The Bolar exemption was originally conceived as a limited mechanism enabling generic and biosimilar manufacturers to complete the regulatory steps necessary to enter the market immediately after patent expiry. The EU Pharma Package now seeks to broaden the exemption substantially, both in terms of the activities covered and the parties entitled to rely on it. This development invites a re-examination of Türkiye’s long-standing – and already notably broad – interpretation of the Bolar exemption.
Significantly, despite its breadth, the Turkish approach has not extended the Bolar safe harbour to conduct amounting to an ‘offer for sale’. The issue becomes even more compelling when considered alongside the WTO’s interpretation of the TRIPS Agreement, which suggests that extending the exemption to commercial conduct such as offers for sale and participation in public tenders may not be compatible with TRIPS.
The EU Pharma Package’s expanded Bolar exemption
Proposed Article 85 of the revised EU Pharmaceutical Directive moves well beyond conventional regulatory studies. It covers health technology assessments, pricing and reimbursement procedures, subsequent practical requirements related to those procedures, and applications to participate in public procurement procedures. Activities conducted exclusively for those purposes may include the manufacture, offer, sale, supply, storage, importation, use, and purchase of patented medicinal products, as well as the use of patented processes.
The provision expressly extends to activities carried out by third-party suppliers and service providers.
Türkiye’s approach to regulatory and commercial activities
Türkiye offers a useful preview of the consequences of an expansive Bolar exemption because Turkish intellectual property (IP) courts have interpreted the exemption broadly almost from the outset. In practice, the exemption has extended beyond the technical preparation of a marketing authorisation dossier to include pricing, sales permission, and reimbursement-related steps necessary to complete the pre-launch regulatory pathway. Turkish courts have generally been reluctant to regard a marketing authorisation, approved price, or comparable administrative status, without more, as evidence of an imminent infringing launch.
Nevertheless, even this permissive approach has recognised a boundary. Turkish IP courts have treated a generic manufacturer’s application for inclusion in the reimbursement system administered by the Social Security Institution as capable of constituting an offer for sale and, therefore, as falling outside the Bolar exemption. This approach reflects the commercial reality of the Turkish pharmaceutical market: approximately 95% of medicines are supplied through the reimbursement channel. An application for reimbursement is therefore directed towards gaining access to the dominant purchasing and payment channel for prescription medicines and determining the commercial conditions under which the product will be supplied.
This reasoning applies with even greater force to public procurement. A tender bid will ordinarily identify the product, quantity, price, delivery terms, and supply period. The purpose of the generic company submitting the bid is to secure a supply contract – not to complete a regulatory requirement.
TRIPS limits and final thoughts
The WTO Panel’s decision in Canada – Patent Protection of Pharmaceutical Products provides the essential benchmark. In assessing the European Communities’ claim that Canada’s regulatory review exemption infringed the TRIPS Agreement, the panel held that Section 55.2(1) of the Canadian Patent Act was compatible with Article 30 because it satisfied each of that provision’s three cumulative conditions:
The exception was limited;
It did not unreasonably conflict with the normal exploitation of the patent; and
It did not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.
The panel thus established that a Bolar exemption may be justified under Article 30, only where all three conditions are fulfilled.
The distinction between regulatory preparation and commercial preparation provides a basis for assessing the broader exemption proposed under Article 85. A binding tender bid capable of acceptance is not a technical or regulatory step serving the preparation of a marketing authorisation dossier. It is an act directed towards securing future demand and obtaining a commercial contract. It may therefore produce immediate competitive consequences while the patent or supplementary protection certificate remains in force, even where delivery is scheduled to take place only after expiry.
The WTO Panel’s reasoning supports the conclusion that extending the Bolar exemption to such commercially oriented conduct may fail to satisfy Article 30’s cumulative requirements. Such an extension may cease to constitute a limited exception, unreasonably conflict with the normal exploitation of the patent, and unreasonably prejudice the patent owner’s legitimate interests.
The approach proposed under the EU Pharma Package conflicts with what may be regarded as the established approach of national and regional courts. Indeed, as recently as August 13 2025, the UPC Court of Appeal held in Boehringer Ingelheim v Zentiva (UPC_CoA_446/2025 and UPC_CoA_520/2025) that participation in a public procurement procedure during the patent term may constitute an offer, even where the procedure is still at the pre-contractual stage.
Türkiye’s experience also demonstrates that broad Bolar protection and meaningful patent enforcement can coexist. The treatment of a reimbursement application as an offer for sale falling outside the exemption reflects the actual structure of the pharmaceutical market. By contrast, an exemption that permits a competitor to manufacture commercial quantities, negotiate prices and volumes, secure future demand, and compete for public contracts before patent expiry cannot readily be characterised as ‘limited’ or as avoiding unreasonable prejudice to the patent owner’s legitimate interests.
