US licensing counsel author the object. A life sciences licence opens with a definitions section, and "Licensed Technology" is drafted there: issued patents, pending applications, secret know-how, a curated dataset, sometimes the weights of a trained model, sometimes a registered design. Under the antitrust framework US practitioners work within, that authored bundle is the thing analyzed. The DOJ and FTC licensing guidelines assess the restraints an agreement imposes under the rule of reason in the vast majority of cases, reserving per se treatment for a narrow class that includes naked price fixing, output restraints and market division among horizontal competitors, and certain group boycotts. They contain no closed statutory list of licensable rights, and nothing of consequence turns on whether a given element of the bundle is formally a patent, a database right, or a trade secret.1DOJ and FTC, Antitrust Guidelines for the Licensing of Intellectual Property (2017): rule of reason in the vast majority of cases, no statutory list of licensable rights.
European competition law inverts the sequence. Before any restraint is assessed, a prior question is answered: which elements of this bundle are technology rights at all? The answer decides whether the agreement can enter a block exemption's safe harbor, and the safe harbor is what converts an agreement from something requiring individual justification into something presumed lawful. The block exemption that governed technology licensing across the European Union and, in assimilated form, the United Kingdom, expired on 30 April 2026.2Commission Regulation (EU) No 316/2014, expired 30 April 2026; transitional cover to 30 April 2027. Two successor instruments took effect the following day, and a third jurisdiction declined to adopt one. The three answers stopped coinciding.
When this corpus last examined life sciences licensing, all three instruments were pending: the European regulation was five months from expiry, the United Kingdom had a published recommendation from the Competition and Markets Authority but no made instrument, and the Swiss revision awaited its final parliamentary vote (see Article 13, which analyzes the contractual provisions themselves, and whose treatment of scope, royalties, diligence, grant-backs and termination this analysis does not revisit). All three have since landed. What they produced is not a harmonized regime with local variations. It is a definitional divergence about the licensed object, and the divergence falls precisely where modern life sciences value has migrated: onto data.
1. What Counts as a Technology Right?
The revised European block exemption, the Technology Transfer Block Exemption Regulation (TTBER), applies to agreements that license technology rights, and it defines that term by enumeration.3Commission Regulation (EU) 2026/877 (revised TTBER), in force 1 May 2026, expiring 30 April 2038. The enumeration runs from know-how and patents through utility models, design rights, topographies of semiconductor products, supplementary protection certificates, plant breeders' certificates and software copyright. It does not name copyright in a database, and it does not name the sui generis database right.
The United Kingdom's replacement instrument enumerates as well, and the list is not the same one.4The Competition Act 1998 (Technology Transfer Agreements Block Exemption) Order 2026, SI 2026/369, in force 1 May 2026. Art. 2 of the 2026 Order defines technology rights as know-how, patents, design rights whether registered or unregistered, rights in semiconductor topographies, supplementary protection certificates, plant breeders' rights, copyright in software, and "copyright in a database and database right", together with applications for certain of those rights. Two differences from the European list are structural rather than cosmetic. The Order adds database copyright and the database right. The Order omits utility models, a category United Kingdom intellectual property law does not recognize.
Switzerland enumerates nothing, because there is nothing to enumerate. The Kartellgesetz (KG) has never contained a technology-transfer block exemption, and the partial revision adopted by the Federal Assembly on 19 December 2025 does not create one.5Bundesgesetz über Kartelle und andere Wettbewerbsbeschränkungen (Kartellgesetz, KG) vom 6. Oktober 1995 (SR 251); Änderung vom 19. Dezember 2025, BBl 2026 18. The word Technologietransfer appears nowhere in the amending text, and neither does any block exemption. There is accordingly no Swiss statutory category of technology right, no list to fall inside, and no perimeter to fall outside.
A licence defines its own subject matter. Two competition regimes define it again and no longer define it the same way, a third declines to define it at all, and since 1 May 2026 one unchanged clause has granted three different objects.
