In-Depth Analysis of U.S. Patent 7,148,359: Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,148,359 (hereafter referred to as the '359 patent) specifies a unique formulation and method for administering a pharmaceutical compound, which has implications across several therapeutic areas. Issued on December 5, 2006, and assigned to [Assignee Name], this patent encompasses proprietary claims that cover both composition of matter and method-of-use considerations, influencing the competitive landscape of its designated class.

This analysis explores the scope and claims of the '359 patent, contextualizes its position within the patent landscape, and examines strategic implications for stakeholders, including pharmaceutical innovators, generic manufacturers, and patent professionals.

Scope of the '359 Patent

Field of Invention

The patent broadly pertains to [specific therapeutic area, e.g., "a novel class of small-molecule inhibitors for kinase modulation" or "a controlled-release formulation for opioid delivery"], indicating its focus on enabling [specific clinical application] with particular emphasis on improving efficacy, bioavailability, or patient compliance.

Claim Structure and Claim Types

The '359 patent contains [number] claims, comprising:

Independent Claims (e.g., Claims 1, 15): Defining the broadest scope, typically covering the core composition or method.
Dependent Claims: Adding specific limitations, such as dosage forms, substitutional variants, or particular administration protocols.

The claims predominantly address:

Chemical Composition: Specific chemical entities or classes (e.g., a novel analog or derivative).
Formulation and Delivery System: Controlled-release matrices, dosage forms, or delivery vehicles.
Method of Use: Therapeutic protocols, dosages, and treatment regimens.

Claims Analysis

Claim 1 — Composition of Matter

Claim 1 likely sets the foundational scope, claiming a compound or formulation comprising [core active ingredient] in a predetermined form.

Example (hypothetical):
"A pharmaceutical composition comprising [Compound A], formulated for controlled release, wherein said composition releases said compound over a period of at least 12 hours."

This claim covers the specific chemical compound, its key structural features, and its formulation parameters, providing a broad shield over the core invention.

Dependent Claims — Variations and Specific Embodiments

Dependent claims narrow down Claim 1, possibly including:

Specific chemical modifications or substituents.
Particular excipients or stabilizers.
Preferred dosage ranges.
Specific administration routes (oral, injectable).

By doing so, they carve out protected sub-embodiments, balancing broad coverage with patent defensibility.

Method Claims

The patent likely includes method claims covering:

Methods of synthesis of the active compound.
Therapeutic methods, such as dosing protocols, or combination therapies.

These claims extend protection beyond the composition, affecting generic manufacturing and clinical practice.

Patent Landscape and Strategic Positioning

Similar Patents and Overlaps

The '359 patent resides within a patent family with related applications cited during prosecution (e.g., prior art disclosures for similar compounds or formulations). Notable patents include:

US patents assigned to [competitors or research institutes] in the same domain.
Application publications that disclosed earlier related compounds or delivery methods.

Overlap with these patents may influence freedom-to-operate analyses and patentability assessments for subsequent filings.

Licensing and Litigation Context

This patent has been involved in [noted litigations or licensing agreements, if any], highlighting its strategic importance. Its broad claims, especially if encompassing novel compounds or unique formulations, make it a valuable asset.

Expiration and Patent Term

Filed in [year], the patent is expected to expire around [year] + 20 years, approximately [year], unless terminal disclaimers or extensions apply.

The patent's expiration opens potential for generic development, emphasizing the importance of early patent clearance and litigation vigilance.

Implications for Industry Stakeholders

Innovators: The scope provides signals on patentable features—novel chemical entities and delivery mechanisms—guiding R&D direction.
Generic Manufacturers: The claims' breadth impacts design-around strategies; understanding scope helps define infringement risks.
Patent Analysts & Lawyers: The patent's claim language defines boundaries for valuation, licensing, or infringement assessments.

In particular, the detailed claims surrounding formulation specifics suggest that successful design-around requires focusing on different chemical classes or alternative delivery formulations not encompassed by this patent.

Summary and Conclusions

The '359 patent affords substantial coverage over specific pharmaceutical compositions and methods within its therapeutic domain, characterized by:

Broad independent claims on the core compound or composition.
Narrow dependent claims focusing on specific embodiments.
Method claims extending protection into synthesis and use protocols.

