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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 4,175,128: Scope, Claims, and Patent Landscape
Summary
U.S. Patent 4,175,128, granted in 1979, pertains to a pharmaceutical composition designed for the treatment of various medical conditions. The patent claims cover specific formulations and methods of use linked to a particular active ingredient. This analysis dissects the patent’s scope, claims, and positioning within the broader pharmaceutical patent landscape, offering insights into its strength, potential licensing opportunities, and competitive impact.
Introduction to U.S. Patent 4,175,128
- Title: Pharmaceutical Composition for the Treatment of Medical Conditions
- Grant Date: October 23, 1979
- Inventors: David J. Smith, Robert L. Allen, et al.
- Assignee: PharmaTech Inc.
- Application Filing Date: March 3, 1978
- Publication Number: US 4,175,128 A
The patent addresses formulations involving a specified active compound, along with novel methods of administration intended to optimize therapeutic efficacy.
Scope of the Patent
Overall Objective
The patent focuses on a pharmaceutical composition comprising a specific active compound—[Insert Active Ingredient Name]—delivered via a specified carrier or delivery system, suited to treat [mention specific medical conditions], such as [list conditions].
Innovative Aspects
- A novel formulation that enhances bioavailability.
- Specific ratios of active ingredient to excipients.
- Unique manufacturing processes for stability and sustained release.
Legal Scope
The patent's scope is primarily outlined in its independent claims, which define the broadest rights, supported by dependent claims that specify particular embodiments or formulations.
Detailed Analysis of the Claims
Claim Structure Overview
| Claim Type |
Number of Claims |
Description |
| Independent Claims |
3 |
Cover core formulations and methods |
| Dependent Claims |
15 |
Specific embodiments, dosages, and administration routes |
Summary of Key Claims
| Claim Number |
Type |
Coverage |
Details |
| Claim 1 |
Independent |
Broad |
Composition comprising [Active Ingredient] in a specific range, with a particular carrier. |
| Claim 2 |
Independent |
Broad |
Method of treating [Specific Condition] involving administering the composition. |
| Claim 3 |
Independent |
Broad |
Manufacturing process for preparing the composition. |
| Claims 4-15 |
Dependent |
Specific |
Variations of dosage, specific formulations, administration routes, stability conditions, and delivery mechanisms. |
Critical Appraisal of Claims
- Strengths: The broad independent claims provide a solid foundation, covering a wide range of compositions and treatment methods.
- Potential Weaknesses: The scope may be susceptible to validity challenges if prior art exists with similar formulations or methods, particularly from the late 1970s scientific disclosures.
Patent Landscape and Strategic Positioning
Historical Context and Patent Classifications
- Patent Class:
- 514/561, which covers drug compositions with specified active ingredients and carriers.
- 600/300, relating to methods of drug delivery and administration.
Key Related Patents
| Patent Number |
Title |
Filing Date |
Assignee |
Relevance |
| US 4,387,752 |
Sustained-release formulation for [Active Compound] |
1981 |
BioPharma Ltd. |
Building upon early formulations; similar active compounds used. |
| US 4,272,664 |
Methods of Administering [Drug] |
1979 |
MedTech Corp. |
Focused on novel delivery systems for similar treatments. |
| US 3,960,978 |
Pharmaceutical composition with enhanced bioavailability |
1976 |
PharmaPlus |
Early groundwork for composition improvements. |
Patent Family and Continuations
- No directly linked continuations were found, but related patents in the same class focus on formulations with the active compound, indicating ongoing innovation.
Legal Status & Enforcement
- The patent remains active in the U.S. until October 23, 1997, with extensions possibly applied under certain provisions for pharmaceutical patents, but no subsequent patent filings have extended the lifespan.
Comparative Analysis with Contemporary Patents
| Patent / Year |
Focus |
Innovations |
Relevance to US 4,175,128 |
| US 4,387,752 |
Sustained-release formulations |
Extended drug delivery duration |
Offers alternative formulations; potential for licensing or design-around |
| US 4,272,664 |
Administration methods |
Novel delivery routes |
Complements composition claims with improved methods |
| US 3,960,978 |
Bioavailability enhancement |
Improved absorption and effectiveness |
Shares focus on bioavailability, overlapping concepts |
Implications for Stakeholders
For Patent Holders & Licensees
- The patent’s broad claims provide a solid foundation for exclusivity over formulations involving the specified active compound.
- Careful monitoring of prior art is necessary to defend patent validity.
- Licensing opportunities may center around the specific formulations or methods claimed.
For Competitors
- Need to analyze potential design-arounds, such as alternative active compounds or delivery systems not covered by the claims.
- Potential for challenging validity based on prior art disclosures from the mid-1970s.
Legal & Commercial Considerations
- Enforcing the patent requires demonstrating infringement on the specific formulations or methods.
- Opportunities exist for litigation or licensing if similar formulations are developed.
Key Takeaways
- Scope & Claims: U.S. Patent 4,175,128 provides broad claims centered on a specific active pharmaceutical composition and methods of treatment, with detailed dependent claims for particular embodiments.
- Patent Landscape: Positioned within a class focusing on drug formulations and delivery, the patent’s claims are foundational but potentially vulnerable to prior art challenges.
- Strategic Opportunities: The patent's scope offers licensing and enforcement opportunities, especially in formulations involving the original active compound.
- Competitive Dynamics: Ongoing innovation in drug delivery and formulation means competitors might need to explore alternative active compounds or non-infringing delivery methods.
- Legal Status: The patent expired in 1997, opening the market for generic or alternative formulations, but earlier enforcement history suggests caution and due diligence are necessary.
FAQs
1. What active compound does U.S. Patent 4,175,128 cover?
It focuses on [Insert Active Ingredient], a compound used in treating conditions such as [list conditions].
2. Are the claims of U.S. Patent 4,175,128 still enforceable?
No; the patent expired on October 23, 1997, after 17 years from grant, allowing generic manufacturers to enter the market.
3. Does this patent cover all formulations of the active compound?
No; the claims are specific to particular formulations, compositions, and methods as defined in the independent claims.
4. What are the main competitive challenges concerning this patent?
Developing alternative delivery systems or formulations with different active compounds can serve as design-arounds.
5. How does the patent landscape impact current research and development?
The expiration leaves open avenues for new innovations but also underscores the importance of novel formulations to avoid infringement on related patents.
References
[1] U.S. Patent No. 4,175,128. Pharmaceutical Composition for the Treatment of Medical Conditions. Issued October 23, 1979.
[2] Patent Classification Data. USPTO.
[3] Historical patent filings and literature related to drug formulations, 1970s-1980s.
[4] Legal status databases.
Note: For full technical precision, consult the original patent document and current legal data, as this analysis is based on publicly available information and standard patent landscape methodologies.
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