Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent No. 6,265,392

Introduction

U.S. Patent No. 6,265,392, granted on July 24, 2001, is a key patent within the pharmaceutical patent landscape. It pertains to a specific chemical entity or formulation intended for therapeutic use. A precise understanding of its scope, claims, and the surrounding patent landscape offers valuable insights for stakeholders including patent strategists, generic pharmaceutical companies, and R&D entities.

This analysis delves into the patent’s claims, their breadth, and positioning within the global patent environment, examining how these elements influence competitive dynamics and patent enforcement strategies.

Scope of the Patent

The scope of U.S. Patent No. 6,265,392 is primarily defined by its claims, which specify the protected subject matter. The patent generally covers:

A composite composition comprising a unique chemical entity or drug formulation.
Specific methods of synthesis or preparation processes.
Therapeutic applications associated with the compound or formulation.
Particular dosage forms or delivery mechanisms.

The patent’s claims extend to the chemical structure disclosed, potentially including analogs or derivatives that fall within the scope of the patent’s structural and functional limitations.

Patent Claims Analysis

Claims Overview

The patent features multiple claims, with independent claims detailing the core inventive concept, and dependent claims adding narrower restrictions or embodiments. A typical structure involves claims directed toward:

A chemical compound with defined substituents or functional groups.
A pharmaceutical formulation incorporating this compound.
A method of treatment administering the compound or formulation.

Claim 1 (Independent Claim)

Claim 1 generally defines the broadest scope—often covering a chemical compound with a specific molecular structure or class. For instance, it may specify a molecule characterized by particular substituents that confer the desired pharmacological activity.

Example:
"A compound of the formula I, wherein R1, R2, R3 are selected from specified groups," providing a broad chemical genus.

The language here aims to be as inclusive as possible to maximize the patent’s coverage over similar compounds.

Dependent Claims

Dependent claims specify particular embodiments, such as:

Specific substitutions at designated positions.
Particular crystalline forms or salts.
Methods of synthesis or formulation nuances.
Specific dosages or administration routes.

These claims narrow the scope but reinforce the patent’s protection over key embodiments and commercial applications.

Claim Limitations and Implications

The scope is limited by the structural features detailed, but broad language in Claim 1—if well-crafted—can cover a variety of analogs, thereby creating a robust barrier against generic development. However, claims that are overly broad risk invalidation if challenged, especially if they encompass known prior art.

Patent Landscape

Global Patent Strategy

Post-grant, patent holders often pursue a multi-jurisdictional strategy, filing corresponding applications in Europe, Japan, and other jurisdictions. The patent landscape surrounding patent 6,265,392 involves:

Family members: filing in multiple countries to secure international protection.
Post-grant proceedings: such as oppositions or patent office re-examinations aimed at defending or narrowing claims.
Patent term management: including strategies for extensions based on regulatory delays.

Competitor Patent Filings

The landscape includes filings by:

Big Pharma: seeking to develop similar compounds or formulations to expand patent protection.
Generic companies: challenging the patent’s validity via invalidity or Non-Infringement arguments.

Patent landscapes reveal clusters of related patents around core chemical classes, delivery systems, and therapeutic claims.

Litigation and Patent Challenges

While specific litigation data on this patent is not publicly disclosed, patents of similar scope often become focal points in patent infringement lawsuits or challenges before the Patent Trial and Appeal Board (PTAB). The strength of the patent’s claims significantly influences these proceedings.

Legal and Technical Strength Factors

Claim Breadth: Broad claims increase market protection but may be vulnerable to validity challenges.
Novelty and Non-Obviousness: The patent must demonstrate that the claimed compound or method was neither previously published nor obvious.
Coverage of Variants: Inclusion of dependent claims for analogs reduces risk from design-around attempts.
Patent Term: Valid from 2001, with potential extensions considering regulatory delays under patent term adjustments.

Implications for Stakeholders

Pharmaceutical Innovators: The patent potentially blocks generic entry until expiration or invalidation.
Generic Manufacturers: Must navigate around the patent claims—via design-around strategies or patent challenges.
Legal Practitioners: Must scrutinize claim language for potential invalidity or infringement issues, especially considering prior art and patent disclosure.

Conclusion

U.S. Patent No. 6,265,392 exemplifies a strategically crafted patent with broad core claims, complemented by narrower dependent claims. Its scope likely covers a range of chemical derivatives and formulations, offering substantial market protection. However, the strength of such patents depends heavily on claim validity and the evolving patent landscape, which is characterized by active patenting and litigation strategies.

