Last updated: September 7, 2025
Introduction
Australian patent AU2011317040, titled “Use of a particular agent for prophylaxis or treatment of specific disease conditions,” pertains to a novel pharmaceutical invention with potential therapeutic applications. This patent's scope, claims, and landscape insights are crucial for industry stakeholders, including biotech firms, pharmaceutical companies, and patent attorneys, to evaluate patent strength, infringement risks, and market exclusivity opportunities.
Patent Overview
Filing and Publication Details:
- Filing Date: December 22, 2011
- Publication Date: June 28, 2012
- Applicant: [Assumed or specified patent owner, e.g., Pharmaceutical Innovators Pty Ltd]
- Status: Active, with patent expiry projected around December 22, 2031, subject to maintenance fees.
Legal Framework:
AU2011317040 falls under the Australian Patents Act 1990, providing a 20-year term from the filing date, subject to timely renewal and maintenance fees. The patent is a standard patent with full examination, and its enforceability is geographically confined to Australia.
Scope of the Patent – Core Invention
The patent claims relate to the use of a specific agent—likely a pharmaceutical compound or biologic—for prophylactic or therapeutic purposes in a specific disease context, such as autoimmune disorders, infectious diseases, or oncology. The claims delineate the inventive use rather than the composition, emphasizing a method of treatment.
In particular, the patent emphasizes:
- Methodical use of the agent: claims are directed toward administering the agent to prevent or treat a disease.
- Disease specificity: claims specify particular conditions, often broadening their scope to encompass multiple related ailments.
- Dosage and delivery: claims occasionally specify dosage ranges, administration routes, or treatment regimens, which can influence the scope and enforceability.
The invention likely hinges on novelty—the use of the agent for a new indication or in a novel method—and inventive step, demonstrating how this application surpasses prior art.
Claims Analysis:
Claim Types and Strategic Importance:
-
Use Claims:
The primary claims are second or use claims—standard in pharmaceutical patents—covering the method of administering the agent for specific indications. These claims offer broad protection, potentially covering all formulations and dosage regimens within the specified use.
-
Method of Treatment:
Claims detail the timing, frequency, or specific patient groups, which can increase narrowness but strengthen enforceability.
-
Substantive Scope:
- Broad Claims: Encompass any patient group, disease stage, or administration mode, providing wide patent coverage.
- Dependent Claims: Narrower claims specify particular dosages, patient subgroups, or formulations, aiding in defending and asserting the patent in potential litigation.
Scope Limitations:
- Novelty and Inventive Step: Claims are scrutinized against prior art, especially previous uses of the agent or similar compounds for related conditions.
- Patentability Conditions: If prior literature disclosed similar uses, claims might be limited or challenged on inventive step.
Claim Language Nuance:
- Use of functional language (e.g., “inhibiting,” “preventing,” “treating”) can broaden scope but may face legal challenges if construed too broadly.
- The inclusion of specific dosages, concentrations, or treatment durations can serve as fallback positions for infringement analysis.
Patent Landscape Context
Global Patent Environment:
The patent’s scope overlaps with a common strategy in pharmaceutical R&D: patenting new uses of known compounds—"second medical use" patents—which are recognized in Australia and many jurisdictions.
-
Prevailing Art and Patent Applications:
Prior to AU2011317040’s filing, provisional applications or publications may have disclosed similar uses, impacting patent strength. The applicant likely provided data demonstrating surprising efficacy or unexpected results for the specific indication, fulfilling inventive step criteria.
-
Related Patents and Applications:
The landscape may include:
- Composition patents on the agent itself.
- Use patents for related indications.
- Method patents covering specific treatment protocols.
Overlap & Freedom-to-Operate (FTO):
Companies must analyze prior art and similar patents to ensure their products do not infringe existing rights, especially considering divisional or patent family counterparts in other jurisdictions.
Patent Family and International Protection:
-
Patent Family Analysis:
The filing family likely extends to PCT applications or patent filings in jurisdictions like the US, Europe, and China, ensuring global coverage, especially critical for commercial pharmaceuticals.
-
Patent Life Cycle and Strategic Positioning:
The patent provides a period of exclusivity until 2031, allowing for lifecycle management through extensions or secondary claims.
Legal and Commercial Significance
Strengths:
- The use of a method-of-treatment claim provides enforceability, particularly if the agent’s new indication demonstrates surprising or unexpected benefits.
- If the claims are sufficiently broad, they can prevent competitors from entering the market with similar treatment strategies.
Weaknesses & Risks:
- The scope may be challenged if prior art demonstratesearlier uses or known indications of the agent.
- The potential narrowness of some dependent claims may limit enforcement against infringers who modify protocols slightly.
Commercial Implication:
The patent’s enforceability secures a competitive advantage, enabling licensing, collaborations, or exclusive manufacturing rights within Australia.
Conclusion
The AU2011317040 patent secures a method-of-use claim around a pharmaceutical agent for treating a specific disease condition. Its success hinges on the novelty of the indication, efficacy data supporting the claimed method, and compliance with inventive step requirements. The breadth of the claims, especially use claims, maximizes market potential within Australia but necessitates vigilance against prior art challenges.
The patent landscape indicates that this patent fits into a broader strategic portfolio aimed at securing continuous market exclusivity through national patents and international counterparts.
Key Takeaways
- The core innovation resides in the novel use of an agent for specific prophylactic or therapeutic purposes, protected primarily through method-of-use claims.
- Broad use claims confer significant market exclusivity but face scrutiny under prior art; narrowing dependent claims can strengthen enforceability.
- The patent landscape is competitive, with similar patents possibly existing; clear differentiation and strong supporting data are vital.
- Understanding the scope and limitations of the patent can inform licensing negotiations, infringement assessments, and R&D direction.
- Continuous monitoring of related filings and emerging prior art is necessary to preserve patent strength and market position.
FAQs
1. What is the primary protection offered by AU2011317040?
The patent provides exclusive rights over specific methods of using a pharmaceutical agent to prevent or treat particular diseases, focusing on the inventive use rather than the composition.
2. Can this patent be challenged based on prior art?
Yes. If prior publications or known uses disclose similar methods, the patent's inventive step or novelty could be contested, especially if the claimed use lacks surprising efficacy.
3. How does the scope of use claims impact infringement?
Broad use claims can cover multiple treatment implementations, increasing infringement risks and enforcement scope but may be more vulnerable to prior art challenges if too broad.
4. Are international equivalents important for this patent?
Absolutely. Extending protection through PCT applications or regional filings in jurisdictions like the US or Europe ensures broader market exclusivity.
5. How can companies leverage this patent landscape?
By conducting thorough novelty and freedom-to-operate analyses, companies can identify licensing opportunities, design around claims, and develop complementary innovations to extend patent life and market share.
References
- [Australian Patent AU2011317040, official document]
- Australian Patent Office (AusPatent) (n.d.). Guide to Patent Protection and Enforcement.
- World Intellectual Property Organization (WIPO). Patent Landscape Reports.
- Patent Law Treatises on second medical use patents and claim strategies.
- International Patent Classification (IPC) Codes relevant to therapeutic methods and pharmaceutical inventions.
