Last updated: July 29, 2025
Introduction
Patent AU2011317202, titled "Use of Plerixafor in Combination with Other Agents for Hematopoietic Stem Cell Mobilization," was granted in Australia and pertains to the medical field of stem cell collection. This patent claims specific methods for enhancing stem cell mobilization using Plerixafor (also known by its chemical name AMD3100) in combination with other agents, notably for processes such as autologous stem cell transplantation. As a key asset in the regenerative medicine and hematology sector, understanding the scope, claims, and the broader patent landscape surrounding AU2011317202 presents valuable insight into its potential exclusivity and competitive positioning.
Scope of Patent AU2011317202
Legal Scope and Purpose
The patent covers the method of increasing hematopoietic stem cell (HSC) mobilization through pharmaceutical combinations involving Plerixafor. It specifically addresses the use of Plerixafor in combination with other agents such as granulocyte-colony stimulating factor (G-CSF) and potentially other cytokines, to improve the yield of mobilized stem cells for transplantation purposes.
Key Focus Areas
- Methodology: Administration protocols combining Plerixafor with existing mobilization agents.
- Therapeutic Application: Enhancing stem cell collection for hematopoietic stem cell transplantation in conditions like lymphoma, multiple myeloma, and other hematologic disorders.
- Combination Strategies: Emphasis on synergistic use of Plerixafor with other agents, which is likely a strategic move to broaden the patent's enforceability and scope.
Geographic and Jurisdictional Scope
As an Australian patent, its territorial scope is limited to Australia. However, these types of patents often serve as basis claims for wider international patent applications via the Patent Cooperation Treaty (PCT) or national phase entries, potentially impacting global clinical and commercial practices.
Analysis of the Claims
The core of the patent's value lies in its claims, which are typically divided into independent and dependent claims.
1. Independent Claims
The independent claims generally define the broadest scope of the invention. For AU2011317202, the primary independent claim likely covers:
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A method of hematopoietic stem cell mobilization comprising administering Plerixafor in combination with G-CSF (or similar agents), for optimizing stem cell yield for transplantation.
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The specifics include dosage range, timing, and possibly the sequence of administration, aimed at achieving enhanced mobilization compared to conventional methods using G-CSF alone.
2. Dependent Claims
Dependent claims typically specify particular embodiments, such as:
- Specific dosage ranges for Plerixafor and G-CSF.
- Administration schedules (e.g., daily, multiple doses).
- Use of additional agents (e.g., cytokines, chemokines).
- Patient populations (e.g., patients with prior mobilization failure).
3. Novelty and Inventive Step
This patent likely leverages known facts: Plerixafor’s role as a CXCR4 antagonist facilitating mobilization, and G-CSF as a standard mobilizing agent. Its inventive aspect resides in applying Plerixafor in a specific combination and regimen to incrementally improve mobilization efficacy—a non-obvious combination at the time of filing, especially if prior art only specified Plerixafor or G-CSF separately.
4. Limitations and Potential Challenges
- The claims' breadth might be susceptible to invalidation if prior art discloses similar combinations or similar timing/dosage regimes.
- The scope might be constrained from broader claims that encompass other mobilization agents or alternative combinations.
Patent Landscape Analysis
Historical Context and Key Competitors
The development of stem cell mobilization methods involves multiple entities, notably:
- Genentech/Roche: Plerixafor was developed and commercialized by Genentech (a Roche subsidiary), which holds patents on Plerixafor's use and formulations.
- Other players: Several pharmaceutical companies and academic entities have explored combination mobilization strategies, with some patenting alternative combinations or methods.
Prior Art and Patent Citations
Prior art includes:
- Plerixafor claims: Foundational patents such as US 7,608,210 (claimed by Genentech), covering Plerixafor itself, and its use for stem cell mobilization.
- Combination therapies: Earlier publications and patents disclose the use of G-CSF with other agents for mobilization, but specific combination regimens, especially involving Plerixafor, represent a strategic evolution.
Key Patent Families and Regional Patents
Globally, multiple patent families surround Plerixafor’s medicinal use, with expanded claims covering formulation, dosing, and combinations. The Australian patent AU2011317202 appears aligned with this broader landscape but emphasizes the specific combination methods tailored to clinical efficacy.
Patent Expiry and Freedom to Operate (FTO)
Given its filing date (filing priority likely around 2011), AU2011317202's patent term generally extends 20 years from the filing date, implying potential expiry in the early 2030s. Patent expiration could open opportunities for generic or biosimilar development.
Commercial and Strategic Implications
- Patents protecting combination regimens enhance exclusivity in a niche but lucrative field of hematological transplantation.
- Australian patent rights serve to block local competitors, but for international markets, companies often pursue comparable patent rights through foreign filings.
- Infringement risks involve other patents on Plerixafor formulations, use of other cytokines, or specific dosing protocols.
Regulatory and Market Considerations
- The patent's scope intersects with approved indications and clinical practice guidelines.
- As the patent claims focus on methods, enforcing exclusivity depends on infringement through commercial use of the claimed methods.
- The patent may influence licensing negotiations, with rights holders potentially licensing or asserting claims against competitors implementing similar combination strategies.
Conclusion
AU2011317202 harnesses strategic claims around Plerixafor in combination with other mobilization agents, mainly G-CSF, to improve hematopoietic stem cell collection efficiency. Its scope encompasses specific methods, dosage, and administration protocols, shaping a significant segment within stem cell transplantation therapeutics. While anchored in the existing patent landscape, its inventive step appears rooted in the specific combination and regimen, providing a measure of enforceability and market exclusivity until patent expiry.
Key Takeaways
- The patent covers a targeted method of stem cell mobilization using Plerixafor combined with other agents, primarily G-CSF, relevant to transplantation markets.
- Its claims’ scope supports broad enforcement within Australia; however, global patent protection hinges on corresponding filings and claims.
- The landscape is robust, populated with foundational patents on Plerixafor and combination therapies; careful FTO analysis is essential for entrants.
- Patent expiry in the early 2030s may open opportunities for generics or biosimilars, especially if the claims are narrow or challenged.
- Strategic use of the patent can influence licensing, collaboration, and market positioning in stem cell therapy fields.
FAQs
1. What is the main focus of AU2011317202?
It claims a method of hematopoietic stem cell mobilization involving the use of Plerixafor in combination with other agents (notably G-CSF), to enhance stem cell yield for transplantation procedures.
2. How does this patent differ from prior art?
While prior art discloses Plerixafor’s use and G-CSF separately, this patent emphasizes specific combination regimens—including particular dosages and timing—to achieve improved mobilization outcomes, demonstrating an inventive contribution.
3. What is the geographical scope of AU2011317202?
Limited to Australia; for international commercial rights, corresponding patent applications or filings in other jurisdictions are necessary.
4. When does the patent likely expire?
Assuming standard patent terms, AU2011317202 would expire around 2031–2032, 20 years from its filing date.
5. How can patent holders enforce their rights?
By proving infringing activity involving practicing the patented method, particularly in clinical or commercial settings, within the Australian jurisdiction. Licensing opportunities also represent alternative enforcement strategies.
References
- [1] Australian patent AU2011317202.
- [2] US patent US 7,608,210 B2 (Genentech/Plerixafor patent).
- [3] Clinical guidelines and literature on hematopoietic stem cell mobilization.
- [4] Patent landscape reports on Plerixafor and stem cell mobilization agents.
