EU Pharma Package: The “Bolar” Exemption Compromise Proposal

Background

In our sixth alert in this EU Pharma Package Series, we provided an analysis of the history and interpretation issues for another highly debated topic: the “Bolar” exemption.

The Bolar exemption provides for a safe harbor against patent (and SPC) infringement when performing certain activities in preparation of a medicinal product launch. It is therefore an essential provision that enables the generic and biosimilar industry to facilitate a day-one market launch following expiry of the originator medicine’s patent rights.

The current wording of the Bolar exemption, as set out in Article 10(6) of Directive 2001/83/EC, reads as follows (own emphasis):

“Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 [related to marketing authorizations for generic and biosimilar medicinal products] and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.”

As explained in Recital 63 of the proposed Directive, it was considered necessary to clarify the scope of the Bolar exemption to ensure a harmonized application in all Member States, both in terms of beneficiaries and in terms of activities covered, in view of the current fragmented application in the different Member States.

In this alert, we discuss the material, personal, and territorial scope of the new Bolar exemption, as included in Article 85 of the compromise text for the proposed Directive.

Material Scope: Which Preparatory Acts Are Covered

As was proposed by the Council and Parliament, the Bolar exemption will explicitly cover not only the necessary studies, trials and other activities for the purposes of a marketing authorization (MA), but also other procedures that are part of the regulatory market access process:

• Not just to the application but also the actual obtaining of an MA.
• Conducting a health technology assessment (HTA).
• Obtaining of pricing and reimbursement (P&R) approval.
• Complying with subsequent practical requirements associated with any of the aforementioned activities.

“Other activities” may include the submission of the MA application and the offer, manufacture, sale, supply, storage, import, use, and purchase of medicinal products or processes to the extent they are exclusively conducted for the aforementioned purposes. The production of even substantial amounts of test production is covered as long as there is no commercial use thereof during the term of the patent or SPC protection. A contrario, it can be argued that there can be commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process afterwards.

In addition, as per the Council’s proposal, the Bolar exemption will protect participation in procurement tenders to the extent that this does not entail the actual sale or offering for sale of the product while still under protection. This means that generic, (bio)hybrid and biosimilar manufacturers can submit their bids while there is still patent protection for the originator drug as long as the actual supply after the tender is awarded, occurs after the patent expiry.

The key question here is at which point are companies considered to venture into “commercialization” territory prior to patent expiry, which has traditionally been the criterion (i.e., activities of a regulatory versus a commercial nature) to determine whether the Bolar exemption would apply. However, it is not always a straightforward exercise to categorize activities as one or the other; some could be considered “mixed-nature” activities.

While the inclusion of tender participation is a win for the generic and biosimilar industry, originator companies have raised questions regarding how a tender participation is not by default considered an “offer for sale” and how this new material scope relates to the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights of 15 April 1994 (TRIPS Agreement). See our previous alert on the Bolar exemption for a more detailed analysis on these criticisms.

This will become particularly relevant for the future of preliminary injunctions (PI). Activities such as P&R applications and participation in tenders have in the past often been viewed as sufficient proof of a threat of an imminent infringement to obtain a PI. The extension of the Bolar safe harbor may therefore have a significant impact on the success rate for originators in obtaining a PI in the future.

The interaction between the existing Bolar exemption and market-entry preparations by generic companies has already come before the Unified Patent Court (UPC). In Boehringer Ingelheim v. Zentiva (UPC_COA_446/2025), the UPC Court of Appeal defined imminent infringement as a situation where the potential infringer “has already set the stage for [the infringement] to occur, so that the infringement is only a matter of starting the action because the preparations for it have been fully completed”. The Court of Appeal stressed that a mere application for, or even the grant of, an MA does not amount to imminent infringement—further concrete steps toward commercialization are required. In this case, Zentiva argued that its post-MA steps—including P&R applications in Portugal—should not count as infringing acts, pointing to the Pharma Package’s broader Bolar provision, which would explicitly extend the exemption to cover P&R procedures. However, the Court of Appeal flatly rejected this argument, making clear that draft legislation has no bearing on current cases and that the proposed new Bolar exemption will only come into play once enacted. This decision is directly relevant to the compromise text discussed in this alert: once the expanded Bolar exemption enters into force, activities such as P&R applications and—to the extent covered—tender participation will no longer serve as grounds for a PI based on imminent infringement, representing a significant shift in the litigation landscape for originator companies.

