Last updated: August 1, 2025
Introduction
Patent AU2013235298, titled “Method of diagnosing or predicting the likelihood of an individual having a particular disease or disorder,” represents a key intellectual property asset in the area of diagnostic biomarkers and personalized medicine. Its strategic importance derives from broad claims covering diagnostic methods based on specific biomarker detection, with potential implications for various diseases. This analysis examines the scope and claims of AU2013235298 within the context of Australian patent law, the global patent landscape, and industry trends, providing critical insights pertinent to stakeholders in pharmaceutical and biotech sectors.
Patent Overview and Filing Background
Filed by Amgen Inc., the patent was granted in 2014, with priority claims dating back to 2012. The patent broadly covers a method for diagnosing or predicting disease likelihood based on the measurement of particular biomarkers or genetic markers in a biological sample. Its assertions aim to encompass diagnostic algorithms based on molecular signatures, emphasizing utility across diverse disorders, especially cancers and neurodegenerative diseases.
The patent's issuance aligns with Amgen's strategic focus on personalized diagnostics, a rapidly advancing frontier driven by genomic and proteomic innovations.
Scope and Core Claims
Claim Construction and Coverage
The core claims of AU2013235298 centrally define a method involving the detection of specific biomarkers—protein or nucleic acid sequences—correlated with disease states in biological samples, typically blood, tissue, or other bodily fluids. The claims can be distilled into:
- Detection step: Measuring the presence or amount of one or more biomarkers.
- Analysis step: Comparing measured levels against reference or threshold levels.
- Prediction or diagnosis: Inferring disease likelihood based on biomarker levels.
This method claims clearance over diagnostic methods that involve biomarker identification, aligning with established patent practices in molecular diagnostics.
Scope of Claims
The claims are designed broadly to encompass:
- Methods for detecting disease predisposition based on biomarker panels rather than single markers;
- Various detection techniques, including immunoassays, PCR, next-generation sequencing, or other molecular detection platforms;
- Use in different sample types, such as blood, saliva, or tissue biopsies;
- Applications across multiple diseases, with emphasis on cancers, autoimmune conditions, and neurodegeneration.
While the claims appear comprehensive, their scope may be limited by specific biomarkers identified in the patent's detailed description, meaning that modifications or alternative biomarkers outside the patent scope could evade infringement.
Claim Limitations
Potential limiting factors include:
- Specificity of the biomarkers: The patent's enforceability hinges on the uniqueness and patentability of the identified biomarkers.
- Detection technologies: The claims may specify certain detection methods, which could be designed around to develop alternative assays.
- Disease specificity: Claims broadly cover diseases, but narrower claims related to particular conditions may offer targeted patent protection.
Patent Landscape Analysis
Global and Regional Patent Environment
The diagnostic patent landscape is highly competitive and dynamic, with key players like Roche, Abbott, and Thermo Fisher actively filing biomarker-related patents. In Australia, AU2013235298 fits within a broader landscape of patents protecting molecular diagnostic methods, many originating from US and European filings.
Due to the rapid evolution of genomics and biomarker discovery, many patents in this field tend to be narrower in scope, often associated with specific disease biomarkers, limiting their applicability to broader diagnostic panels.
Patent Families and Similar Patents
AU2013235298 is part of a patent family extending into jurisdictions like the US, Europe, and China, emphasizing its importance and strategic value. Many of these patent families protect distinct biomarker panels for various diseases, with some overlapping claims, which may give rise to potential patent thickets—a concern for competitors seeking to develop similar diagnostics.
Active patenting in related areas suggests ongoing R&D investment, with implications for freedom-to-operate and licensing strategies.
Potential Challenges and Opportunities
-
Challenges:
- Patent validity disputes due to prior art or lack of novelty, especially in rapidly advancing fields.
- Infringement risks if alternative biomarker combinations are used, which do not fall within the claim scope.
- Patent expiry dates, generally 20 years from filing, could impact commercial exclusivity timelines.
-
Opportunities:
- Licensing or collaborative development of assay platforms based on the patent.
- Expansion into new disease areas using similar diagnostic approaches.
- Strategic patenting of improvements, such as more sensitive detection methods or broader disease panels.
Legal and Commercial Considerations
The enforceability of AU2013235298 hinges on prior art, claim clarity, and sufficient disclosure, consistent with Australian patent law concerning novelty and inventive step. Notably, the patent's broad claims encourage commercial applications but require careful navigation of competing patents.
From a commercial perspective, the patent's coverage facilitates differentiation in molecular diagnostics, enabling Amgen or licensees to commercialize assays under patent protection, thereby securing a competitive advantage.
Conclusion and Implications
AU2013235298 encompasses a fairly broad and strategic patent covering diagnostic methods predicated on biomarker detection, embedding itself within a competitive and evolving landscape. While the claims provide strong commercial protection, their breadth is subject to the usual legal challenges associated with diagnostic patents, particularly in high-innovation sectors characterized by rapid scientific discovery.
Stakeholders must analyze this patent when designing diagnostic assays for diseases covered, assess freedom-to-operate, and consider licensing opportunities or patent filing for improvements.
Key Takeaways
- The patent offers broad coverage for molecular diagnostics centered on biomarker detection, likely providing a significant competitive edge.
- Its claims encompass various detection technologies and disease applications, but may face validity challenges if prior art is identified.
- The global patent landscape is crowded with similar biomarker patents, necessitating careful freedom-to-operate assessments.
- Strategic licensing, patent protection for improvements, and vigilant monitoring of emerging patents are advisable to maximize the patent’s commercial potential.
- Given the rapid evolution of personalized medicine, ongoing innovation and patenting are critical to sustaining competitive advantages.
FAQs
1. What specific diseases does AU2013235298 target?
The patent broadly covers diagnostic methods for various diseases, notably including cancers (e.g., breast, lung, prostate), neurodegenerative disorders, and autoimmune conditions, depending on the biomarkers used.
2. How does the scope of this patent compare internationally?
The patent family extends into major markets like the US and Europe, with similar broad claims. However, regional patent laws and prior art may influence the scope and enforceability differently across jurisdictions.
3. Can alternative detection methods circumvent this patent?
Potentially, yes. If an alternative detection method or different biomarker panel is employed that falls outside the scope of the claims, infringement might be avoided.
4. What is the strategic importance of this patent for Amgen?
It provides a defensible position in molecular diagnostics, enabling commercialization, licensing, or collaboration opportunities within the personalized medicine field.
5. How long will this patent provide protection?
Assuming standard patent durations, AU2013235298 will be enforceable until approximately 2033, barring patent term adjustments or legal challenges.
References
[1] Australian Patent AU2013235298, “Method of diagnosing or predicting the likelihood of an individual having a particular disease or disorder.”
[2] Amgen Inc. Patent Family Records.
[3] Australian Patent Office (IP Australia). Patent Landscape Reports.
[4] International Patent Classification (IPC) codes related to molecular diagnostics and biomarkers.
[5] Industry reports on diagnostic biomarker patenting trends.
