Timo Minssen

New genomic technologies (NGTs) such as genome editing – the modification of DNA in living cells – promise to revolutionize agriculture. Beyond simply yielding new, commercially viable crop varieties, NGTs also hold out the promise of using novel crops as a “biosolution” – methods to improve sustainability practices by reducing pesticide usage, improving drought tolerance, increasing yield, and minimizing food and fertilizer waste. At the same time, the complex global system of intellectual property (IP) protection for crops has largely been unchanged for decades. There is accordingly some concern that the current crop IP system will not bring the promise of agricultural biosolutions to fruition. This article reviews NGTs as biosolution and explores how they fit into the current international IP system for crops. Against this backdrop, the article also reviews several proposals to modify the crop IP regime and the recently enacted EU legislation in this field, before tentatively suggesting recommendations for rebalancing the incentive structures in crop IP.

BACKGROUND As brain-computer interfaces (BCIs) increasingly incorporate artificial intelligence, understanding public readiness for their clinical translation is important. However, cross-national evidence on willingness to use emerging BCI technologies, particularly when framed within nanomedicine, remains limited. OBJECTIVE To evaluate cross-national public readiness for a proposed brain-computer interface (BCI) and identify factors associated with willingness to use it in the context of emerging AI-enabled BCIs. METHODS We conducted a cross-sectional online survey from April 9, 2022, through December 23, 2022, among 6,000 adults (1,000 per country) in Canada, Japan, South Korea, the United States, Germany, and Denmark. Using a hypothetical scenario involving a brain disorder such as Parkinson’s disease, respondents indicated their willingness to use nano link technology for themselves or a family member. Adjusted logistic regression models examined factors associated with willingness. RESULTS Overall, 3,748 respondents (62.5%) were willing to use the proposed technology, ranging from 56.6% in the United States to 74.0% in South Korea. Perceived benefits for improved patient self-control (adjusted odds ratio [aOR], 4.66; 95% CI, 4.02-5.41) and real-time disease prevention (aOR, 2.93; 95% CI, 2.55-3.37) showed the strongest adjusted associations with willingness. Concerns about autonomy and overheating associated with real-time data collection were reported by 39.0% and 36.9% of respondents, respectively. CONCLUSIONS Public willingness to use the proposed BCI was substantial across all six countries but varied across national settings. Therapeutic expectations were strongly associated with willingness, while autonomy and safety concerns remained salient considerations for the responsible development and governance of emerging AI-enabled BCIs.

Background AI-enabled brain-computer interfaces (BCIs) are emerging clinical technologies supported by advances in artificial intelligence, neural engineering, and nanomedicine, yet cross-national evidence on public readiness for their use remains limited. Methods We conducted a cross-sectional, six-country public survey between April 9 and Dec 23, 2022, among 6,000 adults (1,000 per country) in Canada, Japan, South Korea, the United States, Germany, and Denmark. Using a brain disorder such as Parkinson’s disease as a hypothetical clinical scenario, respondents indicated their willingness to use a proposed BCI for themselves or a family member, with the findings considered in the broader context of emerging AI-enabled BCIs. Adjusted logistic regression models examined factors associated with willingness. Findings Overall, 3,748 (62.5%) respondents were willing to use nano link technology; willingness was highest in South Korea (740 [74.0%]) and lowest in the United States (566 [56.6%]). Agreement was more frequent for improved patient self-control (4,416 [73.6%]) and real-time disease prevention (4,108 [68.5%]) than for autonomy concerns (2,341 [39.0%]) or concerns about overheating associated with real-time data collection (2,214 [36.9%]). In the fully adjusted model, the strongest associations with willingness were perceived benefit for patient self-control (adjusted odds ratio [aOR] 4.66, 95% CI 4.02-5.41) and real-time disease prevention (aOR 2.93, 2.55-3.37). Interpretation Public willingness to use AI-enabled BCIs was substantial overall and exceeded 50% in every surveyed country, although it varied across countries. Therapeutic expectations were the strongest correlates of willingness, while concerns about autonomy and overheating associated with real-time data collection remained salient and should inform responsible development and governance.

Genome-edited agricultural microbial products represent a promising tool for sustainable agriculture. By engineering soil and plant microbes to improve nutrient uptake, reduce chemical inputs, and enhance resilience, these innovations could help address food insecurity and environmental degradation. However, their application and impact depend on how they are regulated. This article examines the legal treatment of genome-edited agricultural microbial products in the European Union and the United States. In the EU, a process-based framework has long classified most gene-edited microbes as genetically modified organisms, triggering restrictive approvals regardless of risk. In contrast, the U.S. adopts a use-based philosophy, with oversight divided among agencies depending on product function. While more flexible, this model creates legal fragmentation and gaps in ecological assessment. We argue that both systems struggle to accommodate the complexity of genome-edited agricultural microbial interventions. The article concludes with recommendations for legal reform to support safe, adaptive, and proportionate governance of microbial technologies in agriculture.

