Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 2 of 6)
- In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed further light on the expansion of the definition... ›
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 1 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this trend is likely to continue. As with every health-related product... ›Top 10 Considerations When Drafting and Negotiating SRAs, with U.S. and EU Perspectives
By: Wolfgang Schönig, Matthew Karlyn and Robert Grohmann
Sponsored Research Agreements (SRA) are used by companies to contract a research organization, such as a university, to conduct research and development activities in exchange for fees and the university’s rights to use the results for general research purposes. Care should be taken to... ›The European Commission’s New Pharmaceutical Strategy for Europe
By: Wolfgang Schönig
Nina Schäfer and Jin Ito contributed to this article. On November 25, 2020, the European Commission (the “Commission”) published its “ Pharmaceutical Strategy for Europe ” which outlines the Commission’s multi-year vision for a more patient-centered pharmaceutical system. The strategy aims to achieve various... ›Health Data Made in France- Is France Moving Towards a Sovereign Cloud Requirement for Health Data?
By: Alex van der Wolk
Since the decision of the European Court of Justice (“ECJ”) in the Schrems II case, transfers of personal data from the EU to the United States have been under scrutiny. The ECJ reviewed the situation where personal data are sent from an EU affiliate to its... ›Germany Adopts Administrative Trademark Cancellation Actions
By: Robert Grohmann
On May 1, 2020 the last part of the German Trademark Law Modernization Act ( Markenrechtsmodernisierungsgesetz – “MaMoG”), which contains practical relevant amendments to the procedural rules of the German trademark system, took effect. In particular, an administrative procedure for the revocation and the... ›Patent Offices Extend Certain Deadlines, but Proceed With Caution
Patent applicants facing a funds shortage because of COVID-19 may be glad to hear that many patent offices have extended certain patent prosecution deadlines. For example, the U.S. Patent Office has extended various patent deadlines until June 1, 2020 and the European Patent Office... ›Germany, UK, USA: Are Patent Exceptions the Cure to COVID-19?
By: Wolfgang Schönig, Alistair Maughan and Robert Grohmann
As the COVID-19 pandemic continues to spread globally, the life sciences industry is at the forefront of addressing the urgent need for pharmaceuticals, diagnostics, ventilators, and personal protective equipment capable of helping to contain the surge. While the laws of many countries provide for... ›Hard Knocks Keep Coming for Europe’s Unified Patent Court
By: Wolfgang Schönig and Robert Grohmann
With brexited UK announcing that it will not join Europe’s long-awaited Unified Patent Court (UPC), the establishment of an efficient pan-European patent litigation system faces ever‑mounting challenges. Last Friday, the German Federal Constitutional Court declared that the German Act of Approval of the UPC... ›CAN AI BE AN INVENTOR? NOT AT THE EUROPEAN PATENT OFFICE
By: Alistair Maughan and Anna Yuan
The European Patent Office has denied two patent applications on the grounds that an AI system cannot be listed as the inventor. For the first time, the European Patent Office (EPO) has issued a ruling on its approach to patent applications that designate artificial... ›