Publications
Cross-border intellectual property litigation: a Latin American look with a focus on life sciences and patent enforcement
This article aims to give some advice on how to design a cross-border litigation strategy in Latin America with a focus on the life sciences industry and patent enforcement. Considering such frame, our analysis will encompass the scenario in Brazil and Mexico (the two biggest economies of the region) and Mercosur, giving hints on Latam specific issues concerning the interplay between patent protection and health regulations as well as prosecution strategies.
Released on May 12, 2026
FDA’s Departure from conventional policymaking procedures: policy by journal articles
When the new administration took office in January 2025, it introduced a nontraditional form of policymaking at the United States Food and Drug Administration: drug approval reforms announced in restricted-access journal articles. The policy changes outlined in these articles range from introducing a new regulatory approach for individualised therapies to changing the number of clinical investigations generally required for drug approval from two to one. Such policymaking via a journal article lacks many procedural safeguards. This article explores why policymaking in this manner is potentially inconsistent with US administrative law principles under the Administrative Procedure Act and with FDA’s own statutory and regulatory regime, as set forth in the Food and Drug Administration Modernization Act of 1997. We conclude that regulated industry and the public must pursue creative strategies for communicating their needs to the Agency or urge FDA to comply with its procedural obligations. Doing so will ensure that FDA’s policies better account for the interests of industry and the people the Agency serves.
Released on May 12, 2026
Left to our devices: connected care and its legal challenges
The quiet revolution in healthcare is no longer happening in the operating theatre; it is happening on our wrists, in our pockets, and in the cloud. Wearables, home monitoring kits, and AI-driven dashboards promise continuous, connected care, but they also drag hospitals and manufacturers into a thicket of regulatory, liability, and data-governance questions that traditional health law was not designed to answer.
Released on May 12, 2026
All change in the EU: impact of the new EU legislation on combination products in the UK and Switzerland
The European Union’s pharmaceutical reforms will significantly reform medicines regulation, but changes for combination products are more limited, codifying definitions and providing a framework for coordination; applicants must still comply with both the medicines and devices rules. The United Kingdom and Switzerland often align with EU rules but retain separate frameworks; greater divergence may add complexity. The UK remains broadly aligned post-Brexit, but increased divergence may create challenges for reliance pathways and coordination. Switzerland’s authorisation system remains distinct, but alignment on devices means EU device approaches may influence Swissmedic. Overall, impacts are initially procedural, though future EMA developments could drive further divergence.
Released on May 12, 2026