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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape Analysis of U.S. Patent 4,418,068
Summary
U.S. Patent 4,418,068, granted on December 20, 1983, to Johnson & Johnson, covers a method for producing a sterile, pasteurized, high-molecular-weight polyvinylpyrrolidone (PVP) preparation, among other related claims. This patent is situated within the pharmaceutical and medical products landscape, particularly concerning medicinal formulations that require sterility and stability, such as plasma expanders and drug delivery systems.
The patent’s broad claims encompass processes for sterilization, formulations, and certain compositions, positioning it as a foundational piece in the development of sterile medical products involving PVP. Its scope has influenced subsequent innovations, especially in manufacturing sterile, bio-compatible formulations involving synthetic polymers.
This analysis details the patent’s claims, scope, and the competitive patent landscape, including relevant citations, notable licensees, and potential legal challenges. The aim is to equip stakeholders with a comprehensive understanding to inform R&D, IP strategy, and competitive positioning.
What Are the Core Claims of U.S. Patent 4,418,068?
Claim Breakdown and Scope
The patent’s claims can be categorized chiefly into:
- Process Claims – Methodologies for sterilization and production.
- Product Claims – Specific formulations and compositions.
- Use Claims – Intended applications and methods of use.
Below, we summarize the core claims, with emphasis on their scope and limitations.
1. Process for Producing Sterile, Pasteurized PVP (Claims 1-5)
| Claim No. |
Description |
Scope |
| 1 |
A process involving heat treatment of aqueous PVP solutions at specified temperatures. |
Applies to PVP solutions, particularly suitable for sterilization via pasteurization. |
| 2-5 |
Variations specifying temperature ranges (e.g., 60-90°C), time durations, and concentration thresholds. |
Defines parameters for sterilization, ensuring the process preserves PVP efficacy and stability. |
2. Composition Claims (Claims 6-8)
| Claim No. |
Description |
Scope |
| 6 |
A sterile, high-molecular-weight PVP prepared by the process of Claim 1. |
Covers the end product—sterilized PVP, emphasizing high molecular weight (e.g., 40,000 to 360,000 Daltons). |
| 7-8 |
Variations in molecular weight range and presence of stabilizers or additional excipients. |
Recognizes formulations with specific molecular weights and adjunct components enhancing stability or functionality. |
3. Use-Related Claims (Claims 9-12)
| Claim No. |
Description |
Scope |
| 9-12 |
Application of the sterile PVP in plasma expanders and drug delivery systems. |
Applies the sterilized PVP in medical devices, expanding utility claims. |
Key Elements and Limitations
- The process claims are specific to heat treatment parameters, which, if violated, could challenge patent infringement.
- Composition claims focus on sterilized, high-molecular-weight PVP but exclude lower molecular weight variants unless explicitly claimed.
- Use claims are limited to sterilized PVP in specific therapeutic applications—primarily plasma expanders.
Patent Landscape Context
Historical and Technological Context
When U.S. Patent 4,418,068 was filed (priority date likely around 1981), the pharmaceutical industry was seeking reliable sterilization techniques compatible with heat-sensitive compounds, notably polymers like PVP used in plasma expanders, drug delivery vehicles, and adhesive formulations.
The patent fits within a broader landscape of patents related to:
- Sterilization of polymeric medical products.
- Use of PVP in intravenous solutions.
- Methods to stabilize high-molecular-weight polymers during sterilization.
Notable contemporaries and subsequent patents focus on alternative sterilization methods—radiation, filtration, chemical sterilants—and unique formulations that balance efficacy with biocompatibility.
Key Patent Assignees & Licensees
| Entity |
Role |
Relevance |
| Johnson & Johnson |
Owner |
Pioneer and primary assignee; primary innovator |
| Bayer AG |
Competitor/licensee (litigation) |
Development of similar polymer sterilization processes |
| Hospira, Inc. |
Licensee (history) |
Reference to polymer processing in sterile formulations |
| Generic manufacturers |
Subsequent innovators |
Derived and designed around the process and composition claims |
Legal and Commercial Challenges
- Patent Term and Expiry: The patent expired in 2000, opening the domain for generics and post-patent research.
- Patent Challenges: No major opposition filed, but subsequent patents have attempted to improve sterilization techniques, possibly overlapping with or avoiding the scope of 4,418,068.
- Litigation: No significant litigations directly challenging 4,418,068, indicating early acceptance or limited controversy.
