Introduction to Hungarian Patent Law
In Hungary, the protection of inventions, including biopharmaceutical patents, is governed by several key statutes: the Patent Act (Act XXXIII of 1995), the Utility Model Act (Act XXXVIII of 1991), and the Act on Trade Secrets and Know-how (Act LIV of 2018). These laws, along with Hungarian and European case law, form the foundation for patent protection in the country[1].
Patentability Requirements
For a biopharmaceutical invention to be patentable in Hungary, it must meet the standard requirements of novelty, inventive step, and industrial applicability. Here are the key points:
- Novelty: The invention must be new and not form part of the state of the art.
- Inventive Step: The invention must involve an inventive step, meaning it must not be obvious to a person skilled in the art.
- Industrial Applicability: The invention must be capable of industrial application[1][5].
Filing and Examination Process
To obtain a patent in Hungary, an application must be filed with the Hungarian Intellectual Property Office (HIPO). Here are the steps involved:
- Filing: The application must be filed in Hungarian, although there is a 4-month period to file the translation after the initial filing date. The application should include the description, claims, abstract, drawings, and other necessary documents[5].
- Formal Examination: HIPO conducts a formal examination to ensure all procedural requirements are met.
- Substantive Examination: If the formal examination is successful, a substantive examination is conducted to assess the novelty, inventive step, and industrial applicability of the invention. This step is not applicable for utility model applications[1].
Scope of Claims
The scope of protection for a patent in Hungary is determined by the claims, which are interpreted based on the description and drawings of the patent application.
- Claims Interpretation: The claims define the scope of the patent, and any product or process that realizes each characteristic of the claim is covered by the patent[1].
- Doctrine of Equivalence: Hungarian patent law also implements the doctrine of equivalence, which extends patent protection to products or processes that are equivalent to those specified in the claims[1].
Enforceability and Litigation
Patent enforcement in Hungary involves several key aspects:
- Infringement and Revocation: Patent litigation in Hungary is bifurcated, meaning infringement and revocation actions are handled separately. Infringement lawsuits are typically heard by the Metropolitan Tribunal of Budapest, while revocation actions are initially handled by HIPO and can be appealed to the Metropolitan Tribunal and then the Curia (Supreme Court)[1].
- Preliminary Injunctions: Preliminary injunction procedures are not suspended even if a revocation action is initiated separately before HIPO[1].
- Bolar Exemption: Hungary has a Bolar exemption, which allows for experimental use of patented inventions for the purpose of obtaining marketing authorization. This exemption is particularly broad for pharmaceuticals, covering acts such as manufacturing, use, distribution, and export for the purpose of obtaining authorization in the EEA or third countries[1].
Public Health Compulsory Licenses
In cases of public health emergencies, Hungary allows for the granting of compulsory licenses. However, recent cases highlight the importance of ensuring that such licenses are granted in a manner consistent with fundamental law principles.
- Compulsory License Case: The Hungarian Constitutional Court annulled a compulsory license granted for the manufacture of remdesivir, citing violations of the patentee's fundamental rights, including the right to be heard and the right to substantial legal remedy. This ruling emphasizes the need for careful consideration of the patentee's interests in such proceedings[2].
Supplementary Protection Certificates (SPCs)
For biopharmaceutical products, Hungary offers supplementary protection certificates (SPCs) that extend the patent protection period.
- SPCs for Medicinal Products: SPCs can extend the protection period by up to five years for medicinal products that have been approved for sale in Hungary and are covered by a national patent. An additional six months of protection is available for medicinal products used in pediatric applications[1].
Biotechnological Inventions
Biotechnological inventions, including those in the biopharmaceutical sector, are governed by EU harmonized rules.
- EU Directive: Directive 98/44/EC on the legal protection of biotechnological inventions sets out the rules for the scope and limitations of patent protection for such inventions. These inventions are patentable if they meet the general requirements of novelty, inventiveness, and industrial applicability[4].
Key Takeaways
- Patentability: Biopharmaceutical inventions must meet the requirements of novelty, inventive step, and industrial applicability.
- Filing and Examination: Applications must be filed with HIPO, and the process includes formal and substantive examinations.
- Scope of Claims: The scope of protection is defined by the claims, with the doctrine of equivalence applying.
- Enforceability: Patent litigation is bifurcated, with separate proceedings for infringement and revocation.
- Public Health Compulsory Licenses: Such licenses must be granted in a manner consistent with fundamental law principles.
- SPCs: Available for extending protection periods for approved medicinal products.
FAQs
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What are the key requirements for patenting a biopharmaceutical invention in Hungary?
- The invention must be novel, involve an inventive step, and be industrially applicable.
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How is the scope of a patent determined in Hungary?
- The scope is determined by the claims, interpreted based on the description and drawings, with the doctrine of equivalence applying.
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What is the Bolar exemption in Hungarian patent law?
- It allows for experimental use of patented inventions for obtaining marketing authorization, particularly broad for pharmaceuticals.
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Can a patent be revoked in Hungary, and if so, how?
- Yes, a patent can be revoked by HIPO or through court proceedings, with the possibility of appeals to higher courts.
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What is the significance of the Hungarian Constitutional Court's ruling on public health compulsory licenses?
- The ruling emphasizes the need for ensuring that the patentee's fundamental rights are respected during the granting of such licenses.
