Last updated: October 5, 2025
Introduction
Patent AU2018360752, filed by F. Hoffmann-La Roche AG, concerns a novel aspect of pharmaceutical technology relevant to oncology, more specifically pertaining to a distinct use or formulation involving a drug candidate. This analysis provides an in-depth review of the scope and claims of AU2018360752, contextualizes its position within the broader patent landscape, and evaluates strategic considerations for stakeholders in pharmaceutical innovation and patent management.
Overview of Patent AU2018360752
Title: Use of a BRAF inhibitor in combination with a MEK inhibitor for cancer treatment
Filing Date: December 12, 2018
Priority Date: The patent claims priority from prior applications, reflecting the inventors' earliest filing date, which influences novelty assessments.
Patent Status: Pending (as of 2023); examination outcomes influence final patent rights.
Assignee: F. Hoffmann-La Roche AG, a leading global pharmaceutical entity with substantial IP assets in oncology.
Field: Oncology, specifically targeted therapies involving BRAF and MEK inhibitors.
Scope and Claims Analysis
1. Core Invention and Claim Drafting Strategy
The patent claims focus on combinational use of a BRAF inhibitor (e.g., Vemurafenib or Dabrafenib) with a MEK inhibitor (e.g., Trametinib or Cobimetinib) for treating BRAF-mutant cancers. The claims aim to secure exclusivity over the use of these combinations, possibly in specific indications (e.g., melanoma, non-small cell lung cancer).
The drafting employs "second medical use" claims and method-of-treatment claims, standard in pharmaceutical patents to protect novel therapeutic applications.
2. Claim Hierarchy and Scope
- Independent Claims: Typically cover the use of a BRAF inhibitor in combination with a MEK inhibitor for treating BRAF-mutated cancers, emphasizing pharmaceutical or therapeutic use.
- Dependent Claims: Elaborate on specific combinations, dosages, administration routes, treatment timing, or patient populations, which narrow the scope but strengthen patent defensibility.
3. Key Claim Elements
- Combination therapy: Concurrent administration of specified inhibitors.
- Targeted mutations: BRAF mutations, particularly V600E and V600K.
- Disease indications: Melanoma primarily, with potential extension to other BRAF-mutant tumors.
- Dosage and regimen parameters: Range of dosages, treatment duration, and specifics of administration procedures.
4. Claim Scope and Patentable Subject Matter
The claims appear carefully drafted to navigate patentability requirements:
- Novelty: Likely hinges on a specific combination or therapeutic use not previously disclosed.
- Inventive step: Argued based on synergistic efficacy or unexpected benefits over monotherapies.
- Industrial applicability: Clear, as therapeutically relevant.
However, the scope may face limitations if prior art discloses similar combinations or if claims are overly broad, risking rejection during examination.
Patent Landscape Context
1. Prior Art and Patent Environment
The landscape surrounding AU2018360752 involves several key patent families:
- Existing BRAF inhibitors: Patent portfolios protecting compounds such as Vemurafenib [1].
- MEK inhibitors: Patents on Trametinib and Cobimetinib, with overlapping claims on combinations and specific uses.
- Combination therapy patents: Prior patents by Roche and other entities, covering combined BRAF and MEK pathway inhibition for melanoma and other cancers [2].
2. Competitor Patent filings
Major competitors, including Array BioPharma and Novartis, hold their own claims on similar combinations, often with narrower scope focusing on particular doses or treatment sequences. The AU patent must establish clear novelty over these existing patents and published literature.
3. Publications and Patent Applications
Scientific publications have documented the synergistic effects of BRAF and MEK inhibitors, forming a basis for such patent claims. Yet, prior public disclosures can challenge the novelty if the claims are too broad or lack sufficient inventive steps.
4. Regulatory and Patent Term Considerations
Given the active development in oncology therapeutics, patent term extension considerations may arise, especially to compensate for patent pendency delays and regulatory approval periods.
Strategic Patent Considerations
- Protection of specific combinations and dosing regimens: Narrower claims might provide better enforceability, but broader claims can secure market exclusivity if well-supported.
- Focus on particular indications: Claiming use in specific cancers could minimize overlapping prior art.
- Geographical scope: While this patent pertains to Australia, similar patents likely exist or are pursued in other jurisdictions, influencing the global patent strategy.
Conclusion
Patent AU2018360752 represents Roche’s effort to solidify its intellectual property rights around combined BRAF and MEK inhibition in oncology. The scope emphasizes therapeutic use, targeting specific mutant cancers, with claims structured to balance breadth and patentability. Its success depends upon distinguishability from prior art, strategic claim drafting, and the evolving patent landscape.
Key Takeaways
- Narrow, well-defined claims concerning specific combinations and treatment protocols are crucial to withstand validity challenges.
- Monitoring prior art—especially publications and existing patents—remains essential to maintaining patent strength.
- Strategic claim drafting should aim to cover both broad therapeutic concepts and specific embodiments.
- Patent landscape awareness informs proactive filing strategies in key jurisdictions, enhancing global protection.
- Continual review of emerging scientific disclosures is vital to adapt patent claims and retain market exclusivity.
FAQs
1. How does AU2018360752 differ from other patents on BRAF/MEK inhibitors?
Answer: It specifically claims the therapeutic use of BRAF and MEK inhibitors in combination for treating certain cancers, focusing on application rather than the compounds themselves. Its novelty depends on the specific combinations, indications, or treatment protocols disclosed.
2. Can Roche enforce this patent against generic manufacturers?
Answer: Enforcement depends on the patent's validity and scope. If granted, Roche can prevent unauthorized use of the claimed combination for the indicated treatments in Australia, subject to legal and regulatory considerations.
3. What challenges could face AU2018360752 during examination?
Answer: Prior art disclosures involving similar combinations, treatment methods, or related scientific publications could challenge novelty or inventive step. The examiner may also scrutinize whether the claims are sufficiently supported by data.
4. How important is the claim scope in determining the patent’s commercial value?
Answer: Broad claims can provide extensive market coverage but risk invalidation, whereas narrow claims are easier to defend but may limit exclusivity. Balancing scope and robustness is essential for commercial success.
5. Are there any notable international equivalents or similar patents?
Answer: Yes, both patent families in Europe and the US, and patent applications filed in other jurisdictions, protect similar therapeutic combinations, influencing global patent strategies and competition.
References
- [1] European Patent EP2558012A1, "Pharmaceutical compositions comprising BRAF inhibitors," covering Vemurafenib.
- [2] US Patent US2019203456A1, "Combination therapy with BRAF and MEK inhibitors," detailing specific use protocols in melanoma.
Note: This analysis is based on available patent information and publicly accessible sources as of 2023. Patent statuses and scope may evolve with further prosecution, legal proceedings, or publication of related patents.