Personal Scope: Which Beneficiaries Are Covered

The Bolar exemption covers the aforementioned “other activities,” including when these are performed by third-party suppliers and service providers. This explicit inclusion was a unanimous proposal by all three EU institutions.

Regarding whether the Bolar exemption also extends to originator products, the Bolar exemption refers to the obtaining of an MA, “in particular” of generic, biosimilar or (bio-)hybrid medicinal products, and for subsequent variations. Although the addition of “in particular” could be interpreted as making the wording non-exhaustive, Recitals 63 and 64 are clearly written with a personal scope in mind that excludes originator products. Recital 64 now states “[…] contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection and timely access to these products, whereas it previously stated in the Parliament’s proposal“[…] contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one of loss of the patent or SPC protection” —which was open for interpretation.

Territorial Scope: Which Countries’ MAs Are Covered

The compromise text does not explicitly confirm or refute the extension of the Bolar exemption to trials and studies conducted in Member States to support applications for MAs in third countries outside the EU. Only for HTAs do the proposals explicitly refer to the related EU Regulation (2021/2282), which could imply that—for reasons of consistency—this limitation to the EU also applies to the other activities.

However, this would lead to a more restrictive application of the Bolar exemption in some Member States (such as Germany), where the current the Bolar exemption is interpreted and applied more broadly to cover also ex-EU MA applications. This would conflict with the general premise that the Pharma Package has expanded the Bolar exemption. It will be interesting to see how the Member States will deal with potential conflicts with their current national legislation and how they will transpose and interpret the new wording.

The Bolar Exemption and Its “Link” With Patent Linkage

Patent linkage is the practice of linking the granting of an MA, the pricing and reimbursement status, or any regulatory approval for a generic medicinal product to the status of a patent (application) for the originator reference product. The purpose of this practice is to prevent regulatory approval in light of the patent situation. However, regulatory authorities are not competent to account for and base their decisions on the patent or SPC status of the originator reference medicinal product. This is a competence of the courts alone.

Although it has already been confirmed time and again by the Commission that patent linkage is considered unlawful and anticompetitive in the EU (unlike in the US), patent linkage will explicitly be prohibited in the future under the new pharmaceutical legislation. The compromise text includes a condensed version of the Parliament’s proposal in the second paragraph of Article 85 (own emphasis):

“Decisions adopted concerning the activities referred to in paragraph 1 shall not be considered as infringing intellectual property rights, within the meaning of that paragraph. The intellectual property rights of the reference medicinal product shall not represent a valid ground to refuse, revoke or suspend decisions adopted pursuant to paragraph 1.”

Unlike in the Parliament’s initial proposal, it no longer explicitly includes the “delay” of the adoption of decisions related to MAs, P&R, HTA, or applications for procurement tenders, in addition to the refusal, revocation, and suspension.

Conclusion

The new wording for the Bolar exemption codifies several aspects that in the past have been the topic of discussion or diverging interpretations between Member States, for example, the inclusion of third-party API suppliers in the personal scope.

Unfortunately, there are several points within the Bolar exemption of the Pharma Package where the wording remains ambiguous and/or contentious. We can surely expect litigation before the European Court of Justice or the WTO to clarify and confirm the scope of the new Bolar exemption, for example, with respect to the inclusion of tender participation in the material scope, the territorial scope in general, or the meaning of phrases such as “subsequent practical requirements” (e.g., whether this covers phase IV (post-MA grant) studies).

In the Pharma Package, the Bolar exemption remains included in the proposed Directive, which means it will still need to be transposed into national law. It is imperative that the wording is transposed into national law and interpreted in a uniform way across the EU to achieve harmonization and legal certainty—as was the aim according to Recital 63. If not, we are back to square one.