Bolar exemption: patent exemption for development work

Article 10(6) of Directive 2001/83/EC, inserted by Directive 2004/27/EC, provides that conducting the necessary studies and trials with a view to applying for a generic, hybrid or biosimilar authorisation under Article 10(1) to (4), and the consequential practical requirements, is not regarded as contrary to patent rights or to supplementary protection certificates. The name comes from the US case Roche v Bolar, which led to the equivalent safe harbour in the Hatch-Waxman Act. Without the exemption, bioequivalence studies, pilot batches and stability work would infringe the originator's patent, and generic entry would be delayed by the time those studies take.

The exemption is implemented in national patent law, and Member States have transposed it with different breadth. Some, including Germany, cover any study or trial needed for a marketing authorisation anywhere in the world and for any type of application; others limit it to studies for EU abridged applications. Whether supply of active substance by a third party to the developer, or trials run to support pricing and reimbursement, fall within the exemption has been litigated with different outcomes, which is why the pharma package addresses it. Acts not covered, such as manufacturing commercial stock before expiry, remain infringements unless the SPC manufacturing waiver under Regulation (EU) 2019/933 applies.

Practically, the exemption matters for planning the generic timeline. Data exclusivity sets the earliest filing date; the exemption lets development start before then; the authorisation can be granted before patent and SPC expiry; and launch waits for the later of market protection and patent or SPC expiry. Companies document which activities were performed under the exemption and where, because an originator seeking an injunction will ask.

What goes wrong: development batches are made in a Member State with a narrow exemption and the originator sues there; a contract manufacturer supplying API assumes the developer's exemption covers its own acts; and a company relies on the exemption for validation batches that are later sold, which no national version permits.

Under the new pharma package (not yet in force), the exemption is widened to cover studies, trials and other activities needed for applications for marketing authorisation, pricing and reimbursement and health technology assessment, and to the suppliers and contractors of the applicant, replacing the patchwork of national scope; see exclusivity changes.