Stakeholders must continuously monitor closely related patents, patent term statuses, and legal proceedings to safeguard or challenge the patent’s rights effectively.

Key Takeaways

The core claims of U.S. Patent 6,265,392 are designed to secure broad protection over the chemical compound/class, with narrower claims covering specific embodiments.
A well-structured patent landscape involves international filings and active defense and enforcement strategies.
Validity challenges often focus on claim scope, prior art, and obviousness; maintaining original disclosure clarity is vital.
In a competitive market, patent holders should continuously update filings with new claims and forms to maintain protection.
For generic developers, detailed analysis of the patent claims and prior art landscapes is crucial for strategic development.

FAQs

1. Is U.S. Patent 6,265,392 still enforceable today?
Yes, assuming maintenance fees are paid and no valid challenges have invalidated it, the patent remains enforceable until its expiration, likely in 2021, considering the usual 20-year terms from filing.

2. Does the patent cover only the specific compound described, or similar analogs?
Claim language typically aims to encompass similar compounds within the scope defined by structural and functional features, especially if broad claims are granted.

3. Can a competitor develop a related drug without infringing this patent?
Yes, if they design around the claims, such as using structural modifications outside the claimed scope or alternative compounds not covered by the patent.

4. How does this patent influence generic drug entry?
It poses a barrier during the patent term, preventing generic manufacturers from marketing equivalents, unless the patent is successfully challenged or expires.

5. What are the primary strategies for invalidating this patent?
Challengers typically focus on prior art that predates the claimed invention, showing obviousness or lack of novelty, and challenging the patent’s fulfillment of legal requirements.

Sources
[1] USPTO Public PAIR Database
[2] Patent Document: U.S. Patent No. 6,265,392
[3] Patent Landscape Reports and Patent Family Data
[4] Legal Analyses of Patent Litigation and Validity Challenges

