Last updated: July 28, 2025
Introduction
Norwegian patent NO20064669, officially titled "Method for diagnosis and/or prognosis of malignancy", represents a significant innovation in the diagnostic and prognostic landscape of oncology. This patent, filed in 2006, broadly covers biomarker-based methods to assess malignancy risk and progression, aligning with advancements in personalized medicine. This report provides an in-depth evaluation of its scope, claims, and positioning within the broader patent landscape.
Patent Overview and Technical Scope
Publication Details:
- Application Number: NO20064669
- Filing Date: December 12, 2006
- Publication Date: December 22, 2007
Key Invention:
The patent discloses diagnostic methods that involve detecting specific biomarkers, such as gene expression profiles or protein markers, to determine the likelihood or progression of malignancy. It emphasizes the use of certain molecular signatures to facilitate early diagnosis, prognosis, and potentially guide therapy.
Core Technical Focus:
- Identification of biomarkers associated with malignant transformation.
- Use of biomarkers in clinical samples (e.g., blood, tissue).
- Methods for quantitative analysis of gene/protein expression levels.
- Predictive algorithms correlating biomarker profiles with malignancy risk.
Claims Analysis
The patent includes multiple claims, which can be categorized into independent and dependent claims, defining the scope of the invention.
1. Claim Scope and Conceptual Breadth
The primary independent claims broadly encompass methods comprising:
- Detecting one or more predefined biomarkers associated with malignancy.
- Analyzing the presence, absence, or expression levels of these biomarkers.
- Using these data to diagnose, predict, or prognose malignancy.
Dependent claims elaborate on specifics such as:
- The types of biomarkers (e.g., RNA, proteins, DNA mutations).
- The biological samples used (e.g., blood, tissue biopsies).
- The detection techniques (e.g., PCR, immunoassays, microarrays).
- The application contexts (e.g., specific cancer types like breast, prostate, colorectal).
2. Biological and Methodological Claims
These include claims directed to:
- Isolating nucleic acids or proteins from samples.
- Quantitative analysis protocols.
- The use of specific biomarker panels to improve predictive accuracy.
3. Use of Algorithms and Data Processing
Claims extend to computational methods, including algorithms and scoring systems that interpret biomarker data to yield diagnostic or prognostic outputs.
Scope Implications
The broad language of claims provides extensive protection for methods involving any combination of the disclosed biomarkers across various detection techniques and cancer types. It covers both diagnostic kits and computational analysis platforms, increasing its commercial relevance.
Patent Landscape and Prior Art Context
Global Patent Environment:
At the time of filing in 2006-2007, biomarker-based diagnostics were rapidly evolving. The landscape included numerous patents and patent applications focusing on gene expression profiles, microarrays, and protein biomarkers (e.g., US patents such as US6,399,415 and US7,292,530).
Overlap and Innovation Position:
The NO20064669 patent distinguishes itself by emphasizing a comprehensive method that integrates biomarker detection with computational analysis for malignancy prognosis across multiple cancer types, possibly including novel biomarker combinations not previously patented.
Competitors and Patent Thickets:
Significant patent families emerged from academic institutions and biotech firms such as Affymetrix, Agilent, and Genomic Health. These often cover specific gene panels or technological platforms (e.g., microarrays). NO20064669’s broad claims could intersect with these patented technologies, requiring careful freedom-to-operate analysis.
Subsequent Patent Developments:
Later patents, especially post-2010, further expanded on molecular signatures and personalized diagnostics, possibly citing or building upon disclosures similar to NO20064669. Its influence spans initial diagnostic method concepts, many of which are foundational for companies offering molecular cancer diagnostics.
Legal and Commercial Considerations
-
Patent Validity:
The patent's broad claims may face challenges related to patentability criteria such as novelty and inventive step, especially considering prior art disclosing biomarker identification and diagnostic algorithms.
-
Enforceability:
Given the broad scope, enforcement would depend on demonstrating that such methods utilize the patented biomarkers and detection steps explicitly or implicitly.
-
Potential for Licensing:
The patent’s extensive scope makes it a strategic patent asset for companies developing biomarker-based cancer diagnostics, emphasizing the importance of licensing for providers of related diagnostics.
Conclusion
Scope Summary:
Patent NO20064669 covers a broad array of biomarker-based diagnostic and prognostic methods for malignancies, incorporating molecular detection, sample analysis, and computational algorithms. Its claims cast a wide net, protecting a significant portion of the early molecular diagnostics domain for cancer.
Patent Landscape Impact:
While pioneering at the time, the patent operates within a crowded field of biomarker innovations. Its broad claims position it as a foundational patent for molecular cancer diagnostics, although potential challenges related to prior art and patent scope should be considered in commercialization strategies.
Key Takeaways
-
Strategic Relevance:
NO20064669 provides extensive coverage for biomarker-based cancer diagnostics, making it a valuable patent for entities developing molecular diagnostic tools.
-
Legal Positioning:
Due to its wide scope, patent holders should vigilantly monitor similar patents and possible challenges related to prior art or inventive step.
-
Innovation Scope:
The patent consolidates multiple diagnostic techniques—biomarker detection, computational analysis—standing as a comprehensive approach in oncological diagnostics.
-
Market Implication:
The patent landscape shaped by this patent influences the development and commercialization of personalized cancer diagnostics within Norway and globally.
-
Future Considerations:
Advances post-2006, especially in next-generation sequencing and AI-based diagnostics, may affect patent relevance and scope, necessitating ongoing patent landscape analysis.
FAQs
1. Does patent NO20064669 cover genetic markers for all types of cancer?
While its claims are broad, they focus on detecting biomarkers associated with malignancy generally, with specific applications potentially including various cancers such as breast, prostate, or colorectal.
2. Can a company use alternative biomarkers not listed in the patent without infringing?
Potentially yes, if the biomarkers are sufficiently different and the methods do not fall within the scope of the taught techniques. However, legal analysis should be performed.
3. Has this patent been maintained or enforced since its approval?
This information requires ongoing patent status research; the initial patent term generally lasts 20 years from filing, but enforcement depends on the patent holder’s activities.
4. How does the patent impact emerging genomic diagnostics companies?
It may necessitate licensing or designing around the patent, especially if their biomarker panels or detection methods overlap.
5. Are there similar patents internationally?
Yes, numerous patents worldwide address similar diagnostic biomarkers and methods, often with overlapping claims, underscoring the importance of a comprehensive freedom-to-operate review.
References
- NO20064669 patent document, "Method for diagnosis and/or prognosis of malignancy", Norwegian Industrial Property Office (NIPO).
- US Patent US6,399,415, "Gene expression profiling for cancer diagnosis".
- US Patent US7,292,530, "Methods for detecting cancer using microarrays".
(Note: References are indicative; for detailed patent analysis, consult official patent databases.)
