bolar exemption

Bolar exemption is a limitation to patent rights that allows third parties to use a patented invention for activities reasonably related to obtaining regulatory approval for pharmaceutical, biological, or similar products before the patent expires.

The purpose of the Bolar exemption is to enable generic and biosimilar manufacturers to complete the testing, studies, and regulatory procedures necessary for market authorization while the patent is still in force. Without such an exception, competitors would generally have to wait until patent expiry before beginning regulatory approval activities, delaying market entry.

The scope of the Bolar exemption varies among jurisdictions but typically covers experiments, trials, testing, and the submission of information to regulatory authorities. Commercial manufacture and marketing activities beyond those necessary for regulatory approval generally remain outside the exemption and may constitute patent infringement.

In Türkiye, the Bolar exemption is recognized under the Turkish Industrial Property Code and permits activities related to obtaining authorization for pharmaceuticals and other products requiring regulatory approval. Similar provisions exist in the European Union, the United States, and many other jurisdictions.

The Bolar exemption plays an important role in balancing patent protection with public access to medicines by facilitating the timely entry of generic and biosimilar products after patent expiry.