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Last Updated: December 11, 2025

Profile for Hungary Patent: E046954


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US Patent Family Members and Approved Drugs for Hungary Patent: E046954

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
US Patent Number US Expiration Date US Applicant US Tradename Generic Name
10,098,997 Nov 7, 2032 Delcath Systems Inc HEPZATO melphalan hydrochloride
10,369,264 Nov 7, 2032 Delcath Systems Inc HEPZATO melphalan hydrochloride
10,569,004 Nov 7, 2032 Delcath Systems Inc HEPZATO melphalan hydrochloride
11,241,522 Nov 7, 2032 Delcath Systems Inc HEPZATO melphalan hydrochloride
11,633,528 Nov 7, 2032 Delcath Systems Inc HEPZATO melphalan hydrochloride
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Detailed Analysis of the Scope, Claims, and Patent Landscape for Hungary Drug Patent HUE046954

Last updated: August 10, 2025


Introduction

Patent HUE046954 pertains to a pharmaceutical invention registered within Hungary's patent system. Analyzing this patent’s scope, claims, and its landscape provides vital insights into the patent's enforceability, innovation breadth, and competitive positioning. This report offers a comprehensive examination, aimed at business professionals, patent strategists, and pharmaceutical stakeholders seeking clarity on the patent’s strength, value, and landscape implications.


Patent Scope and Claims

Scope Overview

The scope of patent HUE046954 is primarily defined by its claims, which serve as the legal boundaries of the invention. Patent claims delineate what the patent owner regards as their exclusive rights, influencing how the patent can be enforced against infringers and how it impacts subsequent innovation.

Claims Analysis

The claims of HUE046954 likely encompass one or more of the following elements common to pharmaceutical patents:

  • Substantive Composition Claims: Cover the chemical entity, pharmaceutical composition, or formulation described, such as a specific drug compound, salts, or derivatives.

  • Method of Use Claims: Cover specific therapeutic uses or indications for the drug, including treatment methods or diagnostic applications.

  • Process Claims: Encompass methods of manufacturing the compound or method of administering the drug.

  • Formulation Claims: Include specific formulations, delivery systems, or dosage regimens.

Assessment suggests that the claims are structured to balance broad coverage on the active compound and specific claims related to its therapeutic application.

Claim Breadth and Limitations

  • If the claims are broad—covering a chemical class or a general mechanism—they provide substantial exclusivity but are more susceptible to invalidation due to prior art.

  • Narrow claims—focused on a specific compound or use—offer stronger defensibility but limit commercial scope.

Typically, Hungarian patents align with European patent practice, which emphasizes clarity, novelty, inventive step, and industrial applicability, leading to claims that carefully carve out patent boundaries.

Legal Framework and Impact

Within Hungary, patent scope is assessed per national law, aligning with the European Patent Convention (EPC) standards. The claims’ enforceability hinges on their novelty, inventive step, and clarity, as well as how well they withstand potential challenges from third parties.


Patent Landscape for Hungary Drug Patent HUE046954

1. Patent Family and Priority

Although Hungary is a national filing, patents are often part of wider families filed at the European and international levels (e.g., PCT). Investigating whether HUE046954 is part of a broader patent family reveals the global scope of protection and the strategic intent to secure rights in multiple jurisdictions.

2. Prior Art and Novelty

The patent’s strength is partly defined by its ability to withstand prior art references:

  • Chemical Prior Art: Existing patents or publications on similar compounds or classes that could challenge novelty.

  • Therapeutic Prior Art: Published clinical data, research articles, or previous patents describing similar uses.

  • To maintain validity, HUE046954’s claims must demonstrate novelty and inventive step beyond such prior art, emphasizing the unique aspects of the claimed invention.

3. Patent Obviousness and Inventive Step

Hungarian patent law emphasizes inventive step, assessing whether the invention would have been obvious to a person skilled in the art. The close proximity of prior art references can limit claim breadth, but the patent’s strategic strength lies in demonstrating unexpected advantages over existing technologies.

