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.
Elizabeth Freeman Rosenzweig, a Morrison & Foerster law clerk in our San Francisco office, Biology PhD, and JD candidate at Berkeley Law, contributed to the writing of this article. On January 6, 2020, the Plant Variety Protection Office (PVPO) released the final version of its …›
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 …›
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 …›
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 …›
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 Enforcement Trends In 2019, …›
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 press releases about …›
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 …›
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 as a …›
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 eager to …›
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 than …›