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Last Updated: February 9, 2025

Serbia Drug Patents


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Drug Patents in Serbia and US Equivalents

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
Patent Number Estimated Expiration Equivalent US Patent US Expiry Date Generic Name US Applicant US Tradename
49655 ⤷  Try for Free 6294540 2018-11-14 abacavir sulfate Viiv Hlthcare ZIAGEN
49953 ⤷  Try for Free 6641843 2019-08-04 abacavir sulfate Viiv Hlthcare ZIAGEN
49655 ⤷  Try for Free 6294540 2018-11-14 abacavir sulfate; lamivudine Viiv Hlthcare EPZICOM
49655 ⤷  Try for Free 6294540 2018-11-14 abacavir sulfate; lamivudine; zidovudine Viiv Hlthcare TRIZIVIR
49632 ⤷  Try for Free 6431168 2018-12-08 albuterol sulfate Glaxosmithkline VENTOLIN HFA
>Patent Number >Estimated Expiration >Equivalent US Patent >US Expiry Date >Generic Name >US Applicant >US Tradename

Patentability, Enforceability, and Scope of Claims for Biopharmaceutical Patents in Serbia

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

  1. Serbia - WIPO Lex: The competent authority shall keep Register of Patents and Register of Petty Patents.
  2. Serbia Amends Patent Law - PETOŠEVIĆ: The amendments harmonize Serbia’s patent law with EU Regulation No. 2019/933.
  3. Serbia - WIPO Lex: Article 57. The scope of protection conferred by a patent shall be determined by the content of the claims.
  4. 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.
  5. Serbia | PETOŠEVIĆ: Minimal Filing Requirements for Patent Applications.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.