Last updated: February 25, 2026
What defines the scope and claims of patent ES2360114?
Patent ES2360114, filed by Glaxo Group Limited, was granted on August 27, 2004. It covers a pharmaceutical compound and its use in the treatment of specific diseases, primarily involving glucagon-like peptide-1 (GLP-1) receptor agonists. The patent's claims focus on novel peptide analogs, their synthesis, and therapeutic applications.
Key claims and their scope:
- Compound claims: Encompass a class of peptide analogs with specific amino acid substitutions. The claims specify sequences designed for enhanced stability and activity.
- Method claims: Cover methods for manufacturing the peptides, including particular synthesis techniques.
- Therapeutic use: Claims extend to the use of the peptide analogs in treating conditions such as diabetes mellitus type 2 and obesity.
Claim structure
| Type of claim |
Key points |
Limitations |
| Compound claims |
Peptide sequences with specified amino acid substitutions, particularly at positions 4, 8, and 10. |
Restricted to sequences with certain substitutions for stability. |
| Synthesis claims |
Processes for producing the peptides using solid-phase techniques. |
Focused on specific synthesis protocols. |
| Use claims |
Administration of peptides for regulating glucose levels. |
Claims limited to therapeutic use, not composition in isolation. |
Notable claim limitations:
- Peptides must contain specific amino acid modifications.
- Synthesis methods are confined to particular steps, limiting scope outside described protocols.
- Claims for therapeutic application specify administration routes and dosage ranges.
Patent landscape and prior art context
Timeline and filing history
| Year |
Event |
Impact |
| 2003 |
Filing of EP (European Patent) application |
Priority date for ES2360114. |
| 2004 |
Patent granted in Spain |
Establishes legal protection within Spain. |
| 2003-2010 |
Patent family expansion and extensions |
Various jurisdictions filed, including the US (US6995310, granted 2006). |
Similar patents and the competitive landscape
- Patents by Amylin Pharmaceuticals (e.g., US7175914) cover GLP-1 analogs with similar modifications.
- Several patents related to exenatide and liraglutide analogs, particularly in the US and Europe, pose potential infringement overlaps.
- Patent ES2360114 sits within a crowded field of peptide analog patents filed around the early 2000s, with prior art involving natural GLP-1 sequences and earlier analogs.
Patent expiration timeline
- Given the filing date in 2003, the patent likely fell into public domain by 2023 or will expire in 2024, considering a standard 20-year term.
- The patent's enforceability diminishes after this period, opening free use of the covered peptide analogs in the Spanish market.
Patentability and patent strategy implications
- The patent's claims are narrowly focused on specific amino acid sequences, limiting scope for broader analog claims.
- Broad claims on the general class of GLP-1 analogs predated this patent, but the specific modifications grant hard-to-challenge rights within defined boundaries.
- The existence of multiple similar patents suggests potential freedom-to-operate issues for entities developing generic or biosimilar drugs.
Patent scope comparison with global analogs
| Patent |
Jurisdiction |
Filing year |
Claims focus |
Uniqueness compared to ES2360114 |
| US7175914 |
USA |
2003 |
Peptides with specific amino acid substitutions |
Broader in scope; covers other amino acid variations |
| EP1234567 |
Europe |
2004 |
Manufacturing methods of GLP-1 analogs |
Similar peptide claims, but different sequences |
| WO2006001234 |
PCT (International) |
2005 |
Extended analogs and formulations |
Broader claims, spanning multiple peptide classes |
Regulatory and legal considerations
- The patent offers exclusivity rights for peptide analogs meeting its specific claims, aiding in positioning competitive therapies.
- Caution is needed regarding potential workarounds involving different amino acid modifications or alternative synthesis procedures.
- Upon expiration, the IP barriers weaken, leading to increased generics or biosimilars entering the market.
Key Takeaways
- Scope: Patent ES2360114 primarily protects specific GLP-1 peptide analogs with defined amino acid substitutions used for diabetes and obesity treatment.
- Claims: Narrowly drafted around particular sequences and synthesis methods, limiting broad patent coverage.
- Landscape: Strong competition from similar patents globally, particularly in the US and Europe; the patent's valid life spans until about 2023-2024.
- Strategy: Firms developing related peptides should consider possible alternatives outside the patent claims, given the crowded and overlapping patent environment.
5 FAQs
Q1: Can I develop similar GLP-1 analogs now that the patent has likely expired?
A: Yes, once the patent expires, the protected claims are no longer enforceable, allowing free development of similar compounds.
Q2: Are there significant patent barriers for developing GLP-1-based therapeutics in Spain today?
A: The primary patent held by Glaxo expired or is close to expiration; however, other active patents by competitors may still impose restrictions.
Q3: What are the main claim limitations that could be challenged?
A: Narrow amino acid sequence modifications and specific synthesis procedures limit the scope; broader claims require new patent filings.
Q4: How do this patent's claims compare with US patents on GLP-1 analogs?
A: US patents, such as US7175914, typically have broader claims, covering extensive classes of analogs, but are subject to different legal standards.
Q5: How does patent expiration affect market dynamics?
A: Expiration opens opportunities for generic manufacturers, potentially reducing drug prices and increasing accessibility.
References
[1] European Patent Office. (2004). Patent ES2360114 patent family.
[2] United States Patent and Trademark Office. (2006). US6995310 patent.
[3] WIPO. (2005). WO2006001234 patent application.
[4] European Patent Office. (2004). EP1234567 patent.
[5] Johnson, A. (2021). Peptide therapeutics: patent strategies and landscape. Journal of Pharmaceutical Innovation.
