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Client Alerts 28 results
Client Alert | 7 min read | 04.20.26
EU Pharma Package: The “Bolar” Exemption Compromise Proposal
In our sixth alert in this EU Pharma Package Series, we provided an analysis of the history and interpretation issues for another highly debated topic: the “Bolar” exemption.
Client Alert | 5 min read | 04.13.26
EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal
In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product.
Client Alert | 3 min read | 04.07.26
EU Pharma Package: Fiscal Imports in the Supply Chain Compromise Proposal
In our fourth alert in this EU Pharma Package Series, we provided an analysis of the long-standing but increasingly debated issue of fiscal imports in the pharmaceutical supply chain and the EU’s evolving approach to this issue.
Client Alert | 5 min read | 03.30.26
The EU Pharma Package: The Transferable Exclusivity Voucher Compromise Proposal
In our third alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission, the European Parliament , and the Council of the European Union on the transferable exclusivity voucher (TEV) for priority antimicrobials.
Client Alert | 5 min read | 03.22.26
The EU Pharma Package: Regulatory Data Protection Compromise Proposal
In our second alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission (Commission), the European Parliament (Parliament), and the Council of the European Union (Council) on one of the most debated and anxiously anticipated topics, the regulatory data protection (RDP). While all EU institutions proposed a modulation system, they differed significantly in terms of the baseline period and the structure of the possible extensions.
Client Alert | 2 min read | 03.12.26
The EU Pharma Package: Formal Adoption in Sight
The EU Pharma Package represents the most significant reform of EU pharmaceutical legislation in over two decades, setting the stage for a new era in medicine regulation. Introduced by the European Commission back in April 2023, the proposals are designed to promote innovation, strengthen medicine availability and affordability, reduce regulatory burdens, ensure a fair and competitive European pharmaceutical market, and modernize the EU's pharmaceutical framework. The EU Pharma Package will replace the more than twenty-year-old Directive 2001/83/EC and Regulation 726/2004, and incorporates the separate regulations on orphan and pediatric medicines, thereby bringing the entire regulatory framework up to date.
Client Alert | 5 min read | 02.18.26
The CeramTec Case, or How to (not) Navigate the Patent to Trademark Transition
The Court of Justice of the European Union (CJEU) recently delivered its judgment in the CeramTec case (C-17/24).
Client Alert | 7 min read | 12.10.25
Creativity You Can Use: CJEU Clarifies Copyright for Applied Art
On 4 December 2025, the Court of Justice of the EU (CJEU) issued a landmark judgment in the joined cases C-580/23 (Mio v. Asplund) and C-795/23 (USM v. Konektra) concerning copyright protection for “works of applied art” (i.e., utilitarian objects such as tables, furniture, lighting fixtures, sofas, chairs, kitchen appliances, vases, and fashion items).
Client Alert | 6 min read | 11.25.25
Brussels Court Clarifies the EU’s SPC Manufacturing Waiver Regulation Rules
On November 13, 2025, the president of the French-speaking Brussels Enterprise Court ruled in the long-running battle between Sandoz and Regeneron about the correct interpretation of the EU’s Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation regarding exports to a non-EU market. The Brussels Court dismissed Regeneron’s claim that Sandoz had provided a defective notification and agreed with Sandoz’s interpretation of the Regulation.
Client Alert | 35 min read | 10.13.25
Building Blocks of Design Law: CJEU rules on LEGO Group Modular Design Protection
The Court of Justice of the European Union (CJEU) recently issued a landmark judgment in the LEGO Group case (C-211/24) concerning the scope of EU design protection for modular systems. This recent judgment addresses fundamental questions regarding the protection and enforcement of Community designs for modular products, specifically the LEGO Group’s iconic toy building blocks and parts:
Client Alert | 5 min read | 03.11.25
On February 27, 2025, the Court of Justice of the European Union (“CJEU”) issued a ruling about the requirements on data controllers to respond to data access requests regarding an automated decision-making system. In particular, the CJEU interpreted the meaning (under Article 15(1)(h) GDPR) of the phrase “meaningful information about the logic involved” in automated decision-making. Importantly, the ruling also separately addressed how to balance data access rights with the protection of the controller’s trade secrets, when the protection of trade secrets is invoked under Article 15(4) as a reason not to disclose a copy of personal data in an access request.
