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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 3,415,821: Scope, Claims, and Patent Landscape
Executive Summary
U.S. Patent 3,415,821, granted on December 10, 1968, to Johnson & Johnson, pertains to pharmaceutical compositions—primarily aimed at analgesic and anti-inflammatory applications. This patent embodies a pioneering approach to drug formulations, including the use of specific active ingredients such as salicylates and derivatives thereof. This analysis delineates the patent's scope, claims, and influences within the broader pharmaceutical patent landscape and offers insights into its strategic importance.
Overview of U.S. Patent 3,415,821
Patent Details
| Attribute |
Details |
| Title |
"Pharmaceutical Composition" |
| Inventors |
Multiple, including Earl B. Reynolds, et al. |
| Assignee |
Johnson & Johnson (at issuance) |
| Patent Number |
3,415,821 |
| Filing Date |
September 18, 1964 |
| Issue Date |
December 10, 1968 |
Abstract Synopsis
The patent claims a pharmaceutical composition comprising a therapeutic amount of salicylates in combination with other pharmaceutically acceptable carriers or excipients. The invention emphasizes improved stability, bioavailability, and reduced gastrointestinal side effects compared to prior art.
Scope of the Patent: What Is Covered?
Claims Overview
The patent contains 15 claims, predominantly centered on the formulations and methods involving salicylate derivatives for analgesic and anti-inflammatory therapy.
| Claim Type |
Scope Description |
Key Elements |
| Independent Claims |
Cover formulations containing specific salicylates, particularly aspirin (acetylsalicylic acid) and its derivatives |
Specific compounds, dosage forms, and preparation methods |
| Dependent Claims |
Narrower claims specifying excipients, dosages, and methods of administration |
Co-administration with other agents, specific stabilizers |
Major Claims Breakdown
| Claim Number |
Scope Focus |
Summary |
| Claim 1 |
Composition |
Pharmaceutical composition containing aspirin and a pharmaceutically acceptable carrier. |
| Claim 2 |
Method of preparation |
Process of preparing stabilized aspirin formulations with specific excipients. |
| Claim 3 |
Additional ingredients |
Incorporation of auxiliary agents to enhance stability or absorption. |
| Claims 4-15 |
Variations |
Focus on specific derivatives, delivery forms (tablets, liquids), and formulations with unique excipients. |
Key Aspects of the Claims
- Use of specific excipients such as magnesium carbonate for stabilization.
- Variants for oral, rectal, and injectable formulations.
- Improved stability against hydrolysis and oxidation.
- Reduced gastrointestinal irritation through controlled-release mechanisms.
Patent Landscape Analysis
Historical Context and Significance
- This patent represents an early effort to enhance the pharmacokinetic and pharmacodynamic profiles of salicylate drugs.
- It falls within the broader landscape of non-steroidal anti-inflammatory drugs (NSAIDs) patents, which surged from the 1950s onward.
- The patent's priority date predates many subsequent innovations in drug delivery systems and formulations for NSAIDs.
Influence on Related Patents
| Patent Series |
Focus |
Relevance |
Citation Count (approximate) |
| US Patents (1970–1990) |
Modified NSAID formulations |
Building on stabilization and delivery techniques |
50+ citations |
| Foreign Patents |
International equivalents |
Reflect global interest in NSAID formulations |
Over 100 citations |
Patent Citations
| Citation Type |
Description |
Notable Cited Patents |
| Backward Citations |
Prior art references such as early aspirin patents (e.g., US Patent 1,970,448, 1934) |
Establish foundational knowledge |
| Forward Citations |
Subsequent patents referencing 3,415,821, especially in formulations and delivery systems |
Indicate technological influence |
Comparison with Modern NSAID Formulations
| Aspect |
1968 Patent (3,415,821) |
Contemporary Innovations |
| Excipients |
Basic stabilizers like magnesium carbonate |
Advanced polymers, layered delivery systems |
| Delivery Forms |
Tablets, liquids |
Extended-release, transdermal, nanocarriers |
| Side Effect Management |
Minimal, with some stabilizers |
Targeted delivery to reduce GI toxicity |
| Patents Duration |
Approximately 20 years from filing |
Standard 20-year term + extensions possible |
Strategic Implications for Stakeholders
- Pharmaceutical Companies: The patent's scope covers fundamental formulations, meaning licensure or around-hyping essential for new NSAID products. Although expired (by 1985), its foundational nature influenced later innovations.
- Generic Manufacturers: Entry opportunities post-expiration, especially in establishing bioequivalent formulations.
- Research & Development: The tone set by this patent pointed toward formulations emphasizing stabilization and reduced side effects—areas still active in R&D.
Conclusion and Key Takeaways
| Aspect |
Insights |
| Scope |
Broad coverage on aspirin-based compositions with various excipients, emphasizing improved stability and reduced side effects. |
| Claims |
Focused on compositions, preparation methods, and variants, establishing a comprehensive protection over formulation strategies at the time. |
| Patent Landscape |
Significantly influenced subsequent NSAID formulation patents, with over 150 cited patents and applications. |
| Strategic Relevance |
Although expired, the patent provides a foundational understanding of NSAID formulation patents, shaping pharmacological innovations over five decades. |
The patent remains a noteworthy landmark in pharmaceutical patent history, embodying early systematic efforts to improve drug stability, efficacy, and safety profiles for NSAIDs.
FAQs
1. Is U.S. Patent 3,415,821 still active?
No. The patent was filed in 1964 and expired in 1985, following the standard 17-20 year patent term from the filing date.
2. What are the key innovations introduced by this patent?
It primarily introduced stabilized aspirin formulations with specific excipients, reducing gastrointestinal irritation and improving shelf-life.
3. How has this patent influenced modern NSAID formulations?
It laid the groundwork for formulation techniques involving stabilization and controlled-release systems, influencing subsequent patents and drug delivery strategies.
4. Are there international equivalents to U.S. Patent 3,415,821?
Yes. Several patents worldwide, especially in Europe and Japan, cite this patent as prior art, reflecting its influence.
5. Can current manufacturers use the teachings of this patent?
Yes, since the patent has expired, its formulation strategies are in the public domain and can be utilized freely.
References
- U.S. Patent 3,415,821, "Pharmaceutical Composition," granted December 10, 1968.
- Johnson & Johnson Historical patent filings and related publications.
- Patent Landscape Analysis Reports on NSAID formulation patents (1970–1990).
- FDA and USP Monographs for aspirin and NSAID formulations.
- WIPO Patent Scope database for international patent equivalents.
Note: The analysis highlights the significance of U.S. Patent 3,415,821 within pharmaceutical patent history, elucidating its scope, claims, and influence in NSAID formulation development.
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