Compulsory licensing in Bulgaria

Compulsory licensing refers to the legal mechanism that the Bulgarian Patent Office authorises others to implement a patent without the permission of the patent holder according to the law under certain circumstances.

• Patents and Utility Models Registration Act (1993) (“PUMRA”);
• Ordinance for consideration of disputes under the Patents Act and registration of utility models. (2011) (“Ordinance”)

Compulsory licensing applies to any invention patent and utility model patent, varieties of plants.

• Any interested person or patent owner has a right to submit a request for granting or termination of a compulsory licence. The exception is that a compulsory licence shall not be granted in favour of the infringer of the patent.
• Bilateral and multilateral agreements to which the Republic of Bulgaria is a party may provide for other conditions for granting a compulsory licence for patent holders by the states participating in such agreements.

• Under any of the following circumstances, the Bulgarian Patent Office, based on the application of any entity or individual that is qualified to exploit an invention patent or utility model patent, grants a compulsory licence to any such entity or individual:
  • Where the invention has not been used for four years from the filing of the patent application or for three years from the grant of the patent, whichever is the later;
  • Within the terms under item a., the invention has not been used to a sufficient extent to satisfy the national market, unless the holder proves a valid reason.
  • The applicant under the preceding paragraph must prove that he is able to use the invention within the framework of the requested compulsory licence.
• A compulsory licence may be granted in favour of a holder whose invention is the subject of a later patent and falls within the scope of an earlier patent, and the holder of the earlier patent refuses to grant a licence on fair terms. This could be done where the invention, which is the subject of the later patent, constitutes important technical progress of substantial economic importance compared to the invention, which is the subject of the earlier patent. The holder of the earlier patent is entitled to a cross-licence under reasonable conditions for the use of the invention claimed in the later patent.

6.1 Any negotiation required between the applicant and the right holder before applying for a compulsory licence? 

It depends. A negotiation is required if the compulsory licensing is based on:

• the patentee’s failure to exploit or fully exploit the patent without any legitimate reason within three years as of the date on which the patent right is granted and within four years as of the date of filing the application for a patent; or
• the exploitation of the later invention or utility model where the later patent represents a major technological advancement of remarkable economic significance compared with an earlier patent, and the exploitation of the later patent is directly dependent upon the exploitation of the earlier patent.

6.2 Any urgent situation required in order to grant a compulsory licence?

No, but if public interest requires it, the Patent Office may grant a compulsory licence to exploit the patent for an invention or utility model without negotiating with the holder of the patent-protected invention.

6.3 Any minimum number of years required for the patent to be granted and/or implemented in order to be subject to compulsory licensing?

It depends. For compulsory licensing based on an insufficient degree of exploitation to satisfy the national market, the patent has to be granted four years as of the date of filing the application for the patent.

No.

Yes. The scope of the compulsory licence shall be determined by the purpose for which it was granted.

Bulgarian Patent Office.

The request for granting or termination of a compulsory licence shall be submitted in writing in Bulgarian, accompanied by a document for the paid fee, and with a power of attorney, when submitted through a representative. The request for granting a compulsory licence must be accompanied by evidence in support of the stated circumstances, as well as by evidence that the applicant is able to use the invention within the framework of the requested compulsory licence.

10.1 What materials need to be submitted to the competent authority?

The following materials need to be submitted to the Patent Office: 

• name and address of the applicant;
• identification data (number and name) of the patent, for which the granting or termination of a compulsory licence is requested, as well as the name of the patent owner when he is not an applicant;
• name and address of the representative when the request is submitted through a representative;
• the legal interest of the applicant;
• motives;
• signature of the applicant and seal when the applicant is a sole trader or a legal entity.

10.2 How long will it take to get a compulsory licence?

The Disputes department is responsible for considering requests for the granting and termination of a compulsory licence. It has nine months from the collection of all evidence in the dispute to decide on whether to grant a compulsory licence.

