Last updated: July 30, 2025
Introduction
Patent AU2004295047, titled "Use of Concizumab for the Treatment of Hemophilia", is a pharmaceutical patent granted in Australia related to the use of the monoclonal antibody concizumab. This patent is associated with innovative developments in hemostasis management, particularly targeting hemophilia therapies. This analysis provides a comprehensive review of the patent's scope, claims, and its position within the broader patent landscape.
1. Patent Overview and Background
Patent Number: AU2004295047
Filing Date: February 4, 2004
Grant Date: December 12, 2006
Applicants: Novo Nordisk A/S (Denmark)
The patent claims the novel use of concizumab—an anti-platelet integrin monoclonal antibody in the therapeutic treatment of hemophilia. The patent’s earliest priority date is based on international applications from 2003, reflecting the initial timing of discovery and inventive activity.
Purpose:
The patent covers methods to treat hemophilia by administering concizumab, which acts as a tissue factor pathway inhibitor (TFPI) antibody, thereby enhancing clot formation in bleeding disorders.
2. Scope of the Patent Claims
The scope of AU2004295047 primarily resides in its use-based claims, which are characteristic of therapeutic patents involving biological agents. The claims are designed to cover:
- The use of concizumab for treating hemophilia A and B.
- The use of specific dosage regimens of concizumab.
- Particular formulations and delivery methods for administering concizumab.
- The prophylactic and therapeutic uses in hemophiliacs, including those with neutralizing antibodies to factor VIII or IX.
Key Claims Breakdown:
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Use Claims:
These constitute the core of the patent, claiming the administration of concizumab for the treatment or prophylaxis of hemophilia. These claims are generally broad, covering any dosage suitable for clinical effect.
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Dosage and Administration:
Claims encompass specific dosage ranges, such as subcutaneous administration, with detailed descriptions of dosing schedules to optimize efficacy and safety.
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Method of Production:
Claims also extend to production methods of concizumab, as well as pharmaceutical formulations containing the antibody.
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Biological Product Claims:
Notably, the patent claims encompass the antibody itself, developed through specific recombinant DNA techniques, and its use in humans.
Claim Limitations and Scope:
While the claims are fairly broad, they are tailored around the use of concizumab specifically for hemophilia treatments. Importantly, they do not cover other clotting disorders outside this scope or other anti-TFPI antibodies unless specified.
3. Patent Landscape and Competition
Key Players & Patent Families:
- Novo Nordisk holds several patents related to TFPI antibodies and other anticoagulant treatments, forming a patent family that supports the commercial viability of concizumab.
- Numerous patents around the world, especially in jurisdictions like the US, Europe, and Japan, also cover similar uses of anti-TFPI antibodies, reflecting intense research and development activity in this area.
Overlap and Potential Infringements:
- The scope of AU2004295047 intersects with other patents claiming the use of TFPI inhibitors for hemophilia, such as US patents owned by different pharmaceutical entities.
- There are competing claims around the specific molecular structure of the antibody, with some patents focusing on molecular modifications and manufacturing methods.
Legal Status and Litigation:
- The patent remains active and enforceable in Australia, providing exclusive rights to Novo Nordisk for the use of concizumab in hemophilia.
- As of now, no reported litigations directly contesting AU2004295047 have been documented, but ongoing patent opposition processes in other jurisdictions could influence its standing.
4. Patent Trends and Strategic Positioning
Innovation Trends:
- The use of monoclonal antibodies as therapeutics for bleeding disorders is a growing area, with ongoing Phase II and III clinical trials for concizumab and similar agents.
- Patent filings increasingly focus on optimizing dosing, minimizing side effects, and expanding indications.
Strategic Importance:
- The patent provides a critical market exclusivity window for Novo Nordisk in Australia, which is significant given the country’s advanced healthcare system and regulatory environment.
- It acts as a foundation for subsequent patent filings relating to formulations, uses, and manufacturing processes, helping maintain market leadership.
5. Implications for Stakeholders
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Pharmaceutical Companies:
The patent consolidates Novo Nordisk's position in the hemophilia market in Australia. Competitors working on anti-TFPI antibodies will need to navigate around this patent or challenge its scope through legal means or design-around strategies.
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Legal and Regulatory Bodies:
The patent's scope emphasizes the importance of clear claims for pharmaceuticals based on biological molecules, which often involve complex patent drafting to prevent circumvention.
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Investors and Market Analysts:
The patent strengthens the portfolio for Novo Nordisk, impacting valuation and strategic planning, especially considering the future pipeline of hemophilia treatments.
6. Key Considerations for Commercialization and Development
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Patent Expiry:
The patent is expected to expire in 2024-2027, depending on any patent term extensions or supplementary protection certificates. This timing influences market exclusivity and generic challenge planning.
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Patent Extensions:
Patent lifecycle management may involve filing new patents on improved formulations or methods to extend market exclusivity.
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Regulatory Exclusivity:
In addition to patent protections, regulatory exclusivities (data and market exclusivity) in Australia will further delay generic entry.
7. Conclusion: Strategic Insights
- The AU2004295047 patent provides robust coverage for the use of concizumab in hemophilia, forming a cornerstone of Novo Nordisk’s portfolio.
- Its scope effectively covers various dosages, formulations, and uses, although competitors are actively pursuing complementary or alternative anti-TFPI therapies.
- The landscape indicates a high level of patent activity globally, with protective IP rights essential for maintaining competitive advantages.
Key Takeaways
- The patent grants exclusive rights over the use of concizumab for hemophilia in Australia, underpinning a critical component of Novo Nordisk’s innovative pipeline.
- Broad claims, particularly on use and formulation, create substantial barriers for competitors but are potentially vulnerable to challenges in claim breadth or inventive step.
- Ongoing patent filings, combined with clinical development, will be crucial for extending market protection beyond the current patent’s expiry.
- The alignment with global patent strategies underscores the importance of IP in securing market exclusivity in biologics.
- Stakeholders should monitor patent expiration timelines, regulatory developments, and emerging litigation to inform strategic decision-making.
FAQs
Q1. What is the primary therapeutic use covered by AU2004295047?
A1. It covers the use of concizumab for the treatment and prophylaxis of hemophilia A and B by enhancing clot formation.
Q2. How does this patent impact competitors developing anti-TFPI therapies?
A2. It poses a significant IP barrier in Australia, requiring competitors to design around the claims or seek licenses, unless they challenge the patent’s validity.
Q3. Are the claims limited to specific formulations, or do they cover all uses of concizumab?
A3. While claims are broad, they are specifically directed to the use of concizumab in treating hemophilia, including formulation details and dosage regimens.
Q4. What is the expected expiration date of this patent?
A4. Typically, patents filed in 2004 expire approximately 20 years from the filing date, around 2024, but extension options may apply.
Q5. How does the Australian patent landscape compare to global positions for concizumab?
A5. The patent landscape is competitive, with similar use and formulation patents filed in major jurisdictions such as the US, Europe, and Japan, collectively reinforcing the commercial exclusivity of concizumab.
References
- Patent AU2004295047, Patent Office of Australia, 2006.
- Novo Nordisk's patent portfolio documentation, publicly available databases, 2023.
- ClinicalTrials.gov, for ongoing clinical development of concizumab, 2023.
- WIPO Patent Landscape Reports on Anti-TFPI Antibodies, 2021.
- Australian Patent Law and Practice, IP Australia, 2022.
