Legal Framework
The main source of patent law in Denmark is the Danish Patents Act, No 221 of 26 February 2017, which outlines the rules and regulations governing patent applications and enforcement[3].
Patent Eligibility
In Denmark, anyone who has made an invention that is susceptible to industrial application, or their successor in title, has the right to apply for a patent. The Danish Patents Act does not provide a positive list of what constitutes patent-eligible subject matter but does list what is not eligible, such as methods for treatment of the human or animal body by surgery or therapy, and diagnostic methods practiced on the human or animal body[3].
Biotechnological Inventions
Biotechnological inventions, including those concerning plants or animals, are generally patentable in Denmark, provided they are not technically confined to a single plant or animal. These inventions are governed by the European Patent Convention (EPC) and EU Directive 98/44/EC on the legal protection of biotechnological inventions[4].
Application and Registration Process
To register a patent in Denmark, applicants must file their application with the Danish Patent and Trademark Office (DKPTO). The application must include a description, claims, and any necessary drawings. For European patents, a translation of the claims into Danish must be filed and validated if the patent is to have effect in Denmark[1][3].
Appeal and Opposition Procedures
If the DKPTO does not grant a patent, applicants can appeal the decision to the Board of Appeal for Patents and Trademarks within two months. A fee of DKK 8,000 must be paid within this timeframe to proceed with the appeal[3].
Scope of Claims
The extent of protection conferred by a patent is determined by the claims, with the description serving as a guide for interpretation. The doctrine of equivalents applies in Denmark, meaning that a party can be held liable for patent infringement even if the infringing device or process does not fall within the literal scope of the claims but is equivalent to the claimed invention[3].
Supplementary Protection Certificates (SPCs)
SPCs are crucial for extending the period of exclusivity for biopharmaceutical patents. In Denmark, SPCs can extend the patent term by up to five years for medicinal or plant protection products that have received their first marketing authorization. The basic patent must protect the product and be in force at the time the SPC application is filed. The DKPTO examines SPC applications, and the basic fee for an SPC application is DKK 3,000[1][5].
Preliminary Injunctions (PIs)
For biopharmaceutical patents, PIs can be sought to prevent infringement. The applicant must prove or render it probable that the patent is being infringed. The Maritime and Commercial High Court, composed of technically and legally qualified judges, hears PI applications. In practice, PIs are rarely conducted ex parte, and protective letters are not allowed in Danish courts[1].
Infringement and Enforcement
Infringement in Denmark often involves determining whether there has been an offer for sale of the medicinal products. For second medical use claim patents, it is necessary to "skinny-label" the generic medicinal product to avoid infringement. However, simply having a skinny label may not be sufficient to ensure against infringement, as seen in other jurisdictions like the Netherlands[1][2].
Data and Market Exclusivity
Biopharmaceutical products in Denmark benefit from data and market exclusivity provided by EU Regulations and Danish law. Orphan medicinal products receive ten years of market exclusivity, which can be reduced to six years if the criteria for designation as an orphan medicine are no longer met. Paediatric medicines can receive up to 12 years of market exclusivity[1].
Bolar Exemption
The Danish Patent Act includes a broad Bolar exemption, allowing any act necessary to obtain a marketing authorization for a medicinal product, regardless of whether it is a generic or applied for in Denmark, the EU, or a third country. This exemption does not apply to utility models, but this has limited practical consequence due to the shorter term of utility models[1].
Generic Substitution
Danish law allows the holder of a marketing authorization to notify the Danish Medicines Agency (DKMA) about a patented indication for a medicinal product, preventing generic or biosimilar substitution within that patented indication. However, this does not apply to purchases through hospital tenders, which can complicate enforcement for second medical use claim patents[1].
Parallel Imports
Parallel imports from EU and EEA countries are allowed with authorization from the DKMA, provided the originator is informed. The parallel importer/distributor must prove that relevant IP rights have been exhausted[1].
Regulatory Environment
The regulatory environment in Denmark is robust, with the DKMA playing a crucial role in authorizing medicinal products and enforcing data and market exclusivity. Challenges to data and market exclusivity are rare but can be filed to enforce these rights[1].
National and International Variations
Enforcement of biopharmaceutical patents varies significantly across different countries due to local prescribing and reimbursement practices. For example, the Netherlands offers more thorough protection against infringement compared to the UK, while Denmark's system has its unique aspects, such as the use of skinny labels and the role of the Maritime and Commercial High Court[2].
Future Developments: Unified Patent Court (UPC)
The proposed UPC could offer harmonization across Europe in enforcing second medical use patents, but it would not change local prescribing and dispensing practices. This means that while the UPC could provide clearer legal guidance, its impact on enforcement would be limited by national differences[2].
Key Takeaways
- Patent Eligibility: Biotechnological inventions are generally patentable in Denmark, subject to EPC and EU Directive 98/44/EC.
- Scope of Claims: The doctrine of equivalents applies, and claims are interpreted with the description as a guide.
- SPCs: Extend patent term by up to five years for medicinal or plant protection products.
- Infringement and Enforcement: PIs are available, and infringement often involves offers for sale; skinny-labeling is necessary for second medical use claim patents.
- Data and Market Exclusivity: Provided by EU Regulations and Danish law, with specific durations for orphan and paediatric medicines.
- Bolar Exemption: Allows acts necessary to obtain marketing authorization regardless of the product type or application location.
- Regulatory Environment: Robust framework with the DKMA playing a key role in authorization and enforcement.
FAQs
Q: What is the primary source of patent law in Denmark?
A: The primary source of patent law in Denmark is the Danish Patents Act, No 221 of 26 February 2017[3].
Q: Can biotechnological inventions be patented in Denmark?
A: Yes, biotechnological inventions are generally patentable in Denmark, subject to the EPC and EU Directive 98/44/EC[4].
Q: How can the scope of claims be determined in Danish patent law?
A: The scope of claims is determined by the claims themselves, with the description serving as a guide for interpretation. The doctrine of equivalents also applies[3].
Q: What is the role of Supplementary Protection Certificates (SPCs) in Denmark?
A: SPCs extend the patent term by up to five years for medicinal or plant protection products that have received their first marketing authorization[1][5].
Q: How does Denmark handle parallel imports of medicinal products?
A: Parallel imports from EU and EEA countries are allowed with authorization from the DKMA, provided the originator is informed and IP rights have been exhausted[1].
Cited Sources:
- Life Sciences & Pharma IP Litigation 2024 - Global Practice Guides. Chambers and Partners.
- Denmark the 'perfect solution' to tackle second medical use infringement. Managing IP.
- Patents Comparative Guide - Denmark. Mondaq.
- Patentable biotechnological inventions - European Patent Office. EPO.
- Apply - Patent, Utility Models and SPCs. Danish Patent and Trademark Office.
