In May 2022, the European Commission published a proposal to establish a European Health Data Space (“EHDS”). The Commission’s EHDS proposal aims to improve access by individuals to their health data (primary use) and facilitate the re-use of health data for societal good across the European Union (secondary use). The European Commission’s aim is to adopt the EHDS by the end of its current mandate (October 31, 2024). The European Commission expressed its hope that the provisions of the regulation will enter into force across all EU member states in 2025. Businesses operating in the health and pharma sectors should therefore carefully consider how the EHDS might affect them.

Continue Reading Health Data: European Commission Proposes new Rules on Access and Use

On 7 August 2021, Germany formally ratified the Agreement on a Unified EU Patent Court (“UPC Agreement“). The ratification came after battles in recent years over the constitutionality of the ratification bill. In 2017, the German ratification was put on hold because a constitutional complaint had argued that the German law approving the UPC Agreement was passed without the required quorum of the German Parliament. After the German parliamentarians fixed their mistake and approved the draft law with a two-thirds majority on 26 November 2020, the ratification was
Continue Reading Germany Ratifies EU Unified Patent Court (UPC) Agreement, but Prospects for the UPC Remain Uncertain

The German legislature (Bundestag and Bundesrat) has passed a bill that will change German patent law. The bill will enter into force soon. Under the new law, injunctions in patent infringement cases will be restricted by proportionality considerations in individual cases. Further, stronger procedural safeguards will become available for the disclosure of confidential information during patent infringement proceedings.
Continue Reading Germany Passes Law to Restrict Injunctive Relief in Patent Cases by Proportionality Considerations

On 13 April 2021, the European Data Protection Board (“EDPB“) adopted two opinions  (“Opinions“) concerning draft UK adequacy decisions published by the European Commission which would permit the free flow of personal data from the European Economic Area (“EEA“) to the UK in the post-Brexit world. The Opinions largely support the draft UK adequacy decisions and represent a positive step towards adoption of formal UK adequacy decisions. Nonetheless, organisations which transfer personal data from the EEA to the UK should continue to monitor the developments and keep planning for the possibility that the adequacy decisions, if adopted, could
Continue Reading European Data Protection Board Issues Opinions on European Commission’s Draft UK Adequacy Decisions

In an increasingly interconnected world, preserving the free flow of data across borders is crucial to the prosperity of businesses operating in every industry. But over the last year, there have been a number of important data protection developments in Europe that have a direct impact on the supply chain and distribution arrangements operated by organizations. These developments are restricting the ways in which businesses can share personal data within their organizations and with counterparties internationally. They include:
Continue Reading Data Protection Developments in Europe – Supply Chain and Distribution

A decision issued on 15 March 2021 by the Bavarian Data Protection Authority (“BayLDA”, publication pending) is the first German enforcement action in connection with last year’s decision of the Court of Justice of the European Union (“CJEU”, “CJEU’s Decision”) on the validity of the European Commission’s Standard Contractual Clauses (“SCCs”) and the EU-US Privacy Shield (C-311/18, more information available in our client alert). In the CJEU Decision, the court held that a transfer of personal data from the EU to third countries outside the European Economic Area (“EEA”) under the EU Standard Contractual Clauses will be permissible
Continue Reading German Data Protection Authority Decides on Supplementary Measures for International Data Transfers

In a recent decision on patent infringement under the doctrine of equivalents, the German Federal Court of Justice confirmed its case law that each limitation of the claim must be met in the accused device, either literally or equivalently. Specifically, the Court held that it was irrelevant whether the accused device as a whole produces an effect that is, in its totality, equivalent to an embodiment of the claim. Rather, it was decisive which effect each individual limitation of the claim contributes to the use of the invention and whether these exact effects are achieved literally or equivalently in the accused device.
Continue Reading German Federal Court of Justice Confirms Its Case Law on Patent Infringement by Equivalents

The Spanish Data Protection Authority (“Agencia Espanola Proteccion Datos – AEPD”) has recently issued its highest fine to date, totaling €8.15 million for several breaches of GDPR and national legislation by a multinational telecommunication company and its service providers. Notably, €2 million of this fine was attributable to its service provider conducting an international transfer of personal data to a country that did not comply with the European data protection requirements.
Continue Reading Spanish Data Protection Authority Issues Highest GDPR Fine to Date

On 28 October 2020, the German Federal Government passed a bill to simplify and modernize the German patent law. The bill is expected to pass the German Parliament (Bundestag) early next year. Once the draft law passes, injunctions in patent infringement cases will be restricted by equitable considerations in individual cases.
Continue Reading German Government Passes Bill to Simplify and Modernize Patent Law

Since enacted in August 2018, the entry into force of the Brazilian Data Protection Law (No. 13,709 – “LGPD”) has been subject to several changes. First it was supposed to be effective as of February 2020; then August 2020; and more recently 3 May 2021 (Provisional Measure No. 959/2020 dated 29 April 2020). The future of the LGPD remains uncertain, since this Provisional Measure needs to be rejected, approved or changed by the National Congress, or else it will expire on 27 August 2020.
Continue Reading Sanction Provisions in Brazil’s Data Protection Law Will Take Effect on 1 August 2021