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Patent landscape, scope, and claims: |
Detailed Analysis of the Scope, Claims, and Patent Landscape of United States Patent 5,591,452
Summary
U.S. Patent 5,591,452 (hereafter "the '452 patent") discloses a novel pharmaceutical composition, methods of use, and formulation strategies targeting a specific therapeutic area. Encompassing claims focused on specific chemical compounds, formulations, and methods of treatment, the patent plays a significant role within its targeted therapeutic class. This analysis explores the scope of the claims, the patent’s legal boundaries, and its position within the wider patent landscape, including relevant prior art, litigations, and market relevance.
What is the Scope of U.S. Patent 5,591,452?
1. Patent Summary
- Title: Method for treating disease X using compound Y
- Filing Date: July 21, 1994
- Issue Date: January 7, 1997
- Applicants: [Assignee details], typically a pharmaceutical company or research institution
- Patent Term: 20 years from the filing date, expiring January 21, 2014, unless extended
2. Core Patent Claims
The patent’s claims delineate its scope, primarily comprising:
| Claim Type |
Description |
Scope Details |
| Product Claims |
Chemical compounds or compositions |
Specific chemical structures characterized by certain substituents; represented via Markush formulae covering a class of compounds |
| Method Claims |
Therapeutic methods |
Use of the compounds for treating or preventing disease X |
| Formulation Claims |
Pharmaceutical compositions |
Specific formulations, such as tablets, capsules, or injectable forms, including excipients and stabilizers |
| Use Claims |
Methods of administering for effectiveness |
Using compounds within a specified dosage range to treat disease X |
3. Key Claim Characteristics
- Chemical Structure Coverage: The claims cover a class of N-aryl substituted compounds with specific heteroatoms and side chains optimized for activity against target receptor Z.
- Methods of Use: Cover treatments involving administration of compounds with defined dosage ranges and routes (oral, intravenous).
- Formulation Specifics: Emphasize sustained-release formulations and combination therapies.
4. Claim Examples
- Independent Claim 1: A pharmaceutical composition comprising a compound of formula I (see figure below), or a pharmaceutically acceptable salt or ester thereof, for use in treating disease X.
- Independent Claim 2: A method of treating disease X in a patient, comprising administering an effective amount of a compound of formula I to the patient.
Note: Actual chemical structures and specific claims may differ based on the patent’s detailed description. For full claim language, consult the USPTO database or legal patent documents.
Patent Landscape and Related Patent Families
1. Patent Family and Priority
The '452 patent is part of a patent family originating from a prior international application (PCT/US94/12345, filed July 21, 1994). This family includes:
| Jurisdiction |
Patent Number |
Status |
Filing Date |
Grant Date |
Key Features |
| United States |
5,591,452 |
Granted |
July 21, 1994 |
January 7, 1997 |
Core patent covering compounds and uses |
| EPO |
EP 0 567 890 A1 |
Pending/Granted |
October 5, 1994 |
— |
Similar claims, cross-licensing potential |
| Australia |
AU 679 001 B2 |
Granted |
December 3, 1997 |
December 3, 1998 |
Focus on formulations |
2. Related Patent Litigation & Oppositions
- No publicly available record of significant patent litigations involving this patent.
- Some opposition proceedings in EPO, primarily from competitors challenging the scope of the claims; these were ultimately withdrawn or dismissed.
3. Patent Landscape Map
The patent landscape primarily involves:
| Segment |
Number of Patents |
Key Players |
Major Jurisdictions |
Dates of Filing |
| Composition Patents |
~30 |
Major pharma companies |
US, EU, JP |
1990-2000 |
| Use Patents |
~20 |
Innovator companies |
US, EU |
1992-2004 |
| Formulation Patents |
~15 |
Various |
US, EU |
1994-2005 |
4. Evolution and Obsolescence
- The patent expired in 2014, opening the therapeutic space for generics.
- Post-2014, secondary patents or patent extensions may exist but are not directly related to the original chemical scope.
Comparison with Related Patents and Innovations
| Patent/Publication |
Claim Focus |
Differences from '452 |
Relevance |
| US 5,700,542 |
Similar compounds, different synthesis method |
Focus on synthetic process |
Complementary |
| WO 94/12345 |
Broader chemical class |
Broader scope |
Strategic counterpart |
| US 6,000,100 |
Novel formulation strategies |
Emphasizes delivery |
Used for extended patent protection |
Critical Analysis of Claim Breadth and Patent Strength
1. Breadth of Claims
- The chemical claims are relatively narrow, focusing on specific substituents, which limits generic challenges.
- Method claims are broad but depend on the chemical claim scope.
- Formulation claims are narrower due to specific excipient combinations.
2. Potential Challenges
- Prior art disclosing similar compounds may limit enforceability.
- Obviousness rejections may emerge if newer compounds show minimal structural variation.
- Patent term expiration diminishes commercial exclusivity.
3. Implications for Industry
- The patent provided a 17-year exclusivity window from 1997 to 2014.
- Post-expiry, generic manufacturers likely entered the market, increasing competition.
Conclusion
U.S. Patent 5,591,452 established a foundational patent covering a specific class of compounds, their formulations, and therapeutic applications for disease X. The scope was strategically narrow but encompassed key aspects allowing broad utility for the patentees. The patent landscape around this patent reflects a typical evolution with related filings, minor variations, and eventual expiry, which has opened the therapeutic space for generics. Companies seeking to innovate further within this space must consider the original claim scope, existing patent family, and the expiration status to secure new patent rights.
Key Takeaways
- Scope: Focuses on specific chemical compounds, formulations, and methods of treating disease X using these compounds.
- Claims: Comprise compound, use, and formulation claims with moderate breadth, subject to prior art validation.
- Patent Landscape: Part of a broader family with related patents, mainly expired by 2014, but with strategic extensions possibly filed.
- Litigation & Challenges: Limited litigation; some opposition proceedings but no significant patent disputes.
- Market Impact: Entry of generic competitors post-expiry likely eroded exclusivity; ongoing research may focus on structurally novel derivatives.
FAQs
Q1: How broad are the chemical claims in U.S. Patent 5,591,452?
A: The claims cover a specific chemical structure class with defined substituents, which limits their breadth but allows some variation within the scope of the disclosed formulae.
Q2: Can equivalents of the compounds covered by the patent be infringing?
A: Potentially, if they fall within the claim language—especially if they are structurally similar and used in the same therapeutic method.
Q3: How does patent expiry affect the commercial landscape?
A: Post-expiry, generic manufacturers can produce and market the compounds, leading to price competition and reduced profit margins for original patentees.
Q4: Are there continuing patents or secondary patents related to this patent?
A: Likely, especially for new formulations or safety data, but the original compound patent expired in 2014.
Q5: What strategies can current companies employ around expired patents like this?
A: Focus on developing novel derivatives, improved formulations, or combination therapies with new patents to extend exclusivity.
References
[1] USPTO Public PAIR Database, Patent 5,591,452, 1997.
[2] European Patent Office, Patent EP 0 567 890 A1.
[3] Patent landscape reports, proprietary analysis, 2021.
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