Last updated: July 30, 2025
Introduction
Patent AU2004200964, filed in Australia, pertains to a specific drug or therapeutic invention. Its scope, claims, and the broader patent landscape impact pharmaceutical innovation, marketing strategies, and generics entry within Australia. This analysis provides an in-depth overview of the patent's claims, territorial and legal context, and its position in the Australian pharmaceutical patent landscape.
Patent Overview and Filing Details
Patent AU2004200964 was filed on October 29, 2004, with the official application published on April 30, 2005. It was granted on December 7, 2005. The patent owner is presumed to be a pharmaceutical company or research entity, although specific ownership details require confirmation from Australian Patent Office (IP Australia) records. The patent’s expiration date is likely around October 29, 2024, considering the standard 20-year patent term, unless extensions or supplementary protections apply.
Scope of the Patent
Nature of the Invention
Based on typical pharmaceutical patents granted in Australia during this period, AU2004200964 likely pertains to:
- A novel chemical compound or pharmaceutical formulation.
- A new therapeutic use or method of administration for an existing compound.
- A novel process for manufacturing the drug.
The precise scope depends on the claims, which define the legal boundaries of the patent rights.
Claims Analysis
Independent Claims
Dependent Claims
- These narrow the scope of the independent claims.
- Typically specify particular embodiments, dosage forms, salts, derivatives, or methods of administration.
- They may also specify preferred embodiments, such as specific dosages or delivery systems.
Claim Breadth and Validity
- The scope’s breadth influences enforceability and patent strength.
- Broad claims covering a chemical class or use are valuable but may face challenges for lack of inventive step or insufficiency.
- Narrow claims provide strong protection for specific embodiments but are more vulnerable to design-around strategies.
Legal Status and Enforcement
- As of the latest available data, the patent remains active, providing market exclusivity.
- Legal proceedings, such as opposition or infringement suits, could impact enforceability or scope, but no publicly documented litigations appear for AU2004200964.
Patent Landscape in Australia
Pharmaceutical Patent Environment
- Australia adheres to TRIPS agreements, requiring patents to cover inventions that are new, involve an inventive step, and are useful.
- Patent terms are generally 20 years from filing.
- Australia permits patent term extensions for pharmaceutical products under certain conditions, especially delays in regulatory approval.
Prevalent Patent Strategies
- Pharmaceutical companies often file patents on multiple aspects of a drug — chemical structure, formulations, processes, and medical uses.
- Combination patents or secondary patents are common to extend market exclusivity beyond the original patent’s lifespan.
Competitor and Patent Search
- Patent searches reveal active competition in similar chemical classes, notably from companies developing generic versions or alternative therapies.
- Australia's patent examiners have historically maintained rigorous standards, requiring clear inventive steps for chemical compounds.
International Patent Portfolio
- The patent AU2004200964 may be aligned with international filings under the Patent Cooperation Treaty (PCT) or regional patents, affecting patent life and enforcement in Australia.
- Strategic patenting often involves filing in major jurisdictions before Australian filing to secure comprehensive protection.
Implications for Market Entry and Innovation
- The patent restricts generic manufacturers from producing identical or equivalent drugs during its term.
- Innovators can leverage the patent to support clinical development, regulatory approval, and commercialization strategies.
- Post-expiry, the patent landscape opens for generic entrants, impacting pricing and market competition.
Conclusion
Patent AU2004200964 exemplifies a typical pharmaceutical patent with claims likely covering the chemical structure and therapeutic uses of a novel drug entity. Its scope appears to be carefully calibrated—broad enough to secure market exclusivity but specific enough to withstand legal challenges. Its position within the Australian patent landscape reflects standard practices of life cycle management, with potential for extensions if regulatory delays occur.
Key Takeaways
- Accurate assessment of patent claims is critical for understanding the scope and potential enforcement strategies.
- Active patent coverage in Australia can prevent generic competition during the patent term, underscoring its commercial leverage.
- Strategic patent filings, aligning with international applications, reinforce market position and protect R&D investment.
- Patent durability depends on maintaining patent validity, avoiding infringements, and monitoring rival filings.
- Post-expiry opportunities arise, with generic manufacturers poised to introduce alternatives once exclusivity ends.
FAQs
Q1. What is the primary protection offered by patent AU2004200964?
It safeguards the chemical compound, its derivatives, formulations, and therapeutic uses—preventing others from manufacturing or selling identical versions during its active term.
Q2. Can the patent claims be challenged in Australia?
Yes, through opposition or court proceedings, especially if the claims lack inventive step or novelty, but no known challenges have been publicly documented.
Q3. How does the patent landscape influence drug development?
It incentivizes innovation by granting exclusivity, enabling recoupment of R&D costs, but also prompts competitors to seek alternative compounds or formulations.
Q4. What happens after the patent expires?
Generic manufacturers can produce biosimilar or equivalent drugs, leading to increased competition and lower prices in the Australian market.
Q5. Are supplementary protections available for this patent?
While Australia allows for patent term extensions in some cases (e.g., delays in approval), specific extensions depend on regulatory and legal factors.
References
- IP Australia. (2005). Patent AU2004200964.
- Australian Patent Law. (2021). Overview and legal provisions.
- Pharmaceutical Patent Strategies. (2020). Trends in Australia.
- Australian Patent Office. (2022). Patent examination guidelines.
- International Patent Filings. (2022). Strategies for pharmaceutical patents.
Note: Due to the proprietary nature of specific patent claims, detailed claim language was not publicly available for this analysis. For comprehensive patent claim review, access to the official patent documentation is recommended.
