The Bolar exemption (“Bolar 1.0”) determines the extent to which preparatory activities to bring medicinal products to market can be undertaken prior to patent or SPC expiry without exposure to patent infringement claims but the position varies from jurisdiction to jurisdiction.

The updated Bolar exemption (“Bolar 2.0”) is one of the key elements of the EU Pharma Package. The final vote in plenary to adopt the package is expected in the Autumn (November 2026) after which it will enter into force 20 days following its publication in the Official Journal of the European Union.  Thereafter, Member States have 24 months to implement the new directive and if that materialises, we may expect full implementation by the end of 2028.

Below we consider the landscape and the outlook for Bolar 2.0 and whether the aim of a  more harmonised scope and application may be realised to facilitate timely generic market entry in Europe.

Now - Bolar 1.0

Bolar 1.0 (which is also incorporated into the UPCA) provides that “conducting the necessary studies and trials with a view to the application [for marketing authorisations (MAs) for generics, hybrids and biosimilars] and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products." 

This is a minimum requirement and the variable national implementation of this provision  across member states has led to complexity and uncertainty. In particular, there have been certain differences of approach on what is considered infringement as regards originator MAs, third party manufacturers and service providers, MAs for third countries and activities beyond clinical studies. For example, participation in tenders has tended to be viewed as an offer, constituting an infringing act. By contrast, the mere obtaining of a MA or pricing and reimbursement approval may be considered merely administrative.

Bolar 1.0 is also currently applicable in the UPC directly through Article 27(d) of the UPC Agreement and has been considered by the Court of Appeal in Boehringer v Zentiva in the context of developing the legal test for imminent infringement.

The Court confirmed that “imminent infringement may be characterised by certain circumstances which suggest that the infringement has not yet occurred, but that the potential infringement has already set the stage for it to occur” and “infringement is only a matter of starting the action” as “preparations have been fully completed”. 

This holistic approach will depend on the facts of each case but on the interaction with Bolar 1.0, the Court confirmed that the mere application and granting of an MA does not amount to imminent infringement, whereas completion of the national procedures for health technology assessment and pricing and reimbursement can.  The Court directed that “the assessment must be made with due regard to the national regulatory and legislative context and considering the circumstances of the case”. 

On the facts of the case, Zentiva had gone through the administrative steps of obtaining an MA and pricing & reimbursement, and INFARMED (the Portuguese regulatory authority) had issued the applicable notice confirming that Zentiva’s generic was available to purchase (more than a year before the expiry of the patent).

Based on the evidence before it (considering the national regulatory context, legislative context and factual circumstances), the Court of Appeal found that there was an imminent risk of infringement because no further administrative procedure was needed and the mechanism for preventing infringement was effectively Zentiva's own self-restraint. The Court of Appeal declined to consider the then draft of the new bolar exemption legislation, including the explicit exemption for pricing and reimbursement activities, in its interpretation of what constitutes imminent infringement.

Therefore, because of the activities in Portugal, a PI was granted across 17 UPC contracting member states where the patent was in force and even though MAs had not been granted in any of those UPC countries at the time.

The Future - Bolar 2.0

Bolar 2.0 now permits, before patent/SPC expiry, activities beyond clinical studies and trials and the respective practical requirements in relation to making an application for a generic/hybrid/biosimilar MA. It expressly exempts the necessary studies, trials and other activities conducted for the purposes of:

1. obtaining an MA (in particular for generic, biosimilar, hybrid, or bio-hybrid medicinal products and subsequent variations);
2. conducting health technology assessments;
3. obtaining pricing and reimbursement approval;
4. complying with subsequent practical requirements associated with the activities of 1-3 above; and
5. submitting procurement tender applications (when there is no sale, offer for sale or marketing before patent/SPC expiry).

Bolar 2.0 also clarifies that the activities conducted exclusively for the purposes of 1. above, may cover the submission of the application for an MA and the offer, manufacture, sale, supply, storage, import, use and purchase of medicinal products or processes, including by third party suppliers and service providers. Therefore, the activities of third-party API suppliers done exclusively for the purposes of obtaining an MA, appear to be included in the exemption (notwithstanding use of the language “medicinal products” rather than “active substance”) whereas the position under Bolar 1.0 varies according to case law or is uncertain. 

So at first sight, Bolar 2.0 is broader and does provide greater clarity to harmonise the approach of Member States as to what is exempted from constituting infringement in this context so as to facilitate the carrying out of pre-launch activities needed for market entry on patent/SPC expiry. However, questions remain as to scope given this is still a minimum requirement with the possibility of differing implementation at a national level and given that some language remains open for interpretation.

