The Council and Parliament agree on the EU Pharma Package: dilution of enforcement rights in the UPC arising from the expanded Bolar exemption?

Background

We previously set out the background and genesis of the proposed regulatory provisions of the "Proposal for a Directive of the European Parliament and of the Council on the Union Code concerning medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC," dated 26 April 2023 (COM(2023) 192 final, 2023/0132, (the “EU Pharma Package”) here. The future of the EU Pharma Package is now certain, with the European Council and Parliament reaching agreement on 11 December 2025 after two years of negotiations.1One aspect of note is the extension of the Bolar exemption. 

Back in the Summer, the UPC’s Court of Appeal (CoA) issued a decision which offered guidance regarding the test for imminent injunctions when seeking preliminary injunction (PIs) (Art.62(1) and (4) UPCA). Boehringer Ingelheim International GmBH (BI) obtained a PI against Zentiva Portugal, LDA (Zentiva) following the completion of national pricing procedures on the basis that the only thing preventing Zentiva from placing its infringing generic product on the market was its “self-restraint”. Further details of this judgment can be found in our Irides update, here.  One interesting argument made by Zentiva was for the CoA to interpret “imminent infringement” in light of the EU Pharma Package, given that the existing Bolar exemption is incorporated via Art. 27(d) UPCA, which references Art. 10(6) of Directive 2001/83/EC, as amended.

Once the UPCA is amended to refer to the agreed EU Pharma Package, the Bolar Exemption will be expanded from its current form (exempting clinical trials and the preparation of regulatory dossiers from infringing patent rights/SPCs), to also include pricing and reimbursement procedures. This will have significant implications for both originators and generics/biosimilars, including, as foreshadowed by the arguments made by Zentiva in the UPC, in what could amount to “imminent infringement” for the purpose of obtaining a preliminary injunction in the UPC.

Art. 85: The Extended Bolar Exemption

Assuming the text of the Regulation is unchanged, the proposed text for Art. 85 exempts parties from infringing patent rights or the SPCs of medicinal products when they are conducting the necessary studies, trials and other activities for the purpose of:

(a)   obtaining a marketing authorisation of medicinal products, in particular of generics, hybrid or bio-hybrid medicinal products and for subsequent variations;

(b)   conducting health technology assessment as defined in Regulation (EU) 2021/2282;

(c)    obtaining pricing and reimbursement approval;

(d)   complying with subsequent practical requirements associated with the activities referred to in points (a) – (c); and

(e)   submitting an application on procurement tenders in compliance with Union and national law, to the extent that it does not entail the sale of offering for sale or marketing of the medicinal product concerned during the protection period provided by patent rights or SPCs.

Importantly, it covers any potential infringement for the offer, manufacture, sale, supply, storage, import, use and purchase of medicinal products or processes, including by third parties suppliers and service providers.

Recital 65 stresses that “…the protection of intellectual property rights does not represent a valid ground to refuse or suspend decisions related to relevant pricing and reimbursement, health technology assessment procedures, or where applicable, application for procurement tenders.”

The consequence of this provision means that generics and biosimilars will be able to participate in national tenders and other pricing procedures, such as those conducted by Zentiva, prior to the expiry of the patent providing that actual sale only happens after patent/SPC expiry. It could mean that even if these procedures are initiated by a party earlier than would be necessary to enter onto the market on day 1, an originator may not be able to obtain a preliminary injunction like BI did in this case.

The EU Pharma Package does still stress in recital 63 that there should be no commercial use of the resulting final medical products “…including the sale and offering for sale of such products also with regards to procurement tenders” and that “Member States remain free to introduce rules to ensure the readiness to supply a medical product on the market of that Member State for the period when the patent and SPC have expired” (recital 65).

Comment

The EU Pharma Package and the expansion of the Bolar Exemption will be welcomed news for generic and biosimilars, as well as third parties involved in the supply chain. The SPC Manufacturing Waiver already permits third parties to manufacture in the EU during the term of the SPC for export outside the EU and to prepare for post-expiry launch within the EU. This, along with the extended Bolar Exemption, will be important tools for enabling generic and biosimilar day 1 launch, without the delay otherwise caused by administrative and regulatory steps to place the medicinal products on the market, import delays and with a lower threat of being injuncted across UPC territories.

For originators,  the expanded Bolar Exemption may make it more difficult to obtain a preliminary injunction in the UPC, as completing national regulatory procedures for pricing and reimbursement alone will arguably not amount to an imminent risk of infringement. Moreover, the fact that parties will be able to participate in tenders ahead of patent/SPC expiry may lead to competition for lower prices despite the monopoly held by the originator. It will be interesting to see how the UPC develops the test for imminent risk of infringement once the EU Pharma Package becomes law. If obtaining marketing authorisation, completing national pricing procedures or entering into tenders is covered by the Bolar Exemption, what actions will amount to an imminent risk of infringement? Monitoring the activities of generics and biosimilars will become all the more necessary for originators in their life cycle management strategies to ensure that generics/biosimilars go no further than necessary to complete these procedures. Saisie orders, issued under R.192 RoP, including an order for inspection, are already being utilised in the UPC, but may become all the more important for originators to demonstrate that there is an imminent risk of infringement, particularly where a generic/biosimilar is going beyond the activities covered by the extended Bolar Exemption.

• 1Press release, “‘Pharma package’: Council and Parliament reach a deal on new rules for a fairer and more competitive EU pharmaceutical sector”, accessed 11 December 2025.