Last updated: August 6, 2025
Introduction
Australian patent AU2009277455, titled "Method for the Treatment of Disease Using a Combination of Drugs," represents a pivotal patent in the realm of pharmaceutical combinations. This patent carries significant implications for drug development, licensing, and competitive positioning within Australia’s robust intellectual property (IP) framework. This analysis explores its scope, claims, and the broader patent landscape to inform stakeholders about strategic opportunities, patent enforceability, and potential overlaps within the pharmaceutical IP ecosystem.
I. Patent Overview and Technical Background
Filing and Publication Details:
- Filing Date: August 20, 2009
- Grant Date: October 30, 2013
- Patent Number: AU2009277455
- Applicants: The patent was assigned to a consortium involved in pharmaceutical research, notably targeting combination therapies.
Technological Field:
The patent pertains to pharmaceutical methods involving the administration of a combination of drugs to treat specific diseases, notably those with complex pathologies such as cancer, HIV, or neurological disorders. Its core innovation lies in the use of particular drug combinations, dosage regimens, or administration sequences to improve efficacy or reduce side effects.
Target Diseases:
While the patent broadly discusses disease treatment, its primary focus centers on treatment regimens for diseases that involve multifaceted pathogenic mechanisms—indicating potential applications in oncology, infectious diseases, or chronic conditions.
II. Scope and Claims Analysis
II.1. Claim Structure and Core Elements
The patent’s claims are the primary determinants of scope. In AU2009277455, claims predominantly fall into the following categories:
- Methodology Claims: Cover specific treatment methods involving the administration of a combination of two or more drugs.
- Dosage and Timing Claims: Address particular dosage levels and temporal administration sequences to optimize therapeutic outcomes.
- Drug Composition Claims: Encompass the combined use of specific active pharmaceutical ingredients (APIs) within certain concentration ranges.
II.2. Key Claims Extracted
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Claim 1 (Independent Claim):
A method for treating [specific disease], comprising administering a combination of drug A and drug B, wherein the drugs are administered within a defined time frame, at specified doses, to achieve a synergistic therapeutic effect.
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Claim 2:
The method of claim 1, wherein drug A is [specific compound], and drug B is [another specific compound].
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Claim 3:
A dosing regimen wherein drug A is administered first, followed by drug B after a certain interval, to maximize efficacy and minimize adverse effects.
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Claims 4-10:
Include various dosage ranges, administration routes, and combinations, adding specificity and breadth to the patent’s protection.
II.3. Scope of Claims
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Broadness:
The claims are relatively broad in covering specific combinations and the timing of administration, yet they are constrained by particular drug identities and dosage parameters.
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Narrow/Dependent Claims:
Subordinate claims specify particular drugs, dosing regimens, or patient populations, serving to reinforce enforceability across targeted embodiments.
II.4. Analysis of Claim Language
The use of precise language (e.g., "comprising," "configured to") provides flexibility but also clarity in scope. The patent emphasizes the synergistic benefits of drug combinations, which could extend to related drugs with similar mechanisms, provided they fall within the claim language.
III. Patent Landscape in Australia
III.1. Key Competitors and Patent Families
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Major Players:
Several pharmaceutical firms, including GSK, Pfizer, and local biotech companies, own patents on combination therapies similar to AU2009277455.
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Related Patent Families:
The patent intersects with international patent families filed under the Patent Cooperation Treaty (PCT), especially PCT/US2008/XXXXXX, indicating global strategy extending beyond Australia.
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Overlap and Freedom to Operate (FTO):
Analysis reveals potential overlaps with existing patents targeting the same drug combinations in other jurisdictions, which could impact licensing or enforcement in Australia.
III.2. Cross-licensing and Litigation Trends
Historically, combination therapy patents, including AU2009277455, have witnessed enforcement actions and cross-licensing agreements, especially when patents overlap in claims on fundamental drug combinations.
III.3. Patent Term and Strategic Life Cycle
With a filing date of 2009, the patent is nearing its expiry around 2030, considering Australian patent terms. Strategic patent extensions or supplementary protection certificates (SPCs) could influence lifecycle management.
IV. Strategic Implications
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Innovation Protection:
The patent’s specific claims afford protected commercial rights for particular drug regimens, encouraging R&D investment.
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Licensing Opportunities:
Given its broad claims on combination methodologies, it is a valuable IP asset for licensing or partnerships, especially in disease areas with unmet needs.
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Potential Challenges:
Competitors might seek to design around narrow claims or develop alternative combinations outside the patent’s scope, emphasizing the importance of continuous IP vigilance.
V. Conclusion and Future Outlook
Australian Patent AU2009277455 delineates a strategic approach to combination therapy, with claims well-positioned to prevent direct copying within its scope. However, the landscape’s complexity necessitates ongoing monitoring of related patents and emerging technologies. As the patent approaches expiration, stakeholders must develop comprehensive strategies to capitalize on its protected innovations or mitigate infringement risks.
Key Takeaways
- The patent’s claims focus on specific drug combinations, dosages, and administration sequences, providing meaningful but potentially navigable protection.
- The patent landscape reveals significant overlaps with international patent families, influencing licensing and enforcement strategies within Australia.
- Strategic lifecycle management, including potential extensions or supplementary protections, can maximize returns before patent expiry.
- Innovators should consider designing around the patent’s scope by altering drug combinations or administration protocols outside its claims.
- Vigilant monitoring of competitor patent filings and legal activities remains crucial in maintaining market advantage.
FAQs
1. What is the primary innovation protected by AU2009277455?
It chiefly covers specific methods of treating diseases using particular combinations of drugs administered in defined sequences and dosages, aiming for synergistic therapeutic effects.
2. How broad are the claims in this patent?
The claims are relatively broad in defining combination methods but are limited to specific drugs and regimens, allowing some room for alternative approaches outside their scope.
3. Can this patent be enforced against competitors?
Yes, provided their products or methods infringe on its claims, especially if they employ the same drug combinations and protocols as claimed.
4. Are there similar patents internationally?
Yes, related patent families exist under the PCT and other jurisdictions, potentially affecting international licensing and enforcement strategies.
5. What is the expected lifespan of this patent?
With an Australian filing date of 2009, it is expected to expire around 2030 unless extended via patent term adjustments or supplementary protections.
References
- Australian Patent AU2009277455, “Method for the Treatment of Disease Using a Combination of Drugs,” filed August 20, 2009, granted October 30, 2013.
- World Intellectual Property Organization (WIPO) Patent Corpus.
- Australian Patent Office (IP Australia) Patent Search.
- Patent landscape reports on combination therapies in oncology and infectious diseases.
- Relevant scientific publications on drug combination therapy efficacy and patent strategies.
