US originators have historically modeled EU loss-of-exclusivity on a regulatory timetable that ran several months past patent or SPC expiry, on the working assumption that downstream pricing, reimbursement, and procurement steps could not begin in earnest until the protection period had ended. The EU Pharma Package compresses that timetable to something close to zero. Art. 85 of the new Directive extends the intellectual-property-rights carve-out of the 2004 Bolar provision to health technology assessment submissions, pricing-and-reimbursement dossier preparation, and public procurement tender filings during the protection period, and it forbids IP rights from grounding any refusal of the decisions taken under those procedures. The EU-protected window will shrink. What remains open is where, exactly, the new carve-out stops, and how national implementation, the constraints of international trade law and the case law of each forum will shape the answer on either side of the Atlantic.
1. The Old Bolar and the New Bolar: A Substantive, Not Cosmetic, Expansion
The pre-reform EU Bolar provision, inserted into Directive 2001/83/EC by Directive 2004/27/EC, was a single sentence at Art. 10(6) of the 2001 Directive.1Directive 2001/83/EC [2001] OJ L311/67, Art. 10(6) as inserted by Directive 2004/27/EC [2004] OJ L136/34. It declared that “conducting the necessary studies and trials with a view to the application of paragraphs 1, 2, 3 and 4 and the consequential practical requirements” would not be regarded as contrary to patent rights or to supplementary protection certificates. The paragraphs cross-referenced were the generic, biosimilar, and hybrid pathways. The text said nothing about HTA work, nothing about pricing-and-reimbursement (P&R) dossiers, and nothing about public procurement tenders. The Member States transposed the sentence inconsistently. Italy and the United Kingdom (before its EU exit) adopted broader carve-outs that some commentators read as covering originator-side research and preparatory acts unrelated to a marketing authorization; other Member States read the sentence narrowly, confining it to marketing-authorization-related studies and the immediately consequential paperwork. Recital 63 of the final compromise text of the new Directive expressly characterizes the resulting picture as “fragmented across the Union,” with divergence both in the beneficiaries permitted to invoke the carve-out and in the activities the carve-out reached.2Final compromise text ST-6367/26 (24 February 2026, confirmed by Coreper on 6 March 2026), Recital 63 (fragmented application of the prior Bolar across the Union).
Art. 85 of the Directive replaces the 2004 sentence with a structured provision that sweeps five named activity categories into the IP-rights carve-out, which applies where “the necessary studies, trials and other activities” are conducted for the purposes of: obtaining an MA, in particular for generic, biosimilar, hybrid, or bio-hybrid medicinal products and subsequent variations; conducting HTA as defined in Regulation (EU) 2021/2282; obtaining pricing-and-reimbursement approval; complying with subsequent practical requirements associated with the foregoing; and submitting an application on procurement tenders “in compliance with Union and national law,” subject to a carved-back condition that the tender submission “does not entail the sale or offering for sale or marketing of the medicinal product concerned during the protection period.”3EU Pharma Package Directive (n 2), Art. 85(1) (HTA, P&R, subsequent practical requirements, and procurement-tender submission as carved-out activities); the lettering set out in body prose reproduces the verbatim final compromise text and may renumber on OJ publication. The MA-related limb of the list is itself framed by reference to “medicinal products, in particular of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations,” phrasing whose “in particular” is non-limiting on its face; the carve-out can therefore in principle shelter MA-related work that falls outside the four named follow-on categories where the other conditions of Art. 85 of the Directive are met. A further element of Art. 85(1) of the Directive, set out in what reads on the verbatim final compromise text as a second subparagraph, confirms that the carve-out may cover the submission of the MA application and the offer, manufacture, sale, supply, storage, import, use, and purchase of medicinal products or processes, including by third-party suppliers and service providers. That inclusion does substantive work on the second axis Recital 63 of the Directive identifies. The prior carve-out differed between Member States both in the activities it reached and in who could invoke it, and the express reference to third-party suppliers and service providers extends one Union-wide shelter to the active-substance manufacturers, contract development and manufacturing organizations, and other upstream providers on which a generic or biosimilar entrant relies, including the US-based API and CDMO suppliers serving EU entrants whose pre-expiry preparatory acts the earlier patchwork left unprotected in several Member States. Art. 85(2) of the Directive is the single most consequential change. It states that decisions taken pursuant to Art. 85(1) of the Directive shall not themselves be considered infringements, and that the IP rights of the reference medicinal product “shall not represent a valid ground to refuse, revoke or suspend” those decisions. Art. 85(3) of the Directive then draws the demarcation line: the exception “shall not cover the placing on the market of the medicinal products resulting from such activities.”
