Elisa Stefanini
Partner, Portolano Cavallo, Italy
estefanini@portolano.it

Maria Balestriero
Of Counsel, Portolano Cavallo, Italy
mbalestriero@portolano.it

Francesca Ellena
Associate, Portolano Cavallo, Italy
fellena@portolano.it

Introduction

The Bolar exemption (also referred to solely as the ‘Bolar’), which was first established in the American Patent Term Restoration Act of 1984 following the landmark US case of Roche v Bolar, was introduced at the European Union level in 2004, with the declared aim of striking a balance between the need for patent owners to preserve their proprietary rights as long as possible and the desire of competitors to enter the market without undue delay at Day 1.

In essence, the Bolar carves out certain acts from being considered patent or supplementary protection certificate (SPC) infringement, thereby allowing medicinal product manufacturers to lawfully commence testing their products for the purpose of submitting and obtaining a marketing authorisation (MA). In other words, the exemption creates a ‘safe harbour’ from patent infringement liability for certain pre-launch acts that would otherwise constitute infringement, provided that those acts are directed to the regulatory goal of obtaining an MA.

The Bolar thus sits at the precise intersection of two distinct regimes: pharma-regulatory law, which structures and governs the process of obtaining marketing authorisations, and intellectual property (IP) patent law, which controls exclusivity rights over patented drug products or processes.

The reform under the European Union Pharma Package represents the most significant recalibration of the current balance since 2004. The texts of the new Directive and Regulation were formally confirmed by the Committee of Permanent Representatives of the Member States (COREPER I) in March 2026. Formal adoption by the European Parliament and the Council is expected to take place in Q3 2026. The legislation will then be fully applicable, including the transitional periods encompassed therein, from 2028 (according to the currently expected timeline).

Current EU baseline

The current text of Article 10(6) of Directive 2001/83/EC on the Community Code for medicinal products for human use as amended by Directive 2004/27/EC recites as follows:

‘conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products’.

The EU provision has been interpreted in a non-harmonised way by domestic legislations for two main reasons: (1) the provision is contained in a Directive, and hence necessarily requires transposition into national law; and (2) the EU provision does not address key grey areas in sufficient detail: the particulars of exempted activities, the specification of the countries where an MA must be pursued in order to benefit from the exemption, and the actual beneficiaries of such exemption (eg, innovators? third-party API suppliers?). These aspects have accordingly been left open to Member State interpretation.

As a result, in some countries the Bolar has been implemented broadly to cover trials for innovators, as well as for generic, biosimilar or hybrid medicines, and may be relied upon for studies directed at non-EU MAs. In other countries, by contrast, the Bolar remains limited to studies directed at MAs within the EU and/or to generic and biosimilar medicines, with innovators required to rely on the narrower exemption for research relating to the subject-matter of a patented invention.

The divergence across selected key jurisdictions can be summarised as follows, based on available comparative analysis:

Germany, France, Italy, and Spain might extend Bolar to originator MAs and products, as well as to MAs outside the EU, while the Netherlands limits Bolar to generics and EU MAs only; Belgium extends to originator products but probably not to non-EU MAs; the United Kingdom, following its 2014 legislative broadening, extends Bolar to originator products but not to non-EU MAs; Poland, following a 2020 broadening, extends Bolar to originator products and non-EU MAs. Across all these jurisdictions, the explicit inclusion (ie, in the provision of law) of pricing and reimbursement procedures within the scope of Bolar remains absent or uncertain in most national laws.

The UPC Bolar provision under Article 27(d) of the UPCA did not add any additional wording and instead directly cross-references Article 10(6) of Directive 2001/83/EC.

The Italian interpretation of existing grey areas

The current Italian Bolar exemption is set forth under Article 68(1)(b) of the Italian Industrial Property Code (the ‘IP Code’), which states that:

‘no matter the subject matter of the invention, the exclusive rights conferred by the patent rights do not extend [...] b) to studies and experiments designed to obtain marketing authorisation for a medicinal product — including in foreign countries — and the consequential practical requirements, including preparation and use of pharmacologically active raw materials that are strictly necessary thereto’.

As a result of this formulation of the Bolar and based on case law and Scholars, it appears that the Italian Bolar is quite broad. Hence it covers:

• by literal inclusion in the above quoted text of the IP Code: foreign MA;
• by scholarly interpretation: innovators; and
• by recent case law¹ (unique in the EU panorama): third-party API suppliers, subject to strict conditions. Namely, the Supreme Court held that the activities of third parties producing active ingredients on behalf of generic manufacturers are covered by the exemption, provided that: (1) the registration purpose is declared at the outset and in advance; and (2) the commencement of manufacturing is preceded by a formal request from a generic drug company. The MA-directed purpose of such request must be explicitly stipulated within the relevant contractual agreement (for instance, agreements between suppliers and generic manufacturers should include clauses restricting the utilisation of the active ingredient exclusively to Bolar purposes, accompanied by appropriate sanctions in the event of non-compliance);
• by inclusion in the regulatory legislation: price and reimbursement. In 2022, the regulatory legislation (the so-called ‘Pharma Code’) was amended to specify that equivalent drug makers may pursue MA and also apply for pricing and classification for the purposes of drug reimbursability before the patent or supplementary protection certificate expires (Article 17 of Law No 118/2022, replacing Article 11 of Law Decree 158/2012, the ‘Balduzzi Decree’). This amendment, however, left residual doubts as to the scope of the Bolar, since the law did not formally amend the Bolar exemption in the IP Code.

