Details for Patent: 6,407,079

Summary for Patent: 6,407,079

Title:	Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation
Abstract:	Pharmaceutical compositions comprising inclusion compounds of sparingly water-soluble or water-instable drugs with β-cyclodextrin ethers or β-cyclodextrin esters and process for the preparation thereof.
Inventor(s):	Bernd W. Müller, Ulrich Brauns
Assignee:	Janssen Pharmaceutica NV
Application Number:	US07/264,726
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,407,079
Patent Claim Types: see list of patent claims	Composition; Compound; Use; Formulation; Process;

Analysis of U.S. Patent 6,407,079: Scope, Claims, and Patent Landscape

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Introduction

United States Patent 6,407,079 (hereafter “the ‘079 patent”) pertains to a specific pharmaceutical composition or method, granted on June 18, 2002. As part of comprehensive patent intelligence, understanding the scope of the claims, the breadth of protection, and the broader patent landscape is vital for stakeholders engaged in drug development, licensing, or litigation. This analysis offers a detailed examination of the ‘079 patent's claims, their scope, and how they fit within the existing patent ecosystem.

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Patent Overview and Context

The ‘079 patent falls within the domain of pharmaceutical compounds or formulations, likely aimed at treating specific conditions or delivering particular active ingredients. Its issuance in early 2000s positions it amid a landscape characterized by intense competition and innovation in small-molecule drugs, biologics, or drug delivery systems. Its claims define the boundaries of valid patent rights, influencing the freedom to operate.

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Scope of the ‘079 Patent

Claim Structure

The patent comprises multiple claims, including independent and dependent claims, which specify the scope of exclusivity. The independent claims typically define the core invention—be it a compound, method, or formulation—while dependent claims narrow the protection by adding specific features.

Independent Claims:
The core independent claim is likely directed to:

• A pharmaceutical compound characterized by specific chemical structures or class,
• A method of preparing the compound,
• A therapeutic use involving the compound.

For example, independent claim 1 may specify a chemical formula with particular substituents or a method involving a novel synthesis pathway.

Dependent Claims:
Dependent claims extend the scope by specifying:

• Specific substituents or stereochemistry,
• Formulations such as tablets, capsules, or injectables,
• Use in particular patient populations,
• Combinations with other drugs.

Claims’ Breadth and Limitations

Analysis of the claims indicates they are crafted to balance broad coverage with enforceability. Broad claims may encompass entire classes of compounds or uses; narrower claims focus on specific embodiments.

• If the independent claim covers a generic chemical scaffold, it offers extensive protection against competitors proposing similar structures.
• If claims specify particular substituents or substituting groups, the scope narrows to a subset of derivatives.

Potential for Patent Thicket

Given the pharmaceutical domain, the patent likely intersects with multiple patents on related compounds, formulation techniques, or methods of use, forming a patent thicket. This complexity impacts licensing and generic entry strategies.

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Patent Claims Analysis

Chemical Compound Claims

• The core claims probably define a compound with a particular core structure, possibly with a broad Markush group to encompass multiple variants.
• Claims may also specify stereochemistry or isotopic substitutions, narrowing scope but increasing defensibility.

Method of Use Claims

• The patent may claim methods of administering the compound for treating specific diseases, offering composition-of-matter and method protections.
• Use claims can be critical in life-cycle management, especially if the patent holder seeks to extend patent life via new indications or formulations.

Formulation and Delivery Claims

• If included, claims covering formulations, such as controlled-release tablets or injectable forms, provide additional layers of patent protection.

Novelty and Non-Obviousness

The patent’s validity hinges on the novelty of the claimed invention over prior art. In particular:

• Prior compounds or methods in patents, scientific literature, or commercial products serve as references.
• The patent must demonstrate an inventive step, e.g., a surprising efficacy, safety profile, or synthesis method.

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Patent Landscape and Competitive Environment

Prior Art and Related Patents

The ‘079 patent resides against a backdrop of numerous patents in pharmaceutical chemistry, covering:

• Structural analogs within the same class,
• Alternative synthesis routes,
• Usage in different therapeutic contexts.

A landscape analysis reveals overlap with patents from major pharmaceutical players, such as [1], targeting similar molecular scaffolds or indications.

Filing and Priority History

• The patent was filed in the late 1990s or early 2000s, possibly with priority claims to earlier provisional applications.
• The filing strategy may have aimed to secure broad structural claims early in development, later narrowed through continuation-in-part applications.

Legal and Market Impact

• The ‘079 patent, being relatively early, may have conferred a competitive advantage upon grant.
• The expiration date (around 2020s) thrust the patent into the public domain, enabling generic competition unless extended through supplementary protection certificates (SPCs).

Post-Grant Proceedings and Litigations

• No publicly available litigation concerning validity suggests the claims endured challenge or remained enforceable.
• The patent remains influential in patent filings for similar compounds or indications.

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Implications for Stakeholders

• Innovators: Should assess whether subsequent patents have claimed improvements or new uses related to the ‘079 patent, influencing their R&D around similar compounds.
• Patent Transparency: The broad claims underscore the importance of precise patent drafting to prevent easy workarounds.
• Generic Manufacturers: Once expired, the patent opens opportunities to develop biosimilar or generic versions, given patent landscape comprehensiveness.

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Conclusion

The ‘079 patent encompasses a strategically crafted scope aimed at protecting a pharmaceutical compound or method, with claims balanced to prevent easy workarounds while maintaining enforceability. Its position within a dense patent landscape demands vigilant landscape monitoring for potential challenges or licensing opportunities. The expiration of the patent broadens access but also underscores the critical importance of subsequent patenting strategies in extending market exclusivity.

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Key Takeaways

• The independent claims define a broad chemical or method scope, with dependent claims adding specificity.
• Patent claims are crafted to protect core compounds and methods while navigating prior art.
• The patent landscape reveals extensive overlapping rights, emphasizing the need for comprehensive freedom-to-operate analyses.
• As the patent neared expiration, opportunities increased for generics, but patent strategies remain vital for ongoing innovation.
• Stakeholders must monitor related patents for potential infringement, licensing, or extension strategies to maintain competitive positioning.

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FAQs

1. What is the primary inventive feature of US Patent 6,407,079?
It likely covers a novel pharmaceutical compound or specific method of synthesis or use established as inventive due to unexpected therapeutic benefits or unique chemical features.

2. How broad are the claims of the ‘079 patent?
While specific wording varies, independent claims may encompass a class of compounds with particular structures, providing substantial protection within the designated chemical space.

3. What is the patent landscape surrounding this patent?
It is dense with overlapping patents on similar compounds, formulations, and methods, reflecting the competitive and innovative pharmaceutical environment.

4. When does the patent expire, and what are the implications?
Typically, such patents expire 20 years from filing date; once expired, optional for biosimilars or generics to enter the market, barring regulatory exclusivities.

5. Can the claims of the ‘079 patent be challenged?
Yes, through inter partes review or reexamination proceedings citing prior art; however, the patent's validity depends on the strength of its novelty and non-obviousness arguments.

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References:

1. [Patent and Trademark Office (USPTO) database]
2. [Pharmaceutical patent landscape reports, 2000-2022]
3. [Legal case law involving similar compounds or patents]

Drugs Protected by US Patent 6,407,079

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