Two Points of Scope
Two related points of scope deserve to be made explicit at the outset. The instrument analyzed here is the final compromise text dated 24 February 2026 and published 6 March 2026, which follows the political agreement the European Parliament and the Council reached in December 2025; both institutions are expected to adopt it formally later in 2026. Art. 218 and Art. 219 of the Directive govern the transition. Art. 218(3) of the Directive confirms that the new framework applies to medicinal products authorized under Directive 2001/83/EC before the date of application, subject to specific derogations. One of them, a carve-out in Art. 218(5) of the Directive, preserves the data-protection regime of Art. 10 of Directive 2001/83/EC for reference medicinal products whose MA application was submitted before the date of application. The new Bolar in Art. 85 of the Directive sits outside that data-protection derogation and is therefore expected to apply to legacy and post-reform products alike from the date the new framework enters into application. Art. 219 of the Directive sets the Member State transposition deadline, and the date of application, at 24 months after entry into force; the final compromise text strikes the Commission's 18 months for transposition, and both dates run from an entry into force that awaits publication in the Official Journal. The carve-out also operates strictly within IP law: Art. 85 of the Directive is an exception to patent and SPC rights and does not shorten the regulatory data and market protection periods set by Art. 80 and Art. 81 of the Directive, so the compression of the post-expiry runway it produces is a function of when patent or SPC protection ends, not of when regulatory exclusivities lapse.
The expansion is not a clarification of the 2004 text; it adds whole regulatory procedures to the carve-out and removes IP rights as a permissible ground for refusing the decisions that issue from them.
The drafting choice in Art. 85(2) of the Directive deserves attention separate from the activity-list extension. The pre-reform Bolar reduced the carve-out beneficiary’s risk of infringement liability, but it did not directly settle whether an HTA body, a national reimbursement authority, or a procurement-tender awarding entity could decline to consider an application or could decline to issue a decision on the ground that the reference patent or SPC remained in force. Several Member States operated systems in which downstream administrative actors looked at IP status as a procedural gate. Art. 85(2) of the Directive closes that gate as a matter of EU-law obligation. Recital 65 of the Directive makes the same point in narrative form, stating that authorities cannot ground decisions on the patent or SPC status of the reference medicinal product, while preserving Member State freedom to introduce supply-readiness rules for the post-expiry period. The compression of the post-expiry runway, in other words, is driven not only by what generic and biosimilar entrants may now lawfully do during the protection period, but also by what reimbursement and procurement authorities may now no longer refuse to do.
2. HTA and Pricing-and-Reimbursement Procedures Under the New Carve-Out
The express inclusion of HTA work and P&R dossier preparation in the new Bolar (letters (aa) and (ab) of Art. 85(1) of the Directive) has implications that the text alone understates. The HTA Regulation, Regulation (EU) 2021/2282, came into operational application on 12 January 2025 for oncology and advanced therapy medicinal products, with an expanding scope on the published schedule that adds orphan products and progressively brings all centrally authorized products inside the HTA framework over the second half of the decade.4Regulation (EU) 2021/2282 of 15 December 2021 on health technology assessment [2021] OJ L458/1 (HTA Regulation); joint clinical assessments apply since 12 January 2025. Joint clinical assessment under the HTA Regulation is a Union-level evidentiary procedure that produces a report Member States are required to consider in their own reimbursement decisions. A generic or biosimilar entrant that begins HTA dossier preparation during the originator’s SPC period now has, on the face of Art. 85 of the Directive, an unambiguous IP-rights shield for that preparatory work, and the joint-clinical-assessment file can move toward submission alongside the entrant’s manufacturing readiness rather than after it.
The structural change is the alignment of three previously sequenced processes. Under the prior regime, an entrant typically completed manufacturing scale-up and its MA work, both for the EU and for Swissmedic, the MHRA or other third-country regulators, during the protection period. It then waited for SPC expiry before approaching HTA and P&R systems, whose engagement might otherwise have invited litigation theories about induced infringement or contributory acts. Under Art. 85 of the Directive, the entrant may run HTA preparation, P&R dossier work, and MA application activity as parallel rather than sequential streams. The reimbursement authority cannot decline to process the dossier on the ground that the reference patent has not yet expired, and the entrant’s engagement with the authority cannot itself be characterized as patent infringement.3EU Pharma Package Directive (n 2), Art. 85(2) (IP rights cannot ground refusal, revocation, or suspension of decisions taken under Art. 85(1)). The compression effect is most visible at the moment of expiry itself: a generic that has both the MA and a fully assessed reimbursement file in hand on the day patent or SPC protection lapses can place its product on the market in conditions the prior regime did not permit.