Key changes in the EU Pharma Package: evolution from the proposal to the approved text

Article 85 of the originally proposed new Directive provided that the following acts would not be considered infringing: studies, trials and other activities conducted to generate data for an application for:

• a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;
• health technology assessment as defined in Regulation (EU) 2021/2282; and
• pricing and reimbursement.

The proposal also addressed the beneficiaries covered by the Bolar exemption by expressly including ‘third-party suppliers and service providers’. Article 85(b) – former text – read as follows:

‘the activities conducted exclusively for the purposes set out in point (a) may cover the submission of the application for a marketing authorisation and the offer, manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers’.

Hence, the text was already moving in the direction of the Italian approach by including third-party suppliers and pricing and reimbursement procedures.

The subsequently approved text went even further. As announced on 11 December 2025 by the press release following the agreement reached by the Council and the Parliament on the same day, the co-legislators clarified the wording of the provision and included submissions for procurement tenders, as per the Council’s request during the legislative iter.

As a result, the current key changes to the baseline set in 2004 can be summarised as follows:

• Expanded purpose coverage: the exemption now covers the necessary studies, trials or other activities for the purpose of:

• obtaining a MA for medicinal products, in particular generics, biosimilars, hybrids, bio-hybrids (this level of detail is new);
• conducting health technology assessments (HTA) (new);
• obtaining pricing and reimbursement (P&R) approval (new);
• complying with subsequent practical requirements associated with those activities; and
• submissions for procurement tenders (new).
• Express recognition of third-party suppliers: the exemption covers any potential infringement for the offer, manufacture, sale, supply, storage, import, use and purchase of medicinal products or processes, including by third-party suppliers and service providers (new).
• Procurement tender participation: The exemption expressly includes procurement tender submissions, subject to the condition that the activity does not entail the sale or offering for sale or marketing of the product during the protection period still covered by the patent or SPC (new).

The final text also includes an anti-patent-linkage clause: Article 85(2) stipulates 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, applications for procurement tenders.

Are there still grey areas?

Since the Bolar remains enshrined in a Directive – which will not be directly applicable until transposed into national law by each Member State – non-harmonised interpretation could still occur by default.

The most striking feature of Article 85 is that, unlike the Italian approach, it appears to rule out originators from the scope of the exemption (although, in our view, it could still be argued otherwise on the basis of the late textual evolution). If this reading is confirmed, either differences will continue to exist between EU countries, or the exemption will be narrowed across the board, leaving the research exemption to regulate trials of new drugs.

The meaning of ‘other activities’ and ‘subsequent practical requirements’ in Article 85 remains undefined. The phrase ‘other activities’ is sufficiently open to generate interpretive divergence upon transposition. It is unclear, for instance, whether it encompasses preparatory manufacturing activities beyond those strictly required by the regulatory dossier, comparative effectiveness studies conducted for commercial rather than strictly regulatory purposes, or the full range of logistics and storage activities associated with readiness for Day 1 launch.

The exemption of activities carried out by third parties is explicitly covered, but the ‘exclusive purpose’ condition remains to be interpreted. The proposal does not specify how the causal link between third-party activities and the MA process should be ascertained, leaving that to Member State interpretation. This gap is particularly significant given the Italian Supreme Court's emphasis on ab initio contractual purpose declarations as a condition for third-party API suppliers to benefit from the exemption.

The draft directive does not clarify whether the exemption would cover acts carried out as part of an application for MA outside the EU. In Italy, the law expressly allows MA to be sought everywhere.

There is no time limit to prevent the listing of ‘tendered’ generic or biosimilar prices by Member States prior to patent or SPC expiry. This creates the potential for generic and biosimilar manufacturers to obtain pricing and tender positions well in advance of expiry, without the framework providing a mechanism for originators to challenge the timing of those activities as falling outside the scope of the exemption.

Comments and perspectives

Italy's existing position – which already covers MAs sought globally as well as pricing and reimbursement – means that the operative shift in Italy will primarily concern the tender participation dimension, which, as of today, constitutes full infringement under the IP Code. In addition, the exemption of P&R activities, which was provided for in regulatory law and has not been addressed by IP-specialised case law, will receive confirmation.

On a final note, the Bolar might impact on the assessment of pre-conditions of granting a preliminary injunction (PI) by national courts. At the time of writing, Italian case law is constant in considering MA submission not to be a reason to substantiate the urgency which is needed to pursue a PI, while it not so straightforward with reference to P&R steps, which have been ‘exempted’ only in 2022 and by virtue of a law not included in the IP Code. It might follow from the reform that the factual circumstances that now do not explicitly fall into the IP Code will be evaluated differently by the courts.

Notes

1     Italian Supreme Court Ruling of 5 July 2024.