European Bolar Provisions in Ukraine

It is implemented by the Law of Ukraine “On Elimination of Artificial Bureaucratic Barriers and Corruption Factors in the Sphere of Healthcare” (“Law”), which entered into force on 5 July 2020. The Law introduced Bolar related amendments to the Law “On Protection of Rights for Inventions and Utility Models” (“Patents Law”).

The Law supplements Article 31 of Patents Law with new Section 5, which lists the types of activities that do not constitute infringements of patent holders’ rights: 

• import of goods manufactured using the invention (utility model) for conducting studies (trials) required for the purpose of preparing and submitting regulatory information for marketing authorisation of a medicinal product, and
• using the invention (utility model) in studies (trials) conducted for the purpose of preparing and submitting regulatory information for marketing authorisation of a medicinal product. 

As of today, the Bolar provision is incorporated in the law in a very general and broad manner and is not detailed in the subordinate legislation. This factor combined with novelty of the provision leaves room for its interpretation.

No. The Law does not refer to the type of application/marketing authorisation. Thus, theoretically import of a patented product and its use in the studies conducted for the purpose of preparing and submitting regulatory information for marketing authorisation of another original medicinal product fall under the domestic version of the Bolar provision. 

At the same time, the complete lack of any judicial practice leaves a significant room for possible future interpretations.

Considering the novelty of the Bolar provision in Ukraine, it has never been litigated.

Before its introduction, to import patented products for conducting of studies, some of the Ukrainian generic manufacturers tended to rely on another exemption in the Patents Law, which permits use of patented inventions (or utility models) “for scientific purposes or for carrying out experiments”. This approach, however, was on numerous occasions successfully challenged by patent holders. At that time, Ukrainian courts predominantly considered commencement of any preparations for market entry of a generic product as an infringement of the patent holder’s rights. Thus, any import of patented products by generic manufacturers was viewed as a preparation for commercialisation, not as the “use for scientific purposes”. 

Generally, yes. The Law links the permittable use of the inventions (utility models) to the regulatory purpose, and not to actual commencement of regulatory procedures. Thus, theoretically either failed, or stopped studies initially launched for the regulatory purpose, still meet the criterion of a permittable activity.

Moreover, the Bolar provision is worded in a manner, which allows its broad interpretation, covering use of patented products even in the studies conducted for the purpose of preparing and submitting regulatory information for marketing authorisation in other jurisdictions than Ukraine. 

At the same time, the complete lack of any judicial practice leaves a significant room for possible future interpretations.

The Law does not restrict the application of the Bolar provision to studies conducted solely by the MAH. Therefore, in our opinion third parties such as CROs, SMOs or study sites can also benefit from Bolar provision, as long as the activities conducted by them are clearly linked to the permittable regulatory purpose.