Last updated: August 4, 2025
Introduction
Patent AU2009224895, titled "A method of producing a recombinant protein", was granted by the Australian Patent Office and pertains to biotechnological methods related to recombinant protein production. This patent occupies a strategic position within the pharmaceutical and biopharmaceutical landscape, primarily targeting innovations in the manufacturing of recombinant proteins used in therapeutics, diagnostics, and research.
This analysis provides a comprehensive review of the scope and claims of AU2009224895, scrutinizing the technological breadth, boundaries of its protections, and its position within the evolving patent landscape. Such insights enable stakeholders — including pharmaceutical companies, biotech firms, and legal professionals — to assess the patent's strength, potential for overlapping rights, and strategic implications.
Patent Overview
Patent Number: AU2009224895
Filing Date: December 2009
Publication Date: December 23, 2009
Priority Date: December 23, 2008 (PCT International Application PCT/AU2008/001520)
Applicant: CSL Limited, a globally recognized biopharmaceutical company
This patent claims a novel method for producing recombinant proteins, focusing on specific aspects of cell culture, vector design, and purification processes to improve yield and stability.
Scope and Claims
1. Core Innovation
The patent primarily covers a method of producing recombinant proteins involving a specific expression system, characterized by:
- Use of particular host cells (e.g., mammalian cells such as CHO cells)
- Specific genetic constructs encoding the protein of interest
- Optimized culture conditions to enhance protein expression and stability
- Techniques for purification to improve yield and purity
2. Claims Structure
The claims are categorized into independent and dependent claims, encompassing:
- Independent Claims: Core methods involving engineered host cells containing the recombinant gene and optimized culture conditions.
- Dependent Claims: Variations including specific vectors, promoters, host cell modifications, culture parameters, and purification techniques.
3. Key Claims Analysis
- Claim 1: A method comprising contacting a host cell—engineered to contain a gene encoding the recombinant protein—with specific culture conditions to produce and recover the protein. This broad claim forms the backbone of the patent.
- Claim 2-5: Particular embodiments detail vector design, such as the use of a cytomegalovirus (CMV) promoter, modifications to host cells (e.g., gene knockouts to enhance protein stability), and specific culture parameters like pH, temperature, and feeding strategies.
- Claim 6-10: Emphasize purification steps—chromatography, filtration, or other techniques—to improve product quality.
- Claims 11-15: Encompass the recombinant proteins produced via the described methods, asserting product claims distinct from process claims.
4. Scope of Protection
The patent's claims are directed toward both the methods and products. The method claims are relatively broad—covering a range of host cells, vectors, and culture conditions—yet also contain narrower dependent claims that specify particular biological systems and parameters. The product claims extend protection to recombinant proteins produced by these methods.
5. Limitations and Potential Challenges
- Specificity of claims: Many claims are specific to certain vectors or host cell lines, which could limit their scope against alternative methods or systems.
- Prior art considerations: The range of existing recombinant protein production patents requires case-by-case analysis; overlapping prior art could narrow enforceability.
- Biotech evolution: The rapid development of new expression systems (e.g., plant, insect, or novel mammalian cell lines) may circumvent the patent's scope.
Patent Landscape and Competitive Position
1. Key Competitors and Similar Patents
- The landscape features numerous patents around recombinant protein production, especially in Chinese, US, and European jurisdictions.
- CSL Limited’s patent shares similarities with other biotech patents focusing on expression vectors, cell lines, and culturing techniques—potentially leading to infringement litigation or licensing negotiations if competitors develop similar methods.
2. Patent Families and Related Rights
- The AU2009224895 patent is part of a larger family of patent rights, including applications in Europe (EP), United States (US), and Asia. These family members often have corresponding claims covering significant aspects of recombinant protein manufacture, enhancing CSL’s global IP protection.
- The patent family allows for strategic enforcement in markets with high biotech activity, notably the US and Europe.
3. Expiry and Maintenance
- The term of AU2009224895 lasts 20 years from the earliest priority date—i.e., until December 2028—subject to annuity payments and maintenance fees.
- The patent's enforceability period remains critical for commercial exclusivity, particularly as biosimilar development accelerates.
Strategic Implications
- The combination of broad process claims and specific product claims provides CSL with robust protections for recombinant protein manufacturing.
- The patent’s scope potentially blocks competitors from deploying similar expression and purification protocols, especially in the Australian market and possibly in counterpart jurisdictions.
- The patent landscape underscores the importance of monitoring for competing process patents, particularly those claiming alternative cell systems or vectors.
Conclusion
AU2009224895 holds a significant position within the biotechnological patent landscape, offering broad process claims and specific product protections for recombinant protein production methods. Its strategic value lies in safeguarding CSL’s core manufacturing processes, especially for therapeutic proteins such as clotting factors and other biotherapeutics.
However, the patent’s effectiveness depends on vigilant monitoring of evolving prior art and competing patents. As the biopharmaceutical industry advances with new expression systems, the scope of this patent must be contextualized within a broader portfolio to sustain market exclusivity.
Key Takeaways
- Robust but specific: The patent claims cover comprehensive recombinant protein production methods involving specific vectors, host cells, and culture conditions, providing a solid protection framework.
- Strategic landscape positioning: It is part of a broader IP portfolio, crucial for CSL’s global manufacturing and licensing strategies.
- Limited by scientific evolution: Emerging expression technologies could circumvent scope, emphasizing the importance of continuous innovation and patent updates.
- Potential for litigation or licensing: The patent’s broad claims invite both enforcement and licensing negotiations in competitive markets.
- Expiry approaching: The patent's protection period extends to December 2028; planning for lifecycle management before expiry is critical.
FAQs
1. What is the primary focus of patent AU2009224895?
It covers methods for producing recombinant proteins, emphasizing specific host cells, genetic constructs, and optimized culture conditions to enhance yield and stability.
2. How broad are the claims within this patent?
The independent claims are broad, encompassing general procedures for recombinant protein production with particular vectors and culture parameters, whereas dependent claims narrow the scope to specific embodiments.
3. Can competitors develop alternative production methods without infringing this patent?
Yes. Since many claims are specific to particular vectors and cell types, alternative systems such as insect or plant cell expression could potentially avoid infringement.
4. How does this patent fit into the global patent landscape?
It is part of a patent family with counterparts in Europe and the US, collectively strengthening CSL's worldwide intellectual property position.
5. When will this patent expire, and what are the implications?
Assuming maintenance payments are made, expiry is December 2028. Post-expiry, competitors can freely implement similar production methods, prompting strategic lifecycle planning for CSL.
References
[1] Australian Patent AU2009224895, "A method of producing a recombinant protein," CSL Limited, 2009.
[2] Patent family data and international equivalents (EPO, USPTO).
[3] WIPO Patentscope — broad patent landscape analyses related to recombinant protein production patents.
Note: For detailed legal advice or patent-specific infringement analysis, consult a patent attorney specializing in biotechnology.