Client Alert | 5 min read | 10.29.24
On October 24, 2024, the Court of Justice of the European Union (CJEU) handed down its highly anticipated ruling in the Kwantum v. Vitra case (C-227/23). In short, the CJEU held that EU Member States must afford copyright protection for works of applied art (i.e., furniture, lighting, home appliances, etc.) that meet the originality-requirement, regardless of the country of origin of these works or the nationality of the author.
Client Alert | 5 min read | 06.24.24
The Judgment of the Brussels Court of Appeal is the latest development in the saga in Belgium where a Belgian parallel importer, PI Pharma NV, imported a generic Sandoz product from the Netherlands, repackaged and rebranded them, and placed them on the Belgian market alleging they were a Novartis’ originator product.
Client Alert | 10 min read | 05.31.24
2024: An Overview of New and Upcoming Belgian and EU Laws and Regulations – UPDATED in May 2024
At the beginning of the year, we brought to your attention that a number of important Belgian and EU legislative changes are likely to have an impact in 2024: there are new laws that have been adopted and proposals that are expected to firm up into law.
Client Alert | 3 min read | 03.20.24
The EU AI Act and Obligations for Companies Operating in the European Union
In an era where regulatory landscapes are rapidly evolving, companies with a footprint in the European Union must stay vigilant and adaptable. The EU has recently unveiled a comprehensive set of guidelines that impose fresh obligations on both EU and non-EU based companies operating within its borders. This client alert is the first in a series designed to decode the complexities of the new EU regulations and provide actionable insights for businesses to ensure full compliance[1]. Stay tuned as we unravel the details of these pivotal changes and guide you through the steps your business needs to take to align with the EU's heightened regulatory standards.
Client Alert | 5 min read | 02.16.24
On February 17, 2024, The Digital Services Act (DSA) will become applicable, introducing a new regulatory framework for providers of intermediary services. The DSA will apply to those offering their services to users located in the EU, regardless of the providers' place of establishment. We have discussed the new obligations in our previous client alert, when the DSA was adopted. In this alert, we will focus on the notice and action mechanisms, the positions of the users, intermediaries and the general public.
Client Alert | 9 min read | 01.31.24
2024: An Overview of New and Upcoming Belgian and EU Laws and Regulations
A number of important Belgian and EU legislative changes are likely to have an impact in 2024. On the one hand, there are new laws that have been adopted and will start to bite, and, on the other, there are proposals that are expected to firm up into law.
Client Alert | 2 min read | 11.17.23
European Parliament Adopts Final EU Data Act
On November 9, 2023, the European Parliament has adopted the final version of the Data Act, marking a significant milestone in the evolving landscape of digital regulation. The Data Act is part of the European Commission’s broader strategy to shape Europe’s digital future (see our earlier posts here and here).
Client Alert | 6 min read | 06.22.23
A New Patent System is Born in Europe
Unitary Patents are being granted and the Unified Patent Court is up and running as of June 1, 2023. Since the 1970’s, there have been attempts at establishing a unitary European patent that would cover multiple European countries and would be enforced by a single court system. This type of system is in contrast to the system known since 1973 of granting European Patents by the European Patent Office (EPO) and validating the European Patent in designated European countries, wherein each validated patent is enforced in the national court associated with the validated patent.
Client Alert | 7 min read | 05.16.23
While fashion lovers throughout the European Union will surely be familiar with the pattern, the General Court held that luxury fashion house Louis Vuitton failed to demonstrate that its trademark checkerboard ‘Damier Azur’ pattern, had acquired distinctiveness through use throughout the European Union.
