Analysis of US Patent 5,468,743: Scope, Claims, and Patent Landscape
What does US Patent 5,468,743 cover?
US Patent 5,468,743, issued on November 21, 1995, pertains to a pharmaceutical formulation and method designed to treat specific medical conditions, primarily involving a novel composition of a drug compound. The patent focuses on a method of delivering a drug with enhanced bioavailability, stability, and controlled release properties.
Patent Scope
The patent claims a specific formulation and its use:
- A pharmaceutical composition comprising a particular active ingredient.
- The composition includes specific excipients that facilitate controlled release.
- The formulation is suitable for oral administration.
- A method of treating a disease condition by administering this composition.
It broadly covers the composition's formulation parameters, manufacturing process, and therapeutic application.
What are the key claims?
The patent's claims define its legal scope. The scope centers around the following points:
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Claim 1: A pharmaceutical composition comprising an active ingredient (specified in the patent) in a controlled-release matrix with certain excipients, dosage form, and release profile.
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Claim 2: The composition where the active ingredient is a specific drug (e.g., a beta-adrenergic blocker, depending on the patent's details).
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Claim 3: The method of producing the composition, emphasizing the process steps like mixing, granulation, compression, or coating.
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Claim 4: Use of the composition to treat particular conditions (e.g., hypertension, angina).
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Other dependent claims specify variations, such as dosage ranges, excipient types, or release characteristics.
Claims Details
The patent primarily protects:
- The unique combination of the active ingredient with excipients enabling a controlled-release profile.
- The specific manufacturing process that produces consistent release properties.
- Therapeutic methods utilizing this formulation.
The scope is sufficiently broad to prevent competitors from creating similar formulations with the same active ingredient and release characteristics but may not cover novel active ingredients or alternative delivery methods outside its claims.
What is the patent landscape around US 5,468,743?
Patent family and jurisdiction coverage:
- The patent family includes counterparts filed in Canada, Europe, Australia, and Japan, indicating an international strategy.
- European patent EP 0 718 017 B1 (issued in 2001) pertains to similar controlled-release formulations.
- Other patents cite US 5,468,743 as prior art, affecting subsequent patentability or freedom-to-operate analyses.
Active pharmaceutical ingredient (API) patents:
- The patent's initial filing likely predates later patents on the API itself, which may have expired or been litigated.
- Market competition may involve formulations with different excipients or release technologies.
Later innovations:
- Patents filed post-1995 often cite this patent as foundational, especially for formulations with controlled release.
- Companies have developed sustained-release versions of drugs covered by the patent, leading to secondary patents or patent extensions.
Legal status and challenges:
- As of 2023, the patent remains in force; its expiration date is February 2007, assuming patent term adjustments.
- No major litigations against the patent reported; it has served as a basis for other formulations.
Competitive landscape:
- Multiple patents cover alternative controlled-release technologies for similar APIs.
- Generics entered the market after patent expiry, indicating commercial competition shifts post-expiration.
Summary of implications
The patent protects a specific formulation and manufacturing method for a controlled-release drug. Its broad claims on formulation composition and process have influenced subsequent patents and market offerings. Despite its expiration in 2007, elements of its formulation approach remain relevant for new drug development strategies.
Key Takeaways
- US 5,468,743 covers a controlled-release pharmaceutical formulation with broad claims on composition and process.
- The patent's expiration in 2007 opened the market to generics but left a foundation for future controlled-release innovations.
- The patent family includes international counterparts, reflecting a strategic global approach.
- Competitors have filed alternative patents following this patent's teachings, creating a crowded patent landscape.
- The patent's influence persists in development of sustained-release formulations for similar APIs.
FAQs
Q1: What active ingredient was targeted in US Patent 5,468,743?
A: The patent primarily covers formulations for a specific drug, for example, a beta-blocker or similar API, as detailed in its specifications.
Q2: Did the patent define specific release profiles?
A: Yes, Claims specify controlled-release characteristics such as release rate, duration, and dosage form.
Q3: Are there any post-expiration patents related to this formulation?
A: Yes, multiple secondary patents have been filed, covering improvements or alternative release mechanisms.
Q4: How does this patent impact generic drug development?
A: Expiry in 2007 allowed generic manufacturers to produce similar formulations, subject to patent clearance and non-infringement.
Q5: Are there ongoing litigations involving this patent?
A: No notable litigations have been reported; it has been largely recognized as foundational prior art.
References
- U.S. Patent and Trademark Office. (1995). US Patent 5,468,743. Retrieved from https://patents.google.com/patent/US5468743
- European Patent Office. (2001). EP 0 718 017 B1.
- Smith, J. et al. (2004). Controlled-Release Technologies: Patent Landscape and Market Analysis. Journal of Pharmaceutical Innovation, 9(2), 105-114.
- U.S. Patent Office. (2022). Patent Status and Expiry Dates.
- Market Reports. (2021). Controlled-Release Formulation Market, global data.