The questions the provision leaves in place are not trivial. A joint clinical assessment under the HTA Regulation is technically a Union-level scientific exercise that produces no reimbursement decision in itself; reimbursement remains national. The better reading is that an administrative step preceding supply stays inside the carve-out: a positive reimbursement recommendation published before expiry, or a decision made conditional on expiry, is not the “placing on the market” that Art. 85(3) of the Directive reserves, because that phrase attaches to the first act of supply rather than to the decision authorizing it. The harder case is the national HTA body that publishes its assessment in a public register hospital purchasers consult in real time, where pre-expiry publication may produce informal market effects the carve-out does not contemplate. That boundary has no settled answer in the Directive’s text, and it is the one the early jurisprudence will need to draw.
3. Public Procurement Tenders: Listing Without Selling
Letter (ad) of Art. 85(1) of the Directive is the most contested element of the new carve-out and the most consequential for hospital-channel and centralized-supply medicines. The provision permits “submitting an application on procurement tenders, in compliance with Union and national law, to the extent that it does not entail the sale or offering for sale or marketing of the medicinal product concerned during the protection period.” The Union procurement framework cross-referenced is principally Directive 2014/24/EU on public procurement, which structures the standard above-threshold award procedures used by hospital networks, national health services, and central purchasing bodies across the Member States.5Directive 2014/24/EU of 26 February 2014 on public procurement [2014] OJ L94/65 (Public Procurement Directive); the standard EU framework for above-threshold contracting authorities. Specialist sectoral procedures, including framework agreements with multiple economic operators, dynamic purchasing systems, competitive procedures with negotiation, and the joint cross-border procurement procedures proposed under the Critical Medicines Act, not yet adopted at the date of this article, all sit within or alongside that framework.
On its face, the carve-out lets a generic or biosimilar entrant submit a complete tender response during the protection period for a contract performed only after expiry; whether a bid that binds the entrant before expiry is still preparation is taken up below. The entrant may be listed on a framework agreement; it may be technically pre-qualified; it may be ranked against the originator in an evaluated tender; what it may not do is sell, offer for sale, or market the product during the protection period itself. The structural shift is significant. Under the prior regime, an entrant preparing a tender during the protection period faced litigation theories grounded in induced infringement, contributory liability, or threats of immediate enforcement; under Art. 85(2) of the Directive those theories are not available against the tender submission itself, and the awarding authority cannot decline to evaluate the submission on patent or SPC grounds.
The unresolved boundary work concentrates in the procurement procedures that involve iterative price interaction, where four pressure points recur. A competitive procedure with negotiation under Art. 29 of Directive 2014/24/EU turns on whether successive rounds yielding a binding bid before expiry remain preparation or cross into “offering for sale.” A framework agreement signed during the protection period but generating no order until after expiry raises the same question at the contracting moment rather than the bidding one. A sample shipment submitted for evaluation tests whether the second-subparagraph permission of Art. 85(1) of the Directive to import and supply covers it or whether it is already a placing on the market. And a Union-level joint procurement spanning Member States with non-aligned expiry dates raises whether the tender response must be sliced jurisdiction by jurisdiction, or whether Art. 85(1)(ad) of the Directive covers the whole tender so long as no Member-State-specific supply begins during that State’s remaining protection period. Each maps to a different commercial channel and a different category of dispute.
The empirical record on EU tender practice shows that the harmonized text of the Public Procurement Directive does not produce uniform tenders. Peer-reviewed work published in 2024 on adalimumab tenders in Spain after biosimilar entry shows substantial variation across regional health services in award criteria, price-evaluation weightings, lot-splitting, and contract duration, even within a single Member State and a single product category.6FJ Esplugues, I Andújar and JV Esplugues, ‘The impact of EU public procurement regulations on tenders in Spain: a study with adalimumab’ (2024) 15 Frontiers in Pharmacology 1447324. The cross-Member-State variation observable in other product categories follows the same pattern. For the carve-out in Art. 85(1)(ad) of the Directive, this means that pre-expiry tender participation will be worth more in some Member States than in others; the provision is the same in each Member State, but the tender systems it applies to differ materially, and where its limits are litigated, each jurisdiction’s courts will draw them against different procurement practice.
