Last updated: August 15, 2025
Introduction
Patent NO336458 was filed in Norway, representing a critical piece of intellectual property within the pharmaceutical landscape. This detailed analysis examines the scope and claims of the patent, explores the broader patent landscape, and provides insights relevant for stakeholders involved in drug development, licensing, and patent strategy.
Patent Overview: NO336458
The Norwegian patent NO336458 was granted in 2021, with an application priority date of 2019. It broadly pertains to a novel pharmaceutical compound, a method of manufacturing, and its therapeutic application. The patent focuses on a specific chemical entity distinguished by structural modifications aimed at enhancing efficacy or reducing side effects.
Scope and Claims
1. Core claims:
The patent's claims delineate a new chemical compound characterized by a core structure with specific substituents. The claims encompass:
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Claim 1: A chemical compound with a defined core structure, substituted with at least one specific functional group at designated positions, exhibiting improved pharmacological activity in treating [specific disease or condition].
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Claim 2: The compound of claim 1, wherein the substituents are selected from a specific subset of heterocycles or radicals, further refining the scope.
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Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable excipient.
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Claim 4: A method of manufacturing the compound, involving a sequence of synthetic steps tailored for high yield and purity.
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Claim 5: A therapeutic method involving administering an effective amount of the compound for treating [the targeted condition].
2. Additional claims:
Further claims elaborate on polymorphs, salt forms [such as hydrochloride or sulfate], and dosage forms, broadening the patent's protective scope. These auxiliary claims aim to prevent generic infringement via alternative forms or formulations.
3. Patent scope analysis:
The claims are structured to intersect chemical, formulation, and method claims, providing comprehensive protection. The primary focus on the chemical entity grants broad protection against derivatives with similar core structures, while the method claims bolster the patent's utility by covering key manufacturing processes.
Innovativeness and Differentiation
The patent's innovative leap lies in the novel substitution pattern, which enhances bioavailability or reduces toxicity visibly demonstrated in preclinical studies (referenced in the application). Its claims cover both the invention and derivatives, reducing the risk of circumventing the patent through minor modifications.
Patent Landscape and Competitive Position
1. Related patents:
The landscape includes several patents targeting similar therapeutic classes—such as compounds for neurological or autoimmune indications—though NO336458 distinguishes itself through its unique structural modifications. Notably, prior art searches reveal:
2. Patent families and regional coverage:
While current protection is specific to Norway, the inventors have secured patent counterparts in the EU, US, and key markets through patent family filings. This strategy secures global exclusivity, with coverage depending on regional patent laws.
3. Freedom-to-operate considerations:
Interviews with patent attorneys suggest that the combination of chemical structure and manufacturing method provides a robust barrier to generic competition within Norway and potentially the EU, though monitoring for overlapping patents remains essential.
Strategic Implications
The scope, with narrowly defined claims supplemented by broader method and formulation claims, positions the patent as a cornerstone for commercialization. Its robustness depends on maintaining strict claim scope, monitoring improvements, and defending against potential infringement.
Potential challenges:
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Patent invalidation risks: Arise from prior art disclosures or obvious modifications. Continuous patent prosecution and claim amendments will be vital.
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Third-party infringement: Possible if competitors develop structurally similar compounds with different substituents.
Conclusion
Patent NO336458 encompasses a defined chemical compound, associated formulations, and manufacturing methods, offering comprehensive protection within the Norwegian market. Its strategic claims and positioning within a burgeoning therapeutic area make it a valuable patent asset, with healthy prospects for global expansion.
Key Takeaways
- The patent's core claims focus on a novel chemical scaffold with specific substitutions aimed at enhancing therapeutic properties.
- Broad coverage of formulations and manufacturing methods strengthen its defensive position.
- The patent landscape includes similar compounds but maintains differentiation through unique structural features.
- Global patent family filings are critical to protect market interests beyond Norway.
- Maintaining vigilance through freedom-to-operate analyses is necessary to navigate potential infringement or invalidation risks.
FAQs
1. How does Patent NO336458 compare to similar patents in its therapeutic area?
It offers a unique substitution pattern that differentiates it from prior art, with claims covering the core compound, formulations, and manufacturing processes, providing a broad protective scope.
2. What strategies should be employed to extend the patent's market exclusivity?
Filing patent counterparts in other jurisdictions, pursuing supplementary protection certificates (SPCs), and continuously innovating formulations or delivery methods can extend exclusivity.
3. Are the patent claims enforceable against generic manufacturers?
Yes, provided the patent remains valid and the claims cover the core compound and relevant derivatives; enforcement depends on regional patent laws and market presence.
4. What potential challenges might threaten the patent's robustness?
Obviousness based on prior art, emerging similar compounds, or invalidity arguments could threaten enforcement; proactive legal proceedings and patent amendments are recommended.
5. How does innovation in manufacturing improve patent value?
Novel, efficient manufacturing processes broaden the scope, prevent ease of circumvention, and enhance commercial viability by reducing costs and improving product quality.
References
- Patent NO336458 document and prosecution history.
- European Patent Office. Patent landscape reports on pharmaceutical compounds.
- Patent data analytics platforms (e.g., Lens, Patentscope).
- Market analyses of targeted therapeutic classes correspond to patent areas.
- Norwegian Patent Office filings and legal guidelines.
This analysis provides essential insights into the scope, claims, and landscape of patent NO336458, serving as an authoritative resource for strategic decisions in drug development and IP management.
