Good day! Now I will briefly tell you about the changes to the legislation regarding the implementation of the Bolar provision.
1. **Essence of the law:** The law aims to bring Ukrainian legislation in line with international standards in the field of intellectual property rights protection for medicinal products, in particular, the implementation of the so-called Bolar provision. This provision allows the use of patented inventions for research necessary for the registration of generic medicinal products without the consent of the patent owner, which promotes competition and access to medicines. The law also defines the consequences of intellectual property rights infringement in the circulation of medicinal products, including the possibility of cancellation of state registration of medicines by a court decision.
2. **Structure and main provisions:** The law amends three main laws of Ukraine: “On Medicinal Products” and “On Protection of Rights to Inventions and Utility Models”. The changes concern the procedure of state registration of medicinal products, the rights of patent owners to inventions, and the responsibility for violation of these rights. Key changes include:
* Clarification of the grounds for cancellation of state registration of a medicinal product in case of intellectual property rights infringement.
* The use of patented inventions for research for the purpose of drug registration (Bolar provision) is allowed.
* The obligation to inform patent owners of the intention to submit documents for registration of a medicinal product using their invention is established.
* Liability for infringement of the rights of patent owners for medicinal products is increased, including an increase in the amount of fines.
3. **Key provisions for use:** The most important provisions are those relating to the possibility of conducting research for the registration of generics without the patent holder’s consent (Bolar provision), as well as the provisions on liability for intellectual property rights infringement. Pharmaceutical companies planning to market generic medicinal products should take these changes into account when planning their research and registration procedures. Patent owners should be prepared to receive notifications of intentions to register medicines using their inventions and take steps to protect their rights in case of infringement.
