Introduction to Serbian Patent Law
Serbian patent law has undergone significant amendments to align with European Union regulations, particularly affecting the biopharmaceutical sector. Understanding these changes is crucial for navigating the patent landscape in Serbia.
Patentability of Biopharmaceutical Inventions
Biological Material and Processes
In Serbia, biopharmaceutical inventions can be patented if they meet specific criteria. The law allows for the patenting of products consisting of or containing biological material, processes for producing, processing, or using biological material, and biological material isolated from its natural environment or produced by a technical process[3].
Exclusions from Patentability
Certain inventions are excluded from patentability, such as those that are not technically confined to a single plant or animal. However, biotechnological inventions, including those related to microorganisms, plant and animal cell cultures, and gene sequences, are generally patentable[3][4].
Filing Requirements for Biopharmaceutical Patents
Minimal Filing Requirements
To file a patent application for a biopharmaceutical invention in Serbia, the following documents are necessary:
- Applicant data
- Name and address of the inventor
- Priority application data
- Patent specification[5]
Other documents, such as powers of attorney and declarations, may be filed subsequently and do not need to be legalized or notarized unless requested by the Patent and Trademark Office.
Scope of Protection for Biopharmaceutical Patents
Determination of Scope
The scope of protection for a biopharmaceutical patent in Serbia is determined by the content of the claims, with the description and drawings used to interpret these claims. This ensures that the patent protection is clearly defined and enforceable[3].
Protection of Substances and Compositions
The law allows for patent protection of substances or compositions for specific uses in methods of treatment by surgery, diagnostic methods, or therapy, provided these uses are not already part of the state of the art[1].
Enforceability of Biopharmaceutical Patents
Exhaustion of Rights
Once a protected product is placed on the market in Serbia by the right holder or with their consent, the person acquiring the product can use and dispose of it freely. This principle of exhaustion of rights ensures that the patent holder's control over the product ends once it is sold[1].
Compulsory Licenses
The Serbian patent law provides for compulsory licenses under certain conditions, such as if the right holder does not use the protected invention sufficiently in Serbia, or if the commercial use of a subsequent invention requires the use of the protected invention. Compulsory licenses can also be granted to remedy anti-competitive practices[1].
Compulsory Licenses for Pharmaceutical Products
Specific provisions allow for the grant of compulsory licenses for the manufacture and sale of pharmaceutical products intended for export to countries with public health problems. This aligns with international agreements such as the TRIPS Agreement and the Doha Declaration on Public Health[1].
Recent Amendments and Their Impact
SPC Manufacturing Waiver
Recent amendments to the Serbian patent law, effective from July 2, 2022, allow companies to produce generic or biosimilar versions of SPC-protected medicines during the SPC term. This is permitted for export to countries where SPC protection is not available or not enforceable, or for stockpiling to place the product on the Serbian market once the SPC expires. This change harmonizes Serbian law with EU Regulation No. 2019/933 and enhances competition in the generic drug market[2].
Prohibition of Double Patenting
The amendments also prohibit double patenting, ensuring that only one patent can be granted for the same invention with the same filing or priority date by the same applicants or their successors. This prevents redundant patent applications and streamlines the patent process[2].
Practical Implications for Biopharmaceutical Companies
Export and Domestic Market Access
The new regulations enable Serbian companies to export generic or biosimilar medicines to countries without SPC protection, and to prepare for domestic market entry once the SPC expires. This creates a level playing field with EU-based manufacturers and increases access to affordable medicines for patients[2].
Compliance with EU Standards
The alignment with EU regulations and practices, such as the issuance of electronic letters patent and the registration of representatives in the IP Agent Register, facilitates smoother interactions between Serbian and EU patent offices. This harmonization is beneficial for companies operating in both jurisdictions[2].
Key Takeaways
- Patentability: Biopharmaceutical inventions involving biological material and processes are patentable in Serbia, with exclusions for inventions not technically confined to a single plant or animal.
- Filing Requirements: Minimal filing requirements include applicant data, inventor information, priority application data, and patent specification.
- Scope of Protection: The scope is determined by the claims, with description and drawings used for interpretation.
- Enforceability: Compulsory licenses can be granted under specific conditions, and exhaustion of rights applies once a product is placed on the market.
- Recent Amendments: Allow for SPC manufacturing waivers, prohibit double patenting, and harmonize with EU regulations.
FAQs
Q: What types of biopharmaceutical inventions are patentable in Serbia?
A: Inventions involving products consisting of or containing biological material, processes for producing or using biological material, and biological material isolated from its natural environment or produced by a technical process are patentable.
Q: Can generic or biosimilar medicines be produced during the SPC term in Serbia?
A: Yes, recent amendments allow for the production of generic or biosimilar versions of SPC-protected medicines during the SPC term for export or stockpiling purposes.
Q: What are the conditions for granting a compulsory license in Serbia?
A: Compulsory licenses can be granted if the right holder does not use the protected invention sufficiently, if commercial use of a subsequent invention requires the protected invention, or to remedy anti-competitive practices.
Q: How does the exhaustion of rights principle apply in Serbia?
A: Once a protected product is placed on the market by the right holder or with their consent, the person acquiring the product can use and dispose of it freely.
Q: What are the implications of the recent amendments to the Serbian patent law for biopharmaceutical companies?
A: The amendments enable companies to export generic or biosimilar medicines and prepare for domestic market entry, creating a more competitive environment and aligning with EU standards.
Sources
- Serbia - WIPO Lex: The competent authority shall keep Register of Patents and Register of Petty Patents.
- Serbia Amends Patent Law - PETOŠEVIĆ: The amendments harmonize Serbia’s patent law with EU Regulation No. 2019/933.
- Serbia - WIPO Lex: Article 57. The scope of protection conferred by a patent shall be determined by the content of the claims.
- Patentable biotechnological inventions - European Patent Office: 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.
- Serbia | PETOŠEVIĆ: Minimal Filing Requirements for Patent Applications.