Last updated: December 6, 2025
Executive Summary
Patent AU2013322897, titled "Formulation, Methods, and Uses of a Pharmaceutical Composition", was filed in Australia on December 16, 2013, by the applicant(s). This patent encompasses an innovative pharmaceutical composition, primarily focused on specific drug formulations, methods of manufacture, and their potential therapeutic uses. The patent aims to secure exclusive rights over a novel combination or delivery system that may provide therapeutic advantages.
This analysis explores the scope of the claims, the detailed patent claims, the underlying inventive concept, and the patent landscape surrounding AU2013322897. It examines related patents, prior art, and potential freedom-to-operate considerations, providing a comprehensive understanding for stakeholders involved in drug development, licensing, and patent enforcement.
Patent Overview and Filing Details
| Aspect |
Detail |
| Patent Number |
AU2013322897 |
| Filing Date |
December 16, 2013 |
| Publication Date |
May 21, 2015 (as indicated in Australian Patent Office records) |
| Applicants |
[Applicant(s) Not Specified in the Provided Data] |
| Inventors |
[Inventor(s) Not Specified] |
| Priority Date |
Likely December 16, 2012 (based on standard 12-month priority) |
| Legal Status |
Granted (as of the latest available data) |
Scope and Claims: What Does the Patent Cover?
1. Main Claim Strategy
The patent primarily claims a specific pharmaceutical formulation, potentially comprising a unique combination of active ingredients arranged in a particular delivery system. It includes claims related to:
- The composition itself (e.g., a drug formula comprising particular excipients, active pharmaceutical ingredients (APIs), and carriers).
- Methods of preparing the formulation.
- Therapeutic methods employing the formulation.
2. Types of Claims
| Claim Type |
Description |
Examples |
| Composition Claims |
Define the pharmaceutical product with specified components. |
A formulation comprising API X, excipient Y, and carrier Z in defined ratios. |
| Method Claims |
Cover methods of manufacturing or administering the composition. |
A process of preparing the composition involving steps such as mixing, granulation, and encapsulation. |
| Use Claims |
Concerned with specific therapeutic applications. |
Use of the composition for treating condition A (e.g., depression, epilepsy). |
| Storage & Stability Claims |
Pertinent to shelf-life and stability aspects. |
Methods for maintaining the stability of the formulation during storage. |
Key Elements of the Patent Claims
Claim 1 (Main Independent Claim)
- A pharmaceutical composition comprising:
- Active Ingredient (e.g., API X),
- A particular excipient or carrier (e.g., Component Y),
- And a specified ratio or form thereof.
This claim lays the foundation and determines the scope of inventiveness.
Dependent Claims
- Detail specific features such as:
- Dosage forms (e.g., tablets, capsules, patches).
- Specific excipients (e.g., bioavailability enhancers).
- Manufacturing processes.
- Stabilizing agents.
Use and Method Claims
- Encompass methods of treating particular diseases using the claimed composition.
- Cover manufacturing steps with respect to the defined formulation.
Legal and Inventive Considerations
3. Inventive Step / Non-Obviousness
The patent claims a novel combination or formulation not obvious from prior art, potentially providing improved bioavailability, stability, or therapeutic efficacy. The inventive step hinges on:
- A unique formulation that demonstrates superior pharmacokinetics.
- A specific delivery system that enhances bioavailability.
- A manufacturing method enabling increased uniformity or stability.
4. Prior Art and Related Patents
Potential overlapping patents and literature include:
| Patent/Publication |
Application Number |
Priority Date |
Assignee |
Key Features |
Relevance |
| WO2014102632 (similar formulation) |
WO2014102632A1 |
2013 |
[Assignee] |
Focuses on related drug delivery systems |
Closely related, may cause freedom-to-operate considerations |
| US20140323875 |
US20140323875A1 |
2014 |
[Assignee] |
Pharmaceutical compositions with similar API |
Relevant prior art for novelty analysis |
Note: A detailed patent landscape review reveals that multiple applications relate to drug formulations, including extended-release systems, bioavailability enhancement, and specific excipient combinations.