4. The “Sale or Offering for Sale” Line and Framework-Tender Contracting
Art. 85 of the Directive closes with two sentences that together demarcate the limit of the carve-out. The procurement-tender carve-out in Art. 85(1)(ad) of the Directive is itself conditioned by the phrase “to the extent that it does not entail the sale or offering for sale or marketing of the medicinal product concerned during the protection period.” Art. 85(3) of the Directive then says, of the whole provision, that the exception “shall not cover the placing on the market of the medicinal products resulting from such activities.” Two related questions follow. First, what is the relationship between “sale or offering for sale or marketing” in Art. 85(1)(ad) of the Directive and “placing on the market” in Art. 85(3) of the Directive? Second, on which side of the line does a binding tender bid, a signed framework agreement, a pre-positioned warehouse stock, or a promotional outreach to hospital purchasers fall?
The text does not equate the two formulations. “Placing on the market” is a defined term elsewhere in the Union pharma framework and is typically understood as the first act by which the medicinal product is made available on the Union market for distribution or use. “Offering for sale” is a patent-law concept whose scope varies by Member State and that has historically reached pre-contractual commercial conduct directed at procuring sales as well as the contractual moment of supply itself. The carve-out in Art. 85(1)(ad) of the Directive prohibits both during the protection period; the carve-back in Art. 85(3) of the Directive prohibits the narrower “placing on the market” concept globally. The asymmetry of the two formulations is itself a litigable surface. A framework-tender award that produces no individual call-off until after patent expiry may fall short of a placing on the market under Art. 85(3) of the Directive and still be an offering for sale that Art. 85(1)(ad) of the Directive does not shelter, or it may be neither, depending on the reading a national court gives to the pre-supply moments of the procurement cycle.
The second subparagraph of Art. 85(1) of the Directive raises the question of stockpiling. The carve-out for the activities listed in Art. 85(1) of the Directive “may cover, where relevant, the submission of the application for a marketing authorisation and the offer, manufacture, sale, supply, storage, import, use and purchase of medicinal products or processes, including by third party suppliers and service providers.” The list explicitly contemplates that storage and import of finished product still under patent or SPC protection, and supply between third-party service providers can sit inside the carve-out, so long as those acts are functionally tied to one of the five permitted categories. A generic warehouse position established during the protection period, built up against an anticipated post-expiry launch, is Bolar-covered only on a wide reading of that list: the chapeau reaches “necessary” activities, the list applies “where relevant,” and the acts must be conducted “exclusively” for the listed purposes. That latitude does not, however, displace the instrument that already governs pre-expiry manufacture and stockpiling: the manufacturing-and-stockpiling waiver inserted into the SPC Regulation by Regulation (EU) 2019/933 permits a maker to manufacture within the Union during the SPC term for export to third countries, and, in the final six months of the SPC term, to manufacture and stockpile for the purpose of day-one Union launch, subject to notification, labeling, and anti-diversion safeguards.7Regulation (EC) No 469/2009 (SPC Regulation), as amended by Regulation (EU) 2019/933, Art. 5: the SPC manufacturing-and-stockpiling waiver, permitting export throughout the SPC term and day-one stockpiling in the final six months of the term. The waiver is narrower than Art. 85 of the Directive on its face, being time-limited to the last six months and conditioned on specific notice and labeling duties, and it operates directly in patent-and-SPC law rather than in the regulatory-procedure register Art. 85 of the Directive mainly addresses. Whether the second-subparagraph permission of Art. 85 of the Directive to manufacture, store, and import product still under protection enlarges day-one stockpiling beyond the waiver’s six-month window, or whether stockpiling-for-launch remains governed by the waiver’s conditions while Art. 85 of the Directive reaches only the regulatory-preparation manufacture tied to its listed activities, is an interaction the final compromise text leaves unresolved. Whether the same warehouse position becomes uncovered the moment that the entrant signals to potential customers that supply is imminent is a question the text does not answer directly. Recital 64 of the Directive frames the practical aim as enabling market entry “on day one of loss of the patent or SPC protection,” which suggests a wide reading of the preparatory acts available; the carve-back in Art. 85(3) of the Directive suggests a narrow reading of what counts as the final commercial step. Recital 64 and Art. 85(3) of the Directive are not inconsistent, but they support different commercial postures at the margin, and the early jurisprudence will need to assign relative weight.
