EU pharma package widens the Bolar exemption and moves the line on patent infringement

A generic or biosimilar company that bids in a German rebate-contract tender while the originator's patent is still in force risks a preliminary injunction today. An active-ingredient supplier delivering to a marketing authorisation applicant operates in a grey zone. Both are set to change.

On 28 September 2026 the Council formally adopted its position on the EU pharma package. The European Parliament's final vote is expected in November 2026, with publication in the Official Journal before the end of the year. The Bolar exemption it contains redraws the line between permitted launch preparation and patent infringement – with consequences for originators, follow-on manufacturers and their supply chains.

Narrow wording, inconsistent practice

The current Bolar exemption in Article 10(6) of Directive 2001/83/EC covers only the "necessary studies and trials" for generic and biosimilar marketing authorisations. Member States have transposed it differently. Germany deliberately went further in section 11 no. 2b of the Patent Act (PatG): the provision covers studies for any marketing authorisation, including for originator products and for third countries.

The Düsseldorf Higher Regional Court has accepted that active-ingredient suppliers can rely on the exemption, but only subject to strict conditions. Pricing and reimbursement procedures and tender participation have so far fallen outside the exemption and have routinely served originators as evidence of an imminent infringement.

Four extensions

The new provision in Article 85 of the Directive (numbering of the compromise text) aims to harmonise the exemption across the EU. It extends it in four directions:

• Post-authorisation market access: Alongside studies and trials, all activities needed to obtain a marketing authorisation, to undergo a health technology assessment (HTA) or to obtain a pricing and reimbursement decision are exempt – including the associated practical requirements.
• Tenders: Participating in procurement procedures for supply after expiry of the patent or supplementary protection certificate (SPC) is permitted, provided nothing is sold or actually offered before protection ends.
• Suppliers and service providers: Active-ingredient manufacturers, contract manufacturers and contract research organisations are expressly covered. Offering, manufacturing, selling, storing, importing, using and purchasing are exempt where they serve these purposes exclusively.
• Ban on patent linkage: Intellectual property rights in the reference medicinal product are no longer a valid ground to refuse, revoke or suspend a marketing authorisation, a pricing and reimbursement decision or a tender award.

The wording refers "in particular" to generic, biosimilar, hybrid and bio-hybrid authorisations. The recitals refer only to generics and biosimilars. Whether originators conducting studies on third-party patents are covered remains open.

Consequences for preliminary injunctions

In many Member States, pricing and reimbursement applications or tender bids have so far been sufficient evidence of an imminent infringement. Those hooks disappear.

The Unified Patent Court (UPC) has pointed the way. In Boehringer Ingelheim v Zentiva the Court of Appeal held that a marketing authorisation alone does not establish imminent infringement. Instead, concrete further steps towards commercialisation are required. It naturally rejected reliance on the planned Bolar extension until it enters into force.

In Germany the effect is likely to be split. Listing in the Lauer-Taxe, the German pharmacy price database, is not an administrative pricing or reimbursement procedure but an offer to the market. In our view it remains an infringing offer. Rebate-contract tenders run by the statutory health insurers under section 130a(8) of the Social Code Book V (SGB V), by contrast, sit at the heart of the new rule. Originators will have to base their injunction applications on other circumstances such as distribution preparations, stock levels or marketing activity, for example.

Open questions

• Territorial scope: Whether studies conducted in the EU for third-country authorisations are covered is left open. Only for HTA does the text refer to Regulation (EU) 2021/2282. A narrow reading would be a step backwards for Germany compared with section 11 no. 2b PatG – whether the wider German exemption may stay is for the legislator to resolve.
• Mixed-purpose activities: When does launch preparation tip into commercialisation? Producing validation batches is exempt, and their commercial use after protection ends probably is too. Drawing the line in individual cases will fall to the courts.
• TRIPS: Originators consider the exemption for tender participation incompatible with Article 30 of the TRIPS Agreement. References to the Court of Justice of the EU are foreseeable.

For the UPC the new exemption applies directly: Article 27(d) of the UPC Agreement refers to the Bolar provision of the Directive and, on the prevailing view, captures its recast version.

Timeline

The Bolar exemption sits in the Directive, not the Regulation. Member States must transpose it within 24 months of entry into force. With publication in the Official Journal at the end of 2026, it is therefore likely to apply from around the turn of 2028/2029. There is no transitional provision: the new rule will then also cover patents and SPCs that are already in force today.

Osborne Clarke comment

Originators should revisit their launch forecasts. Day-one launches by generics and biosimilars become more realistic, because follow-on manufacturers may complete their market preparation up to the last day of protection. Patents on formulations, dosing regimens and second medical uses gain weight because they bite on the launch itself.

Generic and biosimilar manufacturers gain legal certainty, but only within clear limits. The regulatory purpose of each activity should be documented and written into supply agreements – which also protects active-ingredient and contract manufacturers. In tenders, the start of supply must unambiguously fall after protection ends. Until transposition, the current law applies unchanged – the UPC has made that plain.

We are tracking transposition in Germany and the UPC's case law on imminent infringement closely. If you would like to know what the new rule means for your portfolio or your launch plan, please get in touch.