EU Pharma Package Expands Bolar Exemption: Insights from Türkiye and TRIPS Compliance Challenges

The Bolar exemption was initially conceived as a narrowly tailored legal mechanism enabling generic and biosimilar manufacturers to undertake necessary regulatory activities to enter the market immediately after patent expiry. Traditionally, this exemption covered only the technical steps required for regulatory approval, ensuring no patent infringement during preparatory work.

However, the European Union’s proposed revision under the EU Pharma Package seeks to substantially broaden the scope of the Bolar exemption. Proposed Article 85 of the revised EU Pharmaceutical Directive extends the exemption beyond conventional regulatory studies to include health technology assessments, pricing and reimbursement procedures, and applications to participate in public procurement processes. The exemption would cover activities such as manufacture, offer, sale, supply, storage, importation, use, and purchase of patented medicinal products, as well as the use of patented processes, even when conducted by third-party suppliers and service providers.

This expansive approach invites a re-examination of Türkiye’s established interpretation of the Bolar exemption, which has been notably broad since its inception. Turkish intellectual property courts have allowed the exemption to encompass not only the preparation of marketing authorisation dossiers but also pricing, sales permission, and reimbursement-related steps necessary for pre-launch regulatory compliance.

Despite this broad interpretation, Turkish courts have drawn a clear boundary by excluding conduct amounting to an ‘offer for sale’ from the exemption. Specifically, a generic manufacturer’s application for inclusion in the reimbursement system administered by the Social Security Institution is treated as a potential offer for sale, thus falling outside the Bolar safe harbour. This distinction reflects the commercial reality in Türkiye, where approximately 95% of medicines are supplied through the reimbursement channel. An application for reimbursement effectively seeks access to the dominant purchasing and payment system for prescription medicines and determines the commercial conditions for supply.

The same reasoning applies with even greater force to public procurement procedures. Tender bids typically specify product details, quantities, prices, delivery terms, and supply periods. The purpose of submitting such bids is to secure supply contracts, which are commercial objectives rather than regulatory requirements.

The World Trade Organization (WTO) Panel’s decision in Canada – Patent Protection of Pharmaceutical Products provides a critical benchmark for assessing the compatibility of such exemptions with the TRIPS Agreement. The panel upheld Canada’s regulatory review exemption under Section 55.2(1) of the Canadian Patent Act, finding it consistent with Article 30 of TRIPS because it met three cumulative conditions: it was limited, did not unreasonably prejudice the patent owner’s legitimate interests, and took into account the interests of third parties.

This ruling underscores that a Bolar exemption must remain a limited exception and cannot extend to commercial activities that may unreasonably prejudice patent holders. Extending the exemption to encompass commercial conduct such as offers for sale and participation in public tenders risks violating these conditions.

The distinction between regulatory preparation and commercial preparation is thus crucial. A binding tender bid, capable of acceptance, is not a technical or regulatory step but a commercial act aimed at securing future demand and contracts. Such conduct may produce immediate competitive effects while the patent or supplementary protection certificate remains in force, even if delivery occurs post-expiry.

The EU Pharma Package’s proposed broadening of the Bolar exemption conflicts with established national and regional court approaches. For instance, the Unified Patent Court (UPC) Court of Appeal recently 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 at the pre-contractual stage.

Türkiye’s experience demonstrates that broad Bolar exemptions and effective patent enforcement can coexist. The exclusion of reimbursement applications from the exemption reflects the pharmaceutical market’s structure and balances patent rights with market access. Conversely, an exemption permitting competitors to manufacture commercial quantities, negotiate prices and volumes, secure future demand, and compete for public contracts before patent expiry cannot be considered limited or free from unreasonable prejudice to patent owners.

In conclusion, while the EU Pharma Package aims to facilitate market entry and competition, its expansive Bolar exemption raises significant legal and policy challenges. Careful calibration is required to ensure compliance with TRIPS obligations and to maintain the delicate balance between encouraging generic competition and protecting patent holders’ legitimate interests.

This article provides a general overview and should not substitute for specialist legal advice tailored to specific circumstances.