Amendments to the Law on Patents – Another Step Towards Alignment with the EU Regulatory Framework

Amendments to the Law on Patents – Another Step Towards Alignment with the EU Regulatory Framework

December 27, 2021

Amendments to the Law on Patents (the “Law”) entered into force on December 23, 2021, upon publication in the Official Gazette of RS no. 123/2021 as of December 15, 2021. The amendments were initially enacted for alignment of the Law with the EU regulations on intellectual property, as well as for elimination of certain deficiencies observed in its application.

Certificate on Additional Protection

The key novelty are provisions on certificate on additional protection.

According to the Law, each product protected by patent in the territory of the Republic of Serbia, whose trade as medicine for humans or animals or plant protection product is subject to licensing by a competent authority, under conditions stipulated by the Law, may be subject to the protection by certificate. The reason for this is the fact that these inventions cannot be commercially used until obtaining the required trading license, which significantly reduces the duration of protection implied by patent.

Within protection recognized by main patent, the protection recognized by certificate only refers to the product covered by trading license for relevant medicine for humans or animals, or plant protection product, as well as any use of product as medicine, i.e., plant protection product, the license wherefore was issued before the expiry of the certificate.

Having in mind that such solution, inter alia, prevents the preparatory activities for manufacturing or storage of medicine, i.e., product protected by certificate in the territory of Serbia, domestic manufacturers of such products (e.g., generic medicines) are thus put in an unfavorable position compared to the entities from countries where such protection does not exist.

These amendments therefore eliminate such imbalance and stipulate that exceptionally, i.e., under the conditions prescribed by the Law, preparatory activities for manufacturing and storage of products under the Article 113 paragraph 2. of the Law may be performed (active component or combination of active components of medicine, or active component from Article 2 paragraph 1. item 24) of the Law, or combination of active substances of plant protection products) or medicine product containing such product, only for the purpose of export and including appropriate mark on the outer product packaging.

The amendments have been made pursuant to the EU Regulation no. 2019/933 that entered into force on July 1, 2019 and which stipulates an exception from protection by certificate on additional protection if manufacturing or storage of medicines or medical products is done in the territory of EU for purpose of export.

The above stated provisions of the Law shall be applied starting from July 2, 2022, and they shall cease to be effective upon accession of the Republic of Serbia to the EU.

Changes in the Procedure of Patent Application

The law also introduced certain amendments regarding the submission of patent applications.

It is therefore stipulated that an application whose date of submission has been approved cannot be subsequently changed by extending the scope of the subject of protection. In relation thereto, it is envisaged that changes of the information included in the application can be done until the adoption of decision upon the patent application.

Before receipt of the search report, the patent applicant cannot change the description, patent requirements and draft application, and upon the receipt of the search report, the applicant can individually change them. The amended patent requirements cannot refer to the elements of patent application that no search report has been done for and which are not related to the invention or group of inventions that make a single invention idea that the initial protection was required for. Along with submitted changed parts of the patent application, the applicant also files the statement regarding the parts of application that have been modified and the parts of the initial patent application that represents a basis for the changes made. Otherwise, the competent authority may invite the applicant to submit such statement within one month after the day of receipt of invitation thereof.

Prohibition of Double Patenting

According to the Law, competent authority may only recognize one patent if two or more applications were made for one invention with the same approved date of application, i.e., priority date, by same applicants or their legal successors.

Amendments Regarding Petty Patent Protection

The Law extended the subject of protection of petty patents, for the purpose of creating a more favorable environment and stimulating innovation activities that would contribute to competition in the market and economic development.

It is stipulated that petty patent may protect a product and not only a solution referring to the construction of product or composition of its parts. Therefore, the products which are not characterized by construction solution, if they can be relevant in the market, will also be subject to the petty patent protection.

In addition, exceptions are also envisaged, i.e., inventions that cannot be protected by petty patent, which refer to inventions in the field of biotechnology, substances, medicines or substances and compositions contained in the state of technique applied in surgical or diagnostic procedure or medical treatment, plant varieties or animal breeds.

With regard to the procedure of petty patent research, it is prescribed that specific activities are undertaken in the procedure, and that the subject of invention stated in the application shall not be analyzed for novelty, invention level or industrial applicability.

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