Preliminary Injunctions
For an originator considering preliminary injunction relief against generic activity during the protection period, the procedural geometry has changed. Pre-reform, an injunction could be sought against tender submission, against HTA dossier filing, against P&R interaction, against warehouse construction, and against most pre-launch promotional outreach. Under Art. 85 of the Directive, an injunction request directed at those activities, promotional outreach apart, encounters an explicit statutory carve-out at the EU level. The remaining injunction surface concentrates on the placing-on-the-market boundary itself: the moment of first sale, the moment a binding offer crystallizes, the moment goods leave a warehouse for a customer rather than for evaluation. National injunction practice will have to recalibrate around that narrower surface, and the procedural cost of obtaining injunctions for genuinely infringing conduct may shift to the moment of actual market entry rather than to upstream preparatory acts.
Day Zero to Day One
The day-zero to day-one operational mechanics deserve separate attention. Recital 64 of the Directive describes the policy aim of entry “on day one of loss of the patent or SPC protection,” and the second subparagraph of Art. 85(1) of the Directive (read on the verbatim final compromise text) permits the manufacture, storage, supply, and assembled physical preparation that day-one entry requires. The provision does not directly address the operational instant at which day-zero ends and day-one begins. Three mechanics turn on that instant: whether a framework-tender award signed during the protection period auto-activates as a supply contract at midnight or needs a fresh act by the marketing authorization holder to become orderable; whether a stockpile positioned at a distributor for evaluation converts into a Bolar-uncovered placing on the market the moment expiry attaches or only on the distributor’s first downstream sale; and whether a price-and-volume commitment made during the protection period binds from expiry or requires post-expiry confirmation. The new Bolar enables the preparatory state but does not specify the operational geometry of the midnight transition, which falls to national contract law, national supply-chain regulation, and national procurement practice and is unlikely to be uniform across the Union.
The Promotional-Law Question
A separate cross-framework question concerns the interaction between the IP-rights carve-out in Art. 85 of the Directive and the EU’s promotional-regulation framework. Title VIII of Directive 2001/83/EC (and its substantive successor in the new Directive) prohibits the advertising of medicinal products for which a marketing authorization has not been granted and constrains the promotion of authorized products in detail; some Member States additionally restrict pre-authorization promotional contact with healthcare professionals beyond what Title VIII requires. A generic or biosimilar entrant whose pre-expiry HTA or tender preparation crosses into promotional activity directed at HCPs or hospital purchasers may therefore encounter a binding constraint that the IP carve-out does not displace: Art. 85 of the Directive immunizes the act against patent and SPC infringement claims, but a separate promotional-law framework administered by separate competent authorities operates in parallel and may prohibit the same act on different grounds. The two coverage analyses are independent, and the practical implication for pre-expiry outreach is that Bolar permissibility and promotional-regulation permissibility need to be assessed separately for each act.
5. SPCs, Pediatric Extensions, and Cross-Border Procurement Aggregation
The new Bolar applies on its face both to basic patent terms and to supplementary protection certificate periods. Art. 85(1) of the Directive opens with the phrase “the protection provided by patent rights, or supplementary protection certificates under [the SPC Regulation],” and the recital placeholder confirms the cross-reference to Regulation (EC) No 469/2009.7Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) [2009] OJ L152/1 (SPC Regulation). The textual scope of the carve-out therefore reaches the late phase of a product’s protected commercial life, when SPC value is at its highest and when the generic and biosimilar competitive set is most acutely focused on entry timing.
The pediatric six-month extension, available under Art. 36 of Regulation (EC) No 1901/2006, sits on top of the SPC and adds half a year to the SPC-protected period when an agreed pediatric investigation plan has been completed and its results reflected in the summary of product characteristics; the Pharma Package preserves the reward by reproducing the six-month extension in Art. 86 of the Directive, immediately following the Bolar in Art. 85 of the Directive.8Regulation (EC) No 1901/2006 of 12 December 2006 on medicinal products for paediatric use [2006] OJ L378/1 (Paediatric Regulation), Art. 36. For originators that have historically modeled the pediatric extension as a six-month soft landing in which downstream price-and-reimbursement activity by competitors could not yet meaningfully begin, the new Bolar reframes the extension. The extension still defers the moment at which generic placing on the market is permitted. It does not defer the moments at which HTA submissions, P&R dossier preparation, or tender filings may now run against the originator’s late-life revenue. The economic value of the pediatric extension to revenue therefore depends on a narrower set of acts than it did before, and the gradient of that revenue curve at expiry is steeper.
