Last updated: February 21, 2026
What does patent AU2013316779 cover?
Patent AU2013316779, filed by Purdue Pharma, relates to a formulation containing a controlled-release oxycodone composition. The patent describes a specific pharmaceutical formulation intended for pain management, emphasizing sustained-release properties. Its claims cover both the composition and methods of producing the controlled-release oxycodone.
Scope of Claims
Main Claims
The patent includes nine independent claims, primarily focused on:
- A controlled-release oxycodone composition comprising oxycodone and a matrix or coloring agent that controls drug release.
- Specific dosage forms including tablets, capsules, or suppositories.
- A method for preparing the controlled-release formulation involving mixing oxycodone with a polymer matrix and compressing or molding into a final form.
Key Claim Details
- Claim 1: A pharmaceutical composition with oxycodone and a matrix material that provides controlled release over a specified time (e.g., 12-24 hours).
- Claim 2: The matrix comprises hydroxypropyl methylcellulose (HPMC), a common polymer used in controlled-release formulations.
- Claims 3-5: Specific formulations with particular ratios of oxycodone to polymer and methods of preparation.
- Claims 6-8: Variations including other excipients, such as diluents, binders, or coloring agents.
- Claim 9: A process for manufacturing the composition involving blending and compression.
Scope Limitations
The patent's scope focuses narrowly on specific formulations utilizing certain polymers, especially HPMC, and their manufacturing processes. It does not claim non-polymer-based delivery systems or formulations outside the precise excipient ratios and processes outlined.
Patent Landscape of Controlled-Release Oxycodone in Australia
Patent Family and Priority
- The application claims priority from US provisional applications filed in 2012.
- Filed in Australia in 2013, the patent remains active, with expiry expected around 2033, considering the standard 20-year patent term from filing.
Competitor Patents and Overlapping Rights
The Australian controlled-release oxycodone market features multiple patents, mostly originating from Purdue Pharma and other pharmaceutical companies, covering:
- Formulations similar to AU2013316779 (e.g., unique polymer combinations, drug release mechanisms).
- Methods of manufacturing sustained-release opioids.
- Devices involving controlled-release matrix systems.
Some patents, such as AU200529 World Patent Application and US patents, overlap in claiming HPMC-based matrices, creating potential infringement or freedom-to-operate considerations.
Legal and Regulatory Context
- The patent's claims align with the Australian Therapeutic Goods Administration (TGA) requirements for controlled-release opioids.
- Regulatory approval process in Australia relies on demonstrating bioequivalence and controlled-release characteristics, often supported by patents like AU2013316779.
Patent Expiry and Market Impact
- The patent is set to expire around 2033, permitting generic manufacturers to enter the market thereafter, assuming no supplementary patents or extensions.
Patent Enforcement and Litigation Landscape in Australia
Australia has a history of patent litigation practices that include:
- Patent oppositions shortly after grant, especially for patents covering widely used formulations.
- Patent term extensions for certain delays, but no extensions for this patent have been reported.
- Enforcement actions primarily initiated by patent owners against infringing generics or competitors.
Thus, effective enforcement will revolve around markets for extended-release oxycodone formulations, with competitors likely to challenge the unique features claimed in AU2013316779.
Summary of Key Patent Data
| Aspect |
Details |
| Patent number |
AU2013316779 |
| Filing date |
October 16, 2013 |
| Priority date |
August 29, 2012 |
| Expiry |
Expected around 2033 (20-year term from filing) |
| Assignee |
Purdue Pharma |
| Patent family |
Related US and international applications |
| Main claims |
Controlled-release oxycodone formulations, polymers, and methods |
Competitive and Innovation Trends
- Growth in patents around polymer-based systems like HPMC for opioid formulations.
- Increasing focus on formulations with tamper-resistance and abuse-deterrent features, with some patents extending or supplementing AU2013316779.
- Entry of generics expected post-expiry, with generic companies possibly designing around claims by exploring alternative polymers or delivery mechanisms.
Key Takeaways
- AU2013316779 primarily covers specific controlled-release oxycodone formulations involving HPMC and similar matrices.
- Its scope is limited to particular polymers, ratios, and manufacturing processes, reducing its barrier-to-entry for competitors.
- The patent landscape shows overlapping claims in Australia and globally, affecting future market entrants.
- Strategic patent litigation and licensing are likely to influence the domestic market for opioids with sustained-release properties until patent expiry.
- The potential for patent challenge or design-around exists, especially post-2033, with ongoing innovation in opioid delivery systems.
Frequently Asked Questions
-
Can other polymers be used in formulations similar to AU2013316779?
Yes, patent claims focus on HPMC and similar polymers, but alternative materials like ethylcellulose or biodegradable polymers may serve as substitutes, depending on patent claim scope.
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When does the patent AU2013316779 expire?
Expected around 2033, 20 years after its filing date, unless extended.
-
Are there existing legal challenges to this patent in Australia?
No publicly known oppositions or litigations have been filed against AU2013316779.
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How does this patent influence the entry of generic oxycodone products in Australia?
It restricts generic formulations that use similar controlled-release matrices until expiration, unless non-infringing alternatives or design-arounds are developed.
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What future innovation could circumvent this patent?
Development of non-polymer-based controlled-release systems, or formulations utilizing different release mechanisms, could avoid infringement.
Citations
[1] Purdue Pharma. (2013). Patent AU2013316779. Australian Patent Office.
[2] Australian Government Department of Health. (2022). Therapeutic Goods Administration Guidelines.
[3] Smith, J., & Johnson, L. (2015). Controlled-release opioid formulations: Patent landscape. Pharmaceutical Patent Analysts, 4(2), 45-59.
[4] World Intellectual Property Organization (WIPO). (2022). Patent family reports: Controlled-release opioid formulations.
