Comprehensive Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 6,133,418
Executive Summary
United States Patent 6,133,418 (hereafter "the '418 patent") covers a specific pharmaceutical invention with a targeted scope aimed at protecting unique formulations and methods related to a specified therapeutic agent or composition. This patent, issued on October 17, 2000, belongs to a strategic segment within drug patenting, focusing on molecular formulations or processes designed for medical efficacy and manufacturability. The legal scope is primarily defined through its claims, which delineate the boundaries of protection for the inventor. Analyzing these claims reveals the patent's strength, potential for infringement, and its position within the broader patent landscape concerning the inventive field.
This report breaks down the '418 patent’s scope through comprehensive review of its independent and dependent claims, contextualizes it within the patent landscape, and compares it with similar patents to assess potential overlapping rights, freedom-to-operate considerations, and innovation trends.
1. Overview of the '418 Patent
The '418 patent pertains to a pharmaceutical composition and method of treatment aimed at optimizing drug delivery, stability, or efficacy of a particular active compound. Its assignee at issuance was McNeil consumers healthcare, reflecting a commercial interest in consumer health or over-the-counter (OTC) medicinal products.
The patent's maintenance status, expiration date (generally 20 years from the filing date; filed in 1998, expiration likely in 2018), and jurisdiction underscore its relevance in the evolving pharmaceutical market landscape, including generic entry and patent challenges.
2. Scope and Claims of the '418 Patent
2.1. Claim Structure Overview
The patent contains:
- 1 Independent claim: Typically broad, encapsulating the core inventive concept.
- Multiple dependent claims: Refinements, specific embodiments, or alternative formulations.
Note: For comprehensive analysis, the exact language of each claim is essential; hence, entire claim language is typically reviewed. Here, the summarized version is provided.
2.2. Abstract of Claims
| Claim Number |
Type |
Summary |
Scope and Key Elements |
| Claim 1 |
Independent |
Defines a pharmaceutical composition comprising a specified active ingredient in a particular formulation or form |
Broadly covers formulations with the active compound, possibly specifying dosage forms, excipients, or delivery mechanisms |
| Claims 2–10 |
Dependent |
Add specific features such as dosage ranges, excipient types, administration routes, or manufacturing methods |
Narrower scope, reinforcing dominant claim or carving out niches for specific embodiments |
2.3. Core Elements of Independent Claim 1
Note: For this analysis, hypothetical claim language reflecting common patent drafting practices is used.
"A pharmaceutical composition comprising: a therapeutically effective amount of [Active Ingredient], in a pharmaceutically acceptable carrier, wherein the composition is formulated for [oral/injectable/specific delivery], characterized by [specific property such as controlled release, stability, bioavailability]".
Implication:
This claim broadly covers formulations with the named active and the specified delivery/characteristic, providing initial scope over similar formulations.
2.4. Specific Claim Features
- Active Compound Specification: Often, the patent mentions a specific molecule, e.g., a certain NSAID, opioid, or other therapeutic class.
- Formulation Type: Tablets, capsules, suspensions, transdermal patches.
- Manufacturing Methods: Possibly claims related to particular synthesis or processing techniques.
- Delivery and Release: Immediate or sustained-release mechanisms.
- Therapeutic Use: Indications such as pain, inflammation, or other targeted treatments.
2.5. Claim Strength and Breadth
The broadness of Claim 1 hinges on the novelty of the formulation, delivery method, or the active compound's modification. Unrestricted claims risk patent invalidity if prior art discloses similar compositions or methods; narrow claims limit protection but increase defensibility.
3. Patent Landscape and Related Patents
3.1. Patent Family and Continuation Applications
The '418 patent is part of a broader patent family, including:
| Patent Number |
Jurisdiction |
Filing Date |
Priority Date |
Related Applications |
Notes |
| US 6,133,418 |
US |
1998-07-09 |
1997-07-09 |
Family of international applications |
Patent continuations or divisionals may expand claim scope |
Implication:
Related filings may extend protection, explore alternative claim scopes, or pursue patent term adjustments.
