New Regime of Supplementary Protection Certificates and Petty Patents in Serbia

December 22, 2021

New Regime of Supplementary Protection Certificates and Petty Patents in Serbia

December 22, 2021

Milan Samardžić

Milan Samardžić

Partner

Nikola Dragić

Nikola Dragić

Junior Associate

On 9 December 2021, the National Assembly of the Republic of Serbia adopted amendments to the Patent Law (the “Law“) whose aim is harmonization with the regulations of the European Union, primarily Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, which was amended by Regulation (EU) No. 2019/933, which entered into force on 1 July 2019 in the territory of the European Union.

The most extensive changes are made to the Law provisions regarding supplementary protection certificate (“SPC“), as well as the provisions governing the protection procedure and the substantive examination of the petty patent. The goal of the amendments is to put domestic generic drug manufacturers on an equal footing with foreign companies, i.e. to increase competitiveness and encourage the development of the generic drug industry in Serbia.

 

Supplementary Protection Certificate 

 

Certainly, the most significant changes are related to the regime of SPC. The amendments pass three new articles which introduce exemptions from protection under SPC, in accordance with Regulation (EU) No. 2019/933. Amendments regarding SPC will be valid from 2 July 2022 and will not affect the certificates issued before the entry into force of adopted amendments. Following actions shall be considered as exemptions by adopted amendments:

  1. Actions related to the export of protected products for the entire period of validity of the certificate, and
  2. Storage of such products on the territory of the Republic of Serbia for the last six months of validity of SPC for commercial use immediately after the expiration of the SPC are considered exemptions.

The manufacturer of such products (mainly medicines) shall inform the holder of the certificate and Intellectual Property Office (“IPO“) in writing about their intention to produce said medicine for the purpose of export, while the IPO will publish such intention on their website. Such products must be marked differently from the original products, and IPO will prescribe the label’s appearance by a bylaw.

The abovementioned exemptions do not apply to any activity required to import a product into the territory of the Republic of Serbia, which is subject to SPC, or import a medical device containing that product only for the purpose of repackaging, re-export or storage.

 

Petty Patent

 

The main novelty regarding the petty patent is the expansion of the subject matter of protection of the petty patent. Instead of the previous rule by which the subject matter of protection is a solution related to the construction of a product or the layout of its components, the amendments of the Law prescribe that product can be protected by petty patent, and thus expand the subject matter of protection. Additionally, it is clearly emphasized what cannot be protected by a petty patent:

  • Inventions in the field of biotechnology;
  • Substances;
  • Medicines;
  • Substances or compositions referred to in Article 10 paragraph 3 and 4 of the Law;
  • Plant and/or animal varieties and
  • Procedure for which patent protection may be granted.

In addition to the above, the Law now precisely defines the actions to be taken in the process of examining a petty patent. Also, it is envisaged that the provisions related to the submission of amendments to the application during the patent grant procedure do not apply in the petty patent grant procedure since the report on the examination of state of the art (“SOA“) is not prepared in this particular case.

 

Manufacturer

 

The amendments introduce the term “manufacturer”. A manufacturer is considered to be a person with a registered office on the territory of the Republic of Serbia in whose name a product protected by an SPC or a medical product containing that product for export or storage is produced. This provision of the Law will enter into force on 2 July 2022.

 

Request For Conversion Of The Application

 

The reason for supplementing Article 166 of the Law is the practice of the IPO, which has shown that applicants submit a request for conversion several times during the grant procedure, which prolongs the duration of the procedure. Competent authority from now on will reject the request for conversion if the patent application was submitted by conversion from a petty patent application and vice versa for more than one time

 

Other Regulations

 

The provisions regarding the exemption related to protection under SPC cease to be valid from the day of the accession of the Republic of Serbia to the European Union, i.e. Regulation (EU) No. 2019/933 will apply afterwards. Finally, bylaws will be adopted within six months from the date of entry into force of the amended Law.

 

 

 

This text is for informational purposes only and should not be considered legal advice. Should you require any additional information, feel free to contact us.

Contact:

Milan Samardžić, Partner
milan.samardzic@sog.rs

Nikola Dragić, Junior Associate
nikola.dragic@sog.rs

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