Serbia Amends Patent Law

Amendments to the Serbian Law on Patents entered into force on December 23, 2021 introducing important changes relating to Supplementary Protection Certificates (SPCs) and utility models.

SPC Manufacturing Waiver

The amendments harmonize Serbia’s patent law with EU Regulation No. 2019/933, enabling companies in Serbia to produce a generic or biosimilar version of an SPC-protected medicine during the SPC term, under two conditions:

• For the purpose of exporting to countries where SPC protection is not available or not enforceable (the packaging must be marked accordingly); or
• For stockpiling during the final six months of the SPC term in order to place the product on the Serbian market once the SPC expires.

These provisions will enter into force on July 2, 2022 and will not apply to SPCs that came into force before this date.

Prior to the amendments, generic drug producers in Serbia were at a competitive disadvantage compared to manufacturers based in countries without SPC protection. They could not carry out preparatory work for drug production or storage during an SPC term, and were therefore not able to place the medicine on the domestic market once the SPC expired. Conversely, the same medicine produced by manufacturers from countries without SPC protection could appear on the Serbian market as soon as the SPC term was over.

Generic drug manufacturers operating in Serbia now have the same legal status as the manufacturers operating in the EU. This creates an incentive to export medicines to countries where SPCs do not exist or have expired. Serbia-based manufacturers will also be able to place a drug on the Serbian market once its SPC expires, creating greater supply and competition, stimulating the development of the generic drug industry and providing patients with access to a broader volume of medicines at more favorable prices.

Utility Model Subject Matter

The amendments extend the utility model subject matter to devices, as opposed to just processes that refer to the construction of the device or the layout of its components, to which utility model subject matter was previously limited.

On the other hand, the amendments limit the utility model subject matter by excluding the following:

• Inventions in the field of biotechnology;
• Substances;
• Drugs;
• Substances or compositions contained in the prior art used in a surgical, diagnostic or treatment procedure;
• Plant varieties or animal breeds; and
• Patentable procedures.

These changes will likely lead to an increase in the number of utility model applications, as chemical mixture producers now may protect their products faster and at lower cost than by using patent protection.

Double Patenting

Double patenting is now prohibited. The Serbian Intellectual Property Office may grant only one patent when two or more applications have been filed for the same invention with the same filing/priority date by the same applicants or their successors. This occurs mainly when a PCT or European patent application is filed based on a national patent application as the priority application, or in the case of divisional applications.

Other Changes

In order to harmonize its practice with the European Patent Office, the Serbian IPO is now able to issue electronic letters patent upon European patent holders’ requests.

The Serbian IPO will now obtain data ex officio for the purpose of registering representatives in its IP Agent Register.

Finally, patent applications will no longer be published simultaneously with letters patent.

Regulations regarding the implementation of the amendments will be adopted within six months from the amendments’ entry into force, by June 23, 2022.

By: Nada Milović

For more information, please contact Nada Milović at our Serbia office.