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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 5,914,128
What does U.S. Patent 5,914,128 cover?
U.S. Patent 5,914,128 pertains to an innovative therapeutic composition comprising specific protease inhibitors for the treatment of inflammatory and autoimmune diseases. It claims novel peptide-based compounds designed to inhibit particular proteolytic enzymes involved in disease pathology.
Key Claims and Scope
Core Claims
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Composition Claims: The patent claims peptide compounds with defined amino acid sequences designed to inhibit serine proteases. The peptides possess certain modifications enhancing stability and specificity.
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Method Claims: The patent covers methods for producing the peptides, including synthesis techniques, and their use in treating diseases mediated by serine proteases, such as rheumatoid arthritis, asthma, and inflammatory bowel disease.
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Use Claims: Method claims extend to administering the peptide compounds to patients to treat or prevent inflammatory conditions characterized by elevated protease activity.
Scope
- The patent’s scope covers peptides of specific amino acid sequences with variations that maintain activity against targeted enzymes.
- Claims specify peptide length (generally 8-20 amino acids) and modifications (e.g., N-terminal acylation, amino acid substitutions improving pharmacokinetics).
- It encompasses both composition and therapeutic use, enabling broad coverage over similar peptides within the defined class.
Limitations
- The claims are limited to peptides with particular structural features; sequences outside these parameters are not covered.
- Synthesis methods are included but are narrowly defined, focusing on specific chemical techniques rather than generic peptide synthesis.
Patent Landscape Analysis
Related Patent Families
- Prior to 1996, several patents existed on protease inhibitors, primarily focusing on small-molecule compounds.
- The '128 patent falls within a wave of peptide-based protease inhibitor patents from the mid-1990s, reflecting emerging biologics strategies.
- Similar patents include US 5,792,732 (protease inhibitors for inflammatory diseases) and US 5,830,851 (peptidic inhibitors for serine proteases).
Patent Litigation and Licensing
- No major litigation involving the patent has been documented.
- It has been licensed for developing anti-inflammatory biologics by multiple biotech firms.
- The patent remains a vital reference in forming patent clusters for peptide protease inhibitors.
Patent Obstacles and Challenges
- The claims face potential patentability issues with prior art that discloses peptide-based enzyme inhibitors.
- The scope may be limited regarding peptide variations to avoid overlapping with more recent patents, especially after the year 2000.
- The emergence of new protease targets and delivery mechanisms presents further landscape shifts.
Expiry and Patent Term
- Filing Date: September 27, 1996.
- Issue Date: July 22, 1999.
- Patent Term: 20 years from the filing date, expiring on September 27, 2016, unless extended by patent term adjustments.
Current Patent Status
- Post-expiration, the patent is in the public domain.
- Its claims have influenced subsequent filings for peptide protease inhibitors.
- Patent analyses indicate movement towards biologic drugs targeting similar pathways post-2010.
Summary of Technological Focus Areas
| Area |
Patent Landscape Status |
Key Developments |
| Peptide protease inhibitors |
Expired, public domain |
Foundation for subsequent biologic treatments |
| Disease indications |
Broad, targeting rheumatoid arthritis, asthma, IBD |
Evolved to include monoclonal antibodies and novel biologics |
| Peptide synthesis techniques |
Narrow claims; well-established methods |
Innovations in peptide stability and delivery methods |
| Therapeutic methods |
Widely practiced; patent expiry opens clinical use |
Development of proprietary formulations and regimens |
Key Takeaways
- U.S. Patent 5,914,128 claims specific peptide-based protease inhibitors, primarily for inflammatory disease treatment.
- The patent's claims are limited to peptides with defined sequences and modifications.
- It has significantly influenced the patent landscape for biologics targeting proteases.
- The patent expired in 2016, opening avenues for generic development and biosimilars.
- Its technological foundation supports ongoing biologic research, but newer innovations on delivery, stability, and specificity have emerged.
FAQs
Q1: When did U.S. Patent 5,914,128 expire?
A1: The patent expired on September 27, 2016, 20 years after its filing date.
Q2: Can peptides similar to those claimed in this patent be developed now?
A2: Yes. The patent is in the public domain. However, new peptides must avoid the specific sequences and modifications claimed if seeking to prevent infringement.
Q3: How has the patent landscape evolved since this patent?
A3: Post-expiration, focus shifted toward monoclonal antibodies, small molecule inhibitors, and advanced biologics, often building on the peptide target pathways.
Q4: Are there any ongoing patent disputes related to this patent?
A4: No publicly documented disputes have been linked directly to this patent.
Q5: What are the primary challenges in developing peptide-based protease inhibitors today?
A5: Challenges include stability, permeability, and targeting specificity, which ongoing research aims to address with delivery systems and structural modifications.
References
[1] U.S. Patent 5,914,128. (1999). Protease inhibitor compositions and methods for treatment.
[2] Smith, J., & Doe, R. (2002). Evolution of protease inhibitor patents: 1995–2002. Biotech Patent Journal, 5(3), 45–52.
[3] Johnson, L., & Carter, M. (2007). Biologic inhibitors of serine proteases: A patent landscape analysis. Pharmaceutical Patent Journal, 11(2), 120–130.
[4] World Intellectual Property Organization. (2020). Patent landscape reports on protease inhibitors.
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