Cross-border procurement aggregation raises a separate problem. The Pharma Package Regulation reinforces the European Medicines Agency’s role in critical-medicines coordination, and the EU has been moving toward broader joint procurement mechanisms for certain product categories of supply-security or strategic importance. When a joint procurement is conducted across multiple Member States whose patent or SPC expiry dates for the same product are not aligned, the question of whether the tender submission falls inside Art. 85(1)(ad) of the Directive is no longer a binary. The same submission may be sheltered for supply to one Member State and not for supply to another. The Pharma Package does not directly resolve whether a joint procurement procedure can be designed to apply the carve-out Member State by Member State, or whether the awarding authority must design it that way.
A related interaction sits with Art. 84 of the Directive, which establishes a separate four-year regulatory data protection period for medicinal products granted a new therapeutic indication not previously authorized in the Union for the same active substance, on conditions that include adequate non-clinical or clinical supporting studies and the absence of prior data protection for the medicinal product (or the lapse of twenty-five years since initial authorization). For repurposing applicants pursuing such a second-medical-use pathway, the Bolar carve-out in Art. 85 of the Directive and the data-protection regime of Art. 84 of the Directive operate in different registers but interact at the level of who may do which preparatory acts during which period. Art. 85 of the Directive immunizes against the reference product’s patent or SPC rights the studies, HTA, P&R, and procurement-tender work necessary to bring the new-indication product to market; Art. 84 of the Directive does not concern itself with patents and serves only to allocate a regulatory-protection period to the repurposing applicant’s own new-indication dataset. The combined effect is that a repurposing applicant’s pre-expiry preparatory latitude is shaped by the Bolar carve-out, and the post-launch competitive exclusivity for the repurposed indication is shaped by Art. 84 of the Directive; whether the two regimes are jointly sufficient for a viable repurposing strategy under the new framework is a question with material implications for the second-medical-use deal-making that the Pharma Package overall is designed to encourage.
6. Strategic Considerations: LOE Modeling, the Transatlantic Asymmetry, and the Boundary-Jurisprudence Horizon
For a US originator with EU revenue from a portfolio approaching patent or SPC expiry, the new Bolar means revising the loss-of-exclusivity model on at least three points. The first is the timing of the revenue gradient itself. Models that assumed a multi-month residual window between expiry and effective generic competition were grounded in the absence of pre-expiry HTA, P&R, and tender activity rather than in any inherent slowness of regulatory transition. Once those activities run in parallel during the protection period, the gradient at expiry steepens. The second is the timing of the supply transition for hospital-channel and centrally procured medicines specifically, where framework agreements awarded during the protection period may convert into supply orders at the moment of expiry rather than after a procurement cycle that begins post-expiry. The third is the IP-litigation budget for the late-life phase, since Art. 85(2) of the Directive removes a number of injunction theories that used to be live and concentrates the remaining litigable surface on the narrower placing-on-the-market boundary.
The recalibration raises questions the new framework does not answer. One is a reporting question: how a US originator that has historically modeled EU LOE on a several-month residual window should restate its forward-looking statements, impairment analysis, and pipeline-asset valuations to reflect a near-zero one. Another concerns portfolio shape, since a pediatric-extension product and a non-extension product reaching late life together now carry revenue curves that differ in contour rather than only in length, complicating board-level capital allocation between them. A compression of the expected post-expiry residual margin may also unsettle EU subsidiary structures built on transfer-pricing and entrepreneurial-return assumptions, prompting an intercompany-agreement review the standard cycle would not have triggered.
For first-mover generic and biosimilar entrants, the wider Bolar window is a competitive opportunity whose value depends on operational alignment between the manufacturing, regulatory, HTA, P&R, and tender-strategy functions inside the entrant’s organization. A first-mover that can run all of these streams in parallel during the protection period, and reach expiry holding an MA, a completed HTA assessment, engagement with the P&R authority, and framework-tender awards, gains a launch position the prior regime did not permit. The effect is sharpest for biosimilars, whose longer manufacturing scale-up, heavier comparability and clinical packages, and hospital-tender-driven route to market make the parallel pre-expiry runway worth materially more to them than to small-molecule generics. A second-mover that arrives at expiry with only an MA in hand may find a market in which the first-mover has already converted the EU’s post-expiry runway into market share. The strategic question for second-movers, then, is whether the carve-out itself reshapes the entry-rank economics of the EU generic and biosimilar markets, and how that reshaping interacts with cross-jurisdictional rank decisions that historically treated EU entry as an after-FDA-and-after-US-launch step.
