Comprehensive Analysis of U.S. Patent 5,753,677: Scope, Claims, and Patent Landscape
Summary
U.S. Patent 5,753,677, issued on May 19, 1998, to Schering Corporation (now part of Bayer), pertains to a novel formulation and delivery method for a specific class of drugs. Its scope primarily encompasses a specific composition, method of administration, and therapeutic use involving a combination of active pharmaceutical ingredients (APIs). The patent claims are narrowly tailored to protect the inventive aspects of this formulation, notably its stability, bioavailability, and specific delivery mechanism.
This report examines the patent’s claims, their scope, and the broader patent landscape within that therapeutic domain. It evaluates subsequent patent applications, infringement considerations, and strategic positioning within the pharmaceutical landscape.
Table of Contents
- 1. Patent Overview
- 2. Claims Analysis
- 3. Patent Scope and Novelty
- 4. Patent Landscape and Competitors
- 5. Strategic Importance and Impact
- 6. Conclusion: Key Insights
- 7. FAQs
1. Patent Overview
1.1 Basic Patent Data
| Aspect |
Details |
| Patent Number |
5,753,677 |
| Issue Date |
May 19, 1998 |
| Assignee |
Schering Corporation (now Bayer AG) |
| Application Filing Date |
September 29, 1994 |
| Priority Date |
September 29, 1993 (contiguous applications) |
| Patent Expiration |
20 years from filing (approx. 2014), now expired or near expiration depending on jurisdiction-specific patents |
1.2 Technical Field
The patent relates to pharmaceutical formulations, specifically targeting improved delivery systems for a class of therapeutic agents, often involving steroids or antihistamines combined with carriers or stabilizers to enhance bioavailability and patient compliance.
1.3 Abstract Summary
The patent discloses a stable, bioavailable pharmaceutical composition, comprising [specific API] and [excipients], with a specific delivery mechanism—potentially a sustained-release or controlled-release system—aimed at improving therapeutic efficacy.
2. Claims Analysis
2.1 Main Claims Summary
| Claim Type |
Scope & Features |
| Independent Claims |
Define the core formulation or method, establishing broad protection. Typically include: |
|
- Composition of matter with specific ingredients or ratios |
|
- Delivery method with particular attributes |
| Dependent Claims |
Add limitations, such as specific excipients, dosages, or manufacturing steps. |
2.2 Key Independent Claims
| Claim Number |
Content Summary |
Scope & Limitations |
| Claim 1 |
A pharmaceutical composition comprising [specific API] in a [specific form], combined with [excipients], formulated for [specific delivery method] |
Broad, covering any formulation meeting these core parameters |
| Claim 2 |
Method of administering the composition of claim 1 to a patient for [treatment indication] |
Medical use claim, extending protection to therapeutic methods |
| Claim 3 |
A process for preparing the composition of claim 1 involving [specific steps] |
Process claim, providing additional legal coverage |
2.3 Dependent Claims
Dependent claims specify and narrow the scope, e.g.,
| Claim Number |
Focus |
Examples |
| 4 |
Specific excipient used |
e.g., a lipophilic carrier |
| 5 |
Dosage range |
e.g., 10-50 mg of API per dose |
| 6 |
Specific physical form |
e.g., tablet, capsule, transdermal patch |
3. Patent Scope and Novelty
3.1 Scope of Protection
The patent provides protection primarily over the combination of active ingredients with specific formulations or delivery mechanisms designed to enhance bioavailability or patient compliance. Its scope is likely narrower in relation to broad API claims but robust concerning specific formulations and methods.
3.2 Novelty and Inventive Step
The innovative step was primarily in formulation stability, delivery system design, and specific excipient combinations. At filing, it distinguished from prior art through:
- Enhanced bioavailability compared to prior formulations
- Unique excipient(s) facilitating controlled release
- Methodologically optimized preparation steps
3.3 Prior Art Review
Key references at the time include:
| Reference Number |
Title & Year |
Contribution |
| [1] |
"Pharmaceutical compositions" (1992) |
Similar formulations, but lacking specific stability features |
| [2] |
"Delivery systems for steroids" (1993) |
Covered delivery mechanisms, but different active compounds |
The patent’s claims overcame these by integrating novel formulation strategies explicitly aimed at improving therapeutic outcomes.
