On March 4, 2021, the Intellectual Property Committee and the Pharmaceutical Law Committee of the Ukrainian Bar Association held an online meeting «Ukrainian Bolar and SPC». Victoria Sopilnyak, partner of Doubinsky & Osharova with an extensive experience of protection of intellectual property rights of pharmaceutical companies, participated in the discussion.
Victoria shared her opinion on the following subjects:
- what is the Bolar exemption in the realities of the Ukrainian legislation?
- whether it is possible in the context of Bolar exemption to advertise for future sales medicines, based on a patented active pharmaceutical ingredient (API)?
- what is the active pharmaceutical ingredient and does its amount matter when implementing the Bolar exemption?
- how to prove the existence of a purpose “for research / use in research”?
- who are the third-party API providers?
- what are the consequences of further non-registration of the medicine?
- what does the international practice of implementation of Bolar indicates?