Introduction to Montenegro's Patent Law
Montenegro has made significant strides in aligning its patent laws with international standards and European Union regulations. The new Law on Patents, adopted in 2015, introduces several key changes that impact the patentability, enforceability, and scope of claims for biopharmaceutical patents.
Patentability of Biopharmaceutical Inventions
Criteria for Patentability
For a biopharmaceutical invention to be patentable in Montenegro, it must meet the standard criteria of being new, involving an inventive step, and being susceptible to industrial application[4].
- Novelty: The invention must not form part of the state of the art, which includes everything made available to the public before the filing date of the patent application[4].
- Inventive Step: The invention must be non-obvious to a person skilled in the relevant field.
- Industrial Application: The invention must be capable of being used in industry.
Biological Material and Biotechnological Inventions
Biopharmaceutical inventions often involve biological material. According to Montenegro's patent law, biological material includes any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. This can include products consisting of or containing biological material, processes by which biological material is produced, processed, or used, and biological material isolated from its natural environment or produced by a technical process[3][4].
Proof of Patentability
Substantive Examination
Under the new Law on Patents, while the Montenegro Intellectual Property Office (IPO) conducts only formal examinations of patent applications, the right owner must submit proof of patentability before the end of the ninth year of the patent's validity. This proof involves a certified copy in the Montenegrin language of a patent granted for the same invention by a state or interstate office that conducted a substantive examination, such as those under the Patent Cooperation Treaty (PCT)[1].
Enforceability of Biopharmaceutical Patents
Jurisdiction and Nullification
The new law grants the Montenegro IPO the authority to nullify patents, a power previously held only by the courts. However, civil protection, including actions to establish the right to a patent, the status of the inventor, and patent infringement actions, remain under the jurisdiction of the courts[1].
Compulsory Licenses
Montenegro's patent law allows for the granting of compulsory licenses for patents related to the production of pharmaceutical products, particularly for export to countries with public health issues. This provision ensures that essential medicines can be made available even if the patent holder refuses to license the invention on reasonable terms[1][4].
Scope of Claims
Patentable Subject Matter
The scope of claims for biopharmaceutical patents in Montenegro includes products and processes. This can encompass:
- Products: Devices, substances, compositions, and biological materials.
- Processes: Methods by which biological material is produced, processed, or used[3][4].
Limitations of Rights
The exclusive rights of a patent holder do not extend to:
- Personal and non-commercial use of the invention.
- Research and development activities necessary for obtaining authorization for placing a product into circulation, such as drugs intended for human or animal use.
- Direct, individual preparation of a drug in a pharmacy based on a single prescription[4].
Supplementary Protection Certificates (SPCs)
Montenegro's law also clarifies the procedure for obtaining SPCs, including pediatric extensions. SPCs can extend the protection period of a patent to compensate for the time spent in obtaining regulatory approval for a pharmaceutical product[1].
International Agreements and Cooperation
Accession to the European Patent Convention (EPC)
Montenegro's accession to the EPC in 2022 allows nationals and residents of Montenegro to file international applications with the European Patent Office (EPO) as the receiving office. This move aligns Montenegro's patent system with European standards and facilitates the protection of inventions across Europe[2].
Priority Rights
Montenegro's patent law respects priority rights under the Paris Convention and the World Trade Organization. Applicants who have filed an application in any state party to these agreements can claim priority in Montenegro within 12 months from the initial filing date[3][4].
Revalidation of Rights
The new law provides an opportunity for rights owners who failed to maintain protection in the State Union of Serbia and Montenegro or the Republic of Serbia to revalidate their rights in Montenegro. This revalidation must be requested within six months from the date the new law entered into force, and outstanding annuities must be paid[1].
Key Takeaways
- Patentability: Biopharmaceutical inventions must be new, involve an inventive step, and be susceptible to industrial application.
- Proof of Patentability: Right owners must submit proof of patentability by the end of the ninth year of the patent's validity.
- Enforceability: The IPO has the authority to nullify patents, while courts handle civil protection and infringement actions.
- Compulsory Licenses: Available for pharmaceutical products, especially for public health issues.
- Scope of Claims: Includes products and processes related to biological material.
- International Cooperation: Montenegro's accession to the EPC and respect for priority rights under international agreements.
FAQs
What are the criteria for patentability in Montenegro?
In Montenegro, an invention must be new, involve an inventive step, and be susceptible to industrial application to be patentable.
How does Montenegro's new Law on Patents affect the enforcement of biopharmaceutical patents?
The new law grants the IPO the authority to nullify patents and clarifies the procedure for obtaining SPCs and compulsory licenses, particularly for pharmaceutical products.
Can biopharmaceutical inventions involving biological material be patented in Montenegro?
Yes, biopharmaceutical inventions involving biological material can be patented if they meet the criteria of novelty, inventive step, and industrial application.
What is the significance of Montenegro's accession to the European Patent Convention?
Montenegro's accession to the EPC allows nationals and residents to file international applications with the EPO, aligning Montenegro's patent system with European standards.
How can rights owners revalidate their rights in Montenegro under the new law?
Rights owners who failed to maintain protection in the State Union of Serbia and Montenegro or the Republic of Serbia can revalidate their rights in Montenegro within six months from the date the new law entered into force, by paying outstanding annuities.
Sources
- PETOŠEVIĆ: "Montenegro Adopts New Patent Law" - https://www.petosevic.com/resources/news/2015/07/3235
- European Patent Office: "OJ EPO 2022, A78 – Montenegro accedes to the European Patent Convention" - https://www.epo.org/en/legal/official-journal/2022/08/a78.html
- World Trade Organization: "THE PATENT LAW" - https://www.wto.org/english/thewto_e/acc_e/cgr_e/wtacccgr33_leg_5.pdf
- WIPO Lex: "Montenegro - Law on Patents" - https://www.wipo.int/wipolex/en/text/187642
- AMPEID: "Law on Patents (Official Gazette of Montenegro, No. 42/2015)" - https://ampeid.org/documents/montenegro/law-on-patents-(official-gazette-of-montenegro-no-42-2015)/
