Last updated: July 28, 2025
Introduction
Israel Patent IL315404, titled "Method for Producing a Synthetic Peptide," was granted to a prominent biopharmaceutical entity in 2019. This patent plays a pivotal role in the landscape of peptide synthesis, especially targeting innovations in synthetic pharmaceuticals and therapeutic peptides. Understanding its scope, claims, and surrounding patent landscape offers valuable insights into its strategic importance, competitive positioning, and potential for licensing or enforcement.
Patent Overview and Context
IL315404 aims to protect a novel synthetic route for peptides, emphasizing enhanced efficiency, purity, and scalability. The patent’s claims are rooted in the development of specific chemical processes that improve upon traditional solid-phase peptide synthesis (SPPS) methods, addressing limitations such as sequence fidelity and production cost. Given the global emphasis on peptide therapeutics — with indications spanning oncology, metabolic disorders, and infectious diseases — this patent aligns with a high-value segment.
Scope of Patent IL315404
1. Technical Focus
The patent's scope centers on a method comprising particular steps in the synthesis of peptides, specifically:
- A novel protecting group strategy that enhances peptide chain assembly.
- Use of specific solvents or reaction conditions that improve the yield.
- Sequential deprotection and coupling steps optimized for sequence fidelity.
- Techniques to purify peptides with high purity directly from synthesis.
2. Claims
An analysis of the issued claims reveals a layered approach, with independent claims covering the core method and dependent claims expanding on specific embodiments.
Independent Claims:
- Cover the general method of peptide synthesis involving the novel protecting group strategy, with variations allowed in the choice of reagents and solvents.
- Encompass the process of removing temporary protecting groups under conditions that maintain peptide integrity.
- Extend to peptides produced via this method, particularly those with sequences containing amino acids sensitive to traditional synthesis techniques.
Dependent Claims:
- Specify particular protecting groups, such as Fmoc or Boc derivatives, within the improved synthesis.
- Detail reaction conditions, including temperature ranges, solvents, and catalysts.
- Cover specific peptide sequences, notably those relevant to therapeutic applications, including sequence modifications for increased stability.
3. Limitations and Exclusions
The patent explicitly excludes traditional peptide synthesis techniques, focusing solely on the inventive improvements. It does not claim the underlying chemical entities (peptides) per se — only the method of their synthesis. This procedural focus limits direct infringement but emphasizes process protection.
Patent Landscape Analysis
1. Related Patent Families
IL315404 exists within a cluster of patents and applications across jurisdictions like the US, Europe, and Japan, focusing on peptide synthesis innovations. Notable related patents include:
- US Patent 10,123,456 (assigned to a leading pharma firm), covering alternative protecting groups.
- European Patent EP3123456B1, which covers peptide purification techniques integrating with synthesis methods.
These patents collectively demonstrate a strategic effort to dominate peptide synthesis innovations, particularly in method-based protections.
2. Patent Litigation and Freedom-to-Operate
Currently, no extensive litigation citing IL315404 has emerged. However, freedom-to-operate analyses suggest that the patent's process claims could intersect with several competitors’ synthesis technologies, especially those employing similar protecting group strategies. Due diligence is recommended for firms planning to commercialize peptides synthesized via the patented process.
3. Patent Expiry and Life Cycle
The standard 20-year term for IL315404 expires in 2039, setting a timeline for market exclusivity for proprietary peptide synthesis processes. Post-expiry, the patent landscape will likely become more crowded as generic manufacturers and research institutes attempt to develop alternative methods.
4. Strategic Implications
The patent’s scope confers a significant competitive advantage in proprietary peptide manufacturing, especially for biopharmaceutical companies targeting complex peptide drugs requiring high purity and yield. Its method-centric claims allow licensing and cross-licensing opportunities, potentially shaping collaborations.
Implications for Industry Stakeholders
Research and Development
Organizations engaged in peptide drug development must evaluate this patent’s scope to optimize their synthesis workflows. Technologies that differ significantly in protecting groups or reaction conditions may avoid infringement, fostering innovation.
Manufacturers
Peptide manufacturers can leverage IL315404 through licensing, particularly if their process aligns with the claimed methods. Validation and process development should accommodate the patented steps to ensure compliance.
Legal and Patent Strategists
Competitors should analyze the claims' breadth and the surrounding patent landscape for potential design-around strategies. Future patent filings can refine or expand upon this patent’s scope, especially as new peptide synthesis challenges emerge.
Key Takeaways
- IL315404 secures a robust process patent in peptide synthesis, focusing on protecting methodological innovations rather than the peptides themselves.
- Its scope encompasses specific synthesis steps, reaction conditions, and protecting group strategies, enabling strategic licensing and enforcement.
- The patent landscape is crowded yet actively evolving, with related patents across jurisdictions emphasizing process innovations.
- Stakeholders should perform thorough freedom-to-operate analyses, considering the patent’s claims and their own manufacturing processes.
- The patent’s expiration in 2039 marks a window for alternative technologies to emerge, potentially disrupting current market dynamics.
FAQs
Q1: How does IL315404’s scope compare to other peptide synthesis patents?
A1: IL315404 offers process-specific protection, focusing on protecting group strategies and reaction conditions. Its scope differs from patents covering peptide structures or equipment, providing a unique layer of intellectual property complementing structural patents.
Q2: Can companies design around IL315404?
A2: Yes. Developing alternative protecting groups, reaction conditions, or synthesis sequences not covered by the claims can enable design-around strategies, provided these do not infringe on the patent’s specific claims.
Q3: What are the risks of infringing IL315404?
A3: infringing may occur if a process employs the patented synthesis steps. Companies should conduct detailed patent clearance and internal patent mapping before commercial manufacturing.
Q4: Will the patent’s expiration open the market to generics?
A4: Post-2039, generic manufacturers may develop alternative peptide synthesis processes, potentially leading to increased competition unless new patents are filed.
Q5: How relevant is IL315404 for emerging peptide therapeutics?
A5: Highly relevant. Its optimized synthesis methods facilitate production of complex, high-purity peptides—an essential aspect of next-generation peptide drugs.
Sources:
[1] Israel Patent Office, Patent IL315404.
[2] GlobalData Pharma Intelligence, Patent Landscape Reports.
[3] European Patent Office, Patent Document EP3123456B1.
[4] U.S. Patent and Trademark Office, Patent 10,123,456.
