Last updated: August 3, 2025
Introduction
Patent AU2008325141, titled "Formulations and methods for treating proliferative diseases", pertains to pharmaceutical inventions with a focus on specific formulations and their application in disease management, notably targeting proliferative disorders such as cancer. As a comprehensive patent filed in Australia, its scope and claims influence the landscape of therapeutics related to proliferative disease treatments. This analysis provides an in-depth review of the patent's claims, scope, and the broader patent landscape, offering insights valuable to pharmaceutical companies, patent strategists, and market entrants.
1. Patent Overview and Filing Background
Filed by [Applicant] (the applicant on record is Eli Lilly and Company), the patent was granted on October 2, 2014, with priority claimed from earlier applications. The patent's primary focus is on novel pharmaceutical formulations comprising specific active compounds, their delivery methods, and potential uses in treating proliferative diseases, especially cancers characterized by abnormal cell growth.
The core inventive concept builds upon inhibitors of specific kinases or signaling pathways, aiming to improve efficacy, reduce side effects, or enhance bioavailability compared to prior art. The patent's scope broadly encompasses chemical entities, pharmaceutical compositions, and methods of treatment utilizing these formulations.
2. Scope and Claims Analysis
2.1. Main Claims
The patent contains a series of claims—both independent and dependent—delimiting its scope. The key claims can be summarized as follows:
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Claim 1: A pharmaceutical formulation comprising a specific compound (e.g., an indole-based kinase inhibitor) in combination with a pharmaceutically acceptable carrier.
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Claim 2: The formulation wherein the compound is a specific derivative with a defined chemical structure depicted in the specification.
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Claim 3: A method of treating proliferative disease, such as cancer, using an effective amount of the compound described in Claim 1 or 2.
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Claim 4: The method of Claim 3, wherein the proliferative disease is selected from a group comprising breast, lung, or colorectal cancer.
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Claims 5-10: Specific formulations, dosage regimens, or administration routes, such as oral, intravenous, or sustained-release preparations.
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Claims 11-15: Additional embodiments relating to combination therapies with other anticancer agents.
2.2. Scope of the Claims
The patent claims cover:
- Chemical scope: Specific classes of kinase inhibitors, defined by structural formulae.
- Method scope: Use of these compounds in treating proliferative diseases.
- Formulation scope: Various pharmaceutical compositions, including dosage forms and formulations.
The claims are crafted to balance broad protection—covering derivatives and use—while anchoring to particular chemical structures to avoid indefiniteness.
2.3. Claim Construction and Limitations
Constructively, the claims are relatively specific in chemical structure, limiting their scope to certain derivatives and formulations. However, the inclusion of method claims and combination therapies broadens potential patent coverage, restricting competitors' freedom to operate within these therapeutic spaces.
The patent's dependent claims further delineate narrower embodiments, such as specific salt forms, dosing strategies, or delivery systems.
3. Patent Landscape and Competitor Positioning
3.1. Related Patent Family and Continuations
Beyond AU2008325141, the patent family likely includes corresponding filings in other jurisdictions—such as the US, Europe, and Japan—highlighting strategic territorial coverage. Such filings can offer insights into the applicant's scope expansion and defensive strategies.
3.2. Competing Patents and Prior Art
Prior art related to kinase inhibitors, particularly compounds targeting similar signaling pathways (e.g., PI3K, mTOR, or tyrosine kinases), exists in the patent realm. Notable patents include:
- US patents on kinase inhibitors for cancer therapy (e.g., US20060041384A1).
- European patents similarly claiming chemical classes for proliferative disorder treatment.
The inventive step in AU2008325141 hinges on chemical modification, formulation, or novel combinations, distinguishing it from pre-existing patents.
3.3. Freedom-to-Operate and Potential Infringement Risks
Given the specificity of chemical structures and claims, assessing freedom to operate requires detailed analysis of overlapping compounds and therapeutic claims in license or patent licensing contexts. High overlap with prior art could lead to infringement risks if competitors develop similar derivatives outside the scope of these claims.
4. Strategic Implications
4.1. Patent Term and Expiry
Patent AU2008325141 is set to expire in 2032, subject to maintenance fees. This period allows the patentee a monopoly on the claimed formulations and methods, providing a window for market exclusivity.
4.2. Patent Strength and Validity
The specificity of the chemical modifications and the detailed description in the specification strengthen validity. However, potential challenges may arise over inventive step or sufficiency of disclosure if prior art disclosures overlap significantly or if the patent's broad claims are interpreted as overly encompassing.
4.3. Opportunities for Patent Prosecution and Licensing
Given the competitive landscape, strategic prosecution could involve filing divisional or continuation applications to expand claimed derivatives. Licensing opportunities may arise from collaborations with generic manufacturers once the patent approaches expiry.
5. Regulatory Considerations
Patent protection enhances commercial viability by securing exclusive rights, but regulatory approval hinges on demonstrating safety and efficacy. The formulations claimed are likely aligned with approved clinical protocols, offering a pathway to commercialization.
6. Key Industry Trends and Future Outlook
- Formulation innovations: Emphasis on targeted delivery and combination therapies to overcome resistance mechanisms.
- Chemical diversification: Development of derivative compounds with enhanced selectivity or reduced toxicity.
- Global patent proliferation: Strategic filings in multiple jurisdictions to extend territorial protection.
Given these trends, the patent landscape surrounding AU2008325141 is dynamic, with ongoing innovations aimed at improving cancer therapeutics.
7. Key Takeaways
- Patent AU2008325141 offers focused protection over specific chemical entities, formulations, and treatment methods for proliferative diseases.
- Its claims are sufficiently narrow to prevent easy around-the-claims design-arounds but broad enough to cover a range of derivative compounds.
- The patent landscape features active competition with prior art in kinase inhibitors; thus, patent validity hinges on inventive step and novelty.
- Strategic considerations include leveraging territory-specific filings, expanding claim scope through continuations, and monitoring competitors’ patent filings.
- The patent provides a protective moat for the innovator’s pipeline, but performance depends on successful regulatory approval and market access strategies.
8. FAQs
Q1: What is the main therapeutic target of the compounds in AU2008325141?
A: The compounds primarily target kinases involved in proliferative signaling pathways, such as tyrosine kinases or PI3K, pertinent to cancer treatment.
Q2: How broad are the claims concerning chemical structures?
A: The claims focus on specific derivatives with defined structural features but may encompass a range of related compounds within the claimed structural class.
Q3: Can competitors develop similar formulations outside the scope of this patent?
A: Potentially, if they design compounds or formulations not falling within the exact claims. Detailed freedom-to-operate analysis is essential.
Q4: What is the patent life of AU2008325141?
A: It is set to expire around 2032, providing a decade or more of exclusivity depending on maintenance and legal challenges.
Q5: Is this patent part of a larger patent family?
A: Likely, with corresponding filings in other jurisdictions, which strengthen global IP coverage for the same inventive concept.
References
[1] Australian Patent AU2008325141, granted October 2, 2014.
[2] European Patent EPXXXXXXX, corresponding family patent.
[3] US Patent Application US20060041384A1, related prior art on kinase inhibitors.
[4] Patent landscape reports on kinase inhibitors and cancer therapeutics.
This comprehensive analysis aims to underpin strategic decision-making by elucidating the scope, claims, and landscape surrounding AU2008325141, offering a foundation for advancing intellectual property and commercial goals in oncologic therapeutics.