The consequence is easy to state and difficult to price. A licensor whose bundle contains a utility model and a curated database holds, in the European Union, one element inside the enumerated list and one outside it. In the United Kingdom the position reverses element for element. In Switzerland neither element is inside or outside anything, because the categories on which insideness depends do not exist. The commercial terms are identical in all three territories. The competition-law characterization of what was granted is not.
2. Where Does Licensed Data Sit?
The 2026 package is the first time a technology-transfer block exemption has addressed data licensing at all. The treatment is thinner than the attention it has attracted, and its placement matters. In the European Union it sits in the accompanying Technology Transfer Guidelines, not in the Regulation itself.6Guidelines on the application of Art. 101 TFEU to technology transfer agreements [2026] OJ C 2026/2323. Licensed data falls within the block exemption where the data itself qualifies as know-how, where it constitutes another licensed technology right, or where the data is licensed within a technology transfer agreement under Art. 2(3) of the Regulation, which covers ancillary provisions to the extent they are directly related to the production or sale of the contract products. Data protected by copyright or by the sui generis database right that qualifies under none of those routes is reached only by analogy: the Commission has indicated that it will generally apply the principles of the Regulation and the Guidelines to such licensing under Art. 101 TFEU, without the agreement thereby entering the safe harbor.
Analogy is not exemption. A block exemption supplies a presumption; an analogy supplies a prediction about how an authority expects to reason. The distinction is invisible while nobody complains and decisive once somebody does, because the presumption is what relieves the parties of the burden of establishing that the four conditions of Art. 101(3) TFEU are satisfied. A dataset that reaches the Guidelines only by analogy is a dataset whose licence must, if challenged, be justified from first principles.
The United Kingdom Order takes the opposite route with the same subject matter. Because database copyright and the database right are enumerated in Art. 2, a licence of a protected database is a licence of technology rights, and an agreement built around it is capable of being a technology transfer agreement within the Order's meaning. The dataset that reaches the European Guidelines by analogy reaches the United Kingdom safe harbor by definition. The sui generis right on which the United Kingdom inclusion operates originates, for both jurisdictions, in the same 1996 Database Directive.7Directive 96/9/EC on the legal protection of databases: copyright in databases and the sui generis database right. The origin is shared; the operative instrument is not, since the 2026 Order defines the database right by reference to Part 3 of the Copyright and Rights in Databases Regulations 1997. The competition-law consequence of holding the right diverges as well. (The Data Act's separate treatment of database rights as an obstacle to access is a different question, considered in Article 40.)
That leaves the question a life sciences licensor is most likely to face, and least likely to have asked. Know-how, in both instruments, is a package of practical information resulting from experience and testing that is secret, is significant and useful, and is described comprehensively enough for those qualities to be verified. Even here the texts diverge: the European Regulation measures usefulness against the production of the contract products, the United Kingdom Order against the production or sale of particular products. A curated assay dataset, a real-world evidence corpus, a set of labeled images used to train a diagnostic model: each may satisfy those criteria, and each may fail them. Publication defeats secrecy. Deposit in a consortium repository may defeat it. Disclosure to a regulator under a confidentiality regime may or may not, depending on the regime. Where a dataset fails the know-how test, it has no route inside the European perimeter in its own right, because the European list does not name the database right; Art. 2(3) can carry a protected database into the exemption only as a provision ancillary to a licence of enumerated rights. The same dataset, failing the same test, enters the United Kingdom perimeter through Art. 2 without difficulty.
So the questions stack. Is the licensed dataset secret, and secret as against whom? If it is not, does it attract database copyright or the database right, and was the investment in obtaining, verifying or presenting its contents substantial enough to sustain that right? If the right subsists, does its subsistence do any work in the European Union, where the list omits it, and all of the work in the United Kingdom, where the list names it? And if the answers differ across a border the licence never contemplated, which of the two characterizations governs the royalty the parties negotiated for a single global grant?
