The European Pharma Package, expected to be adopted this summer by the European Parliament and the Council, significantly broadens the Bolar exemption beyond its current scope. This will enable a generic or biosimilar launch on day one after patent or supplementary protection certificate (SPC) expiry.
According to the proposal, applications for health technology assessment, pricing and reimbursement proceedings, and participation in tenders shall not constitute patent infringement. In particular, the latter was typically seen as a patent-infringing offer in Europe, while for the rest the assessment was not harmonised throughout Europe.
After implementation of the broader Bolar provisions into national laws, caution still needs to be applied to preparatory launch acts that may qualify as imminent infringement of a patent.
What is new regarding market access activities?
Currently, studies and trials and respective practical requirements necessary to obtain a generic/biosimilar EU marketing authorisation (MA) are privileged and do not infringe a patent or an SPC (Article 10, paragraph 6, Directive 2001/83/EC (as amended by Directive 2004/27/EC)/Article 27(d), Agreement on a Unified Patent Court).
The national implementation has been non-uniform across Europe, though. Section 11 No. 2b of the German Patent Act, for instance, goes further, covering originator MAs and those sought in third countries.
The reform now extends the exemption to:
Obtaining an MA for generic, biosimilar, hybrid, or bio-hybrid medicinal products and subsequent variations;
Conducting health technology assessment;
Obtaining pricing and reimbursement approval; and
Submitting procurement tender applications (if not entailing sale, offer for sale, or marketing).
Obtaining an MA is already generally treated as a mere administrative act and not as an (imminent) infringement (see Boehringer Ingelheim v Zentiva, August 13 2025). Accordingly, the new regulation is rather a clarification in that regard.
In Boehringer Ingelheim v Zentiva, the Court of Appeal of the Unified Patent Court (UPC) defined imminent infringement as a situation in which infringement has not yet occurred, but the stage for it to occur has already been set. It is only a matter of starting the action, whereas preparations for infringement have been fully completed.
In Occlutech v Lepu Medical (October 21 2025), the Hamburg Local Division of the UPC found that a Conformité Européenne (CE) mark approval provides an indication of an expected market entry in any of the EU member states in the foreseeable future. In that case, the issuance of the CE mark was not the only act, though: the approval was publicly announced on social media, on the website, and at trade fairs, while providing ‘ordering information’. Accordingly, infringement was deemed to be imminent.
By contrast, in Novartis v Celltrion (September 6 2024), the Düsseldorf Local Division of the UPC rejected an imminent infringement in view of the factual timelines: while the defendant had advertised its biosimilar approval at a conference, there was no evidence for price negotiations or reimbursement applications. The court concluded that customers would therefore regard these statements as vague announcements only. Infringement was therefore not deemed imminent given the further regulatory steps required for the launch.
Generally, it can be concluded that infringement is imminent once no further hurdles are to be overcome to start marketing during the patent term. But how does this apply to the acts soon to be exempted under the Bolar reform?
While acts explicitly carved out from patent infringement should generally not establish its imminence either, they could still add to the ‘full completion’ of market access preparations.
Here, the timing will be highly relevant: if applications for obtaining pricing and reimbursement approval or offers in a tender are performed a long time before patent/SPC expiry, it may be an indication that the generic/biosimilar intends to come on the market during the patent/SPC term (and not on ‘day one’). Any additional circumstances, such as communications of distributors in the market implying an imminent launch, are likewise risky.
Practical takeaways
For patentees: thorough market observation and reliable reporting lines across European affiliates are key to catch any signs of an intended launch at risk.
For potential defendants: be cautious that no acts or market communications create the impression of an imminent launch if a launch on day one after patent/SPC expiry is intended. Close coordination of regulatory activities across Europe is decisive.