Regulation (EU) 2025/327 places data from clinical trials within the European Health Data Space's (EHDS) regime for the secondary use of electronic health data and thereby reconfigures the legal conditions under which such data may be accessed across the Union. This article argues that, in the clinical trial context, the EHDS serves not just as an additional transparency instrument but further marks a shift from disclosure of regulatory documents to administratively managed access to reusable datasets. That shift requires attention because the EHDS superimposes a new permitting structure, centred on national Health Data Access Bodies, onto an already dense framework consisting of Regulation 1049/2001, European Medicines Agency (EMA) Policies 0043 and 0070, and the Clinical Trials Regulation. Article 52 is the fulcrum of the new regime. It requires electronic health data protected by intellectual property rights, trade secrets or regulatory data protection to be made available for secondary use, subject to safeguards and refusal where serious risk cannot be satisfactorily mitigated. The article shows that this architecture may harmonise access in form while fragmenting it in operation through divergent HDAB practice across Member States. It argues that Article 52 requires a translation exercise between commercially confidential information, trade secrets and regulatory data protection, and proposes coordinated Article 52 guidance and a clinicaltrial-data assessment template aligned with EMA and Clinical Trials Information System (CTIS) practice and Court of Justice of the European Union (CJEU) confidentiality case law.

The US Food and Drug Administration (FDA) issues complete response letters (CRLs) after completing a review when it determines that it cannot approve a drug or biological product application in its current form. Historically, the FDA has treated CRLs as confidential, leaving sponsors largely in control of how non-approval decisions are described publicly. This approach has been criticized for relying on an expansive view of confidentiality, which can obscure safety, efficacy, and quality-related concerns, and for enabling selective or incomplete sponsor communications. In 2025, the FDA shifted course. On July 10, 2025, the FDA posted more than 200 CRLs tied to applications that had subsequently been approved, consolidating information that was often already embedded in the approval action packages. On September 4, 2025, the FDA released 89 previously unpublished CRLs for pending or withdrawn applications, and committed to real-time disclosure of newly issued CRLs going forward. Using a comparative FDA-European Medicines Agency (EMA) lens, we assess what these initiatives changed at launch and how early implementation through May 2026 affects their durability, legal footing, and information value. By May 2026, the FDA’s CRL initiative had evolved into a functioning yet unsettled disclosure infrastructure: openFDA now offers searchable access to CRLs for approved and unapproved applications, while the FDA’s FY 2027 budget request simultaneously seeks clearer statutory authority to disclose certain information in CRLs. We argue that FDA CRLs and EMA assessment outputs are complementary, and we propose lessons that FDA can learn from the EMA to maximize the value of CRL disclosure: codifying timelines and redaction standards, adding neutral decisional summaries where redactions or technical language would otherwise obscure the basis for non-approval, and standardizing the classification and discoverability of prior-cycle CRLs in approval packages. These reforms can protect legitimate confidential commercial information while enabling learning from unsuccessful applications.

In Meril v Edwards Lifesciences, the Court of Appeal of the Unified Patent Court (UPC) establishes its foundational approach to inventive step. Central to the framework, the objective technical problem is first determined by what the claimed invention adds over the prior art, before the question turns to whether the skilled person would, not merely could, arrive at the claimed solution. Read alongside earlier appellate guidance, such as NanoString v 10× Genomics, the decision signals the emergence of a harmonized UPC doctrine on inventive step, both in interim proceedings and a full trial on the merits. Beyond doctrinal exposition and legal analysis, the article shows how Meril v Edwards Lifesciences will likely affect future drafting, prosecution and litigation strategies, and argues that the decision has important implications for future proportionality analyses and remedies.

Modern innovation increasingly emerges not within individual firms but across (digital) business ecosystems, where multiple independent actors co-produce knowledge and value whilst competing over the distribution of innovation rents. This article argues that existing legal frameworks to protect and promote innovation, particularly intellectual property (IP) law and competition law, were designed for a more linear, standalone model of innovation and are poorly suited to the relational, ecosystem-embedded and cumulative nature of contemporary innovative activity. Drawing on innovation economics, business ecosystem theory, competition and IP law, the article advances three interconnected arguments. First, in regimes of 'shared' and 'open' innovation, IP rights should give rise not solely to exclusionary entitlements but also, in appropriate circumstances, to compensation rights calibrated to reflect the contributions of all ecosystem participants. Second, competition law and IP rights should be reconceived as institutional complements rather than antagonists, each reinforcing the conditions for sustained cumulative innovation. Third, and most innovatively, the article proposes the tokenization of IP and data access rights - including data tokens, IP rights tokens, and innovation rent tokens built on blockchain infrastructure - as a concrete legal technology for operationalizing this framework. Tokenization enables fractional ownership of innovation rents, reduces transaction costs in fragmented IP landscapes, facilitates collateralization by ecosystem participants, and converts exclusionary property rules into compensatory liability rules, thereby aligning legal entitlements with the distributed, cumulative reality of shared innovation. The article calls for a differentiated legal architecture that combines exclusivity and compensation according to ecosystem structure, actor position, and innovation stage.