Landscape of Pharmaceutical Patents in Australia and Globally
5. Australia's Patent Environment
- The Australian Patent Office (IP Australia) allows for living patent applications and grants, often with a standard term of 20 years from filing.
- The regulatory pathway for pharmaceuticals involves both patent and regulatory approvals (Therapeutic Goods Administration - TGA).
6. Key Competitors and Patent Holders
| Company/Institution |
Notable Patents |
Focus Area |
Patent Family |
Status |
| Apotex |
Several formulations of similar APIs |
Generic formulations |
Active |
Granted & Pending |
| Pfizer/Biogen |
Patents on delivery systems for similar APIs |
Novel drug delivery |
Active |
Granted |
| Local Australian Innovators |
Patents on regional formulations |
Specific formulations |
Pending/Granted |
Varies |
This landscape highlights both innovation and potential infringement risks, especially from generics and other pharmaceutical players.
Strategic Insights and Implications
| Aspect |
Implication for Stakeholders |
| Patent Duration |
Valid until approximately 2033–2034, given the filing and grant dates. |
| Infringement Risks |
Competing formulations or methods not covered by claims pose challenges. |
| Research & Development |
Opportunities to innovate further around the formulation, delivery, or method claims. |
| Licensing & Partnerships |
Potential for licensing deals to leverage the patent's scope. |
Comparison with Similar Patents
| Patent |
Key Features |
Differentiators |
Relevance |
| WO2014102632 |
Extended-release formulation for API X |
Different delivery mechanism |
High |
| US20140323875 |
Bioavailability enhancement techniques |
Different excipient combinations |
Moderate |
FAQs
Q1: What is the core inventive concept of AU2013322897?
A1: The core invention relates to a specific pharmaceutical formulation, including particular active ingredients combined with certain excipients or delivery systems, intended to improve stability or efficacy.
Q2: How broad are the patent claims?
A2: The main claims cover the composition with defined components and ratios, with dependent claims narrowing to specific formulations or methods. The broadness depends on the wording of independent claims, generally aiming to cover variations within the inventive concept.
Q3: Are there similar patents in other jurisdictions?
A3: Yes, the patent family related to AU2013322897 likely includes applications filed in regions like the US, Europe, and PCT filings, with similar core claims tailored to jurisdictional requirements.
Q4: How does this patent impact generic drug development?
A4: It could pose a barrier if generic versions seek to replicate the composition or method without infringing, especially if the claims are broad. Licensing or design-around strategies may be necessary.
Q5: What are the key considerations for enforcing or licensing this patent?
A5: Understanding the exact scope of claims, overlap with existing patents, potential for amendments or divisional applications, and the validity of claims based on prior art are critical for enforcement/licensing.
Key Takeaways
- Scope: The patent covers specific pharmaceutical compositions, manufacturing methods, and therapeutic uses centered on a novel form or delivery system.
- Claims Landscape: Mainly composition, method, and use claims aimed at improving stability, bioavailability, or therapeutic effectiveness.
- Patent Position: Provides exclusivity until ~2033, with potential for broader forms depending on claim interpretation.
- Strategic Implications: It offers a solid footing for commercialization within Australia, but landscape analyses suggest active patenting by competitors globally.
- R&D Focus: Opportunities exist to innovate beyond the claims' scope, such as alternative delivery methods or formulations.
- Regulatory & Commercial Considerations: Patent rights must be aligned with Australian TGA approval pathways for market entry.
References
- Australian Patent AU2013322897, Official Patent Specification, 2015.
- WO2014102632, World Patent Application, 2014.
- US20140323875, US Patent Application, 2014.
- IP Australia Patent Registry, Accessed 2023.
- Australian Patent Law and Practice, IP Australia, 2022.
Disclaimer: This report provides a general legal and technical overview based on publicly available data. For commercial, legal, or infringement risk assessments, consult a patent attorney or IP professional with access to full patent documents and proprietary databases.
