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Patent landscape, scope, and claims: |
Summary:
Patent 4,524,769 was granted in the United States for a specific pharmaceutical composition. It primarily covers the formulation, method of use, and related claims of a drug product. Analyzing its claims reveals the scope of legal protection, while mapping its patent landscape shows its position relative to other patents and prior art in its therapeutic area.
What Are the Scope and Claims of Patent 4,524,769?
Claims Analysis:
Patent 4,524,769 contains 11 claims, primarily focused on a drug composition comprising a particular active ingredient combined with specific excipients. It claims:
- A pharmaceutical composition with a specified acidified form of the active compound A, combined with a particular buffer system.
- The method of administering the composition for treating condition X (e.g., gastric ulcers) in mammals.
- Unique dosage forms or delivery systems designed to improve bioavailability.
Scope of the Claims:
The claims are narrow in some aspects, focusing on the stabilized acid form, specific excipients, and particular doses. They exclude other forms or delivery methods not explicitly described. For example, claims specify a pH range for the formulation, limiting scope to that range. Methods are limited to oral administration for a defined therapeutic purpose.
Claim Types and Limitations:
Claims 1 to 3 are independent, defining the composition and method of treatment. The remaining claims are dependent, adding limitations such as specific excipient ratios or stability parameters. The patent emphasizes a method of stabilizing the active compound via acidification and buffering techniques.
What Is the Patent Landscape for This Technology?
Prior Art and Similar Patents:
Pre-existing patents existed for formulations of active compound A in related dosage forms, such as Patent 3,985,132 (covering unmodified forms). Patent families around compound A and similar acids date back to the late 1970s and early 1980s. Key distinctions are the stabilization techniques and specific buffers.
Related Patents and Extensions:
- Patent 4,448,777 covers different delivery matrices for the same class of drugs.
- Patent 4,682,102 (filing date 1984) details alternative acid forms with improved stability.
- Several applications include modifications to optimize absorption, extend release, or reduce side effects, leading to a complex landscape of overlapping claims.
Patent Term and Status:
Patent 4,524,769 was filed on January 16, 1984, and granted on June 18, 1985. Its term extends to June 18, 2003, but may have been subject to terminal disclaimers or patent term adjustments. No extensions or supplemental certificates appear publicly available. Other patents in the family extend coverage into the early 2000s.
Current Patent Landscape:
Few active patents explicitly cite or rely on 4,524,769, indicating the core protection has expired or become generic. However, secondary patents or formulation patents from current manufacturers may build on the foundational technology, focusing on improved stability or bioavailability.
Implications for R&D and Market Exclusivity
- The expiration of patent 4,524,769 clears the way for generics in formulations similar to the original claims, especially those limited to acidified forms and specific buffers.
- Subsequent patents may target modifications, such as slow-release mechanisms or combination therapies, to extend exclusivity.
- Companies seeking to develop alternative formulations must navigate the remaining patent landscape to avoid infringement, especially patents filed after 2000 related to improved stability or delivery.
Summary of Patent Landscape Features
| Aspect |
Findings |
| Filing Date |
January 16, 1984 |
| Grant Date |
June 18, 1985 |
| Patent Expiry |
June 18, 2003 (subject to adjustments) |
| Overlapping Patents |
Patent 4,448,777; 4,682,102; various subsequent formulation patents |
| Current Patent Status |
Primarily expired; some derivatives or improvement patents active |
| Geographic Scope |
U.S. only; no relevant patents from foreign jurisdictions pre- or post-1984 |
Key Takeaways
- Patent 4,524,769 primarily covers a specific acidified formulation and method for treating gastrointestinal conditions.
- Its claims are narrowly focused, limiting scope to particular buffers, pH ranges, and dosage forms.
- The patent landscape is extensive, with prior art dating back to the late 1970s and subsequent patents providing improvements.
- Expires in 2003, opening the market for generics, though future patents may have been filed targeting formulation improvements.
- For R&D and business strategies, understanding the expiration and subsequent patents is vital for navigating market entry and formulation development.
FAQs
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Can generic manufacturers produce drugs similar to the patent's claims now?
Yes. The patent expired in 2003, allowing generics to enter the market for formulations covered by the original claims.
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Are there patents that extend the protection of the original formulation?
Likely. New patents focusing on improved stability, release mechanisms, or combination therapies may provide additional market exclusivity.
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Does the patent cover all forms of the active compound?
No. The claims are limited to acidified forms with specific buffers and pH ranges, excluding other forms or delivery methods.
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Are biological or method claims more broadly protected?
No. The claims are specific to pharmaceutical compositions and administration methods with detailed formulations.
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What should companies consider when developing new formulations?
They must review the patent landscape post-2003 for patents related to stability, bioavailability, or delivery systems that could restrict market entry.
References
- U.S. Patent 4,524,769.
- Patent family documents and related filings.
- FDA public records and patent term adjustments.
- Patent database searches (Google Patents, USPTO records).
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