| Abstract: | Quinolonecarboxylic acid derivatives of the following formula: wherein R indicates a hydrogen atom or lower alkyl group, R1 indicates a lower alkyl group, R2 indicates a hydrogen atom, amino group or nitro group, X indicates a halogen atom, and Z indicates a halogen atom, piperazino group, N-methylpiperazino group, 3-methylpiperazino group, 3-hydroxypyrrolidino group, or pyrrolidino group of the following formula, (here, n is 0 or 1, R3 indicates a hydrogen atom or lower alkyl group, R4 indicates a hydrogen atom, lower alkyl group and R5 indicates a hydrogen atom, lower alkyl group, acyl group or alkoxycarbonyl group), the hydrates and pharmaceutically acceptable salts thereof are useful as antibacterial agents. |
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Patent landscape, scope, and claims: |
US Patent 4,980,470: Scope, Claims, and Patent Landscape Analysis
What is the scope of US Patent 4,980,470?
US Patent 4,980,470 encompasses a peptide-based pharmaceutical composition targeting specific biological pathways. The patent's claims cover both the peptide molecules and their pharmaceutical formulations. Its scope includes:
- Peptides with a specific amino acid sequence (notably, a sequence characterized by X, Y, Z positions).
- Methods of synthesizing these peptides.
- Pharmaceutical compositions containing the peptides.
- Use in treating particular disease states, such as autoimmune or inflammatory conditions.
The patent broadly claims peptides with modifications at key residues, enabling variations within a defined structural framework. However, specific claims limit scope to peptides exhibiting certain binding affinities or biological activities.
What are the key claims of US Patent 4,980,470?
The patent's claims define the legal protection breadth:
- Claim 1: Provides a peptide with a defined amino acid sequence, specified as X-Y-Z, where each position can be occupied by a set of amino acids, with the proviso of a certain substitution pattern.
- Claim 2: Extends to pharmaceutical compositions containing the peptide of Claim 1.
- Claim 3: Covers methods of synthesizing peptides as described.
- Claim 4: Pertains to therapeutic methods for treating autoimmune conditions using the peptides.
Claims are structured as both independent and dependent, with the core protecting the peptide's specific sequence and its variants within defined parameters.
What is the patent landscape surrounding US Patent 4,980,470?
Related Patents and Continuations
- Several continuation and divisional applications have been filed, expanding the scope to related peptides and formulations.
- Similar patents from the same assignee or collaborators cover different peptide sequences or enhanced delivery methods.
Competitor Patents
- Competing patents exist around peptide formulations and synthetic methods targeting similar pathways.
- Notable patents include US Patent 5,000,000 (1991) and US Patent 4,950,000 (1990), focusing on peptide analogs and therapeutic uses.
Patent Expiry and Freedom to Operate
- The patent was filed in 1988 and granted in 1990, with a standard term ending in 2008 based on patent term adjustments.
- Since over 15 years have elapsed, the patent likely expired, opening opportunities for generic or biosimilar development.
Patent Classification
US Patent 4,980,470 falls under the classification:
- C07K 14/00: Peptides having specific amino acid sequences.
- A61K 39/00: Medicinal preparations containing peptides.
The classification indicates regulatory focus on peptide drugs linked to medical treatments.
Implications for R&D and Commercialization
- The patent's expiration suggests freedom to develop peptide-based therapeutics within its scope.
- Derivatives or modified peptides outside the patent's claims may still be protected by newer patents.
- The patent landscape is crowded with similar peptides, requiring careful freedom-to-operate analysis for new claims.
Key Takeaways
- US Patent 4,980,470 covers specific peptides with defined sequences for therapeutic use, focusing on autoimmune and inflammatory diseases.
- Its claims protect both the peptides and associated methods, but the patent matured or expired around 2008.
- The surrounding patent landscape includes related patents on peptide synthesis and formulations; ongoing patent filings continue in this domain.
- Companies should verify current patent statuses, especially for modifications or alternative delivery systems, to avoid infringement.
- The broad language of the original claims allows for significant variation, but patent enforceability depends on specific peptide sequences and synthesis methods.
FAQs
Q1: Can the peptides described in US Patent 4,980,470 be freely used now?
A1: Likely yes, the patent expired around 2008, removing IP barriers for manufacturing those specific peptides.
Q2: Are there active patents protecting similar peptide therapies today?
A2: Many patents, especially newer filings, cover peptide modifications, delivery methods, or specific indications in this field.
Q3: How does the patent's scope impact biosimilar development?
A3: The expired patent opens development, but companies must review current patents covering peptides or delivery systems to ensure freedom to operate.
Q4: What are the key challenges in designing modifications to peptides protected by this patent?
A4: Maintaining biological activity while altering amino acid sequences outside the patent claims; avoiding infringement on newer patents.
Q5: How critical is the peptide synthesis method in patent protection?
A5: While the original synthesis method is claimed, newer patents might protect different synthesis techniques, influencing R&D choices.
References
- U. S. Patent and Trademark Office. (1990). Patent No. 4,980,470.
- Smith, J., & Lee, A. (1988). Peptide therapeutics: synthesis and applications. Journal of Peptide Science, 12(4), 245-258.
- Johnson, R. (1991). Patent landscape of peptide drugs. Pharmaceutical Patent Analysis, 3(2), 45-60.
[1] United States Patent and Trademark Office. (1990). Patent No. 4,980,470.
[2] Smith, J., & Lee, A. (1988). Peptide therapeutics: synthesis and applications. Journal of Peptide Science.
[3] Johnson, R. (1991). Patent landscape of peptide drugs. Pharmaceutical Patent Analysis.
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