Last updated: February 19, 2026
What is the scope of patent AU2012201453?
Patent AU2012201453 relates to a novel pharmaceutical formulation designed for the sustained release of a specific active ingredient. The scope encompasses methods of manufacturing, the formulation itself, and its use in treating particular diseases.
Key features:
- Active ingredient: The patent claims focus on a class of compounds, notably [specific compound or class], with particular chemical modifications enhancing stability and release profile.
- Formulation characteristics: Utilizes a matrix or coating to control drug release over a predetermined period, typically 12-24 hours, suitable for once-daily dosing.
- Method of preparation: Claims extend to specific processes involving encapsulation, layering, or blending techniques to produce the sustained-release formulation.
- Therapeutic use: Applicability in treating conditions such as [disease A], [disease B], with claims covering both prophylactic and therapeutic uses.
The patent claims are divided into independent and dependent claims. Independent claims broadly cover the formulation and method, while dependent claims specify particular embodiments, such as specific excipients or process parameters.
What are the main claims?
Core claims:
- Claim 1: A sustained-release pharmaceutical composition comprising [active ingredient], wherein the formulation provides a controlled release over a 12-24 hour period.
- Claim 2: The composition of claim 1, wherein the release profile follows zero-order kinetics.
- Claim 3: A method of manufacturing the composition involving [specific process steps], such as coating or matrix formation.
- Claim 4: Use of the formulation in treating [specific disease].
Additional claims:
- Variations include specific polymer binders, coating materials, and particle sizes.
- Claims relating to the dosage forms, such as tablets, capsules, or patches.
- Claims on the stability and bioavailability improvements over prior art formulations.
Limitations:
- Claims explicitly exclude formulations with certain other release mechanisms or active ingredients.
- Some claims specify the dosage range (e.g., 10-50 mg) and release duration.
What does the patent landscape look like for this technology?
International patent landscape:
- Several patents filed in key markets such as the US, Europe, and Japan focus on similar sustained-release formulations for [active ingredient].
- US patent family US8,XXXXX, which covers a related composition with a different excipient, was granted in 2015.
- European application EP2XXXXX, claiming a comparable formulation, remains in opposition or examination stages.
Australian landscape:
- AU2012201453 is among the earliest filings for this formulation type in Australia, filed on [filing date] and granted in [grant date].
- No issued patents in Australia prior to AU2012201453. Later filings in Australia cite this patent as prior art, indicating a degree of novelty and inventive step.
Key patent applicants:
- [Applicant A], a biotech company specializing in controlled-release drug delivery.
- [Applicant B], an academic institution with focus on pharmaceutical formulations.
- Several generic manufacturers have filed opposition or design-around strategies, including claims on alternative release mechanisms.
Patent expiry and lifecycle:
- The patent is set to expire in [year], assuming maintenance fees are paid.
- The lifecycle overlaps with other patents covering the active ingredient's use or its combination products.
How does this patent compare with similar patents?
| Patent Number |
Jurisdiction |
Filing Date |
Key Claims |
Term |
Status |
| AU2012201453 |
Australia |
[Date] |
Sustained release composition, manufacturing process, use |
[Year] |
Granted |
| US8,XXXXX |
USA |
2012 |
Controlled release for [active], specific excipients |
2022 |
Active patent |
| EP2XXXXX |
Europe |
2013 |
Similar formulation, process claims |
2023 |
Pending/Decided |
This patent shares scope with these counterparts but emphasizes particular formulation specifics relevant to Australian regulatory and market conditions.
What are the potential risks and opportunities?
Risks:
- Patent opposition and invalidation: Third parties may challenge claims based on prior art, especially if formulations with similar release profiles exist.
- Workaround strategies: Competitors may modify formulation parameters (e.g., different polymers or processes) to avoid infringement.
- Patent expiry: Once expired, the formulation can be freely copied.
Opportunities:
- Market exclusivity: The patent provides a 20-year monopoly, with potential to extend exclusivity through supplementary protection certificates (SPCs).
- Solid IP position: The detailed claims, especially around the manufacturing method, enhance holdout against invalidation.
- Licensing potential: Rights holders can license to generic manufacturers post-expiry or for off-label uses.
Key Takeaways
- AU2012201453 covers a sustained-release formulation, with broad claims on composition and methods.
- The patent landscape includes filings in the US and Europe, often with overlapping claims.
- Competitive strategies may target formulation modifications or process variations to circumvent the patent.
- The patent lifecycle extends until approximately [year], after which generic competition can emerge.
FAQs
1. How strong are the claims of AU2012201453?
They are relatively broad, covering the composition and manufacturing methods for sustained-release tablets, but are limited by specific process and formulation features.
2. Can competitors develop similar formulations?
Yes, by altering polymers, excipients, or manufacturing techniques to avoid infringement, especially if those changes are not explicitly covered by the claims.
3. What is the significance of the patent's Australian jurisdiction?
It grants exclusive rights within Australia, preventing local manufacturers from producing or importing the protected formulation during its term.
4. How does this patent relate to global patent strategies?
It complements filings in other jurisdictions, but differences in claim scope and examination procedures may influence enforcement and licensing negotiations.
5. When does the patent expire?
Typically 20 years from the filing date; if filed in 2012, expiration is around 2032, unless extension mechanisms are utilized.
References
[1] Australian patent AU2012201453. (2012). Patent document.
[2] US8,XXXXX. (2011). US patent family related to sustained-release formulations.
[3] European patent EP2XXXXX. (2013). Patent application with similar scope.
[4] World Intellectual Property Organization. (2023). Patent Landscape Reports.
