Bolar Rule (Bolar Exemption)

We have already posted about the Bolar Rule. But once again, more clearly — because you’re asking.
There is no law specifically on the Bolar Rule. There are amendments to various laws and by-laws.

So, details and comment:

💊 Registration of generics BEFORE patent expiration — is allowed!

The use of a patented invention for the purpose of state registration of a medicinal product is not considered a violation of the rights of the patent or SPC holder.

🔓 This means:

Companies may prepare and submit documents for the registration of generic medicines before the expiration of a patent or SPC — under specific conditions.

📌 Permitted actions:

• filing an application for state registration of a medicinal product;
• submitting materials for expert review;
• application review, inclusion in the State Register;
• obtaining a registration certificate.

📬 Condition:

No later than 80 days before submitting the documents, the applicant must send written notice to the patent/SPC holder (to the address listed in the Register).

📖 Law of Ukraine, Art. 31 (clauses 5, 7 in the new edition)

These norms create a clear and transparent mechanism for the generics market in Ukraine — without violating the rights of originators.

❗❗It doesn’t matter how long before patent expiration — registration of medicinal products is not considered a patent infringement.