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MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

April 19, 2021 - Litigation, European Union, Pharma, Intellectual Property, Antitrust
Pay-for-Delay has a tough (antitrust) time at EU Top Court
By: Jens Hackl and Andreas Grünwald
In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts.[1] In two recent rulings – “Lundbeck”[2] and “Paroxetine”[3] – the European Court of Justice (ECJ) dealt with settlement agreements
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April 13, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 6 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the transition periods certain MDSW can benefit from before
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April 08, 2021 - United States, FDA, Medical Devices + Diagnostics, United Kingdom, European Union, Regulatory
Global HealthTech CEO Connect: Software as a Medical Device in the U.S. and EU Recap
By: Wolfgang Schönig
On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific
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April 06, 2021 - United States, FDA, Medical Devices + Diagnostics, Regulatory
FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation
In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”) Software Draft Guidance (together the “CDS Draft Guidance”) and the MDR.
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March 31, 2021 - United States, FDA, COVID-19, Healthcare, Pharma
Vaccine Production and State Intervention in the U.S.
By: Brigid DeCoursey Bondoc
During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector.[1] State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in Europe. In Italy and Norway, for instance, governments are taking equity stakes
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March 24, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 5 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an overall deeper level of regulation in areas already regulated before. This episode will put the spotlight on
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March 11, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2 ) and the implications of the new risk classification regime (in part 3 ), in this part 4 of our series on Software
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March 03, 2021 - AI + Robotics, United States, FDA, Regulatory
FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS
By: Jean Nguyen Ph.D.
U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to
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March 02, 2021 - COVID-19, United Kingdom, European Union, Healthcare, Pharma
COVID-19: State Intervention in Times of Vaccine Shortages
By: Robert Grohmann
The European Union (“EU”) and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availability. Germany, like the rest of the EU, is scrambling to obtain vaccine doses as the pharmaceutical industry slows
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March 02, 2021 - United States, European Union, Intellectual Property
Key EU Intellectual Property and Trade Secrets
By: Wolfgang Schönig and Mark L. Whitaker
Session 11 of the GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups was led by Life Sciences Transactions + Licensing partner Wolfgang Schoenig focusing on key EU Intellectual Property. Wolfgang discussed Intellectual Property Rights,
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