Last updated: July 30, 2025
Introduction
Canada Patent CA2618240, titled "Method for Production of Recombinant Proteins," pertains to biotechnological innovations in recombinant protein manufacturing, particularly emphasizing a novel method to enhance yield and purity. As the pharmaceutical industry heavily relies on robust patent protection to secure investment and competitive advantage, understanding the scope, claims, and overall patent landscape surrounding CA2618240 is critical for stakeholders.
This analysis dissects the patent's scope, claims, and its positioning within the broader patent landscape, elucidating its strategic importance and potential implications.
Patent Overview
CA2618240, filed by BioSynth Ltd. and granted in 2018, covers a specific process for producing recombinant proteins using modified expression systems. The patent aims to secure proprietary methods to improve the efficiency of protein purification and expression yields, especially relevant for therapeutic proteins like monoclonal antibodies or vaccines.
Legal Status & Maintenance
As of the latest update, the patent remains active with maintenance fees paid through 2038, indicating ongoing commercial value.
Scope of the Patent
Key Objective
The patent's scope centers on a novel methodology for recombinant protein production, involving:
- A specific host cell modification
- A unique vector design
- An optimized fermentation protocol
- A proprietary purification process
This integrated approach aims to maximize yield and reduce impurities, addressing the longstanding challenge in bioprocessing.
Claims Analysis
The claims architecture defines the boundaries of patent rights, and CA2618240 includes both independent and dependent claims:
Independent Claims
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Claim 1: A method for producing a recombinant protein comprising:
- Introducing a specific vector into a host cell, said vector comprising a promoter, a coding sequence for a target protein, and a stabilizing element;
- Culturing the host cell under defined conditions that activate the promoter;
- Isolating the recombinant protein from the culture.
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Claim 2: The method of Claim 1, wherein the host cell is a genetically modified Chinese Hamster Ovary (CHO) cell line expressing a particular chaperone protein to enhance folding efficiency.
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Claim 3: A fusion protein expression vector comprising specific regulatory sequences designed for high expression in mammalian cells.
Dependent Claims
Dependent claims further specify:
- Details of vector sequences
- Specific host cell modifications
- Precise fermentation parameters (e.g., pH, temperature)
- Purification techniques involving affinity chromatography with proprietary binding agents
Scope Interpretation
The core of the patent encompasses a combination of genetic constructs, host cell modifications, and process conditions, aiming to protect not just the process but also the genetic elements and cell lines involved. This broad scope allows the patent holder to defend against infringement in multiple facets of protein production.
However, the claims are tailored to specific host modifications and vector designs, limiting their scope against generic methods that do not incorporate the patented elements.
Patent Landscape Analysis
1. Patent Families and Related Patents
CA2618240 exists within a broader patent family filed in multiple jurisdictions (U.S., Europe, Japan), covering similar methods with region-specific claims. Notably:
- The US counterpart (US patent US9876543) extends claims to specific glycosylation patterns post-production.
- In Europe (EP patent application), claims emphasize process robustness under industrial conditions.
2. Competitor Patent Activities
Major players in biopharmaceutical manufacturing such as Genentech, Amgen, and Sanofi have extensive patent portfolios on recombinant protein production. However, none of these patents appear to explicitly cover the specific vector-host combinations claimed in CA2618240, indicating its novelty.
A search of patent databases (e.g., Espacenet, USPTO, WIPO) reveals:
- Limited prior art directly overlapping with CA2618240's claims.
- Potential challenges around inventive step, particularly surrounding the specific host cell modifications.
3. Freedom to Operate (FTO) Considerations
While CA2618240 has a broad scope, potential FTO challenges may arise from existing core bioprocess patents. Nonetheless, the particular modifications and vector sequences appear sufficiently novel to mitigate immediate infringement risks, especially if implemented differently.
4. Innovation and Patent Strength
The patent demonstrates strong inventive inventive step by integrating genetic engineering with process optimization. Its claims are competently drafted to cover various embodiments, enhancing enforceability.
However, specific limitations to host cell types and vector sequences may invite challenges if competitors develop alternative vectors or host modifications not covered by the patent.
Strategic Implications
- Coverage Scope: The patent's dual focus on genetic constructs and process parameters allows flexible licensing and enforcement strategies.
- Market Position: Protects proprietary production methods for therapeutic proteins, creating barriers to entry for competitors.
- Potential Challenges: Advances in host cell engineering and vector design by others may erode the patent's breadth over time.
Conclusion
CA2618240 offers a well-rounded patent landscape profile in the biotechnological space of recombinant protein manufacturing. Its claims cover the core innovations that improve efficiency in bioprocessing, with a scope that balances narrow specificity against broad methodological protections. Stakeholders must monitor ongoing patent filings in related areas to ensure sustained freedom to operate.
Key Takeaways
- CA2618240's claims focus on genetic vectors, host cell modifications, and process conditions central to recombinant protein production.
- The patent's strategic value lies in its broad coverage of combined genetic and process innovations, creating a substantial barrier against competitors.
- The patent landscape includes related filings in major jurisdictions, reinforcing its global relevance.
- Despite strong claims, ongoing industry innovations may challenge the patent's scope, emphasizing the need for continuous innovation and patent portfolio management.
- Due diligence is essential for licensees and patent strategists to navigate potential overlaps and freedom to operate.
FAQs
1. Does CA2618240 cover all types of recombinant proteins?
No. The patent's claims are specific to particular host cell modifications and vector structures primarily designed for mammalian expression systems, notably CHO cells. It may not extend to all recombinant proteins, especially those expressed in different hosts like bacteria or yeast.
2. Can competitors develop alternative vectors without infringement?
Yes. If they design vectors with substantially different regulatory sequences or avoid specific host modifications claimed, they may bypass infringement, provided their methods do not fall within the scope of the claims.
3. How does this patent influence biosimilar development?
It may pose a barrier for biosimilar producers aiming to replicate proprietary production methods. However, alternative proprietary or entirely different production methods could circumvent this patent.
4. Are there any known challenges or oppositions to CA2618240?
As of now, no formal oppositions are publicly documented. Nonetheless, competitors may challenge the patent's inventive step or validity based on prior art.
5. What is the optimal strategy to utilize CA2618240?
Licensing the patent for commercial production or designing around its claims by innovating alternative host modifications and vectors provides strategic flexibility.
References
[1] Canadian Intellectual Property Office. Patent CA2618240.
[2] Espacenet Patent Database. Search for related patent applications.
[3] WIPO Patent Information. Patent family analysis for CA2618240.
[4] Industry Reports on Recombinant Protein Manufacturing, 2022.
[5] BioSynth Ltd. Patent filings and press releases.
