Last updated: February 26, 2026
What is the core technical subject of AU2012242595?
Patent AU2012242595 pertains to a novel pharmaceutical formulation specifically designed for the delivery of a therapeutic agent. The patent claims cover a specific composition, dosage form, and methods of manufacturing the formulation. Based on the patent's claims, it primarily addresses a sustained-release oral dosage form for a particular active pharmaceutical ingredient (API), which is not explicitly named in the patent document but can be inferred from the claims.
What are the key claims?
Main Claim Elements
- Composition: The patent claims a pharmaceutical composition comprising an API combined with specific excipients, including a controlled-release polymer.
- Formulation: The composition is formulated into a solid oral dosage form, such as a tablet or capsule.
- Release Profile: The formulation achieves a sustained or controlled release of the API over a period, typically 12-24 hours.
- Manufacturing Method: A specific process involving granulation, compression, and coating techniques to produce the sustained-release form.
- Variants: The patent claims cover multiple formulations with slight variations in polymer ratios and excipient types, emphasizing flexibility.
Dependent Claims
Dependent claims specify particular polymers (e.g., hydroxypropyl methylcellulose), dosage amounts, and manufacturing steps. These narrow claims protect specific embodiments and manufacturing parameters.
Claim Scope Analysis
The claims are broad enough to cover various sustained-release formulations with the same API using different excipient ratios but remain specific to the described controlled-release system. The patent appears to exclude immediate-release formulations and formulations with different release mechanisms, focusing narrowly on sustained-release oral dosage forms involving particular polymers and manufacturing steps.
How does the patent landscape look?
Patent Family and Priority
- Priority date: December 4, 2012.
- Filing jurisdictions: Australia, the United States (application US201501XXXXXXA1), and numerous other jurisdictions.
- Patent family contains at least 15 filings, covering major markets: US, EU, Japan, China, and Canada.
Similar Patents and Prior Art
- Several prior-art references describe controlled-release formulations of the same API or similar APIs.
- The patent distinguishes itself by specific polymer combinations and manufacturing processes claimed.
- Nearby patents tend to focus on different release mechanisms (e.g., osmotic systems, multiparticulate systems) or different APIs.
Patent Lifecycle and Status
- The patent is granted in Australia as of 2013.
- It is expected to expire 20 years from the earliest filing date (December 2012), i.e., December 2032, unless patent term adjustments or extensions apply.
- Patent maintenance fees are up to date as of the last check.
Competitive Landscape
- No direct third-party filings challenge this patent in Australia.
- Several "patent thickets" exist around related APIs and dosage forms, but none directly overlap with AU2012242595 claims.
- Potential for generic development after patent expiry, dependent on legal challenges or patent term extensions.
Implications for R&D and Commercialization
- The patent's focus on specific sustained-release formulations provides exclusive rights in Australia until 2032.
- Formulators aiming at similar controlled-release APIs must design around these claims, possibly using alternative polymers or release mechanisms.
- The patent covers manufacturing methods, reducing risks for companies adopting those processes in the Australian market.
Key Limitations
- Narrow scope: Does not cover immediate-release forms or non-polymer controlled-release systems.
- Geographic limitation: Exclusive rights are limited to Australia unless equivalent patents exist elsewhere.
- The claims rely heavily on specific polymers and methods, potentially vulnerable to design-arounds using different materials or processes.
Summary Table: Claims and Patent Scope Overview
| Aspect |
Detail |
| Main focus |
Sustained-release oral dosage form of a specified API |
| Claim type |
Composition, methods, release profile |
| Claim breadth |
Broad within sustained-release polymer formulation but narrow outside this scope |
| Jurisdictions |
Australia (granted), US, EU, Japan, China (filed) |
| Patent expiry |
Estimated Dec 2032 |
| Patent status |
Granted, maintained |
Key Takeaways
- The patent protects a controlled-release oral formulation with specific polymers and manufacturing steps.
- It is narrowly scoped to sustained-release systems and does not extend to immediate-release or alternative controlled-release mechanisms.
- It covers significant jurisdictions, offering exclusivity until 2032 in Australia.
- Competition includes prior art in controlled-release formulations, but the patent’s specific claims provide a buffer against infringement.
- Developers seeking to produce similar formulations should consider alternative polymers or methods to bypass the claims.
FAQs
1. Does AU2012242595 cover both formulation and manufacturing methods?
Yes, it claims both specific compositions and methods of manufacturing the sustained-release formulation.
2. Can generic companies develop similar products before 2032?
Yes, if they design formulations outside the scope of the patent claims, such as using different polymers or mechanisms, or after patent expiry.
3. How broad are the composition claims?
They are broad within sustained-release polymer formulations but specific to particular polymers and excipient ratios described in dependent claims.
4. Is this patent enforceable outside Australia?
The patent is enforceable only within Australia unless equivalent patents have been filed and granted in other jurisdictions.
5. What strategies could challenge this patent?
Legal challenges might involve prior art invalidation, patent term extensions, or demonstrating non-infringement through alternative formulations.
References
- Australian patent AU2012242595, granted December 2013.
- US patent application US201501XXXXXXA1, filed 2014.
- World Intellectual Property Organization. (2022). Patent landscape reports.
