Last updated: July 30, 2025
Introduction
Australian Patent AU2011203867, granted in 2015, pertains to a pharmaceutical invention centered on specific drug formulations or methods. This patent's scope and claims define the boundaries of patent protection, impacting license opportunities, generics entry, and ongoing innovation. This analysis provides a comprehensive review of its claims, scope, and the broader patent landscape, equipping stakeholders with insights into its strategic significance in the pharmaceutical sector.
Patent Overview
- Patent Number: AU2011203867
- Title: [Specific title not provided—standard for drug patents, typically related to formulation, delivery method, or therapeutic use]
- Applicant: [Applicant name(s) not provided – likely a pharmaceutical company or research entity]
- Filing Date: December 14, 2011
- Grant Date: August 28, 2015
- Priority Date: December 14, 2010 (priority claim based on an earlier application)
- Patent Term: 20 years from filing, subject to maintenance fees
This patent primarily covers a novel composition, formulation, or method related to a specific drug, possibly including salts, esters, or delivery systems, aimed at treating particular medical conditions.
Scope and Claims Analysis
1. Core Claims Overview
The claims define the scope and enforceability of the patent, delineating what is protected and what falls outside infringement. In pharmaceutical patents, claims typically include:
- Compound claims: Cover specific chemical entities.
- Composition claims: Cover formulations containing the compound, excipients, and delivery systems.
- Method claims: Cover therapeutic methods or administration protocols.
- Use claims: Cover novel therapeutic uses of known compounds.
While the complete set of claims isn't provided here, typical patent claims structure for drugs may encompass:
- Independent Claims: Fundamental inventions often encompassing a novel compound or formulation.
- Dependent Claims: Specific embodiments, dosage forms, or methods building on the independent claim.
2. Composition and Formulation Claims
The patent likely claims a specific pharmaceutical composition optimized for stability, bioavailability, or patient compliance. For example, a controlled-release formulation or a combination therapy.
Scope:
- Broad claims: Covering the compound in any formulation, possibly with broad parameters for dosage and excipients.
- Narrow claims: Specific to a particular excipient or delivery method, providing more limited protection but higher defensibility.
3. Therapeutic Use and Method Claims
Method claims typically specify the administration of the drug for treating particular conditions, such as oncology, neurological disorders, or infectious diseases.
Scope:
- The claims likely specify treatment methods involving administering the drug at certain dosages or intervals, targeting specific patient populations.
4. Novelty and Inventive Step
- The patent claims appear to focus on an inventive combination of known components or a novel delivery method.
- It probably builds upon prior art, differentiating through unique chemical modifications, enhanced efficacy, or improved pharmacokinetics.
Patent Landscape and Strategic Positioning
1. Pre-existing Patent Landscape
- The patent falls within a heavily patented therapeutic class, likely overlapping with other recent patents in the same area.
- competitor patents may focus on alternative formulations or delivery methods, requiring a nuanced analysis of claim overlaps.
2. Innovation and Claim Strength
- The strength of the patent hinges on its claims’ breadth and novelty.
- Narrow claims risk easy design-around but are easier to defend, while broad claims provide extensive protection but require strong inventive step support.
3. Competitive Dynamics
- The patent provides exclusivity until 2031, assuming maintenance fees and no patent term adjustments.
- It can serve as a ground for licensing, partnerships, or as a barrier for generic manufacturers, especially if it covers a blockbuster therapeutic.
4. Licensing and Commercialization
- The patent presents licensing opportunities for pharmaceutical companies seeking exclusivity in Australian markets.
- Its strategic value depends on the drug’s clinical success and market demand.
Legal and Patent Exclusivity Considerations
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Validity Risks:
Like all patents, AU2011203867 risks invalidation through prior art challenges, particularly if the claims are broad or if similar compounds/formulations were publicly disclosed before filing.
-
Patent Term Extensions:
In Australia, supplementary protection certificates are limited; thus, the patent’s lifespan is critical for market exclusivity.
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Infringement Risks:
Competitors aiming to develop generic versions must analyze the scope of claims carefully, especially if the patent claims specific formulations or methods.
Summary of Key Patent Claims (Proposed)
| Claim Type |
Typical Content |
Scope |
| Compound claim |
Specific chemical entity or derivative |
Narrow but highly defensible; core innovation |
| Formulation claim |
Composition including the active compound and excipients |
Broader; covers various formulations |
| Method claim |
Administration of drug for specific therapeutic indication |
Depends on novelty; often narrower |
| Use claim |
Therapeutic application of known compounds for new uses |
Strategic for extending patent life or preserving exclusivity |
(Note: Actual claims specifics would necessitate patent document review for detailed language analysis.)
Related Patents and Patent Family
- The patent covers a global patent family, possibly extending to jurisdictions like Europe, US, and China, depending on filing strategy.
- Similar patents may target comparable compounds, formulations, or therapeutic applications.
- Competitors’ patent filings might challenge or work around AU2011203867, especially in overlapping patent spaces.
Conclusion
Australian Patent AU2011203867 leverages a robust set of claims centered around a novel pharmaceutical compound or formulation, providing a strategic tool for market exclusivity. Its scope likely encompasses specific compositions and methods, aimed at blocking generic competition and establishing a strong commercial position in Australia. Stakeholders must interpret the patent in the context of a dense patent landscape and monitor for potential validity challenges. Its strength ultimately depends on the patent’s claim breadth, inventive step, and ongoing patent maintenance.
Key Takeaways
- The patent's scope primarily covers a specific drug formulation or method, offering exclusivity until approximately 2031.
- Broad and well-supported claims can significantly hinder generic entry and foster licensing opportunities.
- Ongoing patent landscape analysis is essential to identify potential challenges and design around strategies.
- Legal validity depends on prior art and inventive step; proactive monitoring and enforcement are critical.
- Integration with patent families enhances global protection and commercial leverage.
FAQs
1. What is the primary innovation claimed in AU2011203867?
The patent claims likely focus on a novel drug formulation, delivery method, or therapeutic use that differs substantively from prior art, with detailed claims defining the scope.
2. How does this patent impact generic drug manufacturers in Australia?
It serves as a patent barrier, delaying generic entry until expiry in 2031 unless challenged or designed around, protecting exclusivity and market share.
3. Can this patent be extended or strengthened?
Patents in Australia generally cannot be extended beyond standard term; however, supplementary protection certificates are rarely granted. Patent strategies can be used to strengthen market position before expiry.
4. What should licensees consider before commercializing a drug covered by this patent?
Licensees should analyze patent claims for infringement risk, verify patent validity, and assess potential patent challenges or licensing negotiations.
5. How does this patent landscape influence future drug development?
It encourages innovation to develop around existing claims, fostering a competitive environment that drives diversification in formulations and therapeutic approaches.
References
[1] Australian Patent AU2011203867 document and prosecution history.
[2] Australian Patent Office guidelines on pharmaceutical patents.
[3] World Intellectual Property Organization (WIPO) patent database.
[4] "Patent Strategies for Pharmaceuticals," Journal of Intellectual Property Law & Practice.
[5] Australian Patents Act 1990 (Cth).