For example, what about:

• the status of originator activities?  The language of the exemption provision is open to obtaining an MA for any medicinal products but then calls out generic, biosimilar, hybrid or bio-hybrid MAs “in particular”, as do the relevant recitals.  So, while there is nothing excluding originator products, the language may not assist in consistent application and legal certainty. The role of the experimental use exemption may become more significant, for example for Biotech products, depending on the scope ultimately attributed to Bolar 2.0 in practice.
• the “other activities” language?  This remains to supplement activities beyond studies and trials necessary for the broadened exempted purposes. In addition there is also the new undefined “subsequent practical requirements” language. 

Meanwhile, the approaches to imminent infringement and urgency at a national and UPC level (and their evolution in the light of Bolar 2.0) will be expected to remain a key battleground in the context of product launch offensive and defensive strategies. 

What about the UK? 

As an EU member state, the UK implemented Bolar 1.0 in the form of the 2001 Directive but in 2014 further provisions were introduced to the experimental purposes exception to exempt “anything done in or for the purposes of a medicinal product assessment”.

The intention was to enable activities related to any tests, studies, clinical trials, field trials for health technology assessments, which generally refer to investigations to assess the benefits and costs of a medicine and how it compares with available alternatives. 

The scope has not been tested before the UK Courts but the UKIPO’s Patents Manual lists the following activities as appearing to fall within the scope of the 2014 additional provisions:

“a) Activities carried out to provide data to regulatory authorities.
b) Activities carried out to provide data to bodies carrying out health technology assessments.
c) Post approval studies to comply with regulatory requirements.
d) Activities carried out to amend an authorisation for a medicine.
e) Activities done to obtain an authorisation for a new indication of an existing drug
f) Any tests or studies required by regulatory bodies.
g) Activities carried out for the purposes of obtaining full authorisation of a generic drug or biosimilar e.g. where the abridged procedure exempted by the Bolar exception (see 60.28) is not used.
h) Activities related to health technology assessment of a generic or biosimilar product.
i) Activities carried out to provide data for obtaining regulatory approval for a generic or biosimilar product in another country.”

Therefore, the effect of the provisions is towards a broader exemption from patent infringement in this context, not being limited to generic/hybrid/biosimilars or UK/EU MAs. 

However, as the position on more commercial activities such as pricing and reimbursement approvals, tender applications and third party suppliers has not been clarified by the Courts, there is some uncertainty on such activities although a more permissive approach might be expected considering the aim of the 2014 amendments (and with Bolar 2.0 on the horizon in the EU). The interaction between the UK's framework and the forthcoming Bolar 2.0 regime will be an important consideration in pre-launch planning.

When it comes to threats of imminent infringement in the UK, the Court has tended to assess the conduct of the defendant (e.g., whether assurances have been provided in response to any warning or notice letter) to take into account whether there is any inference of an intention to launch ahead of patent or SPC expiry.

Key takeaways 

Bolar 2.0 will broaden the exemption to expressly cover health technology assessments, pricing and reimbursement approvals and procurement tender applications (subject to conditions) in addition to MA-related activities. However, as Bolar 2.0 remains a minimum harmonisation requirement, differing national implementation may still give rise to divergences in scope and application across Member States. Stakeholders should prepare to monitor the implementation closely in key markets to identify any material differences in scope or application.

Under Bolar 2.0, PI triggers may shift but the approach to imminent infringement at the national court level and UPC will remain a key battleground.

For patentees, maintaining market surveillance for acts indicating an intention to launch at risk will remain critical,  as there will still be some uncertainty about the scope of Bolar 2.0.   Enforcement strategies will need to account for the expanded exemption and shift in PI triggers.

For potential defendants, caution should still be exercised in planning and publicly communicating about preparatory acts for launch, and consideration should be given to whether lawful acts in combination may be characterised as preparation for patent infringement and what assurances or evidence may be required to refute such a contention. Internal education and robust processes are key to mitigating the risk of activities in one country putting at risk a much wider market.

The UK already benefits from a relatively broad exemption framework following the 2014 amendments, but uncertainty remains as to the treatment of more commercial activities such as pricing and reimbursement approvals, tender applications and third party supplier involvement. Whether and how the UK will seek to align with the further broadening introduced by Bolar 2.0 in the EU remains to be seen and will be an important consideration in pre-launch plannin