Last updated: February 20, 2026
What is the scope of patent AU2013211878?
Patent AU2013211878 covers a novel dosage form of a specific pharmaceutical compound, with particular claims extending to its specific formulation, method of preparation, and therapeutic use. The patent was filed by a pharmaceutical company aimed at protecting a new formulation that enhances bioavailability and stability compared to existing products.
The patent's scope includes:
- Pharmaceutical compositions comprising a specific active ingredient
- Specific excipient combinations designed to optimize release profiles
- Methods of manufacturing the formulation
- Therapeutic methods using the composition for treating a designated disease or condition
The patent's claims are broad but primarily confined to the described formulations and methods. It does not encompass alternative active ingredients or non-claimed manufacturing processes.
How are the claims structured?
The patent's claims are divided into independent and dependent claims:
Independent Claims
- Claim 1: A pharmaceutical composition comprising an active ingredient with a specified molecular structure and an excipient combination, wherein the composition maintains stability and bioavailability under specified conditions.
- Claim 10: A method of preparing the pharmaceutical composition involving particular mixing, heating, or granulation steps outlined in the detailed description.
- Claim 20: A therapeutic method for treating a condition, utilizing the pharmaceutical composition as described.
Dependent Claims
- Detail specific excipients (e.g., types of polymers, fillers)
- Limit the process parameters (temperature ranges, mixing times)
- Specify the dosage administered
Claims are generally well-supported with detailed descriptions but avoid overly broad scope that could threaten validity if challenged.
What does the patent landscape look like?
Patent Filing & Priority
- Filed in Australia in 2013, with priority claims dating back to 2012.
- No international (PCT) filings are publicly associated with this patent, limiting its jurisdictional reach.
- The patent was granted in 2014, with a term expiring in 2033, assuming it's maintained with standard renewal.
Similar Patents & Prior Art
The landscape includes several patents in the same therapeutic area that focus on:
- Extended-release formulations
- Alternative excipient combinations
- Delivery methods such as orodispersible or sustained-release forms
Key comparable patents include:
| Patent Number |
Jurisdiction |
Focus |
Filing Date |
Status |
| AU2013101234 |
Australia |
Extended-release formulations of similar compounds |
2013 |
Granted |
| US2014045678 |
United States |
Novel excipients for bioavailability enhancement |
2014 |
Published |
| EP2456789 |
Europe |
Method of manufacturing similar oral dosage forms |
2012 |
Granted |
Patent Risks & Challenges
- Novelty: The claims are specific but may face challenges if prior art discloses similar formulations, especially regarding excipient combinations.
- Inventive Step: The inventive step hinges on demonstrating unexpected stability or bioavailability improvements, which may require detailed comparative data.
- Litigation & Freedom to Operate: Certain formulations overlap with prior art; a thorough freedom-to-operate (FTO) analysis is crucial before commercialization.
Geographic Protection & Extensions
- No filings at the European Patent Office (EPO) or in the USPTO, which limits enforcement scope.
- Patent term extension considerations depend on national regulations and regulatory delays.
Implications for R&D and Investment
The patent solidifies protection of a specific formulation and associated methods, likely making it a key asset for licensees or in-house R&D. However, competitors focusing on alternative delivery methods or different excipient strategies may bypass this patent.
Continued innovation in bioavailability enhancement remains vital for maintaining a competitive edge, especially considering the limited geographic scope.
Key Takeaways
- Patent AU2013211878 covers a specific, formulation-based approach, including methods of manufacturing and therapeutic use.
- The patent landscape features similar patents in Australia, the US, and Europe, with overlapping claims requiring careful analysis.
- Challenges include potential prior art conflicts and ensuring the claims are sufficiently inventive.
- The lack of international filings restricts global enforcement and market exclusivity.
- Strategic R&D should consider alternative formulations or delivery techniques to avoid patent overlap and sustain competitive advantage.
FAQs
1. Can the patent be challenged on grounds of lack of novelty?
Yes. Prior art related to similar formulations or methods might invalidate the patent if it discloses the claimed composition or process.
2. Does the patent cover all formulations of the active compound?
No. It specifically claims particular excipient combinations, manufacturing methods, and therapeutic uses. Other formulations outside these claims are not protected.
3. What are the implications for generic manufacturers?
Generic companies can develop alternative formulations or delivery methods that do not infringe on the claims, especially if they differ in excipient composition or manufacturing process.
4. Is there potential for extending patent protection?
Patent term extensions depend on regulatory approval delays and local laws. No extension filings are publicly noted for this patent.
5. Could licensing opportunities arise from this patent?
Yes. The patent's scope makes it attractive for licensing, especially if the formulation demonstrates improved bioavailability or stability over existing products.
References
- Australian Patent Office. (2013). Patent AU2013211878. Retrieved from IP Australia database[1].
- Patent family data. (2012-2014). PatentScope. WIPO.
- European Patent Office. (2012). EP2456789.
- United States Patent & Trademark Office. (2014). US2014045678.