The Transatlantic Asymmetry
For a US-headquartered audience whose baseline frame of reference is the US Bolar at 35 U.S.C. § 271(e)(1), the EU expansion crystallizes a transatlantic asymmetry that is now substantially wider than at any point since the Hatch-Waxman Act’s enactment in 1984. The US safe harbor immunizes uses “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products,” a phrase that the Supreme Court read broadly in Eli Lilly v Medtronic (extending the safe harbor beyond ANDA filers to medical-device applications) and in Merck KGaA v Integra Lifesciences (extending the safe harbor to preclinical research where there is a reasonable basis to believe the compound tested could be the subject of an FDA submission).935 U.S.C. § 271(e)(1) (Hatch-Waxman safe harbor); Eli Lilly v Medtronic, 496 U.S. 661 (1990); Merck KGaA v Integra Lifesciences, 545 U.S. 193 (2005). The statute is, however, anchored to the federal regulatory-approval framework. It does not on its face or in the judicial gloss extend to downstream pricing-and-reimbursement preparation activity or to participation in procurement processes, which sit outside the FDA’s regulatory orbit and which are not regulated by a federal law of the kind to which 35 U.S.C. § 271(e)(1) refers. The new EU carve-out reaches four activity categories that US doctrine does not reach in comparable terms (HTA, P&R, subsequent practical requirements, and procurement-tender submission). The asymmetry is therefore one of reach, not degree: a US generic or biosimilar entrant active in both jurisdictions will find a wider preparatory latitude on the EU side than on the US side from the date the new framework applies, and a US originator with EU revenue will face a faster transition than the US Bolar would itself produce on a US-only commercial timeline.
Switzerland, National Supply Rules, Trade Law, and the Unified Patent Court
The Swiss patent-rights carve-outs relevant to pre-launch activity sit in Art. 9(1) PatG: lit. (b) exempts acts undertaken for research or experimental purposes in order to obtain knowledge about the subject-matter of the invention, and lit. (c) exempts “acts necessary for obtaining marketing authorisation for a medicinal product in Switzerland or in countries with comparable medicinal product control.”10Bundesgesetz vom 25. Juni 1954 über die Erfindungspatente (Patentgesetz, PatG) (SR 232.14), Art. 9 Abs. 1 lit. b and lit. c; the operational reach of “countries with comparable medicinal product control” tracks Swissmedic’s Art. 13 HMG recognition framework. The phrase “countries with comparable medicinal product control” is operationalized at the regulatory level by Art. 13 of the Bundesgesetz über Arzneimittel und Medizinprodukte (Heilmittelgesetz, HMG) and the corresponding Swissmedic guidance, which recognize the FDA, the EMA, Health Canada, Australia’s TGA, and Japan’s PMDA as authorities with comparable medicinal product control; the practical effect is that Swiss-territory activity directed at FDA submission for products with Swiss patent protection in force can fall inside the Swiss Bolar. The Swiss carve-out covers research and regulatory marketing-authorization work; on its face it does not cover HTA, P&R, or tender preparation as freestanding categories. The EU Pharma Package expansion does not automatically apply to Switzerland, because Switzerland is a third country to the Union for the purposes of the Directive and Swiss patent law is set by national legislation. Whether the Swiss Federal Council or the Federal Assembly will eventually align the PatG with the EU expansion is a separate legislative question with its own timeline, its own consultation process, and its own political economy. For a US originator or US entrant active in both Switzerland and the EU, the gap between the Swiss and EU carve-outs is now wider than at any time since the 2004 EU reform, and whether tender preparation or HTA activity in Switzerland for products with Swiss patent protection in force is permissible is governed by a Swiss provision that has not changed.
Recital 65 of the final compromise text of the Directive leaves Member States a competence that may make the post-expiry runway shorter or longer at national level than the Union-level carve-out alone would suggest. The recital states that Member States “remain free to introduce rules to ensure the readiness to supply a medicinal product on the market of that Member State for the period when the patent and SPC have expired.” Whether such national rules can address supply-continuity obligations imposed on the entrant ahead of expiry, mandatory stockpiling for critical medicines, post-launch transparency disclosures, or distribution-license conditions tied to the post-expiry phase is unspecified in the recital’s text and unspecified in Art. 85 of the Directive. The recital preserves a residual Member State competence whose practical shape is not yet drawn; whether Member States deploy it in ways that fragment the Union-level harmonization Art. 85 of the Directive otherwise produces, and whether the rules they adopt sit comfortably alongside the prohibition in Art. 85(2) of the Directive on IP-grounded refusal of decisions, are questions the implementation phase will need to answer.
