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Bulgaria

European Bolar Provisions in Bulgaria

Table of contents
  1.  How is Bolar implemented?
  2.  How does the Bolar provision work?
  3.  Is Bolar restricted to exempting studies for generic marketing authorisations?
  4.  Has Bolar been litigated in your jurisdiction?
  5.  Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 
  6.  Does Bolar extend to a third party who assists the MAH in carrying out the activities? 
Bulgaria
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1. How is Bolar implemented?

The Bolar exemption has been implemented in Bulgaria through provisions in the Medicinal Products in Human Medicine Act, promulgated in State Gazette Issue 31, dated 13 April 2007, as amended (“MPHMA”).

2. How does the Bolar provision work?

Article 33 of the MPHMA provides that conducting the necessary studies and trials for the purpose of preparing documentation for marketing authorisation and the consequential practical requirements, in respect of generic medicinal products and other medicinal products which are not bioequivalent or similar shall not be considered an infringement of the patent or the supplementary protection certificate for a medicinal product. Thus, the Bulgarian Bolar provision exempts only studies and trials that are strictly necessary, not merely useful, or recommendable. 

Except the Bolar exemption for medicinal products, under Bulgarian law there is a broader exemption for use of an invention for experimental or research purposes. Article 20 of the Patents and Registration of Utility Models Act, promulgated in State Gazette Issue 27, dated 2 April 1993, as amended (“PRUMA”) provides that protection granted by the patent shall not cover use of the invention for experimental or research purposes related to the subject matter of the patented invention. In addition, single and direct preparation of a medicine in a pharmacy upon a doctor’s prescription does not constitute a patent infringement. 

3. Is Bolar restricted to exempting studies for generic marketing authorisations?

Bolar is not restricted to exempting studies for generic marketing authorisations. 

The Bolar provision also covers pre-clinical and clinical trials when the medicinal product: i) cannot be defined as generic; or ii) the bioavailability tests do not demonstrate bioequivalence; or iii) there is a change in the active substance or substances in the quantity of the active substance or substances in dosage unit, of the therapeutic indications, of the medicinal form, or route of administration in relation to the reference medicinal product. Additionally, trials relating to a biological medicinal product which is similar to a reference medicinal product, but does not meet the conditions to be designated as a generic medicinal product due to a different manufacturing method or different raw materials or due to other reasons, would also be covered by the exemption. 

Thus, the Bolar provision will also cover trials in relation to innovative medicinal products. 

4. Has Bolar been litigated in your jurisdiction?

There is no case law on the Bolar provision at present. 

5. Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 

The exempted activities will be covered by the Bolar provision if the marketing authorisation is sought from a regulator in another EU or EEA member state. The provision would not exempt studies and trials related to a marketing authorisation application in non-EU/EEA countries. 

6. Does Bolar extend to a third party who assists the MAH in carrying out the activities? 

Given the absence of an express provision and case law, it is unclear whether Bolar extends in Bulgaria to a third party who assists the MAH in carrying out the exempted studies.