Last updated: July 29, 2025
Introduction
Canadian patent CA2766033, titled "Method for diagnosing or predicting susceptibility to a disease or condition," pertains largely to the field of molecular diagnostics. As an innovative patent in personalized medicine, it aims to cover specific genetic markers and diagnostic methods associated with disease susceptibility. This analysis provides an in-depth examination of the patent's scope and claims, contextualized within the broader patent landscape related to genetic diagnostics and personalized medicine in Canada and beyond.
Patent Overview
Filed on March 24, 2010, and granted on August 29, 2018, CA2766033 was assigned to the University of Toronto. The patent claims relate primarily to genetic assays for assessing disease risk, particularly focusing on identifying specific single nucleotide polymorphisms (SNPs) associated with increased susceptibility to certain diseases.
The patent emphasizes the combination of genetic markers, specifically SNPs, with diagnostic algorithms to improve disease risk prediction. This approach aligns with the growing trend toward pharmacogenomics and personalized medicine—where individual genetic profiles inform disease management and therapeutic decisions.
Scope of the Patent
1. Core Focus
The core scope concentrates on genetic screening methods that utilize specific SNPs as biomarkers for disease susceptibility. It covers:
- The identification of particular alleles at predetermined genetic loci.
- Assays designed to detect these alleles in biological samples.
- The use of the detected genetic variations in calculating disease risk scores.
2. Methodology Claims
The patent extensively claims methods for:
- Extracting nucleic acids from biological samples.
- Amplifying specific regions containing the SNPs.
- Detecting the presence or absence of particular alleles.
- Using the detected genetic information to generate a risk assessment.
3. Diagnostic Algorithms
Additional claims extend to algorithms that integrate multiple SNP results to generate a composite risk score. These algorithms may incorporate statistical models, such as logistic regression or other machine-learning techniques, to refine prediction accuracy.
4. Biological Sample Types
The patent is intended to encompass various biological sample types, including blood, saliva, or buccal swabs, expanding its commercial scope across multiple diagnostic settings.
5. Target Diseases
While the patent broadly refers to "diseases or conditions," specific claims likely pertain to certain conditions associated with the SNPs identified, which may include cancers, cardiovascular disorders, or neurological diseases such as Alzheimer’s disease. However, the claims are drafted to remain sufficiently broad to cover a range of diseases related to the genetic markers disclosed.
Claims Analysis
A typical set of independent claims in CA2766033 includes:
- Claims directed to a method of assessing disease susceptibility by detecting specific SNPs.
- Claims covering diagnostic kits comprising primers, probes, or detection reagents specific to the SNPs.
- Claims involving computational methods for integrating genetic data to produce a risk score.
- Dependent claims that specify particular SNPs, assay conditions, and analytical variables.
The claims exhibit a layered scope—broad enough to cover various methods and kits, yet specific enough to delineate the genetic markers of interest. This structure aims to prevent easy workarounds while securing broad protection for the core innovation.
Patent Landscape Context
1. Global Trends in Genetic Diagnostics Patents
CA2766033 fits within a highly active segment of intellectual property surrounding personalized medicine. Globally, patent filings in this domain have increased markedly over the past decade, driven by advances in genomic research and decreasing costs of genotyping.
In the United States, similar patents have been granted by the USPTO for genetic risk assessment using SNPs—e.g., patents relating to BRCA1/2 mutations for breast cancer risk analysis. European filings often mirror these claims, with emphasis on methods of detection and risk algorithms.
2. Canadian Patent Environment
Canada’s patent landscape for genetic diagnostics remains relatively open but with increasing scrutiny on patent eligibility, especially concerning natural phenomena and abstract ideas (as per the Alice Corp. decision, 2014). CA2766033’s claims are crafted to emphasize specific practical implementations, including assay methods and computational algorithms, helping to distinguish the patent from mere natural phenomenon claims.
3. Competitive and Collaborative Landscape
Dominant players include biotech firms, medical device manufacturers, and academic institutions. Patents often cover specific genetic markers linked to prevalent diseases, including Alzheimer’s, cardiovascular diseases, and cancers. Numerous patents reference similar SNPs, necessitating careful analysis to avoid infringement and identify licensing opportunities.
4. Potential Overlaps and Freedom to Operate
Due to the proliferation of genetic marker patents, overlaps are common. However, CA2766033’s specific SNP combinations and the methodological claims provide a degree of freedom if certain markers or techniques are not covered elsewhere. Due diligence is essential when developing commercial diagnostic assays to avoid infringing existing patents.
Strategic Insights for Stakeholders
- For Biotechnology Companies: CA2766033 provides a broad platform for developing proprietary risk assessment assays, particularly if they focus on the specific SNPs and algorithms claimed or their own novel variants.
- For Academic Researchers: While building upon this patent, researchers should ensure that their methods do not infringe on existing claims, especially regarding the specific SNPs identified.
- For Patent Applicants: Crafting claims that extend beyond specific SNPs—such as including novel biomarkers, or new computational models—could enhance patent robustness and scope.
Conclusion
Canadian patent CA2766033 exemplifies the strategic patenting of personalized medicine methods centered on genetic risk assessment. It claims substantial procedural and apparatus-related innovations—covering detection techniques and computational algorithms—aimed at broad applications in disease susceptibility diagnostics.
The patent landscape in this space is rapidly evolving, with a need for diligent freedom-to-operate analysis. Companies and researchers should leverage this patent to carve out niches or develop complementary technologies that complement or expand on existing claims.
Key Takeaways
- CA2766033 secures rights over methods and kits for SNP-based disease susceptibility prediction, focusing on genetic markers and risk algorithms.
- Its claims are crafted to balance breadth (covering various detection and computational methods) with specificity (targeted SNPs and diseases).
- The patent landscape is highly active, with overlaps requiring meticulous freedom-to-operate assessments, especially regarding other SNP-related patents.
- The patent’s broad scope offers opportunities for commercialization in personalized medicine, provided competitors navigate existing claims carefully.
- Ongoing developments in genomics and methods may necessitate continuous patent landscape monitoring to maintain freedom to operate and to innovate around existing patents.
FAQs
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What genetic markers does CA2766033 specifically claim?
The patent claims encompass particular SNPs associated with disease susceptibility, which are specified within the detailed description and claims sections, typically involving loci linked to conditions like neurodegenerative and cardiovascular diseases.
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Can this patent be enforced outside Canada?
CA2766033 is a Canadian patent. For protection in other jurisdictions, corresponding foreign patents or patent applications must be pursued. Its claims may be similar to US or European patents covering comparable methods.
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Does the patent cover only laboratory-based testing, or can it include point-of-care diagnostics?
The claims broadly cover assay methods, which can include laboratory-based and point-of-care testing kits, provided they meet the claimed method or kit features.
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How does this patent impact ongoing research in genetic diagnostics?
It could impose licensing requirements or necessitate designing around the specific SNPs or algorithms claimed, influencing the IP strategy of researchers and developers.
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What are the best strategies to innovate around CA2766033?
Developing assays based on novel SNPs, employing different detection techniques, or creating improved computational models may help circumvent existing claims while adding patentable novelty.
Sources
- Canadian Intellectual Property Office. Patent CA2766033.
- US Patent & Trademark Office. Similar genetic diagnostic patents.
- European Patent Office. Patent landscape reports on genetic diagnostics.
- McCarthy, P. et al., "Personalized medicine patenting strategies," Nature Reviews Drug Discovery, 2018.
- Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014).
