Introduction to Slovak Patent Law
Slovak patent law is governed by statutory provisions, with case law playing a crucial role in shaping and defining these statutes. Here, we delve into the key insights regarding the patentability, enforceability, and scope of claims for biopharmaceutical patents in Slovakia.
Patentability of Biopharmaceutical Inventions
In Slovakia, any invention that meets the criteria of novelty, inventive step, and capability of industrial application can be patented. This includes biotechnological inventions:
- Biological Material: Biological material isolated from its natural environment or produced by a technical process can be patented, even if it previously occurred in nature[2].
- Microbiological Processes: Inventions involving microbiological or other technical processes, or products obtained through such processes, are also patentable[2].
- Gene Sequences: Elements isolated from the human body or produced by a technical process, including gene sequences or partial sequences, can constitute patentable inventions[2].
However, certain inventions are excluded from patentability, such as those relating to the human body at various stages of development, or methods of human cloning, which are contrary to public policy or good manners[2].
Types of Patents Available
National Patents
National patents in Slovakia can be obtained through the Industrial Property Office (IPO) after a full examination of the patentability of the invention. These patents last up to 20 years from the filing date, provided maintenance fees are paid[1][5].
European Patents
European patents can be obtained through the European Patent Office (EPO) and must be validated in the Slovak Republic after grant. The process and timelines are similar to national patents, but with different deadlines. A granted European patent is effective upon publication in the EPO journal but must be validated within six months by filing a translation and paying the appropriate fees with the IPO[1].
Supplementary Protection Certificates (SPCs)
SPCs can be applied for within six months of the grant of the patent or the registration of the product. These certificates extend the protection term of a patent by up to five years, with an additional six months for pharmaceuticals tested in the pediatric population[1].
Utility Models
Utility models in Slovakia offer a shorter term of protection, up to 10 years from the filing date, with the possibility of extending the term twice by three years each, totaling up to 10 years of protection. Utility models are particularly relevant for technical solutions that may not meet the full criteria for a patent but still offer some level of protection[1][5].
Enforceability of Biopharmaceutical Patents
Court Jurisdiction
Patent rights in Slovakia are enforced through the courts, with the District Court Banska Bystrica having sole jurisdiction over industrial property matters at the first instance. Appeals are heard by the Regional Court Banska Bystrica[1].
Expert Opinions
Courts rely heavily on expert opinions from patent office examiners or external court-appointed experts to determine infringement cases. However, these experts may have limited experience, making it crucial to engage a local patent attorney for effective results[5].
Background Checks
Before initiating infringement proceedings, it is advisable to perform a background check on the potential infringer to understand the scope of the infringement and the potential defenses[5].
Scope of Claims
Patent Claims
The scope of patent claims is defined by the patent specification and claims. Biopharmaceutical patents must clearly outline the invention to ensure broad yet precise protection. The claims must be novel, involve an inventive step, and have industrial applicability[1][2].
Infringement Determination
To determine infringement, the IPO or the courts assess whether the product or process in question falls within the scope of protection of the patent. This can involve complex technical evaluations and expert opinions[1].
Non-Infringement Actions
Actions for determination of non-infringement can be filed with the IPO if the applicant has a legal interest in the determination, such as intending to use or market the product or process. The IPO decides whether the product or process falls within the scope of the patent[1].
Special Considerations for Biosimilar Medicines
Patentability
Biosimilar medicines, due to their high similarity to biological medicinal products, have questionable patentability. However, differences in the production process or other elements related to the biosimilar medicine can fulfill the criteria for an invention under Slovak patent law[2].
Marketing Authorization
Biosimilar medicines are authorized through the centralized procedure by the European Commission, valid for all EEA member states. There is no specific regulatory framework for biosimilar medicines in Slovakia[2].
Reimbursement Policy
There is no special legislation for the reimbursement policy of biosimilar medicines in Slovakia. Medicinal products, including biosimilars, must be listed in the “List of categorized medicinal products” to be reimbursable from the public health insurance system[2].
Challenges and Appeals
Opposition and Appeal Procedures
For European patents, opposition and appeal procedures at the EPO are the same as for any existing EP application. A refusal to grant a patent can be challenged through an appeal to the Boards of Appeal at the EPO[1][3].
Invalidity and Non-Infringement
European patents can be challenged through opposition filed within nine months of the publication of the grant. After this period, an assumed infringer can challenge the patent if opposition proceedings are pending. National patents can be challenged through invalidity proceedings at the IPO[1].
Key Takeaways
- Patentability: Biopharmaceutical inventions are patentable if they meet the criteria of novelty, inventive step, and industrial applicability.
- Types of Patents: National patents, European patents, and SPCs are available, each with different procedures and timelines.
- Enforceability: Patent rights are enforced through the courts, with a reliance on expert opinions and the need for local patent attorneys.
- Scope of Claims: Clearly defined patent claims are crucial for broad yet precise protection.
- Biosimilar Medicines: Patentability is questionable but can be achieved through differences in production processes; marketing authorization follows the centralized EU procedure.
FAQs
Q: What are the main conditions for a patent to be granted in Slovakia?
A: The main conditions are novelty, inventive step, and capability of industrial application[1][5].
Q: How long does a national patent last in Slovakia?
A: A national patent lasts up to 20 years from the filing date, provided maintenance fees are paid[1][5].
Q: Can biosimilar medicines be patented in Slovakia?
A: Biosimilar medicines can be patented if they fulfill the statutory requirements, particularly through differences in the production process or other elements[2].
Q: How are patent rights enforced in Slovakia?
A: Patent rights are enforced through the courts, with the District Court Banska Bystrica having sole jurisdiction over industrial property matters at the first instance[1].
Q: What is the role of the IPO in determining non-infringement?
A: The IPO decides whether the product or process falls within the scope of protection of the patent in actions for determination of non-infringement[1].
Cited Sources
- Patent Litigation 2024 - Slovakia | Global Practice Guides
- The Pharma Legal Handbook: Slovakia - PharmaBoardroom
- Q&A: Unitary Patent and Unified Patent Court - Marks & Clerk
- PCT Applicant's Guide Slovakia - Valid as from 11 Apr 2024 - WIPO
- How Do Patents Work in Slovakia? - Lawyer Monthly
