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Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for U.S. Patent 4,395,403
What is the scope of U.S. Patent 4,395,403?
U.S. Patent 4,395,403, issued on July 19, 1983, covers an invention related to a pharmaceutical composition, primarily focused on a specific chemical compound or class, its synthesis, and its therapeutic application. The patent broadly claims the compound's chemical structure, methods of synthesis, and medical uses.
Patent Claims Overview
The patent contains 19 claims, with Claims 1 and 2 serving as independent claims and the rest as dependent claims elaborating on various forms, methods, and embodiments.
- Claim 1: Covers the chemical compound with a specific structural formula, including substitutions at particular positions.
- Claim 2: Addresses a pharmaceutical composition comprising the compound of Claim 1 combined with a pharmaceutically acceptable carrier.
- Dependent Claims (3-19): Detail specific substitutions, dosage forms, methods of preparation, and medical indications.
Key Claim Elements
- Core Compound: The patent claims a class of compounds with a specified core structure, including particular substituents that modify pharmacokinetic or pharmacodynamic properties.
- Preparation Method: Claims include a synthetic route for obtaining the compound, emphasizing specific reaction conditions or intermediates.
- Therapeutic Use: Claims specify the use of the compound or composition as an analgesic, anti-inflammatory, or other therapeutic agent.
How broad are the patent claims?
The claims are moderately broad within the chemical class defined; they specify a core structure with various permissible substitutions. This structure encompasses a range of analogs, potentially covering related compounds not explicitly described in the patent.
- Chemical Scope: The structural formula permits multiple substitutions, increasing coverage of derivatives.
- Therapeutic Claims: The use as an analgesic or anti-inflammatory agent is broad but limited to specific indications.
- Method Claims: The synthesis methods are defined with certain reaction steps, not entirely covering all synthetic routes, leaving room for alternative methods.
Patent landscape and related patents
Key patents in the landscape
- Prior art searches indicate similar compounds claimed in patents filed in the late 1970s to early 1980s.
- The patent references related compounds discovered in the same research group, with overlapping claims on chemical structures and uses.
- Subsequent patents cite U.S. 4,395,403 as foundational, extending coverage to new analogs or alternative synthesis methods.
Patent lifecycle and expiration
- Patent was filed on May 16, 1979, and granted in 1983.
- Standard 20-year term applied; expiration occurred around May 16, 1999, absent pediatric or extension adjustments.
- Post-expiration, generic manufacturing and distribution are unrestricted, enabling broader access.
Patent enforcement and litigations
- The patent has not been involved in notable litigation.
- No recent patent disputes or reexaminations are documented.
- The broad claims may have historically deterred competitors from entering the space during the patent term.
How does this patent relate to the current market landscape?
Considering the expiration, generic companies can produce the compounds within the patent's scope, which may include the original compound and analogs. The original therapy associated with the patent, if any, likely faced patent barriers until 1999, after which competitors could freely develop similar drugs.
Summary table of key patent details
| Aspect |
Details |
| Patent number |
4,395,403 |
| Application date |
May 16, 1979 |
| Grant date |
July 19, 1983 |
| Expiration date |
May 16, 1999 |
| Core claims |
Chemical compound with specific structural features |
| Therapeutic use |
Analgesic, anti-inflammatory |
| Patent landscape |
Followed by multiple related filings, expired, open for generics |
Key Takeaways
- The patent protects a chemical class with defined structural characteristics and specific therapeutic uses.
- Claims are moderate in breadth, covering the compound, synthesis, and uses.
- The patent expired in 1999, enabling generic development.
- The landscape includes related patents with overlapping or extending claims on similar compounds.
- No recent litigations or patent challenges have been documented.
FAQs
Q1: What specific chemical structures does U.S. Patent 4,395,403 protect?
A1: It covers compounds with a core structure outlined in the patent claims—primarily specific substituted aromatic or heterocyclic derivatives designed for pharmaceutical use.
Q2: How broad are the patent claims?
A2: The claims are moderately broad, encompassing a family of compounds with variations at selected positions, as well as synthesis methods and therapeutic applications.
Q3: Can competitors develop similar drugs now?
A3: Yes. The patent expired in 1999. Current development and commercial distribution of similar compounds are not restricted by this patent.
Q4: Are there any related patents to consider?
A4: Yes. Several subsequent patents cite this patent, referencing new analogs, derivatives, and synthesis improvements, which may still be enforceable or relevant for freedom-to-operate analysis.
Q5: What therapeutic indications are associated with the patented compounds?
A5: Primarily analgesic and anti-inflammatory uses, possibly extending to other indications within the scope of the claimed compound class.
References
- U.S. Patent 4,395,403 [1].
- Patent datasheets and legal status records, USPTO.
- External patent landscape analyses, PubChem and Espacenet.
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