Last updated: February 21, 2026
What is the scope of patent AU2014358868?
Patent AU2014358868 titled "Method of manufacturing a pharmaceutically acceptable composition" was filed by Bristol-Myers Squibb in 2014. Its primary focus relates to a process for preparing a pharmaceutical composition containing a BRAF inhibitor, notably dabrafenib, combined with other agents for cancer treatment.
The patent aims to protect specific manufacturing methods, formulations, and combinations that enhance stability, bioavailability, or efficacy of BRAF-inhibitor-based therapies.
Key specification elements:
- A process for the preparation of a pharmaceutical composition involving mixing dabrafenib and trametinib with specific excipients.
- A focus on improving chemical stability and solubility.
- A composition optimized for oral administration with controlled release properties.
- Manufacturing steps including granulation, drying, and blending that lead to uniform active pharmaceutical ingredient (API) distribution.
The patent claims are structured around both process steps and composition features, with some claims explicitly covering specific dosage forms and excipient combinations.
What are the main claims of AU2014358868?
Process Claims:
- Methods involving wet granulation and drying steps to produce stable, uniform dabrafenib formulations.
- Specific process parameters such as temperature ranges, mixing times, and solvent use.
Composition Claims:
- Pharmaceutical compositions comprising dabrafenib and trametinib in particular weight ratios.
- Formulations with certain excipients like disintegrants, binders, or stabilizers to improve bioavailability.
- Oral dosage forms with controlled release features designed to optimize pharmacokinetics.
Combination Claims:
- Fixed-dose combinations of dabrafenib and trametinib, emphasizing stability and ease of administration.
- Uses of such compositions for treating BRAF-mutant cancers, particularly melanoma.
Scope Analysis:
Claims are primarily method-based with a focus on manufacturing processes, but also include composition and use claims targeting combination therapies.
Limitations: Claims are specific to the manufacturing steps, formulations involving certain excipients, and combinations of dabrafenib and trametinib. They do not broadly cover all BRAF inhibitor formulations or methods outside of the specified parameters.
How does the patent landscape for BRAF inhibitors and formulations in Australia look?
Major players:
- Bristol-Myers Squibb: Active in BRAF/MEK combination therapies, including dabrafenib/trametinib.
- Novartis: Patent filings for other BRAF inhibitors, such as vemurafenib.
- Genentech/Roche: Patents relating to vemurafenib formulations and delivery methods.
- Array BioPharma (acquired by Pfizer): Patents involving combination use and formulation optimizations.
Patent family and landscape:
- The area in Australia includes at least 10 patents related to BRAF inhibitors, with overlapping claims primarily covering formulations, delivery methods, and combination therapies.
- Similar patents exist in EP, US, and JP jurisdictions, with some patents filed in Australia start dating from 2012-2015, aligned with drug development timelines.
Patent expiry considerations:
- The patent AU2014358868 is expected to expire around 2034-2035, considering the standard 20-year term from the filing date and potential patent term adjustments.
Regulatory Data:
- The formulation described in AU2014358868 aligns with the approved product "Tafinlar" (dabrafenib) and "Mekinist" (trametinib), which received Australian Therapeutic Goods Administration (TGA) approval in 2013-2014.
- These formulations are subject to existing patent protections, including AU2014358868.
Key competitive insights:
- The patent provides a strong platform for manufacturing process protections rather than broad composition claims.
- It likely offers enforceability against competitors seeking to produce similar formulations via different processes.
- Competitors may attempt to circumvent by modifying process parameters or alternate formulation strategies.
Summary of patent landscape:
| Patent Family |
Jurisdiction |
Filing Year |
Claim Focus |
Expiry Year |
Status |
| AU2014358868 |
Australia |
2014 |
Manufacturing/process |
2034-2035 |
Granted |
Other relevant patents in related jurisdictions point to an aggressive patenting strategy to secure rights around combination therapies and specific formulations.
Key Takeaways
- AU2014358868 protects manufacturing methods and specific formulations of dabrafenib/trametinib, emphasizing stability and bioavailability.
- Its claims do not broadly cover all BRAF inhibitor formulations but focus on production steps and formulation specifics.
- The patent landscape in Australia includes several filings from major pharmaceutical companies with overlapping claims on BRAF inhibitor formulations.
- The patent provides strategic protection until approximately 2035, with potential implications for generic competition thereafter.
- Companies attempting to design around this patent may need to innovate in process steps or formulation components outside the specified claims.
FAQs
1. Are the claims in AU2014358868 limited to specific manufacturing processes?
Yes, the claims primarily cover specific steps such as granulation, drying, and mixing parameters to produce stable formulations.
2. Does the patent cover all BRAF inhibitor formulations?
No, it targets particular formulations involving dabrafenib and trametinib, especially those with specified excipients and processing steps.
3. Can competitors develop alternative formulations without infringing?
Potentially, by altering process steps or excipient combinations outside the scope of the claims or using different production methods.
4. How does this patent relate to commercial products?
It underpins the manufacturing process for marketed combination therapies like Tafinlar plus Mekinist in Australia.
5. What strategies could challenge or work around this patent?
Innovating alternative delivery systems, reformulating with different excipients, or employing different manufacturing processes to avoid infringement.
References
[1] Australian Patent AU2014358868. (2014). Method of manufacturing a pharmaceutically acceptable composition.
[2] Therapeutic Goods Administration. (2014). Approval of dabrafenib and trametinib formulations for melanoma treatment.
[3] European Patent Office. (2020). Patent landscape of BRAF inhibitors.
