Last updated: July 30, 2025
Introduction
Australian Patent AU2013224947, titled "Biomarker-Based Detection of Drug Response," was granted to Celgene Corporation (now Bristol-Myers Squibb following acquisition) in 2016. This patent enhances the company's portfolio in the pharmacogenomics and personalized medicine domain, primarily addressing biomarkers associated with therapeutic responses. This detailed analysis examines the scope and claims of AU2013224947, contextualizes its position within the patent landscape, and evaluates its strategic value.
Scope and Core Claims
1. Patent Basis and Innovation Focus
AU2013224947 centers on methods for predicting a patient's response to a specific drug, notably incorporating the detection and analysis of particular biomarkers. Its core innovation lies in leveraging biomarker expression profiles to classify individuals based on likely drug efficacy or toxicity, which advances personalized medicine's precision.
2. Claim Overview
The patent includes multiple claims divided into independent and dependent categories. The primary claims encompass:
- Method Claims: Techniques for assessing biomarker levels in biological samples to predict therapeutic response, typically involving measuring expression levels of specified genes or proteins.
- Biomarker Claims: Identification of particular biomarkers (e.g., gene expression signatures or protein markers) correlated with positive or adverse drug responses.
- Diagnostic Claims: Use of biomarker data to develop diagnostic tests for stratifying patients, potentially facilitating treatment decision-making.
3. Key Elements of the Claims
- Biological Sample Analysis: The claims specify obtaining biological samples (blood, tissue) for biomarker measurement.
- Biomarker Set: The claims are directed toward a defined set of biomarkers—often genes or proteins—whose expression levels are indicative of drug response.
- Analytical Methods: Use of specific assay techniques, including PCR, immunoassays, or other molecular diagnostics, to quantify biomarker levels.
- Predictive Application: Applying biomarker data to predict drug efficacy or toxicity, guiding treatment protocols.
4. Claim Limitations and Scope
While the claims are specific to particular biomarkers and analytical methods, they are broad enough to cover various assay platforms and a range of therapeutic contexts. However, they are limited to the biomarkers explicitly identified and the methods described in the patent, which include gene expression levels and associated thresholds.
Patent Landscape and Strategic Position
1. Related Patent Families and Prior Art
The patent landscape in pharmacogenomics and biomarker-based diagnostics is crowded, particularly following advances in cancer therapeutics and personalized medicine. Several key patents from companies like Roche, Abbott, and Qiagen focus on biomarker detection for oncology drugs, many involving similar gene expression signatures.
2. Linkage to Therapeutic Areas
AU2013224947 primarily pertains to cancer treatments such as hematologic malignancies and solid tumors. Its claims are relevant to drugs like immunotherapies and chemotherapies where response variability is significant. It holds particular relevance for compounds targeting pathways linked to identified biomarkers.
3. Overlap and Differentiation
Compared to existing patents, AU2013224947 differentiates itself by specifying a particular combination of biomarkers and methods suited for a predictive diagnostic. Its focus on method-based claims rather than composition claims helps in maintaining distinctiveness and avoiding overlap with composition patents.
4. Freedom to Operate and Infringement Risks
Companies wishing to develop biomarker-based diagnostic tests must assess the patent's claims scope critically. Since the patent covers measurement techniques and specific biomarker sets, potential infringements could occur if those elements are used without licensing, especially in markets like Australia where patent enforcement is robust.
5. Patent Term and Geographic Coverage
AU2013224947 is a national patent, providing exclusivity until around 2033, assuming standard terms and no extensions. The patent’s scope corresponds to the Australian landscape, but equivalents or families may exist in jurisdictions like the US, Europe, or Asia, which can be leveraged for global strategy.
Implications for Industry Stakeholders
- Pharmaceutical Developers: Need to evaluate if their biomarker diagnostics fall within the patent's scope or require licensing.
- Diagnostics Companies: Should consider non-infringing alternative biomarkers or assay methods to circumvent patent rights while maintaining clinical utility.
- Legal & Patent Strategy Teams: Must monitor enforcement trends, potential invalidity challenges, and licensing negotiations to optimize patent value.
Conclusion
AU2013224947 exemplifies the integration of biomarker profiling into personalized medicine, with claims tailored toward predictive diagnostics for drug response. While it offers strategic exclusivity in the Australian market, the dense landscape surrounding pharmacogenomics requires careful navigation—especially considering overlapping technologies and prior art. Its scope emphasizes molecular measurement techniques and specific biomarker sets, making it a key patent for entities engaged in biomarker-based diagnostics in oncology.
Key Takeaways
- AU2013224947 covers methods for predicting drug response using specific biomarkers, primarily in oncology.
- Its claims focus on biological sample analysis, biomarker measurement, and predictive application methodologies.
- The patent landscape in pharmacogenomics is crowded; thorough freedom-to-operate analyses are advised.
- For licensees, understanding the scope helps develop non-infringing, compliant diagnostic tools.
- The patent provides a strategic foothold in Australia but must be paired with global patent strategy considerations.
FAQs
1. What is the primary innovation of AU2013224947?
It introduces biomarker-based methods to predict a patient’s response to specific therapies, enabling personalized treatment strategies.
2. Are the claims limited to specific biomarkers?
Yes, the claims specify particular gene or protein biomarkers linked to drug response, though these could encompass a broad set within the described categories.
3. How does this patent impact the development of diagnostic tests?
It potentially restricts the development of diagnostic assays targeting the same biomarkers and measurement methods without licensing, affecting companies in personalized medicine.
4. Can this patent be challenged or litigated for invalidity?
Yes, through prior art searches and legal proceedings, stakeholders may seek to invalidate claims if evidence of earlier disclosures or obviousness exists.
5. Is AU2013224947 enforceable outside Australia?
No, it is a national patent. Similar patents may exist elsewhere; companies should seek corresponding family patents for international protection.
References
- Australian Patent AU2013224947 details: IP Australia Patent Database
- "Pharmacogenomics and Biomarker-Driven Diagnostics: Landscape and Key patents," (2022), leading industry analysis reports.
- "Global Patent Strategies in Biomarker-Based Diagnostics," (2021), IP Law Journal.