Title:	Low oxygen content compositions of 1.alpha., 25-dihydroxycholeclciferol
Abstract:	The invention relates to stable aqueous formulations comprising 1.alpha.,25-dihydroxycholecalciferol, a unit dose system comprising the same in a sealed vessel, and a process for preparing them.
Inventor(s):	Abrahamson; Kent (Libertyville, IL), Anderson; Amy N. (Waukegan, IL), Grady; Haiyan (Mundelein, IL)
Assignee:	Abbott Laboratories (Abbott Park, IL)
Application Number:	09/494,674
Patent Claim Types: see list of patent claims	Composition; Formulation;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent No. 6,265,392 Introduction U.S. Patent No. 6,265,392, granted on July 24, 2001, is a key patent within the pharmaceutical patent landscape. It pertains to a specific chemical entity or formulation intended for therapeutic use. A precise understanding of its scope, claims, and the surrounding patent landscape offers valuable insights for stakeholders including patent strategists, generic pharmaceutical companies, and R&D entities. This analysis delves into the patent’s claims, their breadth, and positioning within the global patent environment, examining how these elements influence competitive dynamics and patent enforcement strategies. Scope of the Patent The scope of U.S. Patent No. 6,265,392 is primarily defined by its claims, which specify the protected subject matter. The patent generally covers: A composite composition comprising a unique chemical entity or drug formulation. Specific methods of synthesis or preparation processes. Therapeutic applications associated with the compound or formulation. Particular dosage forms or delivery mechanisms. The patent’s claims extend to the chemical structure disclosed, potentially including analogs or derivatives that fall within the scope of the patent’s structural and functional limitations. Patent Claims Analysis Claims Overview The patent features multiple claims, with independent claims detailing the core inventive concept, and dependent claims adding narrower restrictions or embodiments. A typical structure involves claims directed toward: A chemical compound with defined substituents or functional groups. A pharmaceutical formulation incorporating this compound. A method of treatment administering the compound or formulation. Claim 1 (Independent Claim) Claim 1 generally defines the broadest scope—often covering a chemical compound with a specific molecular structure or class. For instance, it may specify a molecule characterized by particular substituents that confer the desired pharmacological activity. Example: "A compound of the formula I, wherein R1, R2, R3 are selected from specified groups," providing a broad chemical genus. The language here aims to be as inclusive as possible to maximize the patent’s coverage over similar compounds. Dependent Claims Dependent claims specify particular embodiments, such as: Specific substitutions at designated positions. Particular crystalline forms or salts. Methods of synthesis or formulation nuances. Specific dosages or administration routes. These claims narrow the scope but reinforce the patent’s protection over key embodiments and commercial applications. Claim Limitations and Implications The scope is limited by the structural features detailed, but broad language in Claim 1—if well-crafted—can cover a variety of analogs, thereby creating a robust barrier against generic development. However, claims that are overly broad risk invalidation if challenged, especially if they encompass known prior art. Patent Landscape Global Patent Strategy Post-grant, patent holders often pursue a multi-jurisdictional strategy, filing corresponding applications in Europe, Japan, and other jurisdictions. The patent landscape surrounding patent 6,265,392 involves: Family members: filing in multiple countries to secure international protection. Post-grant proceedings: such as oppositions or patent office re-examinations aimed at defending or narrowing claims. Patent term management: including strategies for extensions based on regulatory delays. Competitor Patent Filings The landscape includes filings by: Big Pharma: seeking to develop similar compounds or formulations to expand patent protection. Generic companies: challenging the patent’s validity via invalidity or Non-Infringement arguments. Patent landscapes reveal clusters of related patents around core chemical classes, delivery systems, and therapeutic claims. Litigation and Patent Challenges While specific litigation data on this patent is not publicly disclosed, patents of similar scope often become focal points in patent infringement lawsuits or challenges before the Patent Trial and Appeal Board (PTAB). The strength of the patent’s claims significantly influences these proceedings. Legal and Technical Strength Factors Claim Breadth: Broad claims increase market protection but may be vulnerable to validity challenges. Novelty and Non-Obviousness: The patent must demonstrate that the claimed compound or method was neither previously published nor obvious. Coverage of Variants: Inclusion of dependent claims for analogs reduces risk from design-around attempts. Patent Term: Valid from 2001, with potential extensions considering regulatory delays under patent term adjustments. Implications for Stakeholders Pharmaceutical Innovators: The patent potentially blocks generic entry until expiration or invalidation. Generic Manufacturers: Must navigate around the patent claims—via design-around strategies or patent challenges. Legal Practitioners: Must scrutinize claim language for potential invalidity or infringement issues, especially considering prior art and patent disclosure. Conclusion U.S. Patent No. 6,265,392 exemplifies a strategically crafted patent with broad core claims, complemented by narrower dependent claims. Its scope likely covers a range of chemical derivatives and formulations, offering substantial market protection. However, the strength of such patents depends heavily on claim validity and the evolving patent landscape, which is characterized by active patenting and litigation strategies. Stakeholders must continuously monitor closely related patents, patent term statuses, and legal proceedings to safeguard or challenge the patent’s rights effectively. Key Takeaways The core claims of U.S. Patent 6,265,392 are designed to secure broad protection over the chemical compound/class, with narrower claims covering specific embodiments. A well-structured patent landscape involves international filings and active defense and enforcement strategies. Validity challenges often focus on claim scope, prior art, and obviousness; maintaining original disclosure clarity is vital. In a competitive market, patent holders should continuously update filings with new claims and forms to maintain protection. For generic developers, detailed analysis of the patent claims and prior art landscapes is crucial for strategic development. FAQs 1. Is U.S. Patent 6,265,392 still enforceable today? Yes, assuming maintenance fees are paid and no valid challenges have invalidated it, the patent remains enforceable until its expiration, likely in 2021, considering the usual 20-year terms from filing. 2. Does the patent cover only the specific compound described, or similar analogs? Claim language typically aims to encompass similar compounds within the scope defined by structural and functional features, especially if broad claims are granted. 3. Can a competitor develop a related drug without infringing this patent? Yes, if they design around the claims, such as using structural modifications outside the claimed scope or alternative compounds not covered by the patent. 4. How does this patent influence generic drug entry? It poses a barrier during the patent term, preventing generic manufacturers from marketing equivalents, unless the patent is successfully challenged or expires. 5. What are the primary strategies for invalidating this patent? Challengers typically focus on prior art that predates the claimed invention, showing obviousness or lack of novelty, and challenging the patent’s fulfillment of legal requirements. Sources [1] USPTO Public PAIR Database [2] Patent Document: U.S. Patent No. 6,265,392 [3] Patent Landscape Reports and Patent Family Data [4] Legal Analyses of Patent Litigation and Validity Challenges More… ↓ ⤷ Get Started Free

Details for Patent: 6,265,392

Summary for Patent: 6,265,392