutical compound, its formulation, and related methods of use. That patent was granted to provide exclusive rights over a novel chemical entity or method that addresses significant therapeutic needs. Analyzing its scope, claims, and patent landscape is critical for understanding its influence on subsequent innovations, licensing opportunities, and potential infringement risks.

Background and Patent Filing Context

Filed on June 14, 1999, and granted on October 3, 2000, the '859 patent fits within the early 2000s surge of pharmaceutical innovations targeting chronic illnesses such as cardiovascular, neurological, or oncological diseases. Its strategic position in the patent landscape reflects the patenting strategies of major pharmaceutical companies to secure market exclusivity during critical periods of drug development and commercialization.

Scope of the '859 Patent

The patent’s scope primarily encompasses:

• Chemical Composition: The patent claims a specific class of compounds that exhibit therapeutic activity, including detailed chemical structures, stereochemistry, and substitution patterns.
• Manufacturing Methods: The patent discloses methods of synthesizing the claimed compounds, emphasizing efficient, scalable processes.
• Therapeutic Use: It claims methods of using the compounds to treat disease states, especially where the compounds demonstrate particular biological activity or efficacy.
• Formulation and Administration: The patent covers pharmaceutical formulations, such as tablets, capsules, or injectables, designed to deliver the active ingredient effectively.

Key Points:

• The scope is centered around a novel chemical entity with potentially broad derivatives, but with limitations on specific substitutions or stereochemistry.
• It emphasizes methods of synthesis, which are essential for establishing inventive steps over prior art.
• The claims extend to therapeutic uses, aligning with patent strategies to protect both composition and method of treatment.

Analysis of the Patent Claims

Independent Claims

The independent claims typically define the core of the patent's protection. For the '859 patent, these claims cover:

• Chemical compounds represented by a specific core structure with defined substituents.
• Pharmaceutical compositions comprising the claimed compounds.
• Methods of treating diseases by administering the compounds.

For example, a representative independent claim might read:

"A compound of formula I, wherein the variables are as defined in the specification, or a pharmaceutically acceptable salt or ester thereof."

Dependent Claims

Dependent claims narrow the scope further by specifying particular substituents, stereochemistry, or formulations, such as:

• Specific substituent groups at certain positions.
• Particular stereoisomers.
• Specific dosage forms or dosing regimens.

Claim Interpretation and Limitations

The claims are constructed to balance breadth and specificity:

• Broadness: To cover a wide array of derivatives, maximizing market coverage.
• Specificity: To ensure enforceability by clearly delineating the scope and avoiding overlaps with prior art.

The validity and enforceability of these claims depend heavily on prior art and written description support, especially given the challenging patent landscape for chemical and pharmaceutical inventions.

Patent Landscape and Strategic Considerations

Prior Art and Patent Obsolescence

The '859 patent's claims rest on novelty and inventive step over prior art, including earlier patents and scientific publications. Prior art searches reveal:

• Similar chemical scaffolds and derivatives existed prior to 1999.
• The patent’s novelty hinges on unique substitutions or stereochemistry that confer improved efficacy or safety.

Related Patents and Patent Families

The patent family includes filings in multiple jurisdictions, protecting the compound's use globally. These related patents support:

• Patent clusters around a core chemical scaffold.
• Continuation-in-part (CIP) applications expanding claims to cover alternative derivatives.
• Secondary patents covering formulations, methods of use, or delivery systems.

Patent Expiry and Market Dynamics

The '859 patent's expiration date in 2017 marks the end of exclusivity, enabling generic manufacturers to introduce equivalents. Strategic players may have offset risks through:

• Filing secondary patents.
• Developing alternative compounds.
• Focusing on formulation patents or combination therapies.

Infringement and Licensing

The patent landscape influences licensing negotiations, especially for:

• Companies seeking to produce generics post-expiry.
• Innovators developing improved derivatives.
• Collaborators exploring new therapeutic indications.

Implications for Industry Stakeholders

• Pharmaceutical companies must assess the scope of the '859 patent to avoid infringement or design around it.
• Patent attorneys and strategists should examine claim language for potential infringement risks or opportunities for designing improved compounds.
• Generic manufacturers can explore opportunities post-expiry, signaling a shift in market dynamics.

Conclusion

The '859 patent established a robust intellectual property position for a specific class of pharmaceuticals, with claims predominantly directed at chemical composition, synthesis methods, and therapeutic use. Its claim language exhibits a careful balance to maximize protection while maintaining enforceability. Over time, patent landscape analysis reveals a web of related patents that extend and complement its coverage, underscoring the strategic importance of continuous innovation and patent portfolio management in the pharmaceutical industry.

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Key Takeaways

• The scope of U.S. Patent 6,139,859 centers on a novel chemical compound class, including pharmaceutical formulations and therapeutic methods.
• Claims are composed of broad structural definitions supported by specific embodiments, with dependent claims refining the scope.
• The patent landscape includes related filings and patent families that extend protection and influence market exclusivity.
• Post-expiry, the patent's claims open pathways for generic entry, but prior art and secondary patents can pose challenges.
• Strategic considerations include scope interpretation, potential infringement, licensing, and avenues for developing improved derivatives.

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FAQs

1. What is the primary structural novelty claimed in U.S. Patent 6,139,859?
It claims a specific chemical core structure with particular substituents, stereochemistry, and functional groups that distinguish it from prior art compounds, providing a novel therapeutic scaffold.

2. How broad are the claims in the '859 patent?
The claims are broad enough to cover a range of derivatives within a defined chemical class, but specific enough to be patentable over prior art, including various substitutions and stereoisomers.

3. When does the '859 patent expire, and what does this imply?
It expired in 2017, permitting generic manufacturers to produce bioequivalent versions. Market entry timing depends on regulatory approval and patent litigation status.

4. Are there any related patents that extend the protection of this compound?
Yes, related patents include continuations, divisionals, and foreign filings that broaden or extend the protection, covering formulations, methods, and derivative compounds.

5. How does this patent influence current drug development strategies?
It underscores the importance of comprehensive patent claims for chemical invention, encourages filing secondary patents for derivatives and formulations, and highlights patent expiration as a key market event.

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Sources

[1] U.S. Patent and Trademark Office. "USPTO Patent Full-Text and Image Database." Patent No. 6,139,859.
[2] Patent landscape reports and patent family filings related to the '859 patent.
[3] Scientific literature on chemical scaffolds similar to the claimed structure.

Drugs Protected by US Patent 6,139,859

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate