Granting, modification and review of compulsory licences relating to the manufacture of pharmaceutical products for export to countries with public health problems

The HIPO shall grant a compulsory license for the exploitation of a patent in the cases laid down Regulation No 816/2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, furthermore modifies the conditions of the licence based on the request of the licencee.

Upon request, the HIPO reviews whether the conditions set out in the compulsory licence have been complied with, and may request access to the books of the compulsory licensee in order to check whether the conditions of the licence have been met.

Kulcsszavak: compulsory licence, medical product, public health

Compulsory licence: any natural or legal person and their representative.

Modification: compulsory licensee

Review: holder of the patent/compulsory licensee

Access to the books of the compulsory licensee: holder of the patent 

The possibility of electronic administration is available through the electronic administration system of the Hungarian Intellectual Property Office (HIPO) (available only in Hungarian)

Electronic submissions may be filed with the HIPO only by using the free-of-charge form provided for this purpose. The form can be accessed by clicking the Electronically button.

In proceedings before the HIPO, electronic communication is possible only in a manner linked to identification, except for requests for information and their execution, as well as international patent cases.

Identification can be done in the following ways:

User identification system created by the HIPO, based on a one-time re-identification with the Central Authentication Agent.

Electronic signature with enhanced security is a minimum requirement.

When turning to the HIPO after identification through a partner card or the Central Authentication Agent, the HIPO will send its decisions, notifications and other calls made during the procedure to the client’s official electronic storage space.

It is important to emphasize that in case of identification with an electronic signature, the HIPO cannot communicate with its clients electronically and can deliver its decisions only on paper.

The filing procedure is as follows:

1. Download the form to your device. Filling out the form in a web browser is not recommended.

2. Login to the electronic administration system of the HIPO by using the Central Authorization Agent, partner card or electronic signature. If you have an electronic signature, please choose identification using an electronic signature with enhanced security.

3. Upload the filled form into the system. Based on the attachments marked in the form, a table will appear in which the attachments must be uploaded one by one. If you have already compiled these into a directory, you will easily find the right documents.

The size of files that can be attached to forms cannot exceed 150 MB each. The total size of the submission and all attachments may not exceed 300MB.

4. Indicate that you really intended to compile this submission, or look at the HTML submission summary.

The system compiles your submission, encrypts it and sends it to HIPO. HIPO sends an automatic notification about the arrival of the submission.

There is no administration deadline defined in the applicable laws. The administrative deadlines laid down in the Act on General Public Administration Procedure do not apply nor do apply the provisions of the Act on General Public Administration Procedure which set a deadline for other measures of the acting authority.

The application for compulsory licence shall set out the following:

  1. the name and contact details of the applicant and of any agent or representative whom the applicant has appointed to act for him before the competent authority;
  2. the non-proprietary name of the pharmaceutical product or products which the applicant intends to manufacture and sell for export under the compulsory licence;
  3. the amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence;
  4. the importing country or countries;
  5. where applicable, evidence of prior negotiation with the rights-holder pursuant to Article 9 of Regulation (EC) No 816/2006;
  6. evidence of a specific request from:

    ​- of authorized representatives of the importing country or countries or,

           - a non-governmental organization acting with the formal authorization of one or more importing countries

          - UN bodies or other health organizations acting with the formal authorization of one or more importing countries

indicating the quantity of product required.

7. Register number of the patent for which the compulsory licence is requested

8. Pursuant to Article 10 (5) of Regulation (EC) No 816/2006, characteristics that distinguish a pharmaceutical product intended to be manufactured under a compulsory license from such a product manufactured by the patentee or another person authorized by him (eg individual packaging, colors or shapes);

9. the address of the website referred to in Article 10 (6) of Regulation (EC) No 816/2006.

Modification: request with justification.

Review: request with justification.

Access to the books of the compulsory licensee: request

The fee for requesting the compulsory licence, modification. review and request for access to the books of the compulsory licensee is 140 800 HUF.

All fees shall be payable to the account No. 10032000-01731842-00000000 of the Hungarian Intellectual Property Office kept with the Hungarian State Treasury by bank transfer or money order, with the indication of data for identification (reference number or the registration number) and destination.

Hungarian Intellectual Property Office

The procedure for reviewing the decisions of the HIPO falls within the competence and exclusive jurisdiction of the Budapest-Capital Regional Court. Review of a decision may be requested by any party to the procedures before the HIPO, any person excluded from, or limited in, the inspection of files or any person whose legal status as a party to the procedure has been denied. Other participants in the proceedings before the HIPO may, in their own right, file an independent request for review against the relevant provision of the decision or the decision concerning them. The deadline for submitting a request for reviewing the decision is 30 days from the date of notification of the decision to the party or other party to the proceedings. The request shall be filed with the HIPO, but it shall be addressed to the Budapest-Capital Regional Court. A fee of HUF 10,500 must be paid when filing the request, in the case of electronic submission by bank transfer.

In the absence of a provision of an international treaty to the contrary, foreign applicants shall be represented by an authorised patent attorney or an attorney-at-law in all patent matters.

This provision shall not apply if the foreigner is a natural person or a legal entity whose permanent residence or domicile is in the territory of a Member State of the European Economic Area.

Please also be advised that the language of proceedings before the HIPO is Hungarian.

Further information is available at https://www.sztnh.gov.hu/en/client-service

Act XXXIII of 1995 on the protection of inventions by patents

Decree No. 19/2005. (IV. 12.) GKM on the fees for administrative services in industrial property procedures before the Hungarian Patent Office

Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems

SZTNH