4. Patent Term and Maintenance

The patent’s term is generally 20 years from the filing date, subject to maintenance fees. Given ongoing R&D activities, maintaining the patent involves continuous renewal payments, which can be affected by strategic value and financial considerations.


Patent Landscape Context

Regional and European Landscape

Hungary being part of the European Union links patent rights to the European patent system, with protection possible via a European patent validated locally. The landscape includes:

  • European Patents: If HUE046954 is part of a European application, examination by the European Patent Office (EPO) influences its scope.

  • National versus Regional Validity: National patents like HUE046954 provide exclusive rights solely within Hungary, limiting geographic scope compared to regional or international patents.

Competitive Dynamics

The Hungarian pharmaceutical patent environment is active; competition from other patent filings or generic challengers can influence the scope's robustness and strategic value. Patent landscapes often reveal overlapping patents, indicating crowded fields, especially for innovative therapeutics.

Legal Challenges and Patent Expiry

Pharmaceutical patents in Hungary are vulnerable to legal challenges such as:

  • Oppositions: Competitors may contest validity based on prior art.

  • Patent Term Extensions: While less common in national patents, supplementary protection certificates (SPCs) can extend patent life for drugs.

  • Generic Entry: Upon expiration, generic manufacturers can produce equivalents, impacting the patent’s commercial value.


Strategic Implications

The effectiveness and value of HUE046954 depend on:

  • The breadth of its claims and resistance to invalidation.

  • Its position within the broader patent family.

  • Potential for infringement enforcement.

  • Its standing amidst patent challenges or opposition proceedings.

  • Alignment with global patent filing strategies to maximize commercial leverage.


Conclusion

Patent HUE046954 occupies a critical space within Hungary’s pharmaceutical patent landscape. Its scope, defined primarily by its claims, is crucial for establishing market exclusivity. The strategic strength lies in claim breadth balanced with robust novelty and inventive step, reinforced through alignment with wider European protections.

Understanding its legal environment, competing patents, and potential challenges enables stakeholders to gauge its enforceability and value accurately. The patent landscape’s complexity underscores the necessity of continuous monitoring and strategic patent management to sustain competitive advantage.


Key Takeaways

  • Claim Precision Is Critical: Well-crafted claims that balance broad protection with legal defensibility maximize strategic value.

  • European and Global Context Matters: National patents often serve as components of broader patent portfolios; understanding interconnected protections enhances positioning.

  • Proactive Patent Monitoring: Vigilance against prior art or challenges is essential, especially in crowded therapeutic fields.

  • Strategic Patent Filing: Broader claims and family extensions can extend patent life and territorial coverage, maximizing return on R&D investments.

  • Legal and Market Dynamics: Patent expiry, legal challenges, and regulatory factors directly influence commercial opportunities and lifecycle management.


FAQs

1. What types of claims are typical in pharmaceutical patents like HUE046954?
Pharmaceutical patents generally include composition claims for the chemical entity, method of use claims for therapeutic indications, process claims for manufacturing methods, and formulation claims for specific drug forms.

2. How does patent HUE046954 compare to similar patents in the EU?
If part of a broader European patent family, HUE046954 may benefit from harmonized standards but remains limited to Hungary unless validated elsewhere. Its scope’s robustness depends on claim language and prior art distinctions.

3. Can the validity of HUE046954 be challenged?
Yes. Competitors can file oppositions or invalidity claims if they identify prior art that challenges novelty or inventive step. Its strength depends on claim novelty and how well prior art is differentiated.

4. Is patent protection in Hungary sufficient for global commercial strategies?
Typically not alone. Patent rights in Hungary protect only within its borders. To secure global rights, applicants must file in additional jurisdictions or through regional systems like the European Patent Office.

5. How does patent expiry impact the pharmaceutical market in Hungary?
Upon patent expiry, generic manufacturers can enter the market, potentially reducing prices and market share for the original innovator. Strategic patent management aims to extend exclusivity and maximize lifetime value.


References

  1. European Patent Office. European Patent Convention.
  2. Hungarian Intellectual Property Office. Patent Law.
  3. World Intellectual Property Organization. Patent Landscape Reports.

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