Introduction
Norway, as part of the European Economic Area (EEA), has a robust legal framework for protecting intellectual property, including biopharmaceutical patents. This article delves into the key aspects of patentability, enforceability, and the scope of claims for biopharmaceutical patents in Norway.
Patentability of Biopharmaceutical Inventions
General Principles
Biopharmaceutical inventions are generally patentable in Norway, provided they meet the standard criteria of novelty, inventiveness, and industrial applicability. The European Patent Convention (EPC) and relevant EU directives, such as Directive 98/44/EC on the legal protection of biotechnological inventions, serve as guiding principles[4].
Naturally Occurring Biological Material
Patent applications concerning naturally occurring biological material must clearly outline how the material can be isolated, purified, or otherwise transformed into a patentable invention. This ensures that the scope of the patent is not overly broad and does not encompass unpatentable subject matter[3].
Plant and Animal Inventions
Inventions related to plants or animals are patentable if the application of the invention is not technically confined to a single plant or animal. This means that the invention must have a broader applicability beyond a specific species[4].
Filing and Examination Process
Filing Options
Patent applications in Norway can be filed through various routes, including the European Patent Office (EPO), the Patent Cooperation Treaty (PCT) system, or as a national application under the Paris Convention. The Norwegian Industrial Property Office (NIPO) accepts these applications and coordinates the examination process[5].
Automatic Examination
Examination of a patent application in Norway starts automatically upon filing. Applicants must respond to the First Examination Report (FER) within three months, addressing any objections or requirements raised by the examiner[5].
Annuity Payments
After the grant of a patent, annuity payments are due starting from the third year. The total protection period for a patent in Norway is 20 years from the international filing date[5].
Enforceability of Biopharmaceutical Patents
Infringement and Revocation Actions
In Norway, infringement and revocation actions are typically handled together in the same proceedings, with the Oslo District Court being the mandatory venue. This means that infringement proceedings are not usually stayed pending the outcome of revocation actions[1].
Ex Parte Injunctions
Ex parte injunctions, which can be granted without a full hearing, are rarely awarded in complex patent cases due to the high threshold of extreme urgency and substantial harm to the patentee’s interest. This cautious approach ensures that such measures are not abused[1].
Defenses Against Infringement
Defendants in infringement actions can invoke several defenses, including the right to a compulsory license, prior use rights if they were using the invention before the priority date, experimental use, and exhaustion. The Norwegian “Bolar” exemption is particularly relevant for life sciences cases, allowing for tests and trials necessary for obtaining market authorization without infringing the patent[1].
Scope of Claims
Bolar Exemption
The Bolar exemption, implemented in the Norwegian Patent Act, permits the undertaking of tests, trials, and similar activities necessary for obtaining market authorization for pharmaceuticals. This exemption applies to patents and Supplementary Protection Certificates (SPCs) and is not limited to EU/EEA countries but extends to all WTO-signatory countries[1].
Supplementary Protection Certificates (SPCs)
SPCs are available in Norway for patents covering authorized medicinal or plant pharmaceutical products. These certificates extend the patent protection period, providing additional protection beyond the standard 20-year term[1].
SPC Manufacturing Waiver
As of February 1, 2023, the SPC manufacturing waiver has been implemented in Norway, allowing manufacturers of generics and biosimilars to produce these medicines for export outside the EU during the SPC protection term. This waiver aligns Norway with EU regulations and facilitates the global supply of generic and biosimilar medicines[2].
Regulatory Data and Market Exclusivity
Data and Market Protection
Norwegian law, under the Norwegian Medicine Regulation, distinguishes between an eight-year period of data protection and a ten-year period of market protection (the “8+2 system”). This system prohibits the placing on the market of generic medicinal products during the two-year period following the expiration of data protection but allows preparatory actions before market entry[1].
Freedom of Information
Freedom of information requests to the Norwegian Medicines Agency (NOMA) are limited, especially regarding pending applications, which are generally classified as trade secrets. NOMA does not notify generic MA applicants if someone requests information under the Freedom of Information Act[1].
Publicly Available Drug and Patent Information
Access to Information
Publicly available drug and patent information in Norway is governed by the Freedom of Information Act. However, additional information about pending applications is typically excluded from disclosure due to trade secret protections[1].
Acceptable Pre-launch Preparations
Preparatory Actions
Applicants can undertake preparatory actions for generic or biosimilar products before the expiration of the patent or SPC, but these actions must not involve the actual placing of the product on the market. This allows for a smoother transition to market entry once the protection period ends[1].
Reimbursement and Pricing
Regulatory Considerations
NOMA does not consider the patent situation when making decisions on marketing authorization, pricing, and reimbursement. This separation ensures that regulatory and patent issues are handled independently[1].
Key Takeaways
- Patentability: Biopharmaceutical inventions are patentable in Norway if they meet the criteria of novelty, inventiveness, and industrial applicability.
- Filing and Examination: Patent applications can be filed through the EPO, PCT, or national routes, with automatic examination starting upon filing.
- Enforceability: Infringement and revocation actions are handled together, with ex parte injunctions rarely granted. Defenses include compulsory licenses, prior use rights, and the Bolar exemption.
- Scope of Claims: The Bolar exemption and SPC manufacturing waiver are crucial for life sciences, allowing for tests and trials and export of generics and biosimilars.
- Regulatory Data and Market Exclusivity: Norway follows the “8+2 system” for data and market protection, with limited access to pending application information.
FAQs
What is the Bolar exemption in Norwegian patent law?
The Bolar exemption allows for tests, trials, and similar activities necessary for obtaining market authorization for pharmaceuticals without infringing the patent. It applies to patents and SPCs and is not limited to EU/EEA countries[1].
How does the SPC manufacturing waiver affect biopharmaceutical manufacturers in Norway?
The SPC manufacturing waiver, implemented on February 1, 2023, allows manufacturers of generics and biosimilars to produce these medicines for export outside the EU during the SPC protection term, facilitating global supply[2].
What is the typical timeline for a revocation and/or infringement action in Norway?
Infringement and revocation actions are typically handled together, with the Oslo District Court being the mandatory venue. The proceedings are not usually stayed pending the outcome of revocation actions[1].
Can ex parte injunctions be granted in biopharmaceutical patent cases in Norway?
Ex parte injunctions are rarely granted in complex patent cases due to the high threshold of extreme urgency and substantial harm to the patentee’s interest[1].
How does Norway protect data and market exclusivity for biopharmaceutical products?
Norway follows the “8+2 system,” providing an eight-year period of data protection and a ten-year period of market protection. This system prohibits the placing on the market of generic medicinal products during the two-year period following the expiration of data protection[1].
Sources
- Life Sciences & Pharma IP Litigation 2024 - Norway. Chambers and Partners.
- SPC manufacturing waiver has entered into force in Norway. Wikborg Rein.
- Biotech Patents: Norway's Government Issues Consultation Paper. Vlex.
- Patentable biotechnological inventions - European Patent Office. European Patent Office.
- Patent filing in Norway. Global Patent Filing.
