Insights
Professional
Practice
Industry
Region
Trending Topics
Location
Type
Sort by:
Client Alerts 21 results
Client Alert | 6 min read | 07.25.24
The EU legal and policy framework regarding critical medicines and medicine shortages is rapidly changing. In the past 12 months alone, there have been numerous developments: from the ‘Non-Paper’; to the Communication on ‘Addressing medicine shortages’; and the launch of the Critical Medicines Alliance. In the next 12 months, there is likely to be similar developments – including a possible draft proposal for a ‘Critical Medicines Act’. As the new regulatory framework becomes clearer, pharma companies will need to understand it, and prepare for the impact it will have.
Client Alert | 3 min read | 07.02.24
The New Urban Wastewater Treatment Directive
New EU legislation is about to be adopted which will require pharmaceutical and cosmetics companies to pay water pollution costs. More specifically, it will oblige those companies to pay for the clean-up and removal of micropollutants from effluent water. In addition, it will increase the risk of pharmaceutical and other companies facing legal damage-to-health claims. The new EU legislation – called the (Recast) Urban Wastewater Treatment Directive (“New UWWTD”) – is expected to be formally adopted in Q3/4 of this year.
Client Alert | 4 min read | 06.26.24
Preparing for the U.S. BIOSECURE Act
Momentum is building for the US BIOSECURE Act, and it is becoming more and more likely that it will soon become law. It may significantly impact pharmaceutical and biotechnology companies and supply chains, particularly if they or their customers do business with the U.S. Federal Government. It is therefore important to prepare now to avoid potentially serious adverse effects.
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 | 22 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 | 19 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 | 7 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.
Client Alert | 6 min read | 05.04.23
Opening up the Long-Awaited EU Pharmaceutical Package
On April 26, 2023, the European Commission finally published its long-awaited EU Pharmaceutical Package. This Package introduces new draft legislation that would revise and replace existing EU pharmaceutical legislation in line with the Pharmaceutical Strategy for Europe, which was adopted by the EU on November 25, 2020.
Client Alert | 5 min read | 11.29.22
On November 17, 2022, the European Court of Justice (ECJ) issued four important decisions (here) relating to parallel imports of branded products within the internal market of the European Union (EU). This is a complex topic at the crossroads of free movement of goods and trademark enforcement in the EU.
Client Alert | 5 min read | 11.17.22
Unveiling the Complexity of the Belgian MedTech Legal Landscape
The Belgian regulatory framework for medical devices is highly complex, and the already dense legal landscape was recently added to by the adoption of two new Belgian royal decrees: the Royal Decree of 25 September 2022 relating to performance studies involving in vitro diagnostic medical devices and the Royal Decree of 13 September 2022 amending and repealing various provisions regarding in vitro diagnostic medical devices.
Client Alert | 4 min read | 03.25.20
EU Court of Justice Confirms Approach to Reverse Payment Settlements
The case relates to settlements entered into by GlaxoSmithKline (GSK) with three generic manufacturers. The generics had challenged a secondary patent relating held by GSK in relation to the active ingredient in its anti-depressant paroxetine. The original patent had expired in 1999 and the secondary patent, which covered production process and 4 polymorphs, was partially annulled by the UK courts.
Client Alert | 2 min read | 01.23.19
In November 2018, the European Patent Office (EPO) published a study aimed at providing a comprehensive picture of current trends and emerging leaders in technologies related to self-driving vehicles (SDV), based on patent applications ranging from 2011 to 2017. Below are some examples of the key findings from this study.
Client Alert | 11 min read | 11.17.15
Unified Patent Court: Preliminary Injunction Proceedings
This series of alerts will provide practical information and
professional comment on all the ramifications regarding the introduction
of the Unified Patent Court (UPC). For further information, please see our UPC leaflet PDF or contact the lawyers listed near the bottom of each alert. To view other alerts in this series, please click here.
Client Alert | 11 min read | 11.03.15
Unified Patent Court: Measures for Preserving Evidence
This is the first alert of a series which will provide practical information and professional comment on all the ramifications regarding the introduction of the Unified Patent Court (UPC). For further information, please see our UPC leaflet PDF or contact the lawyers listed below. To track Crowell & Moring's UPC alerts, please click here.
Client Alert | 4 min read | 09.30.14
On September 12, 2013, the Belgian Supreme Court (Cour de Cassation / Hof van Cassatie) issued a decision that fundamentally changes patent enforcement in Belgium. The Supreme Court ruled that a patent judge ruling (as) in summary proceedings on the prima facie (in)validity of the Belgian national part of a European patent cannot simply ignore foreign rulings on the (in)validity of the same patent. The Court also decided that a patent invalidation in first instance cannot be ignored by only relying on the suspending effect of the appeal lodged against the first instance decision.
Client Alert | 4 min read | 09.19.14
Preliminary injunction (PI) and seizure proceedings are powerful weapons in the hands of patentees in Belgium. Often, the success of a product launch and the outcome of a patent dispute will in practice be determined by a PI or seizure that prevents or ceases market entry by the alleged infringer.
Client Alert | 4 min read | 11.28.13
EU Lays Foundation For Harmonized Trade Secret Protection Across Member States
On November 28, 2013, the European Commission (EC) proposed a directive "on the protection of undisclosed know-how and confidential business information (trade secrets) against their unlawful acquisition, use and disclosure." If adopted, the directive will establish a common definition of "trade secrets" and set of remedies in all 28 European Union (EU) Member States. The proposed directive now goes to the European Parliament and EU Member State governments via the European Council for adoption.
Client Alert | 8 min read | 02.08.12
This Month In International Trade - January 2012
On 2 February 2012, the Court of Justice of the European Union (CJEU) decided in a ground-breaking judgment that the European Commission was wrong not to consider claims of market economy treatment (MET) made by several Chinese footwear producers that were not among those sampled by the Commission in the context of an anti-dumping case.
Client Alert | 5 min read | 01.20.12
Recent Guidance For The Protection of Intellectual Property Rights at The EU Border
In December 2011, the Court of Justice of the European Union (CJEU) provided practical guidance regarding the application of the EU legislation for customs action against goods suspected of infringing certain intellectual property rights (IPR) which are not yet cleared for free circulation in the EU1.