Yes. Hearings are not required in the event a request for a compulsory licence is to be granted in the following circumstances:

• for the public interest;
• to a proprietor of a patent whose invention is the subject of a later patent and within the extent of another earlier patent, in a case where the invention that is the subject of the later patent constitutes important technical progress of essential economic significance.

Yes. The compulsory licence shall be terminated:

• under all circumstances if within two years of its granting the licensee has not begun to use the invention.
• when the grounds for it cease to exist.

12.1 What are the conditions for the revocation/termination of a compulsory licence? 

The compulsory licence may be terminated if the licensee, within one year of its granting, has not commenced preparation for the use of the invention.

12.2 How should products made under a compulsory licence be treated if the compulsory licence is terminated/revoked?

No specific provisions exist in the law.

Yes.

13.1 If the compulsory licensee is required to pay a royalty, how is the amount of royalty determined and who will decide the amount of the royalty?

It is not explicitly provided for in the law. However, the royalty should be market-based and agreed between the patent holder and the patent owner. In case of dispute, the royalty shall be determined by the Sofia City Court.

Yes. The interested persons can submit an appeal to the Disputes Department within three months from the receipt of the decision regarding the compulsory licensing, and a document for a paid fee should be attached to it.

The present law does not address this point. 

The present law does not address this point. 

16.1 If the compulsory licensee discloses the confidential information in violation of its obligation, does the right holder have a basis of claim against the compulsory licensee? 

The present patent law does not address this point, but the provisions of the Trade Secret Law should be taken into account, if applicable. 

Yes. For the purpose of public health, an entity satisfying the conditions for patent exploitation may request a compulsory licence for the manufacture of a generic medicine exported to:

• the world's least developed countries;
• those that have informed the World Trade Organization of their intention to do so;
• those listed in the OECD development assistance committee list of low-income countries.

17.1 If the compulsory licensee is permitted to export products under the compulsory licence, are there any requirements and limitations on the export of such products?

Yes. The following requirements will be specified in the compulsory licence-granting decision by the Patent Office:

• The amount of product manufactured under the licence shall not exceed what is necessary to meet the needs of the importing country or countries cited in the application, taking into account the amount of product manufactured under other compulsory licences granted elsewhere.
• The duration of the licence shall be indicated.
• The licence shall be strictly limited to all acts necessary for the purpose of manufacturing the product in question for export and distribution in the country or countries cited in the application. No product made or imported under the compulsory licence shall be offered for sale or put on the market in any country other than that cited in the application.
• Products made under the licence shall be clearly identified through specific labelling or marking as manufactured under a compulsory licence.
• The products shall be distinguished from those made by the rights-holder through special packaging and/or special colouring/shaping, provided that such distinction is feasible and does not have a significant impact on price.
• The packaging and any associated literature shall bear an indication that the product is subject to a compulsory licence, giving the name of the competent authority and any identifying reference number, and specifying clearly that the product is exclusively for export to and distribution in the importing country or countries concerned.
• Details of the product characteristics shall be made available to the customs authorities of the member states.
• Before shipment to the importing country or countries, the licensee shall post on a website, communicated to the competent authority, the following information:
  • the quantities being supplied under the licence and the importing countries to which they are supplied;
  • the distinguishing features of the product or products concerned.

No.

Yes, any person may apply to the Patent Office if the conditions for granting a compulsory licence, set out in Question 5, have been complied with.

No.

Yes. It may be transferred only together with the undertaking in which the invention is the subject of such a licence.

The present law does not address this point. However, compulsory licensing may only be non-exclusive, so the granting of it may not affect previously agreed upon non-exclusive licences by default.

Yes, primarily for pharmaceutical drugs. Specific labels or marks shall be indicated on the drugs manufactured under a compulsory licence clearly indicating that they are manufactured according to the compulsory licence; and the drugs shall be distinguished from those made by the rights-holder through special packaging and/or special colouring/shaping, provided that such distinction is feasible and does not have a significant impact on price.

Yes. At least for drugs produced under the compulsory licence, the distribution channel should be published on the relevant website of WTO.

The patented pharmaceutical product, which is imported to Bulgaria under the licence, shall not be exported from Bulgaria.

Not specified.