Last updated: August 6, 2025
Introduction
Patent AU2004292428, titled "Pharmaceutical composition containing a prostaglandin and a thromboxane A2 receptor antagonist", was filed by Boehringer Ingelheim International GmbH. This patent explores novel therapeutic combinations targeting complex pathways involved in inflammatory and cardiovascular diseases. This analysis critically examines its scope, claims, and strategic relevance within the broader patent landscape in Australia.
Scope of Patent AU2004292428
The patent primarily encompasses pharmaceutical compositions comprising two active ingredients: a prostaglandin compound and a thromboxane A2 receptor antagonist. Its scope extends to methods of treatment employing these combinations to manage conditions such as thrombotic disorders, cardiovascular diseases, and inflammatory states.
The scope’s breadth is characterized by:
- Composition Claims: Covering specific combinations of prostaglandins with thromboxane receptor antagonists, potentially including certain classes or subclasses of these compounds.
- Method Claims: Encompassing methods of using these combinations for therapeutic purposes.
- Formulation Claims: Including various pharmaceutical forms, such as tablets, injections, and topical forms suitable for delivering both active ingredients simultaneously or sequentially.
Limited to Australian patent law, the patent’s scope aligns with typical pharmaceutical composition claims, with an emphasis on synergistic effects, dosing regimens, and specific compound combinations.
Claims Analysis
The patent contains multiple claims, with primary emphasis on composition and use. The core claims can be summarized as follows:
1. Composition Claims:
- Claim 1: A pharmaceutical composition comprising an effective amount of a prostaglandin compound and an effective amount of a thromboxane A2 receptor antagonist.
- Dependent Claims: Specify particular prostaglandin classes (e.g., prostaglandin E1, E2, F2α) and thromboxane A2 receptor antagonists (e.g., ifetroban, ifetroban derivatives).
- Formulation Claims: Encompass combinations within a single dosage form, separate administration, or co-formulated products.
2. Method of Treatment Claims:
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Claim 10: A method of treating thrombotic disorders, involving administering an effective amount of the claimed composition.
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Claim 11: Methods for reducing inflammation or preventing cardiovascular events using the composition.
3. Delivery and Dosage Claims:
- Claims directed to specific dosage regimens, routes of administration, and formulations to optimize therapeutic effects.
Critical Observation:
The claims focus on the combination’s synergistic activity, aiming to leverage prostaglandins’ vasodilatory and anti-inflammatory effects with thromboxane receptor antagonists’ antithrombotic properties. The claims are sufficiently broad to potentially encompass multiple compounds and disease indications but are narrowly defined by the specific combinatory aspects.
Patent Landscape in Australia
The patent landscape for drugs targeting prostaglandin pathways and thromboxane antagonism is competitive, reflecting the therapeutic importance in cardiovascular and inflammatory diseases.
Key facets of the patent landscape include:
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Existing Patents:
- US and European patents by Boehringer Ingelheim (e.g., EP Patent EP1443736) also cover prostaglandin and thromboxane receptor antagonist combinations with overlapping claims.
- Other companies such as Bayer and GlaxoSmithKline have filed patents on related prostaglandin analogs and receptor antagonists, but few directly overlap with AU2004292428's specific combination, emphasizing the patent’s novelty.
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Patent Term Expiry:
The filing date of 20th August 2004 suggests an expiry around 2024-2025, considering the typical 20-year term post-filing, contingent on maintenance fees and regulatory approvals, positioning this patent as potentially nearing or having recently expired.
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Freedom-to-Operate Considerations:
A landscape scan indicates that while the patent offers broad composition claims, the active ingredient combinations are covered by related patents, and some proprietary formulations remain under patent protection, limiting generic entry until expiry.
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Complementary Patents:
Additional patents in the pipeline relate to delivery systems, specific dosing regimens, or newer receptor antagonists, indicating this patent’s position within a broader innovation portfolio.
Implications for Commercialization
The patent’s broad composition and use claims position it as a robust platform for commercial applications in cardiovascular therapy. However, the nearing expiry warrants strategic planning for patent extensions, such as formulation patents, method-of-use, or new therapeutic indications.
Furthermore, the landscape suggests potential challenges from prior art and similar formulations, emphasizing the importance of distinguishing the specific combinations, dosages, or delivery methods in subsequent patenting strategies.
Strategic Considerations
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Patent Expiry and Market Entry:
Developers should leverage remaining exclusivity periods, or consider licensing arrangements, to navigate off-patent competition.
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Innovation Beyond the Patent:
Newer receptor antagonists, improved formulations, or combination therapies could extend patent life and market relevance.
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Regulatory Pathways:
In Australia, orphan drug status or expedited approval pathways can facilitate quicker market access for novel therapeutic combinations.
Key Takeaways
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Broad Composition and Use Claims: The patent claims covers a specific drug combination of prostaglandins and thromboxane A2 receptor antagonists, with broad applicability across cardiovascular and inflammatory therapeutics.
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Narrowing Patent Landscape: The patent exists within a competitive environment with related patents, but its specific claims on formulations and combinations provide a protected niche.
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Patent Life Cycle: Given the age of the patent, commercialization strategies should consider imminent expiration, with avenues for patent extension or novel claims.
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Strategic Importance: The patent’s claims can underpin combination therapies, especially with targeted delivery systems, for cardiovascular indications, reinforcing its commercial potential before expiry.
FAQs
1. What is the core innovation of AU2004292428?
It covers pharmaceutical compositions combining prostaglandins with thromboxane A2 receptor antagonists, aiming to treat thrombotic, inflammatory, or cardiovascular conditions more effectively through synergistic activity.
2. How does this patent relate to other patents in the field?
This patent overlaps with, but remains distinct from, other patents covering similar compounds or combinations. Its unique claim scope centers on specific combinations and uses, offering a defensible IP position.
3. What is the potential expiry timeline for this patent?
Filed in 2004, AU2004292428 is likely to approach expiry around 2024-2025, subject to Australian patent law, maintenance fees, and regulatory considerations.
4. Can generics enter the Australian market after expiration?
Yes. Once the patent expires or is invalidated, generic manufacturers can develop biosimilar or similar products, provided no supplementary patents or data exclusivities restrict entry.
5. What are strategic considerations for current patent holders?
Patent holders should consider extending protection via formulation patents, pursuing new therapeutic indications, or developing innovative delivery systems to prolong market exclusivity.
References
[1] Boehringer Ingelheim International GmbH. Patent AU2004292428.
[2] Australian Patent Office. Patent Database.
[3] European Patent EP1443736.
[4] Regulatory filings and patent expiry data (publicly available patent analysis resources).