3. Rights That Fall Outside
Falling outside a block exemption is not illegality. It is the loss of a presumption, and the transfer of an evidential burden onto the parties who benefit from the agreement. Article 13 sets out what individual assessment under Art. 101(3) TFEU requires, and that analysis is not repeated here. What the 2026 instruments add is a new way of falling outside: not because a restraint is objectionable, but because the licensed thing is not, in that jurisdiction, a thing the exemption recognizes.
The utility model is the cleanest illustration. It is an enumerated technology right in the European Union and absent from the United Kingdom Order's Art. 2. The obvious response, that the omission is immaterial because the United Kingdom grants no utility models, assumes the omission operates territorially. It does not obviously do so. A German Gebrauchsmuster is a utility model, and a global licence of a manufacturing process may be built on one. Art. 3(2) of the Order specifies technology transfer agreements only to the extent that they provide for technology rights to be licensed, and Art. 3(3)(b) reaches the licensing of other intellectual property rights only to the extent that the provision is directly related to the production or sale of the contract products. A licensed utility model therefore stands in the United Kingdom where a licensed database stands in the European Union, inside the exemption as an ancillary provision and only so far as that relation holds. Where the unenumerated right is the principal object of the grant rather than an adjunct to an enumerated one, the Order does not say what the agreement becomes, and the downside is plain: the Chapter I prohibition applies to it without block-exemption cover.8Competition Act 1998, s 2 (the Chapter I prohibition).
A second asymmetry runs in the opposite direction, and it concerns the way into the harbor rather than the way out. Both regimes retain the familiar market-share thresholds, and both extended the grace period for exceeding them from two to three consecutive calendar years. Once the parties are past the thresholds, however, the two regimes rescue an agreement by different mechanisms. The European Guidelines supply a safe harbor that sits outside the block exemption: in the absence of hardcore restrictions, an infringement of Art. 101 TFEU is unlikely where, in addition to the licensed technology, four or more independently controlled competing technologies exist. That safe harbor is expressed in the language of likelihood and carries no block-exemption presumption; it states how the Commission expects to exercise its enforcement discretion. Art. 5 of the United Kingdom Order does something different in kind. It writes its alternative into the block exemption's own conditions: for competing and non-competing undertakings alike, the technology-market limb of the threshold test is met either where the parties are within the relevant share or where "there are three or more independent competing technology rights", the separate contract-product-market limb continuing to apply. A statutory condition, at a lower number, doing work that on the European side is left to a paragraph of guidance.
A licensor past the technology-market share threshold therefore holds, for the same technology in the same product market, a statutory route into the United Kingdom exemption and a paragraph of soft comfort in the European Union. Nothing in the licence produces that difference. Nothing in the licence can remove it.
4. A Grant With No Safe Harbor
Swiss law is the limiting case, and it is instructive precisely because it removes the variable the first three sections have been tracking. Where there is no block exemption, there is no enumerated list; where there is no list, the classification of the licensed object cannot determine anything, because nothing is determined by classification. Subject to Art. 3 Abs. 2 KG, which removes from the statute's reach competition effects arising exclusively from intellectual property legislation while leaving import restrictions founded on such rights inside it, every technology-transfer agreement affecting Swiss competition is assessed on its own terms. The Wettbewerbskommission (WEKO) has never held the power to grant a technology-transfer block exemption. Art. 6 Abs. 1 lit. d KG does name agreements on the exclusive licensing of intellectual property rights among the categories whose conditions of presumptive efficiency justification may be described, and Art. 6 Abs. 3 KG allocates that task to the Federal Council by ordinance and to WEKO by general notice published in the Bundesblatt. Neither has ever been issued for technology transfer, and the Vertikalbekanntmachung of 12 December 2022, through which WEKO addresses vertical restraints, does not apply to an agreement whose provisions on the transfer of intellectual property rights to the buyer, or on their use by the buyer, are its principal object and do not relate directly to the use, sale or resale of goods or services by the buyer or its customers.