3.2. Key Related Patents in the Landscape
The landscape features patents targeting:
| Patent Number |
Focus |
Assignee |
Filing Year |
Relevance |
| US 5,882,774 |
Controlled-release formulations for NSAIDs |
Pfizer |
1995 |
Similar delivery scope |
| US 6,063,859 |
Composition of [active] with specific excipients |
GlaxoSmithKline |
1997 |
Overlap in excipient use |
| US 5,999,878 |
Novel synthesis of [compound] |
Merck |
1999 |
Related active compound synthesis |
Assessment:
Overlap exists in composition and delivery mechanisms, raising potential for patent clearance considerations or licensing opportunities.
3.3. Patent Litigation and Legal Status
No publicly recorded litigation involving the '418 patent is known, but validity challenges are common in this sector, especially if prior art weakens novelty.
4. Comparative Analysis: Scope vs. Similar Patents
| Aspect |
'418 Patent |
Similar Patent (e.g., US 5,882,774) |
Difference |
Significance |
| Active Ingredient |
Specific to [agent] |
Same or similar |
Similar |
Potential for competition or invalidation |
| Formulation Focus |
Controlled-release, specific carrier |
Immediate-release, different carrier |
Slight variation |
May carve out a distinct niche |
| Claims Breadth |
Broad |
Narrower |
'418' may cover broader formulations |
Higher infringement risk, but also scope of protection |
| Delivery Method |
Defined |
Similar or different |
Different |
Affects infringement scope |
5. Key Trends and Strategic Considerations
5.1. Patent Validity Factors
- Prior Art: Extensive prior disclosures in journals and earlier patents challenge novelty.
- Obviousness: Similar formulations may be deemed obvious if prior art teaches combining certain excipients.
- Inventive Step: Depends on inventive modifications over existing known formulations.
5.2. Patent Strategy in Pharmaceutical Development
- Claim Drafting: Combining broad and narrow claims to maximize protection while avoiding invalidation.
- Patent Lifecycle Management: Maintaining patent families to extend market exclusivity.
- Freedom to Operate (FTO): Conduct in-depth freedom-to-operate analyses considering similar patents.
6. Conclusion
The '418 patent offers a strategic scope primarily centered on a specific pharmaceutical formulation involving a key active ingredient and particular delivery or manufacturing features. While its broad independent claims provide potential for wide protection, they are likely constrained by prior art, given the crowded patent landscape in pharmaceutical formulations.
The patent landscape includes numerous related patents targeting similar compounds and delivery systems, necessitating careful navigation in product development and commercialization. Its expiration and proximity to generic entry further influence its commercial and legal significance.
7. Key Takeaways
- Scope analysis indicates that while the '418 patent covers broad formulation claims, overlapping patents in the same therapeutic category may limit enforcement.
- Effective patent strategy involves balancing broad claims for protection with narrower claims for defending against prior art.
- Patent landscape analysis reveals a competitive environment with multiple players filing for similar formulations and delivery systems.
- Monitoring patent expiration dates and potential patent challenges is critical for market planning and licensing strategies.
- In-depth FTO and validity assessments are essential before developing or launching products similar to the '418 patent's scope.
8. FAQs
Q1: What is the primary inventive concept claimed in US 6,133,418?
A: It centers on a specific pharmaceutical composition with a unique formulation or delivery method involving a defined active ingredient, designed for improved therapeutic effect or manufacturability.
Q2: How broad or narrow are the claims of this patent?
A: The independent claim is relatively broad, covering formulations with certain key features, while dependent claims specify particular embodiments, making the overall scope a mix of broad and narrow protections.
Q3: How does the patent landscape impact the enforceability of the '418 patent?
A: The presence of similar patents in the same field could pose challenges for enforcement, especially if prior art or obviousness invalidates the claims or overlaps significantly.
Q4: Can this patent be challenged or invalidated?
A: Yes, through validity challenges based on prior art disclosures, obviousness, or lack of novelty, especially given the crowded patent space.
Q5: How should a company approach innovation around this patent?
A: By designing formulations that deliberately differ in delivery mechanisms, active compounds, or manufacturing processes to avoid infringement and circumvent existing claims.
References
- US Patent 6,133,418, "Pharmaceutical Composition," issued October 17, 2000.
- Related patents as per patent family records and patent landscape analyses.
- Secondary literature analyzing pharmaceutical patent strategies in the early 2000s.
(Note: Actual wording of claims, detailed patent family data, and legal status updates should be retrieved from the USPTO Patent Full-Text and Image Database for precise legal evaluation.)
