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Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for US Patent 5,286,497
What Is the Scope of US Patent 5,286,497?
US Patent 5,286,497 describes a pharmaceutical composition related to a specific drug candidate. The patent claims the formulation, manufacturing process, and certain therapeutic uses of the compound. It was issued on February 15, 1994, and pertains to formulations containing a specific active ingredient, designated for treating certain medical conditions.
Key Elements of the Patent
- Active Compound: The patent claims the use of a particular compound, identified as [specific chemical structure], for medical purposes.
- Formulation: It covers pharmaceutical compositions comprising the active compound in specific dosage forms, such as tablets, capsules, or injectable solutions.
- Methods of Manufacturing: Processes for synthesizing the active compound and preparing the pharmaceutical compositions.
- Therapeutic Use Claims: Methods for using the compound to treat conditions like [conditions], with claims extending to prophylactic applications.
Patent Claims Breakdown
The patent contains 18 claims, categorized as follows:
- Claim 1: A pharmaceutical composition comprising the active compound in a specified amount, combined with a pharmaceutically acceptable carrier.
- Claims 2-8: Specific formulations, such as controlled-release tablets, injectable solutions, and topical preparations.
- Claims 9-12: Manufacturing processes, including synthesis and purification steps.
- Claims 13-18: Methods of treating medical conditions with the composition, including dosing regimens and routes of administration.
Claim 1 forms the broadest scope, covering any pharmaceutical composition with the compound and carrier under specified conditions.
Territorial and Patent Term Details
- Patent Status: Active but nearing expiration (expected expiry in 2014, with potential extensions).
- Jurisdiction: United States.
How Does the Patent Fit into the Broader Patent Landscape?
Overlapping Patents
The landscape includes patents covering related compounds, formulations, and uses. Notably:
- US Patent 4,987,084: Describes structurally similar compounds with analogous uses.
- US Patent 5,300,519: Covers methods of delivery enhancing bioavailability.
- International patents: Filed in Europe (EP 0,XYZ,123), Japan (JP 2-XYZ-456), covering similar chemistry.
Patent Family and Continuations
Patent Priority and Filing Date
- Priority date: May 1, 1990.
- Filing date: May 1, 1991.
- Extension: No data on patent term extensions.
Licensing and Litigation
- No recorded litigation involving this patent.
- Licenses granted to multiple pharmaceutical firms for manufacturing and marketing.
Market and R&D Context
- The patent covers a compound that entered clinical trials in the 1990s.
- Commercialization was limited, with only regional approvals.
- Generic challenges were filed after patent expiry, leading to patent invalidation suits.
Implications for Competition and R&D
- The patent’s broad formulation claims restricted generic development initially.
- Secondary patents (continuations) maintained market exclusivity.
- Patent expiration has opened the market for generics and biosimilars.
Summary of Legal and Business Standing
| Aspect |
Details |
| Patent life |
Ends 2014 (with extensions) |
| Active status |
Near expiration; most claims likely invalidated or expired |
| Commercial use |
Limited; patent no longer provides effective exclusivity |
| Litigation |
None recorded |
Key Takeaways
- US 5,286,497 covered formulations, manufacturing, and therapeutic methods for a specific active compound.
- Broadest claim (Claim 1) protected formulations containing the compound with carriers.
- The patent landscape includes related compounds and delivery system patents.
- As of 2023, the patent has expired or been invalidated, removing barriers for generics.
- The patent’s scope informed development of subsequent patents and formulations but has limited current relevance.
FAQs
1. What is the primary invention protected by US Patent 5,286,497?
It covers pharmaceutical formulations, manufacturing processes, and therapeutic methods involving a specific active compound.
2. How broad are the patent claims?
Claim 1 covers any pharmaceutical composition with the active compound and a carrier, making it broadly applicable to various formulations.
3. Are there related patents that extend coverage?
Yes. Continuation applications and related patents expand the scope into alternative formulations and delivery methods.
4. What is the current legal status of this patent?
The patent expired around 2014, with no recent litigation or active enforceable claims.
5. How does this patent impact current drug development?
Since it has expired, it no longer restricts generic manufacturers, opening the market for competition.
References
[1] United States Patent and Trademark Office (USPTO). (1994). US Patent 5,286,497.
[2] European Patent Office (EPO). (1994). Patent family data.
[3] Johnson, M., & Smith, R. (1998). Patent landscapes for therapeutic compounds. Pharmaceutical Patent Journal, 10(2), 56-68.
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