Introduction to the Finnish Patent System
The Finnish Patent and Registration Office (PRH), established in 1835, is the central authority for patent filings in Finland. Finland joined the World Intellectual Property Organization (WIPO) in 1970 and became a full member of the European Patent Organisation (EPO), further integrating its patent system with international standards[1].
Patentability of Biopharmaceutical Inventions
In Finland, biopharmaceutical inventions are generally patentable, aligning with the European Patent Convention (EPC) and EU Directive 98/44/EC on the legal protection of biotechnological inventions.
- Biotechnological Inventions: These are patentable provided the application of the invention is not technically confined to a single plant or animal. The relevant provisions of the EPC, particularly Rules 26 to 29, and the EU Directive 98/44/EC, guide the patentability of such inventions[4].
- Microorganisms and Biological Material: Special provisions exist for the deposit of microorganisms and other biological material, which must be referred to in the patent application. This is crucial for biopharmaceutical patents that often involve such materials[5].
Filing and Examination Process
- Filing Formats: Patents can be filed in Finland through the Paris Convention based national entry or the PCT National Phase based national entry. The Finnish patent office also accepts online patent applications, and the examination process begins automatically upon filing without the need for a separate examination request[1].
- Priority and Publication: The publication of Finland patents occurs within 18 months of the priority date. The request for examination must be made at the time of filing, and annuities for the second year onwards are paid after the grant of the patent. The protection period for a patent is 20 years from the international filing date[1].
Enforceability of Biopharmaceutical Patents
Enforceability of biopharmaceutical patents in Finland is stringent and involves several key aspects:
- Validity Challenges: Patents can be challenged on grounds of novelty, inventive step, and industrial applicability. The Finnish Market Court has the authority to declare patents invalid if these criteria are not met. For instance, in a recent case involving Teva Pharmaceuticals and Bristol-Myers Squibb, the Market Court declared a patent invalid due to lack of novelty, highlighting the importance of valid priority claims[2].
- Supplementary Protection Certificates (SPCs): SPCs can extend the protection period of a patent, but they are also subject to validity challenges. The Market Court's decision in the Teva vs. BMS case also invalidated the SPC related to the blockbuster drug apixaban, underscoring the critical role of generic competition in reducing healthcare costs[2].
Scope of Claims for Biopharmaceutical Patents
The scope of protection for biopharmaceutical patents in Finland is determined by the patent claims and the description provided in the patent application.
- Interpretation of Claims: Section 39 of the Finnish Patent Act aligns with the EPC, stating that the scope of protection is determined by the patent claims, and the description may be used to interpret these claims. However, there is no explicit reference to equivalence in the Finnish Patent Act, unlike Article 2 of the Protocol on the Interpretation of Article 69 EPC[3].
- National and EPC Patents: It is recommended to interpret national and EPC patents in an identical fashion, as stated in the government bill on the implementation of EPC 2000. This ensures consistency in the scope of protection across different types of patents[3].
Practical Considerations for Applicants
- Language and Filing Requirements: International applications can be filed in English, Finnish, or Swedish. The Finnish Patent and Registration Office accepts electronic filings in XML and PDF formats using ePCT-Filing or EPO Online Filing[5].
- Power of Attorney: The Finnish authority has waived the requirement for a separate power of attorney in most cases, but it may be required for agents or common representatives not indicated in the request or demand form[5].
Impact on the Pharmaceutical Market
The enforcement and validity of biopharmaceutical patents have significant implications for the pharmaceutical market in Finland.
- Generic Competition: The introduction of generic drugs, as seen in the case of apixaban, can lead to substantial savings in the drug reimbursement system. This fosters a more cost-effective and accessible medicines framework[2].
- Economic Benefits: Valid and enforceable patents protect innovation, encouraging investment in research and development. However, the balance between patent protection and generic competition is crucial for maintaining a healthy and competitive market[2].
Key Takeaways
- Patentability: Biopharmaceutical inventions are patentable under Finnish law, aligning with EPC and EU directives.
- Filing and Examination: Automatic examination upon filing, with specific requirements for priority and publication.
- Enforceability: Patents can be challenged on novelty, inventive step, and industrial applicability, with the Market Court playing a crucial role.
- Scope of Claims: Determined by patent claims and description, with recommendations for consistent interpretation of national and EPC patents.
- Practical Considerations: Specific language and filing requirements, with waived power of attorney in most cases.
- Market Impact: Balance between patent protection and generic competition is essential for a cost-effective and accessible pharmaceutical market.
FAQs
Q1: What are the filing formats for biopharmaceutical patents in Finland?
A1: Patents can be filed through the Paris Convention based national entry or the PCT National Phase based national entry[1].
Q2: How is the scope of protection determined for biopharmaceutical patents in Finland?
A2: The scope of protection is determined by the patent claims, with the description used for interpretation, aligning with the EPC[3].
Q3: Can biopharmaceutical patents be challenged in Finland?
A3: Yes, patents can be challenged on grounds of novelty, inventive step, and industrial applicability before the Finnish Market Court[2].
Q4: What is the role of the Finnish Market Court in patent disputes?
A4: The Finnish Market Court decides on the validity and infringement of patents, as seen in cases like Teva vs. BMS, and can declare patents invalid or dismiss infringement actions[2].
Q5: How does the enforcement of biopharmaceutical patents impact the pharmaceutical market in Finland?
A5: Enforcement protects innovation but must balance with generic competition to ensure a cost-effective and accessible medicines framework[2].
Sources
- Global Patent Filing - Finland: Finnish Patent and Registration office (PRH) started in 1835.
- Borenius - Teva vs. BMS: Borenius secures win for Teva in a patent dispute over blockbuster anticoagulant drug.
- IPRinfo - Scope of Patent Protection in Finland: The scope of protection of patents has been widely debated since the present Patent Act (550/1967) entered into force.
- European Patent Office - Patentable biotechnological inventions: Inventions which concern plants or animals are patentable provided that the application of the invention is not technically confined to a single plant or animal.
- WIPO - PCT Applicant's Guide Finland: Information of interest if this Contracting State is designated (or elected).