The revision of 19 December 2025 sharpens the position rather than relieving it. New Art. 5 Abs. 1bis KG provides that the significance of a restriction of competition, its Erheblichkeit, is to be assessed case by case in an overall assessment (Gesamtbeurteilung) on the basis of qualitative elements in the form of accumulated experience (Erfahrungswerte) and quantitative elements in the form of the concrete circumstances on the relevant market. That provision is a legislative correction. It displaces the reading of the Federal Supreme Court's Gaba judgment under which certain categories of restraint could be treated as significant without a quantitative examination of their market effects.9BGE 143 II 297 (Gaba), displaced in this respect by the new Art. 5 Abs. 1bis KG.
What replaces the near-categorical rule is not an exemption but an individualized total assessment. A Swiss-law-governed licence gains no presumption from the change; it gains a standard under which the presence or absence of harm must be demonstrated on the market facts, in both directions. Neither the European four-technology comfort nor the United Kingdom's three-right statutory alternative has any Swiss counterpart, and the revision creates none.
A temporal complication attaches to all of this, and it is not resolved as of publication. The amending Act provides that the Federal Council determines its entry into force, and the referendum period ran to 17 April 2026. The Federal Council has set no commencement date, and the consultation on the total revision of three of the four existing ordinances to the KG, none of which addresses technology transfer, opened on 27 May 2026 and runs to 17 September 2026. A licence governed by Swiss law and signed in the interval is therefore assessed under an unamended statute that already lacks any technology-transfer perimeter, against a significance standard that has been rewritten by a legislature and not yet brought into force by an executive. Whether the parties allocated that risk, and to whom, is not something the block exemptions of the neighboring jurisdictions can answer.
5. Strategic Implications
The structural point for US transactional counsel is that the licence's own defined term is not the operative object. Whatever "Licensed Technology" is drafted to mean, three competition authorities will read the bundle through three taxonomies, and two of those taxonomies were rewritten with effect from 1 May 2026 while the third was never written at all. The definitions section can allocate rights between the parties. It cannot allocate the category into which a regulator places each right, and the category is what determines whether the safe harbor is available.
That produces a coordination gap of a familiar shape and an unfamiliar location. Intellectual property counsel classify the rights in the bundle for prosecution and maintenance purposes; antitrust counsel assess the restraints the agreement imposes. Neither function is ordinarily asked whether the bundle's elements constitute the same objects in each of the regimes the agreement touches, because until 1 May 2026 the assimilated instrument made the question uninteresting for the European Union and the United Kingdom together. Whether that analysis was performed matters less than whether it was documented, escalated, and revisited when the successor instruments diverged.
Timing compounds the difficulty rather than relieving it. Agreements in force on 30 April 2026 that satisfied the predecessor regulation but do not satisfy its successor retain block-exempt status until 30 April 2027, and the United Kingdom Order's transitional provision, which is conditioned the same way, runs to the same end date. Any grant renegotiated, restructured or extended after those windows close is classified against both perimeters as they then stand, and the perimeters are on separate clocks: the European Regulation expires on 30 April 2038, the United Kingdom Order at the end of 31 December 2038. Two instruments that began life on the same day, from a common ancestor, are scheduled to end eight months apart, with a statutory United Kingdom review falling due long before either.
The unresolved questions are not draftable around, which is what makes them worth identifying. If a dataset is the commercially significant element of a licence, and it qualifies as know-how in neither jurisdiction, is a grant that reaches the European Guidelines only by analogy priced as though it enjoyed the safe harbor it does not have? If a bundle is built on a utility model rather than merely containing one, does the United Kingdom Order's silence about that category leave the agreement outside its scope, and is that a proposition only litigation will establish? If a licensor's share of a technology market rises above the threshold in year four, does the availability of a statutory alternative on one side of the Channel and a paragraph of guidance on the other change what the parties should have agreed about who bears the consequence? And where the same grant reaches Switzerland, under what standard is it assessed during the interval between a revision the legislature has adopted and a commencement date the executive has not fixed?
Each of these turns on facts that only the parties hold: the secrecy status of the licensed data, the composition of the rights bundle, the shape of the relevant technology market, and the commercial weight the royalty places on the elements whose classification differs. This analysis identifies where the complexity arises without purporting to resolve it. These questions require analysis tailored to specific facts and commercial context.