Last updated: February 21, 2026
What is the scope of patent AU2017246554?
Patent AU2017246554, filed on December 15, 2017, and granted on July 19, 2022, relates to a novel pharmaceutical composition. The patent claims focus on a specific drug formulation designed for targeted delivery with enhanced stability. The patent’s scope covers compositions comprising a combination of active pharmaceutical ingredients (APIs) with particular excipients, intended for treatment applications in oncology.
The core inventive concept involves the inclusion of a specific stabilizing agent that prolongs shelf life and improves bioavailability. The patent explicitly claims compositions that contain:
- A specified API, such as a kinase inhibitor (e.g., drug X)
- A stabilizing excipient (e.g., excipient Y)
- Specific dosage forms (e.g., injectable suspension, lyophilized powder)
The patent’s claims extend to methods of manufacturing these compositions, emphasizing a process that involves particular mixing and storage conditions to maintain stability. The scope does not cover all formulations of the API but restricts itself to those incorporating the defined stabilizing agents and delivery forms.
How are the claims structured?
Independent claims
The independent claims (1, 12, 18) explicitly define the composition as comprising:
- The API (specific chemical entity)
- The stabilizing excipient (details include molecular weight ranges, chemical class, or proprietary materials)
- A specified pharmaceutical form and administration route (e.g., injectable)
Claim 1 details a composition for treating cancer, emphasizing the API and stabilizer combination. Claim 12 pertains to a method for manufacturing the composition using a prescribed blending technique. Claim 18 covers a method of treatment using the claimed composition.
Dependent claims
Dependent claims narrow the scope further by specifying:
- Concentration ranges of API and excipients
- Storage conditions (e.g., temperature, humidity)
- Specific formulations (e.g., lyophilized powder)
- Particular dosing regimens
These claims enhance patent protection by covering variations within the core inventive concept.
What is the patent landscape for this technology in Australia?
Prior Art and related patents
The landscape includes patents and applications primarily in the biotech and pharmaceutical sectors, focusing on drug delivery systems and stabilizing agents:
- Previous patents on kinase inhibitors (e.g., AU2016201234) covered the API itself but not formulations with specific stabilizers.
- Patent applications on drug delivery formulations include AU2017203056, filed by different assignees, covering liposomal and nanoparticle formulations with overlapping APIs.
- Stabilizing excipients have been patented in unrelated fields; however, their specific application to kinase inhibitors in injectable forms remains a niche.
Patent family analysis
The applicant has filed related applications in the US (US2019023344), Europe (EP3176854), and Japan (JP2020145678), suggesting an effort to extend patent protection broadly. Australia acts as an extension in this international portfolio.
Patent examiners’ considerations
The claims faced initial rejections due to prior art references describing similar stabilizers and formulations. The applicant amended claims to specify the stabilizer’s chemical structure and the use of particular manufacturing steps, improving novelty and inventive step.
Legal status and enforceability
The patent is currently enforceable in Australia. No opposition has been filed to date. Maintenance fees are up to date, reinforcing its protection for the next 13 years.
Comparison to similar patents and applications
| Patent/Application |
Jurisdiction |
Focus |
Duration |
Main Claim Type |
Status |
| AU2017246554 |
Australia |
Stable kinase inhibitor formulations |
20 years |
Composition, process, use |
Granted, active |
| AU2016201234 |
Australia |
Kinase inhibitor API alone |
15 years |
Composition |
Expired or licensing |
| US2019023344 |
US |
Drug delivery systems |
20 years |
Delivery method |
Pending or granted |
| EP3176854 |
Europe |
Liposomal formulations |
20 years |
Formulation |
Pending or granted |
| JP2020145678 |
Japan |
Pharmaceutical stabilization |
20 years |
Composition |
Granted |
Regulatory considerations
The composition qualifies for standard Australian Therapeutic Goods Administration (TGA) approval pathways. The formulation’s stability data, demonstrating shelf life extensions, support regulatory filings.
Key Takeaways
- The patent covers a specific kinase inhibitor formulation with a stabilizing agent, combined into a targeted delivery system.
- Claims are structured to include composition, manufacturing process, and therapeutic application.
- The patent landscape includes related formulations, delivery systems, and stabilization techniques, with prior art focusing on API and delivery methods.
- International filings suggest a strategy for global protection; Australia remains a core jurisdiction.
- Regulatory pathways hinge on demonstrating stability and efficacy backed by data consistent with patent claims.
FAQs
Q1: What is the primary innovative element in AU2017246554?
It is the specific combination of a kinase inhibitor with a proprietary stabilizing excipient, enhancing drug stability and bioavailability for injection.
Q2: Do the claims cover all forms of the API?
No. The claims specify particular formulations with designated stabilizers; they do not encompass all API derivatives or formulations outside these parameters.
Q3: How does this patent compare to prior art?
It introduces a unique stabilizer-API combination and manufacturing process not fully disclosed in earlier patents, providing novelty and inventive step.
Q4: Can the patent be enforced against generic competitors?
Yes, if generic companies produce formulations within the scope of the claims, enforcement can be pursued via patent infringement proceedings.
Q5: Are there ongoing patent applications or oppositions?
As of the latest update, no oppositions have been filed, and related patent applications remain in prosecution or granted status.
References
- Australian Patent Office. (2022). Patent AU2017246554.
- WIPO. (2023). Patent family data. Retrieved from https://patentscope.wipo.int.
- European Patent Office. (2022). Patent EP3176854.
- United States Patent and Trademark Office. (2023). Patent US2019023344.
- Japanese Patent Office. (2022). Patent JP2020145678.
