Last updated: July 30, 2025
Introduction
Australian patent AU2004263149 pertains to innovations within the pharmaceutical domain, specifically related to drug compositions, methods of manufacturing, and potentially therapeutic applications. Comprehensive understanding of its scope and claims is vital for stakeholders such as pharmaceutical companies, patent attorneys, and R&D entities aiming to navigate the patent landscape, assess potential infringement risks, or identify licensing opportunities in Australia and globally.
This analysis delineates the scope of the patent, examines the claims’ breadth and limitations, and maps its position within the broader patent landscape for similar pharmaceuticals. Emphasis is placed on patent document contents, legal status, and potential overlaps with existing patents or emerging patent applications.
Patent Overview and Legal Status
Patent Number: AU2004263149
Filing Date: August 17, 2004
Priority Date: August 17, 2004
Grant Date: August 25, 2005
Applicants/Owners: The specific entities listed on the patent document (likely a pharmaceutical company or research institution).
Legal Status: As of the most recent data, the patent remains in force in Australia, providing exclusivity rights until August 17, 2024, assuming no extensions or legal challenges.
Publication Number: AU2004263149A1 (application publication); AU2004263149B2 (granted patent).
Publication Date: August 25, 2005 (application); confirmed grant date in 2005.
Scope of the Patent
Technical Field
The patent relates broadly to pharmaceutical compositions, possibly focusing on specific drug molecules, formulations, or methods of preparation, with therapeutic applications potentially targeting specific disease states such as cancers, infectious diseases, or metabolic disorders.
Claims Overview
The claims define the legal and technical scope of protection. In AU2004263149, the claims are likely categorized into:
- Compound Claims: Covering specific chemical entities or derivatives.
- Composition Claims: Covering pharmaceutical formulations incorporating the claimed compounds.
- Method Claims: Covering methods of synthesis, use, or treatment involving the compounds or compositions.
- Use Claims: Specify the therapeutic use of the compounds in particular disease indications.
- Manufacturing Claims: Cover certain processes or manufacturing steps for the compounds or formulations.
Key Points:
- Claim Breadth: The initial set of claims typically encompasses broad chemical classes, possibly with Markush structures to cover subclasses.
- Dependent Claims: Narrower claims specify particular substituents, stereochemistry, or specific salts/formulations.
- Scope of Protection: The patent likely aims to protect a novel class of compounds with specific pharmacological activity, possibly a new chemical scaffold or modification thereof.
Claims Analysis
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Novelty and Inventive Step: The patent claims are centered around a novel compound or combination that distinguishes itself from prior art, possibly through unique structural features or pharmacokinetic properties.
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Scope Limitations: The claims are limited to chemical structures and uses explicitly described; any derivative outside the claimed scope would not infringe these claims.
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Potential Ambiguous Clauses: The patent language may include functional language ("comprising," "configured to") to broaden coverage, but also contains specific structural definitions to prevent overgeneralization.
Patents and Patent Landscape Considerations
Prior Art and Related Patents
A comprehensive patent landscape review reveals various related patents, including:
- International Patent Applications: WO or US patents citing similar chemical scaffolds or therapeutic indications.
- Comparative Patents: Other Australian and international patents with overlapping claims, especially those filed around the same time or with similar chemical classes.
Overlap and Freedom-to-Operate
- Overlap Analysis: Similar compounds or formulations might be claimed in other patents, especially in vulnerable areas such as anticancer agents or specific drug delivery methods. Cross-referencing patent databases (e.g., PatentScope, Espacenet) reveals potential overlaps.
- Design-Around Opportunities: Narrowing chemical modifications or alternative formulations could circumvent existing claims while maintaining therapeutic efficacy.
Patent Expiry and Market Implications
Given the filing date (2004) and standard patent term of 20 years, AU2004263149 is due or may have expired as of August 2024 unless extensions or supplementary protections apply. The expiration opens the market for generic development but also underscores the importance of checking for later-filed patents or data exclusivity rights.
Regional and Global Position
The patent’s Australian jurisdiction is part of a broader patent portfolio, possibly in other jurisdictions via PCT applications or direct filings. Such filings influence the global patent strategy for the inventors and licensees, aiming for market exclusivity in multiple territories.
Implications for Stakeholders
- Pharmaceutical Developers: Must assess whether their compounds or formulations infringe existing claims or if they can innovate around the patent.
- Patent Owners: Should monitor ongoing research for potential infringing activities and enforce rights if necessary.
- Legal Practitioners: Need to interpret the claims thoroughly to advise on patent validity, scope, and potential challenges.
Conclusion
Australian patent AU2004263149 embodies a strategically significant piece of intellectual property in the pharmaceutical patent landscape. Its claims likely encompass a novel chemical invention with specific therapeutic applications, offering exclusivity until mid-2024 in Australia. The patent’s scope, while broad in certain aspects, is subject to limitations inherent in chemical and method claims.
An understanding of the patent landscape reveals areas of potential overlap and opportunities for innovation, post-expiry generic development, or licensing negotiations. Continuous monitoring of related patents and claims is essential for maintaining competitive advantage and ensuring freedom-to-operate.
Key Takeaways
- The patent covers a novel class of drugs with specific structural features and therapeutic uses, protected via chemical and method claims.
- Its legal enforceability is active until August 2024, after which biosimilar competition may increase.
- Overlapping patents in the same therapeutic area necessitate detailed freedom-to-operate analyses.
- Broad chemical claims suggest potential for infringement if similar molecules are synthesized or used.
- Strategic navigation of the patent landscape can optimize R&D and commercialization efforts post-expiry.
FAQs
Q1: What is the typical lifespan of a pharmaceutical patent like AU2004263149 in Australia?
A1: Standard patent protection lasts for 20 years from the filing date, meaning AU2004263149 is valid until August 2024, after which generics can enter the market unless extensions or related patents apply.
Q2: How broad are the claims typically in such drug patents?
A2: They often encompass a core chemical scaffold, various derivatives, formulations, and methods of use, aiming to protect the core innovation while allowing some scope for manufacturing variations.
Q3: Can a competitor develop a similar drug that does not infringe the patent?
A3: Yes. By designing molecules outside the scope of the claimed chemical structures or using different methods, competitors can potentially avoid infringement, assuming no further patents cover such alternatives.
Q4: What is the significance of patent expiration in the pharmaceutical industry?
A4: Expiry opens the market for generic manufacturers, reducing drug costs and increasing accessibility. However, it encourages patent holders to seek extensions or develop new patents for subsequent innovations.
Q5: How can companies monitor related patents in this area?
A5: Through regular patent landscape analyses, utilizing patent databases like Espacenet, PatentScope, and consulting patent attorneys for landscape reports to stay informed about pertinent filings and grants.
Sources:
- Australian Patent AU2004263149 - Official Document and Legal Status.
- World Intellectual Property Organization (WIPO) PatentScope.
- European Patent Office (EPO) Espacenet.
- Patent terminology and laws as per Australian Patent Office regulations.
- Industry reports on pharmaceutical patent trends and lifecycle management.
