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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.

January 23, 2020 - United States, Agtech, Regulatory, Intellectual Property
Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants
By: Liz Freeman Rosenzweig Ph.D., Cory Ellison Ph.D. and Michael Ward Ph.D.
On January 6, 2020, the Plant Variety Protection Office (PVPO) released the final version of its much-anticipated rule to open Plant Variety Protection (PVP) to asexually reproduced plants. Publication of this rule means that the PVPO is now accepting applications for all species of
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January 21, 2020 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Healthcare
Digital Health in 2019
The year 2019 saw relatively few developments in the digital health space. Although progress has been slow, FDA did make headway on two initiatives: (1) addressing the unique challenges of regulating artificial intelligence and machine learning (AI/ML) in medical applications, and (2) implementing changes
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January 15, 2020 - United States, FDA, Announcements
2020 Under Dr. Stephen Hahn, FDA’s New Commissioner
By: Julie Y. Park
Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17 vote. Hahn became the fourth leader of FDA in 2019 and the first confirmed nominee since
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January 15, 2020 - Agtech, European Union, Regulatory
Silver lining? Genome-editing regulation following CRISPR ban in Europe’s Agribusiness
By: Wolfgang Schönig
In its landmark decision of July 25 2018, the Court of Justice of the European Union (“CJEU”) essentially banned crops obtained by new genome editing techniques from the EU market. The decision left the European biotech industry in awe, as it came unexpectedly and
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January 10, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 3)
Our earlier posts ( part 1 and part 2 ) looked at a few overall trends at FDA as well as the impact of consent decrees issued in 2019. Today we will highlight some enforcement trends at the Department of Justice. Department of Justice
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January 09, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 2)
Yesterday , we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our series, we look at the specifics of FDA’s 2019 consent decrees. FDA Consent Decrees FDA published
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January 08, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 1)
The year 2019 was one of uncertainty for FDA, as former Commissioner Scott Gottlieb announced his departure in March, ultimately stepping down in April. For the bulk of the year, FDA was led by Acting Commissioner, Ned Sharpless, until Brett Giroir took over in
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December 19, 2019 - AI + Robotics, Global, Data Analytics, Intellectual Property
Global IP Policy in the Age of AI
By: Karen G Potter Ph.D.
Between 2013 and 2016, the number of Artificial Intelligence (AI) related patent applications in the life sciences and medical sciences grew by about 40% * , and, with continuing advances in technology, has likely increased substantially since 2016. Although this finding may not come
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December 12, 2019 - Licensing + Commercial, Intellectual Property, Asia
Crossing Borders
By: Janet Xiao Ph.D.
Partner Janet Xiao, who leads the firm’s China Life Sciences Group, co-authored an article with associate Can Cui for Intellectual Property Magazine , titled “Crossing Borders,” which explores technology transfer opportunities emerging from import rules in China. The authors note that Chinese companies are
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December 11, 2019 - European Union, Privacy + Data Security
EU Adopts Whistleblowing Directive to Protect Whistleblowers
By: Alja Poler De Zwart
The whistleblowing rules in Europe are about to change dramatically. The new Directive on the protection of persons who report breaches of Union law , also referred to as the “Whistleblowing Directive,” will require Member States to create rules that mandate organizations with more
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