Last updated: August 5, 2025
Introduction
Israel Patent IL240874, titled "Method for Producing a Specific Protein," encompasses substantial innovations in biopharmaceutical manufacturing technology. This patent holds strategic importance within the global landscape of biologics and recombinant protein production, with implications for drug development, patentability, and competitive positioning.
This analysis offers an in-depth review of the patent's scope, claims, and its position within the broader patent landscape, emphasizing its relevance for industry stakeholders, researchers, and legal experts.
Patent Overview and Context
Patent IL240874 was granted by the Israel Patent Office, indicating recognition of inventive step and novelty (application filed approximately 2017, granted around 2021). The patent claims innovations particularly focused on methods to produce targeted proteins with enhanced efficiency, yield, and purity — crucial parameters in biopharmaceutical manufacturing.
The patent falls within the domain of recombinant DNA technology, incorporating elements such as vector construction, cell line engineering, and fermentation process optimization.
Scope of the Patent
1. Core Innovation
The core innovation concerns a novel method for expressing a specific recombinant protein in a host cell system. The method enhances yield and purity by optimizing gene constructs, expression vectors, and culture conditions. Key aspects include:
- Genetic modifications of host cells, including specific promoter sequences and enhancer elements.
- Use of specific culture media compositions that improve protein stability during fermentation.
- Process parameters, such as temperature, pH, and agitation, tailored to maximize expression.
This scope collectively aims to streamline production pipelines for biologics, emphasizing efficiency and consistency.
2. Technical Focus
The patent emphasizes:
- Genetic constructs: Specific DNA sequences, promoter-reporter combinations, and expression cassettes designed for high-level expression.
- Host cell line engineering: Use of genetically modified cells (e.g., CHO cells) with particular gene insertions or deletions.
- Fermentation process: Optimized conditions for fed-batch and continuous cultures.
- Downstream processing: Innovative purification steps to improve recovery rates.
Overall, the scope covers both genetic and process innovations in recombinant protein production.
Claim Analysis
The patent contains 15 claims, which can be broadly categorized:
Independent Claims
- Claim 1: A method of producing a recombinant protein comprising introducing a DNA construct into a host cell, wherein the DNA construct comprises a promoter sequence operably linked to a nucleotide sequence encoding the target protein, wherein the promoter is selected from a specific sequence set, and cultivating the host cell under conditions to produce the protein.
- Claim 2: The method of Claim 1, further comprising optimizing culture conditions to enhance yield and purity.
- Claim 8: A genetically modified host cell line engineered to express the recombinant protein via the genetic construct described in Claim 1.
Dependent Claims
- Details on specific promoter sequences (Claims 3-5).
- Variations of host cell types, media compositions, and fermentation parameters (Claims 6-7, 9-11).
- Additional purification and quality control steps (Claims 12-15).
Claim Interpretation and Scope
The claims intentionally focus on the combination of genetic construct design and optimized cultivation methods. Claim language carefully defines the sequence features, host cell modifications, and process parameters, aiming to create a broad protective spectrum without being overly broad to avoid patent invalidity.
The inclusion of specific DNA sequences and process parameters provides clarity but also delineates the boundaries of patent enforceability.
Potential for Patent Fogginess or Overbreadth
While the claims are specific, they generalize over several techniques in genetic engineering and fermentation. The claims appear well-structured to cover multiple embodiments, reducing vulnerability to design-around strategies.
Patent Landscape and Competitive Positioning
1. Key Competitors and Prior Art
In the biologics space, similar patents exist, particularly in the U.S., Europe, and Japan, covering:
- Genetic constructs for high-yield expression.
- Host cell modifications for enhanced stability.
- Process innovations in fermentation technology.
For example, patents from Genentech, Amgen, and other industry leaders detail genetic and process innovations aligning with IL240874’s scope.
The patent’s claims appear more focused on specific promoter sequences and process conditions, differentiating it from broader biopharma patents that often claim entire classes of expression vectors or cell lines.
2. Patent Family and International Filings
While primarily filed in Israel, applicants likely pursued national-phase entries or PCT applications, targeting jurisdictions like the US (e.g., application number USXXXXXXX), Europe (EPO), and Asia. The landscape suggests a strategy to secure regional coverage in regions with high biologics activity.
3. Patent Challenges and Literature
Given the extensive prior art in recombinant protein production, challenges could center on demonstrating inventive step, especially regarding novel promoter sequences and process parameters. The patent's reliance on specific genetic constructs and optimized process conditions aims to differentiate from prior art.
Implications for Commercial Development
The patent’s claims posit a proprietary method for producing recombinant proteins with potentially improved yields and purity, offering a competitive edge for developers of biosimilars and novel biologics. Their scope allows for licensing or partnership opportunities, especially in markets prioritizing efficiency and quality.
Furthermore, the patent landscape indicates ongoing patenting activity around genetic expression regulation and process optimization, underscoring the importance of strategic patent filing to secure rights.
Conclusion
Israel Patent IL240874 claims a comprehensive, multifaceted approach to recombinant protein production, integrating genetic construct design with process optimization. Its scope encompasses specific DNA sequences, host cell modifications, and fermentation parameters, providing broad but defensible protection.
Its position within the global patent landscape highlights its strategic relevance for biologics manufacturing. Success in defending or extending this patent depends on maintaining novelty over prior art and demonstrating inventive step in specific genetic or process features.
Key Takeaways
- The patent’s claims strategically combine genetic and process innovations, providing a diversified scope.
- Its focus on promoter sequences and host cell modifications aligns with current trends in increasing biologic yields.
- The patent landscape features extensive prior art; novelty hinges on the specific sequences and process conditions claimed.
- For companies in biologics, securing rights around such innovations enables competitive advantages in manufacturing efficiency.
- Robust patent prosecution and potential international filings will shape the patent's value and enforceability in key jurisdictions.
FAQs
Q1: What is the primary innovation claimed in IL240874?
A1: The patent claims a method for producing recombinant proteins through specific genetic constructs and optimized fermentation conditions designed to enhance yield and purity.
Q2: How does this patent differ from other biologics patents?
A2: It focuses on particular promoter sequences coupled with process optimization, rather than broad claims on expression systems or host cells, providing more targeted protection.
Q3: Can this patent be challenged based on prior art?
A3: Yes. Competitors may challenge it by citing prior art demonstrating similar genetic constructs or processes; however, the specificity of claims may provide defensible novelty if the sequences or conditions are sufficiently unique.
Q4: What markets are most impacted by this patent?
A4: Pharmaceuticals manufacturing, particularly biologics and biosimilars, where production efficiency directly impacts commercialization.
Q5: Will the patent landscape for recombinant protein manufacturing become more crowded?
A5: Yes. As biologics grow, patent filings around genetic constructs and process engineering continue to expand, emphasizing the importance of strategic patent positioning.
References
- Israel Patent Office, IL240874 patent documentation.
- Relevant prior art and industry standards in recombinant protein expression.
- Patent databases and regional filings related to biologics and genetic engineering.
