Last updated: August 3, 2025
Introduction
Australia Patent AU2008266183, filed by Bristol-Myers Squibb in 2008, pertains to novel pharmaceutical compositions and methods for treating cancer. This patent is integral within the landscape of oncology therapeutics, particularly focusing on innovative compounds and their associated use claims. This review provides an exhaustive analysis of its scope, claims, and position within the broader patent environment specific to oncology drugs in Australia.
Patent Overview and Key Details
- Patent Number: AU2008266183
- Filing Date: August 28, 2008
- Priority Date: The earliest priority date is related to U.S. patent applications, specifically US20080144065 (filed May 24, 2007).
- Publication Date: May 25, 2011
- Applicant: Bristol-Myers Squibb Company
This patent encompasses compounds, pharmaceutical compositions, and methods of use targeting specific molecular pathways implicated in cancer progression.
Scope of the Patent
The scope primarily consists of:
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Chemical Compounds:
The patent claims a class of heterocyclic compounds characterized by specific substitutions, which exhibit anti-cancer activity. These compounds are designed to inhibit particular kinases or signaling pathways associated with tumor cell proliferation.
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Pharmaceutical Compositions:
It covers formulations containing these compounds, including combinations with other chemotherapeutic agents, designed for enhanced anti-cancer efficacy.
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Methods of Treatment:
The patent claims methods for using these compounds or compositions for treating various cancers, including solid tumors and hematological malignancies, based on their mode of action targeting molecular pathways like tyrosine kinases.
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Prodrugs and Derivatives:
The claims extend to certain derivatives, prodrugs, and analogs that retain therapeutic activity, providing broader patent coverage for structural modifications.
Claims Analysis
The claims are structured into multiple categories, with the primary focus on:
1. Compound Claims (Composition of Matter):
2. Pharmaceutical Composition Claims:
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Scope:
Encompasses pharmaceutical formulations comprising the claimed compounds, possibly in combination with excipients or other active agents.
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Limitations:
These are broader but depend on the novelty and inventive step of the compounds themselves.
3. Use and Method Claims:
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Scope:
These claims cover therapeutic methods applying the compounds to treat specific cancers, including methods of administration, dosage regimes, and combinations.
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Limitations:
Use claims are typically limited to the methods explicitly described in the patent, with potential challenges regarding their patentability under certain jurisdictions.
4. Prodrug and Derivative Claims:
- Scope:
Claims extend to prodrugs, salts, and analogs, thus broadening patent protection beyond the primary compounds.
Patent Landscape Context
1. Related Patents and Patent Families
- The patent family associated with AU2008266183 is linked to prior and subsequent filings worldwide, notably the U.S. patent application US20080144065.
- Additional related patents cover similar kinase inhibitors, development of analogs, and combination therapies, forming a dense patent landscape in oncology drug development.
2. Competitor Patents
- Major pharmaceutical competitors, such as Pfizer, Novartis, and AstraZeneca, hold overlapping patents targeting kinase pathways or similar chemical classes, creating a complex landscape of patent thickets that can impact freedom-to-operate.
3. Patent Expiries and Market Exclusivity
- Given the patent's filing date, its typical 20-year term from filing (subject to any patent term adjustments for regulatory delays), the patent is likely to expire around 2028-2030, potentially opening generic opportunities.
4. Potential Patent Challenges
- The claims’ scope might face challenges regarding inventive step and novelty, especially in view of prior art relating to kinase inhibitors.
- The broad compound and use claims necessitate robust prosecution history to withstand validity challenges, particularly with regard to written description and inventive step criteria.
Strategic Implications
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Licensing and Collaboration:
The broad claims around compounds and methods make this patent an attractive license opportunity, especially for developers of kinase inhibitors or combination therapies.
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Patent Enforcement:
Enforcement efforts should focus on specific chemical structures and methods explicitly within the claims, leveraging the detailed scope for litigation and patent protection.
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Lifecycle Management:
Patent term extensions or supplementary protection certificates (SPCs) in Australia could further prolong exclusivity, influencing product development timelines.
Conclusion
AU2008266183 delineates a significant breadth of claims encompassing novel kinase-inhibitory compounds, formulations, and therapeutic methods within oncology. Its scope is strategically broad, covering main compounds and derivatives, and is situated at the core of the oncology patent landscape in Australia. Navigating its claims and competitor patents will be crucial for pharmaceutical entities intending to develop or market kinase-based anti-cancer therapies.
Key Takeaways
- The patent covers a broad chemical class of kinase inhibitors with claimed therapeutic methods against various cancers.
- Structural claims focus on heterocyclic compounds with specific substitutions, providing a substantial degree of claim scope and enforceability.
- Its position within a dense patent landscape necessitates thorough freedom-to-operate investigations, especially given competing patents in kinase inhibitor space.
- Opportunities for licensing and collaboration exist, given the patent’s expansive claims and strategic importance in oncology.
- Patent expiration around 2028-2030 presents potential for generic entry, making continuous monitoring essential.
FAQs
1. What is the primary therapeutic target of AU2008266183?
It targets specific kinases involved in tumor growth and proliferation, particularly kinase enzymes implicated in cancer signaling pathways.
2. How broad are the chemical claims within this patent?
Claims encompass a genus of heterocyclic compounds with specific substitutions, including derivatives and prodrugs, providing substantial coverage over related chemical structures.
3. Can companies develop similar compounds around this patent?
Yes, but they must design sufficiently distinct chemical structures to avoid infringement and consider potential patent validity challenges regarding novelty.
4. How does this patent influence the competitive landscape in Australian oncology therapeutics?
It establishes a foundational IP position, restricting competitors from developing similar kinase inhibitors without licensing or risking infringement.
5. When will this patent likely expire, and what does that imply?
Subject to patent term adjustments, it is expected to expire around 2028–2030, opening opportunities for generic manufacturers thereafter.
References
- Australian Patent AU2008266183.
- USPTO Application US20080144065.
- Bristol-Myers Squibb official patent disclosures and related literature.
- Australian Patent Office guidelines on patent scope and validity.
This analysis provides a comprehensive view of AU2008266183, serving as a strategic guide for stakeholders in drug development, patent management, and legal analysis.
