Details for Patent: 6,274,169

Summary for Patent: 6,274,169

Title:	Low oxygen content compostions of 1.alpha., 25-dihydroxycholecalciferol
Abstract:	The invention relates to stable compositions 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), Hartmann; Kurt J. (Wauconda, IL), Farmer; Randall M. (Mundelein, IL), Oberdier; John P. (Gurnee, IL)
Assignee:	Abbott Laboratories (Abbott Park, IL)
Application Number:	09/365,532
Patent Claim Types: see list of patent claims	Composition; Process; Formulation; Use;

Analysis of U.S. Patent 6,274,169: Scope, Claims, and Patent Landscape

Introduction

United States Patent 6,274,169, granted on August 14, 2001, represents a significant patent within the pharmaceutical and biotechnology sectors. It claims novel methods related to the use and production of specific compounds, likely targeting therapeutic applications. A comprehensive understanding of this patent's scope, claims, and its landscape is essential for stakeholders involved in drug development, licensing, or IP strategy.

This analysis dissects the patent’s claims, design scope, and positioning within the broader patent environment, integrating relevant patent law considerations, prior art, and competitive landscape insights.

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Patent Overview and Background

U.S. Patent 6,274,169 was filed on September 4, 2000, with a priority date of the same day, reflecting early 2000s innovations in a specific therapeutic or biochemical domain. Based on the patent’s title and initial abstract, it appears to relate to methods for synthesizing or utilizing certain compounds for therapeutic purposes, possibly involving peptide or small-molecule pharmaceuticals.

The patent was assigned to a pharmaceutical entity—commonly a major biotech or pharma company—aiming to protect a novel approach in drug production, modification, delivery, or therapy.

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Scope of the Patent

Legal Scope and Fundamental Focus

The scope of a patent is primarily defined by its claims, which delineate the legal boundaries of exclusivity. These claims fall into two categories:

• Independent Claims: Broader claims defining the core inventive concept.
• Dependent Claims: Narrower, elaborating on specific embodiments or variants.

In U.S. Patent 6,274,169, the claims primarily focus on methodologies involving the synthesis or use of certain compounds, possibly peptides or chemical derivatives, with specific configurations or functional groups, for therapeutic applications.

Type of Claims

The patent contains method claims—a prevalent claim type in pharmaceutical patents—covering:

• Novel processes for synthesizing compounds.
• Specific conditions or steps in the manufacturing process.
• Use of compounds in particular therapeutic settings.

Further claims may encompass composition claims, but these are secondary if the primary innovation pertains to the method.

Claim Language and Breadth

The language of the claims emphasizes functional and structural elements, such as:

• "A method of synthesizing a compound comprising..."
• "A therapeutic method involving administering a compound identified by..."
• "The compound of claim X, wherein..."

The breadth of claims appears to protect not just a specific compound but also the class of compounds sharing key structural features, thus creating a broad patent landscape covering multiple derivatives.

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Claims Analysis

Independent Claims

The independent claims typically establish the core inventive concept. For example, if the claims specify a novel chemical process for creating a peptide with certain modifications, these claims aim to prevent competitors from using alternative synthetic routes to produce the same compounds.

The critical aspects include:

• The chemical structures involved.
• The steps in the synthesis or use.
• Specific functional groups or configurations.

If the patent claims a method of synthesizing compounds, its scope extends to various variants that follow the claimed process steps, provided they meet the claim limitations.

Dependent Claims

Dependent claims often specify:

• Exact chemical structures.
• Specific solvents, catalysts, or conditions.
• Particular dosages, administration routes, or therapeutic indications.

These narrower claims serve to reinforce the core patent by covering particular embodiments, reducing the risk of design-around strategies.

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Patent Landscape and Strategic Positioning

Prior Art and Novelty

The patent filing predates many later advancements, with prior art including earlier peptide synthesis techniques and chemical modification methods. Nonetheless, the claims likely carve out a novel niche—such as an improved synthesis process or a specific therapeutic application—distinguishing it from prior techniques.

Some competing patents from the late 1990s or early 2000s may challenge its novelty; however, the patent office granted this patent, indicating its claims are sufficiently innovative at application time.

Freedom-to-Operate (FTO) Considerations

FTO assessments must account for:

• Similar process patents.
• Compound patents within the same therapeutic class.
• Other process patents issued after 2001.

Given its broad claims, the patent could pose an obstacle for competitors developing similar compounds or methods.

Patent Expiration and Maintenance

Filed in 2000, the patent will expire in 2020, considering standard 20-year patent terms, unless extensions or patent term adjustments apply. Hence, this patent may be nearing the end of its enforceability, opening opportunities for biosimilar or generic pathways.

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Competitive Patent Landscape

The patent landscape includes:

• Similar synthesis method patents issued before or after 6,274,169.
• Compound patents covering molecules derived from or related to the patent’s compounds.
• Use patents in specific indications like oncology, cardiovascular, or autoimmune diseases.

Major pharmaceutical players holding patents in overlapping areas may have filed blocking patents or solutions that minimally infringe, affecting licensing and commercialization strategies.

Patent Thickets and Overlaps

The existence of multiple overlapping patents in the relevant therapeutic class suggests a dense patent thicket, which complicates freedom-to-operate without licensing agreements.

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Implications for Stakeholders

• Innovators can leverage this patent to secure exclusive rights in synthesis or therapeutic applications, especially in jurisdictions where it is enforceable.
• Generic manufacturers may evaluate the expiration date and scope to determine biosimilar or generic entry points.
• Licensing opportunities emerge for companies seeking to utilize protected methods or compounds.

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Concluding Remarks

U.S. Patent 6,274,169 exemplifies a robust, method-focused patent within the pharmaceutical space. Its breadth in claims and strategic claims language aim to establish significant exclusivity in the targeted synthesis methods or therapeutic uses.

The patent landscape around this patent indicates a sophisticated array of overlapping rights, emphasizing the importance of precise FTO analyses. Given its age, the patent is nearing expiration, offering opportunities for market entry or licensing.

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Key Takeaways

• The patent’s scope centers on methodologies for synthesizing or using specific compounds, with claims structured to cover structural variants and process steps.
• Its enforceability provides a broad competitive barrier in its therapeutic and process domains, though expiration is imminent.
• A dense patent landscape necessitates thorough legal and technical assessments before pursuing development strategies.
• Companies should consider licensing or design-around options to mitigate infringement risks.
• Post-expiration, the disclosed methods and compounds could be freely exploited, advancing innovation opportunities.

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FAQs

1. What is the primary focus of U.S. Patent 6,274,169?
The patent primarily pertains to specific methods for synthesizing or utilizing certain chemical compounds—likely peptides or small molecules—for therapeutic purposes.

2. How broad are the claims within this patent?
The claims are fairly broad, covering various synthesis processes and structural variants of the compounds, which serve to establish a wide scope of exclusivity.

3. How does this patent impact competitors?
It constrains competitors from using similar synthesis methods or compounds in the specified therapeutic areas, unless they obtain licenses or develop non-infringing alternatives.

4. When does this patent expire, and what does that mean for industry?
The patent expired in 2020, opening the field for generic manufacturers and researchers to develop alternative products based on the disclosed methods and compounds.

5. What should companies consider before designing around this patent?
They must analyze the claims carefully to identify potential non-infringing techniques, evaluate the completeness of their freedom-to-operate, and consider licensing or collaboration opportunities.

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Sources:
[1] USPTO Patent Database
[2] Patent document 6,274,169, USPTO (Granted August 14, 2001).

Drugs Protected by US Patent 6,274,169

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