- How is Bolar implemented?
- How does the Bolar provision work?
- Is Bolar restricted to exempting studies for generic marketing authorisations?
- Has Bolar been litigated in your jurisdiction?
- Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought?
- Does Bolar extend to a third party who assists the MAH in carrying out the activities?
jurisdiction
1. How is Bolar implemented?
Russian law does not expressly provide for the Bolar provision. However, there are some general provisions which are close to the idea of a Bolar exemption.
According to Paragraph 2 of Article 1359 of the Civil Code of the Russian Federation, carrying out scientific studies on a patented product or method, is not deemed a patent infringement.
Nevertheless, in absence of an explicit Bolar provision, courts interpret applicable legislative provisions differently in practice and follow various approaches in respect of disputes on medicine-related patents.
2. How does the Bolar provision work?
In 2009, the Supreme Commercial Arbitration Court made a landmark ruling (case No. А40-65668/08-27-569), in which pre-authorisation activity and marketing authorisation of medicine were not qualified as a patent infringement. Among others, the court substantiated its conclusions by the fact that it was beneficial for patients and ensured their access to medicines.
This position had been dominating in court practice for many years until recently it was changed. In several recent cases (see, for example, case No. А41-85807/2016, case No. А40-106405/2018), the courts have recognised certain activities aimed to marketing of medicines as a patent infringement or, at least, as a threat of patent infringement. Such activities include marketing authorisation and (or) registration of price for medicine (required for medicines included into the essential drug list as a pre-requisite for sales). Moreover, in one of the cases the court stated that a whole chain of actions, including development of medicine, conducting bioequivalence studies, marketing authorisation and price registration evidences the intention of wrongdoer to release the medicine in the market. Consequently, it may be qualified as a threat of patent infringement.
Therefore, there are some new trends in the courts’ attitude to allowable pre-marketing activities. Nevertheless, the final decision of the court still may vary depending on circumstances of a particular case until the Bolar provision is clearly implemented in the Russian law.
3. Is Bolar restricted to exempting studies for generic marketing authorisations?
In lack of clear regulation, allowability of studies are separately reviewed by courts on a case-by-case basis.
4. Has Bolar been litigated in your jurisdiction?
Bolar-like exemptions are assessed by Russian courts regularly. Please see the question “How does the Bolar provision work” above.
5. Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought?
This issue is not directly regulated by Russian laws. Thus, it shall be assessed by courts on a case by-case basis.
6. Does Bolar extend to a third party who assists the MAH in carrying out the activities?
This issue is not directly regulated by Russian laws. Thus, it shall be assessed by courts on a case by-case basis.