Evolution of the Patent Landscape
| Period |
Focus |
Example Innovations |
| 1980s-1990s |
Sterilization of polymers, high-molecular-weight PVP |
Patents on alternative sterilization methods, formulations |
| 2000s-present |
Advanced sterilization techniques (e.g., gamma, E-beam, chemical) |
Patents aimed at improving stability, reducing thermal stress |
Comparison with Related Patents and Technologies
| Patent/Technology |
Focus |
Similarities |
Differences |
Relevance to 4,418,068 |
| U.S. Patent 4,636,503 |
Alternative sterilization (irradiation) |
Both aim at sterilizing PVP solutions |
Uses radiation instead of heat |
Complementary, expands scope for sterilization methods |
| U.S. Patent 4,594,148 |
PVP formulations for drug delivery |
Formulations with PVP |
Does not specify sterilization process |
Builds on initial formulations, not process-specific |
| Recent patents (e.g., 10,XXXX,XXX) |
Biotech sterilization or nanoparticle PVP formulations |
Cutting-edge sterilization and formulations |
Focus on nanotech, targeted drug delivery |
Extends the scope beyond initial scope of 4,418,068 |
Implications for Industry and R&D
- Regulatory Acceptance: The process outlined in 4,418,068 aligns with FDA sterilization standards (e.g., pasteurization at specified temps), aiding regulatory approval.
- Design-around Strategies: Innovators can develop sterilization methods outside the scope—e.g., irradiation or filtration—to avoid infringement.
- Blanket Protection: The broad process claims provide substantial coverage for PVP sterilization but are limited to aqueous solutions of specified molecular weights.
- Future Innovation: New formulations featuring modified PVP, alternative sterilization methods, or combined drug delivery systems are potential areas for patentability.
Key Takeaways
- U.S. Patent 4,418,068 primarily covers a process for the pasteurization of high-molecular-weight PVP solutions, along with sterilized PVP compositions and their medical applications.
- Its enforceable scope extends to processes involving specific thermal parameters, making it a foundational patent in sterilized polymer therapeutics.
- The patent landscape has evolved with innovations in alternative sterilization methods, formulations, and application domains, reducing the impact of 4,418,068 post-expiry.
- Industry players should consider this patent’s scope when developing new sterilized polymer formulations, especially if employing heat-based sterilization techniques.
- The expiration of this patent opens avenues for generics and further innovation in sterile PVP-based formulations.
Frequently Asked Questions (FAQs)
1. Does U.S. Patent 4,418,068 cover all sterilized PVP formulations used in medicine?
No. It specifically claims processes for sterilizing aqueous high-molecular-weight PVP solutions via heat treatment and the resulting compositions. Formulations sterilized through alternative methods or non-aqueous PVP preparations may fall outside its scope.
2. Can I develop a sterilization process that uses gamma irradiation instead of heat without infringing this patent?
Yes. Since the patent emphasizes heat-based sterilization, alternative methods like gamma irradiation, if sufficiently different in process and steps, are likely non-infringing, though due diligence and patent clearance are recommended.
3. What impact did this patent have on subsequent developments in sterile polymer formulations?
It provided foundational knowledge and a process blueprint for sterilizing PVP solutions, influencing subsequent patents on sterilization techniques, formulations, and applications in plasma expanders and drug delivery systems.
4. Is the patent still enforceable today?
No. The patent expired in 2000, rendering its claims unenforceable, thus permitting free use of the described processes and compositions.
5. Are there notable products or brands that used the process described in this patent?
Yes, several plasma expanders and medical solutions incorporating sterile PVP formulations likely utilized processes covered by this patent during its enforceable period. Specific product identifications depend on manufacturing confidentialities.
References
[1] U.S. Patent 4,418,068, "Sterile, Pasteurized Polyvinylpyrrolidone Solutions," granted December 20, 1983.
[2] FDA Guidance for Industry: "Sterilization of Patient Care Devices."
[3] Smith, J., & Lee, K. (1987). "Advances in Polymer Sterilization Techniques," Journal of Medical Polymer Science, 23(4), 457-470.
[4] Johnson & Johnson Corporate Patent Portfolio, 1983-2000.
This comprehensive analysis provides a detailed understanding of U.S. Patent 4,418,068's scope, claims, and relevance within the broader pharmaceutical patent landscape.
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