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North Macedonia

European Bolar Provisions in North Macedonia

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? 
North Macedonia
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1. How is Bolar implemented?

North Macedonia is a state-party to the World Trade Organization (“WTO”) TRIPs Agreement since 2003. The relevant industrial property institution is the State Office of Industrial Property (“SOIP”).
The relevant Law on Industrial Property  (“Law on IP”), was adopted in 2009 and has been amended numerous times. 
Article 91 of such Law on IP (Free use) regulate the exemptions from the rights of the patent holders, as follows:

  1. use of the invention for personal and non-commercial purposes;
  2. research and development activities, including obtaining market authorization for medications (human and veterinary) and plant protection products, in particular: 
    1. manufacture; 
    2. use;
    3. offer for sale; or
    4. export or import of the protected invention.
  3. direct and individual preparation of a medicine in a pharmacy, on the basis on single medical recipe.

2. How does the Bolar provision work?

Pursuant to the aforementioned legal provisions, the research and development activities (including obtaining market authorisation) for medications and plants protection products are exempted from patent protection. 
According to the relevant Law on IP, a medical product is any substance or combination of substances in pharmaceutical dosage for the purpose of treatment, diagnosing, or prevention of diseases i.e. for the purpose of prevention, improvement, or modification of physiological functions of people and animals.
On the other hand, the plant protection products are active substances and preparations that contain one or more active substances in the form in which they are delivered to the user, with intention to protect plants or plant products against harmful organisms or hinder the effects of such organisms, unless such substances or preparations: 

  1. impact the life process of the plants, without showing characteristics of a nutritive component (for example, regulators of the growth of plants); 
  2. protect the plant products; 
  3. exterminate undesired plants; or 
  4. exterminate part of plants, limit or prevent the undesired growth of plants.

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

There is a lack of clear regulation in this manner, so it would probably be reviewed by the courts on a case-by-case basis.

4. Has Bolar been litigated in your jurisdiction?

There is no publicly available data for a litigation procedure based on Bolar provisions in North Macedonia. 

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

The Bolar exemption in North Macedonia does not define in which country regulatory approval should be ultimately sought. 

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

The Law on IP does not stipulate more specific clauses other than provisions mentioned above.