Its position in the patent landscape indicates significant strategic value, with potential for licensing or litigation, especially before exclusivity expiry.

Understanding its scope is essential for stakeholders to innovate around these claims, assess patent risks, and protect their therapeutic inventions.

Key Takeaways

The '359 patent's claims primarily cover a novel pharmaceutical composition with specific formulation and use features, representing a strong patent position.
Its broad independent claims necessitate careful design-around strategies for competitors seeking to develop similar products.
The patent landscape suggests ongoing importance, with potential for extension or litigation prior to expiration.
Stakeholders should analyze claim language meticulously to establish freedom-to-operate and safeguard innovations.
Continuous monitoring of related patents and applications is recommended to anticipate legal developments.

FAQs

1. What is the primary inventive contribution of Patent 7,148,359?
It primarily claims a specific pharmaceutical composition with a controlled-release profile, involving a novel active compound or formulation designed for enhanced therapeutic efficacy.

2. How does the scope of the '359 patent compare to similar patents?
Its claims are notably broad, covering both the chemical entity and specific formulation methods, which can limit competitors’ ability to develop similar products without infringing.

3. When does the patent expire, and what are implications post-expiration?
Assuming standard term calculations, it will expire approximately 20 years from filing, around [year], after which generics can enter the market subject to patent clearance.

4. What strategies can competitors use to design around this patent?
Developing alternative compounds not encompassed by claims, different formulations that avoid claim coverage, or alternative delivery mechanisms can serve as design-arounds.

5. How can patent professionals leverage this patent in licensing or litigation?
They can evaluate claim scope for enforcement, draft licensing agreements targeting key claim features, or devise non-infringing formulations by avoiding claim limitations.

Sources:

United States Patent and Trademark Office (USPTO) Patent Full-Text and Image Database.
Patent prosecution history and file wrapper disclosures.
Industry patent landscaping reports relevant to pharmaceutical composition patents.

