63 results found

Das japanische Pharmaunternehmen Daiichi Sankyo hat sich erfolgreich gegen den frühzeitigen Markteintritt generischer Wettbewerbsprodukte zu seinem erfolgreichen Arzneimittel Sevikar® gewehrt.

The EU Pharma Package introduces a novel approach to combat antimicrobial resistance through transferable exclusivity vouchers that reward innovation in priority antimicrobials while simultaneously implementing stricter antibiotic stewardship measures. This regulatory framework attempts to resolve the fundamental tension between incentivizing pharmaceutical companies to develop new antibiotics and ensuring these critical medicines are used prudently to prevent further resistance development.

When interpreting a patent claim, the person skilled in the art does not apply a philological understanding, but determines the technical meaning of the terms used...

On 26 October 2022, the German government approved a detailed key proposals paper setting out its plan to legalise the consumption of cannabis for recreational purposes.

The story of part German/part Danish company Haribo's signature gummy bear is a fascinating tale of trade mark protection and legal disputes in the food and drink industry.

The EU Pharmaceutical Package represents the most significant reform of EU pharmaceutical law in over twenty years, but what does it mean for parallel imports of medicines? This analysis examines how the Package affects the regulatory framework for parallel trade, from repackaging requirements to shortage management and electronic package leaflets.

While it is getting cold outside, and everyone is preparing for the flu season of the year, the Commission is continuously and vigorously enforcing the bloc's competition law in the pharmaceutical sector.

The 14th Amendment of the German Drug Act came into force on 6 September 2005 making Germany the first EU member state to transpose the revised EU Pharmaceutical Legislation<SUP>6</SUP> into national law. This article provides an overview of the contents and highlights some of its key provisions

This decision relates to an European patent application for an interactive food and/or drink ordering system and method. Here are the practical takeaways from the decision T 2251/13...

The EU pharma package introduces comprehensive measures to prevent medicinal product supply shortages through early warning systems, risk assessments, and preventive supply chain management. Marketing authorisation holders face expanded reporting obligations, mandatory shortage prevention plans, and stricter governance requirements designed to ensure patients receive medicines when needed across all Member States.

Now that both houses of the German parliament have passed the new Digital Act (Digital-Gesetz, "DigiG"), the German healthcare system has certainty regarding the substance of the Act.

On 16 December 2024, the Council of the European Union formally approved the new Packaging and Packaging Waste Regulation (PPWR), following its adoption by the European Parliament on 24 April 2024.

The Local Division of Düsseldorf is the first UPC panel to set out the prerequisites and establish essential factors for assessing infringement of second medical use claims in the UPC system. Its approach builds on the criteria developed by national (German) courts.

Peter Homberg, Partner and Head of Dentons German Life Sciences practice, gave insights about the recent legalization of medical cannabis in Germany in LABIOTECH.eu, a leading digital porta...

The EU Pharma Package introduces significant reforms to regulatory data and market protection periods for medicinal products, fundamentally altering the current "8+2(+1)" protection formula.

Slogans continue to enjoy great popularity in the consumer goods industry. Following the groundbreaking judgment of the European Court of Justice on the registrability...

Since its entry into force on June 1, 2023, the Unified Patent Court (UPC) has seen a growing number of cases across various fields, including pharmaceuticals, biotechnology...