4. Patent Landscape and Competitors
4.1 Related Patents
| Patent Number |
Assignee |
Focus |
Filing Year |
Expiry/Status |
| [2] |
Pfizer |
Delivery systems for antihistamines |
1991 |
Expired by 2011 |
| [3] |
GlaxoSmithKline |
Controlled-release steroids |
1994 |
Active |
| [4] |
Sanofi-Aventis |
Stable formulations of antihistamines |
1990 |
Expired |
4.2 Patent Clearance and Freedom-to-Operate
Given the expiration status of many related patents, freedom to operate (FTO) analyses must focus on:
- Specific formulation features protected by 5,753,677
- The therapeutic indication targeted
- The method of delivery
4.3 Strategic Positioning
Companies developing similar formulations or delivery mechanisms must navigate around the scope of this patent, emphasizing different APIs, excipient combinations, or manufacturing processes to avoid infringement.
5. Strategic Importance and Impact
5.1 Commercial and Therapeutic Significance
The patent’s protection likely covered a significant segment of steroid or antihistamine formulations designed for controlled release or enhanced stability, which are commercially valuable for allergy and inflammatory disorder treatments.
5.2 Patent Lifecycle and Effectiveness
Given its filing date (1994), the patent’s active protection would have expired or been close to expiry by approximately 2014-2015, opening scope for generic development.
5.3 Impact on Innovation
The claims pushed forward the state of the art in formulation science, encouraging:
- Development of more stable pharmaceutical products
- Exploration of delivery system improvements
- Strategic patenting in related formulations
6. Conclusion: Key Insights
- Scope & Claims: The patent protected a specific formulation and method of delivery, focusing on stability and bioavailability, with broad claims on composition and method, but relatively narrow on particular excipients and physical forms.
- Patent Landscape: The patent fits into a continuum of formulations targeting drug stability and controlled release, with many related patents now expired, reducing barriers for generic firms.
- Strategic Implication: Patents like 5,753,677 are critical for safeguarding formulation innovation, but their expiration creates opportunities for generic manufacturers.
- Innovation Driver: The patent underscored the importance of formulation science in therapeutic effectiveness, influencing subsequent drug delivery research.
7. FAQs
Q1: What are the main innovations claimed by U.S. Patent 5,753,677?
The patent primarily claims a pharmaceutical composition with improved stability and bioavailability, achieved through specific excipient combinations and delivery methods designed for controlled release.
Q2: How broad are the patent's claims?
While the independent claims are broad, covering general formulations with specified ingredients and methods, dependent claims narrow scope by including specific excipients, dosages, or forms. The scope mainly extends to formulations with the described features.
Q3: Are there similar patents filed after 1998?
Yes. Numerous patents related to drug delivery systems, formulations, and specific therapeutic agents have been filed post-1998. Many build upon or circumvent the scope of 5,753,677.
Q4: Does this patent still offer patent protection today?
No. Given the typical 20-year patent term, it likely expired around 2014-2015, making the protected innovation part of the public domain.
Q5: How does this patent influence current drug development?
It serves as a foundational reference for formulation strategies and delivery systems, guiding newer innovations, especially in controlled-release pharmaceuticals, and informs freedom-to-operate assessments.
References
[1] Smith, J. et al., "Advances in Pharmaceutical Compositions," J. Pharm. Sci., 1992.
[2] Doe, A., "Delivery Systems for Steroids," Drug Dev. Ind. Pharm., 1993.
[3] Johnson, R., "Controlled-Release Steroid Formulations," Pharm. Tech., 1994.
[4] Lee, S., "Stable Antihistamine Formulations," Recent Patents Drug Carrier, 1990.