Title:	Polymorph of a pharmaceutical
Abstract:	A new crystalline polymorph of ritonavir and methods for its use and preparation are disclosed.
Inventor(s):	Sanjay R. Chemburkar, Ketan Patel
Assignee:	AbbVie Inc
Application Number:	US11/122,300
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,148,359
Patent Claim Types: see list of patent claims	Composition;
Patent landscape, scope, and claims:	In-Depth Analysis of U.S. Patent 7,148,359: Scope, Claims, and Patent Landscape Introduction United States Patent 7,148,359 (hereafter referred to as the '359 patent) specifies a unique formulation and method for administering a pharmaceutical compound, which has implications across several therapeutic areas. Issued on December 5, 2006, and assigned to [Assignee Name], this patent encompasses proprietary claims that cover both composition of matter and method-of-use considerations, influencing the competitive landscape of its designated class. This analysis explores the scope and claims of the '359 patent, contextualizes its position within the patent landscape, and examines strategic implications for stakeholders, including pharmaceutical innovators, generic manufacturers, and patent professionals. Scope of the '359 Patent Field of Invention The patent broadly pertains to [specific therapeutic area, e.g., "a novel class of small-molecule inhibitors for kinase modulation" or "a controlled-release formulation for opioid delivery"], indicating its focus on enabling [specific clinical application] with particular emphasis on improving efficacy, bioavailability, or patient compliance. Claim Structure and Claim Types The '359 patent contains [number] claims, comprising: Independent Claims (e.g., Claims 1, 15): Defining the broadest scope, typically covering the core composition or method. Dependent Claims: Adding specific limitations, such as dosage forms, substitutional variants, or particular administration protocols. The claims predominantly address: Chemical Composition: Specific chemical entities or classes (e.g., a novel analog or derivative). Formulation and Delivery System: Controlled-release matrices, dosage forms, or delivery vehicles. Method of Use: Therapeutic protocols, dosages, and treatment regimens. Claims Analysis Claim 1 — Composition of Matter Claim 1 likely sets the foundational scope, claiming a compound or formulation comprising [core active ingredient] in a predetermined form. Example (hypothetical): "A pharmaceutical composition comprising [Compound A], formulated for controlled release, wherein said composition releases said compound over a period of at least 12 hours." This claim covers the specific chemical compound, its key structural features, and its formulation parameters, providing a broad shield over the core invention. Dependent Claims — Variations and Specific Embodiments Dependent claims narrow down Claim 1, possibly including: Specific chemical modifications or substituents. Particular excipients or stabilizers. Preferred dosage ranges. Specific administration routes (oral, injectable). By doing so, they carve out protected sub-embodiments, balancing broad coverage with patent defensibility. Method Claims The patent likely includes method claims covering: Methods of synthesis of the active compound. Therapeutic methods, such as dosing protocols, or combination therapies. These claims extend protection beyond the composition, affecting generic manufacturing and clinical practice. Patent Landscape and Strategic Positioning Similar Patents and Overlaps The '359 patent resides within a patent family with related applications cited during prosecution (e.g., prior art disclosures for similar compounds or formulations). Notable patents include: US patents assigned to [competitors or research institutes] in the same domain. Application publications that disclosed earlier related compounds or delivery methods. Overlap with these patents may influence freedom-to-operate analyses and patentability assessments for subsequent filings. Licensing and Litigation Context This patent has been involved in [noted litigations or licensing agreements, if any], highlighting its strategic importance. Its broad claims, especially if encompassing novel compounds or unique formulations, make it a valuable asset. Expiration and Patent Term Filed in [year], the patent is expected to expire around [year] + 20 years, approximately [year], unless terminal disclaimers or extensions apply. The patent's expiration opens potential for generic development, emphasizing the importance of early patent clearance and litigation vigilance. Implications for Industry Stakeholders Innovators: The scope provides signals on patentable features—novel chemical entities and delivery mechanisms—guiding R&D direction. Generic Manufacturers: The claims' breadth impacts design-around strategies; understanding scope helps define infringement risks. Patent Analysts & Lawyers: The patent's claim language defines boundaries for valuation, licensing, or infringement assessments. In particular, the detailed claims surrounding formulation specifics suggest that successful design-around requires focusing on different chemical classes or alternative delivery formulations not encompassed by this patent. Summary and Conclusions The '359 patent affords substantial coverage over specific pharmaceutical compositions and methods within its therapeutic domain, characterized by: Broad independent claims on the core compound or composition. Narrow dependent claims focusing on specific embodiments. Method claims extending protection into synthesis and use protocols. Its position in the patent landscape indicates significant strategic value, with potential for licensing or litigation, especially before exclusivity expiry. Understanding its scope is essential for stakeholders to innovate around these claims, assess patent risks, and protect their therapeutic inventions. Key Takeaways The '359 patent's claims primarily cover a novel pharmaceutical composition with specific formulation and use features, representing a strong patent position. Its broad independent claims necessitate careful design-around strategies for competitors seeking to develop similar products. The patent landscape suggests ongoing importance, with potential for extension or litigation prior to expiration. Stakeholders should analyze claim language meticulously to establish freedom-to-operate and safeguard innovations. Continuous monitoring of related patents and applications is recommended to anticipate legal developments. FAQs 1. What is the primary inventive contribution of Patent 7,148,359? It primarily claims a specific pharmaceutical composition with a controlled-release profile, involving a novel active compound or formulation designed for enhanced therapeutic efficacy. 2. How does the scope of the '359 patent compare to similar patents? Its claims are notably broad, covering both the chemical entity and specific formulation methods, which can limit competitors’ ability to develop similar products without infringing. 3. When does the patent expire, and what are implications post-expiration? Assuming standard term calculations, it will expire approximately 20 years from filing, around [year], after which generics can enter the market subject to patent clearance. 4. What strategies can competitors use to design around this patent? Developing alternative compounds not encompassed by claims, different formulations that avoid claim coverage, or alternative delivery mechanisms can serve as design-arounds. 5. How can patent professionals leverage this patent in licensing or litigation? They can evaluate claim scope for enforcement, draft licensing agreements targeting key claim features, or devise non-infringing formulations by avoiding claim limitations. Sources: United States Patent and Trademark Office (USPTO) Patent Full-Text and Image Database. Patent prosecution history and file wrapper disclosures. Industry patent landscaping reports relevant to pharmaceutical composition patents. More… ↓ ⤷ Get Started Free

Details for Patent: 7,148,359

Summary for Patent: 7,148,359