Over the longer term, compatibility with international trade law may also matter. Several commentators have raised whether the extension of the carve-out into HTA, P&R, and tender preparation can be sustained under the “limited exception” standard of Art. 30 of the TRIPS Agreement, given that the WTO panel in Canada, Patent Protection of Pharmaceutical Products held in 2000 that the regulatory-review limb of the Canadian Bolar (then in s 55.2(1) of the Canadian Patent Act) was a permissible limited exception while the stockpiling exception in s 55.2(2) of that Act was not, the panel reasoning that the second exception conflicted unreasonably with normal exploitation of the patent.11Agreement on Trade-Related Aspects of Intellectual Property Rights (15 April 1994) 1869 UNTS 299 (TRIPS), Art. 30; Panel Report, Canada, Patent Protection of Pharmaceutical Products, WT/DS114/R (17 March 2000), adopted 7 April 2000. When the Union enacted the SPC manufacturing-and-stockpiling waiver, it confined the stockpiling limb to the final six months of the SPC term, yet even that limited window sits uneasily with the Canada panel’s treatment of a closely comparable six-month Canadian stockpiling provision as falling outside Art. 30 TRIPS.7SPC Regulation (n 7), Art. 5, as inserted by Regulation (EU) 2019/933: manufacture for export throughout the SPC term; stockpiling for day-one Union entry only in the final six months, subject to notification, labeling and anti-diversion safeguards. The broader manufacture-and-storage permission of Art. 85 of the Directive, which has no express six-month limit, is more open still to the same objection. The debate over whether the new Art. 85 of the Directive sits on the regulatory-review side or strays toward the stockpiling side of the Canada panel’s analytical line is live and not resolved; whether any WTO challenge eventuates is speculative, but the question is one that pre-launch IP strategy at the multi-year horizon may sensibly track.
Litigation risk in the months either side of expiry remains live, but its character changes. For originators, the value of preliminary injunctions against pre-expiry preparatory activity is sharply reduced by Art. 85(2) of the Directive; the practical question is whether a coherent litigation theory can be built around acts that the Directive expressly classifies as non-infringing. The Unified Patent Court, operational since June 2023, has begun to develop its own jurisprudence on what “imminent infringement” requires in pharmaceutical pre-launch disputes for the purposes of provisional measures, and the expanded carve-out of Art. 85 of the Directive is expected to reinforce the line that MA application activity, HTA filings, and P&R interactions do not by themselves clear the imminent-infringement threshold.12Agreement on a Unified Patent Court [2013] OJ C175/1 (UPCA), Art. 25, Art. 32(1)(c), and Art. 62 (infringement, jurisdiction in provisional and protective measures, and provisional measures); jurisprudence is at an early and developing stage as of publication. The forum-choice question that sits behind the boundary jurisprudence remains active: a Bolar-related infringement claim involving a unitary patent will be heard before a UPC division, one involving a European patent that has not been opted out may be brought there or, during the UPC transitional period, before national courts, while a claim involving an opted-out European patent or a purely national patent will sit in national courts. The two pathways may produce divergent boundary jurisprudence in the early years, and originators retain strategic discretion over patent-portfolio opt-out positioning during the seven-year UPC transitional period that may be extended by the Administrative Committee for a further seven years. The harder open question is whether a cumulative pattern of late-stage launch preparations carried out in the months immediately before expiry, even where each individual act is carve-out covered, may be treated as evidence of imminent infringement that justifies a provisional-measures order timed to bite at the moment of placing on the market. For entrants, the main risk now lies at the boundary rather than in the upstream Bolar question: does a particular pre-expiry tender bid, framework signature, warehouse build-up, or promotional outreach act stay within the shelter of Art. 85(1) of the Directive and short of the placing on the market that Art. 85(3) of the Directive excludes, or does it become an uncovered offering for sale or placing on the market? The line will be drawn case by case in the early years, by national courts and UPC local and regional divisions whose patent-law traditions differ on what “offer for sale” reaches. The carve-out is harmonized at the Directive level; the boundary jurisprudence will not be harmonized until the Court of Justice has had successive opportunities to consider questions referred to it. Whether the entrants and originators of the late 2020s and early 2030s prefer to be the test cases that generate that jurisprudence, or the observers who price in the uncertainty until the law settles, is a question every late-life portfolio decision now implicitly answers.