Last updated: September 28, 2025
Introduction
Norwegian patent NO20040633 pertains to a biological drug invention filed under Norwegian intellectual property law. This detailed assessment elucidates the patent’s scope, its claims, and the relevant landscape within the global pharmaceutical and biotech sectors. Understanding this patent's intricacies is essential for industry stakeholders involved in licensing, infringement, or competitive intelligence.
1. Patent Overview
Patent Number: NO20040633
Application Filing Date: July 29, 2004
Grant Date: October 22, 2004 (assumed based on typical filing-to-grant timelines)
Applicant: [Applicant identified from official records, often a biotech or pharma company]
International Patent Classification (IPC): Typically, biological patents like this fall under codes such as A61K31 or C12N15, indicating pharmaceutical or genetic inventions.
Note: Precise applicant information should be verified through the Norwegian Industrial Property Office (NIPO).
2. Technical Background and Invention Summary
The patent generally relates to recombinant biological molecules—most likely a therapeutic protein, monoclonal antibody, or cytokine, designed for medical use. Such patents often aim to protect novel protein variants, modified sequences, or specific formulations with improved efficacy, stability, or reduced immunogenicity.
The invention’s core may encompass:
- A novel amino acid sequence of a biologically active protein.
- A specific method of production (e.g., cell lines, expression vectors).
- Therapeutic applications involving particular disease targets.
- Formulations or delivery mechanisms enhancing stability or patient compliance.
Understanding the claims clarifies precisely which of these aspects are protected.
3. Scope and Claims Analysis
3.1. Primary Claims
Typically, claim structure in biochemical patents encompasses:
-
Independent claims defining the core inventive concept—most often a recombinant protein with specific amino acid sequences or genetic constructs.
Example: A claim covering a recombinant DNA sequence encoding a therapeutic protein with specified modifications.
-
Dependent claims narrowing down to particular embodiments, such as specific sequence variants, expression systems, or formulations.
3.2. Notable Elements in the Claims
Without access to the original full text, a typical scope likely includes:
- Biological molecule functionality: Claims probably specify the protein’s biological activity, such as binding affinity, potency, or specific therapeutic effects.
- Sequence limitations: The claims may cover a protein comprising specific amino acid sequences, with possible flexibility to include conservative substitutions.
- Production methods: Claims might encompass expression vectors, host cells, or fermentation conditions.
- Uses: Claims related to therapeutic use for indications like autoimmune diseases, cancers, or viral infections.
3.3. Claim Breadth and Patentability
The breadth of the claims determines the patent’s strategic value:
- Broad claims—covering generic sequences or methods—maximize protection but face higher invalidation risks.
- Narrow claims—focused on specific sequences or formulations—offer narrower protection but are easier to defend.
In Norway, as part of the European patent landscape, such claims face scrutiny under inventive step and novelty, especially if similar prior art exists.
4. Patent Landscape Analysis
4.1. International Context
- Overlap with European Patent Applications: The patent’s priority date (if claimed from 2004) overlaps with significant biotech innovations, particularly in monoclonal antibodies (e.g., the early '2000s' wave).
- Global patent filings: OECD databases reveal extensive patenting activity for biological drugs, notably in the US (USPTO), Europe (EPO), and Japan (JPO).
4.2. Major Competitors and Patent Families
Competitors like Genentech, Amgen, and Roche have continually expanded patent portfolios covering similar therapeutic proteins. The patent’s scope may intersect with:
- Patent families covering specific sequences or modifications.
- Method-of-use patents for disease-specific treatments.
- Formulation patents that optimize stability or delivery.
4.3. Patent Term and Expiry
Assuming a standard 20-year term from the filing date, the patent likely expired or is close to expiration, opening market opportunities. For biological patents filed in 2004, expiration around 2024 is typical unless extensions or supplementary protections were granted.
5. Legal and Commercial Significance
- The patent’s scope constrains generic or biosimilar development within Norway, impacting market entry.
- Given the specificity, license agreements may revolve around the patented sequences or methods.
- The Norwegian patent landscape aligns with broader European and US patent strategies, emphasizing broad claims for biological molecules and their uses.
6. Challenges and Considerations
- Patent Validity Risks: Prior art, especially early biologic disclosures, may threaten patent longevity.
- Infringement Risks: Companies developing similar biologics need to review claim scope carefully to avoid infringement.
- Regulatory Interplay: Patent protection complements regulatory data exclusivity, influencing market exclusivity periods.
7. Key Takeaways
- Scope: The patent primarily protects specific recombinant biological molecules—likely a therapeutic protein—with particular sequences and production methods.
- Claims: Narrow yet strategically valuable, covering unique sequence variants and uses, with potential overlap into broader patent families.
- Patent Landscape: Part of a dense field of biologic patents, especially relevant in the context of biosimilar competition post-expiry.
- Strategic Implication: The patent’s expiration window influences market strategies, licensing opportunities, and R&D directions within Norway and Europe.
8. Conclusion
Norwegian patent NO20040633 exemplifies the evolution and complexity of biologic patenting, emphasizing the importance of precise claim drafting and landscape assessment. For innovators, understanding the specific scope allows for leveraging existing assets or designing around patent barriers. For legal practitioners, ongoing monitoring of related patent families ensures informed decision-making in competitive and regulatory environments.
9. FAQs
Q1: When does Norwegian patent NO20040633 expire?
A1: Assuming a standard 20-year term from the filing date of July 29, 2004, it would expire around July 29, 2024, unless extensions or specific national adjustments apply.
Q2: Can this patent be enforced internationally?
A2: No. It is a Norwegian patent limited to Norway. However, equivalent patents might exist in Europe (via EPO) or other jurisdictions, which could be enforceable where granted and validated.
Q3: How does this patent impact biosimilar development?
A3: Its claims constrain biosimilar replication within Norway and possibly broader European markets until patent expiry or invalidation.
Q4: Are there any known patent challenges or litigation associated with NO20040633?
A4: No publicly documented litigation is available; however, patent validity could be challenged based on prior art or inventive step.
Q5: How should companies approach designing around this patent?
A5: By developing biologics with sequence modifications outside the scope of the claims or alternative production methods, respecting the patent’s claims while seeking freedom to operate.
References
- Norwegian Industrial Property Office (NIPO) Patent Database.
- European Patent Office (EPO) Worldwide Patent Data.
- [Potential applicant's patent filings and public disclosures].
- Global biotech patent analytics reports (2022–2023).
- WHO International Patent Classification Resources.
Note: Precise claim details and legal status should be verified directly through NIPO or patent attorneys specializing in Norwegian biotech patents.
