MoFo Life Sciences

January 8, 2020 - Biotech, FDA, Healthcare, Litigation, Medical Devices + Diagnostics, Pharma, Regulatory, United States

2019 FDA Enforcement and Related Litigation Trends (Part 1)

By: Hilary R. Hoffman and Bethany J. Hills

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 …›

December 19, 2019 - AI + Robotics, Data Analytics, Global, Intellectual Property

Global IP Policy in the Age of AI

By: Amanda Elisabeth Casale and Karen G Potter

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 …›

December 12, 2019 - Asia, Intellectual Property, Licensing + Commercial

Crossing Borders

By: Janet Xiao and Can Cui

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 …›

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 than …›

December 9, 2019 - Intellectual Property, Litigation, Pharma, United States

Striking the Balance in Trade Secret and Corporate Espionage Disputes

By: Matthew A. Chivvis and Anthony Michael Parenti

In 2017, the Commission on the Theft of American Intellectual Property issued a report to Congress estimating that the theft of trade secrets could cost the United States economy as much as $600 billion annually. In the years following, news reports indicate that alleged …›

November 22, 2019 - Biotech, FDA, Healthcare, Intellectual Property, Litigation, Pharma, Regulatory, United States

FDA Approves 25th Biosimilar

By: Steve Keane

On November 15, Pfizer’s adalimumab product became the 25th biosimilar approved by FDA under the Biologics Price Competition and Innovation Act (BPCIA). The road to the 25th approval has been long and has involved some of the biggest companies and medications in the …›

October 30, 2019 - AI + Robotics, Asia, Data Analytics, Medical Devices + Diagnostics

Reflecting on the Challenges and Opportunities of Data at the Hitachi Social Innovation Forum 2019

By: Ani Hamparsumyan

Are companies keeping up with technological advances, and what are they doing specifically to contribute to society and provide value? What are the future prospects, and what kind of opportunities are being created for progress, including in the digital and scientific arenas? As Japanese companies …›

October 15, 2019 - CFIUS, Regulatory, United States

Foreign Investment 2020: CFIUS Spotlight on “TID” U.S. Businesses

By: John P. Carlin, Nicholas J. Spiliotes, Panagiotis C. Bayz, Charles L. Capito III, Amy S. Josselyn, and Joseph A. Benkert

FIRRMA directed the U.S. Department of the Treasury (“Treasury”), as the chair of CFIUS, to issue regulations that, among other things, address national security concerns arising from foreign investment in U.S. businesses with critical technologies, critical infrastructure, and personal data (referred to in the …›

October 1, 2019 - Asia, Biotech, Intellectual Property, Licensing + Commercial, Regulatory

China Patent Eligibility Update: Human Embryonic Stem Cells

By: Can Cui

On September 23, 2019, China National Intellectual Property Administration (“CNIPA”) announced its proposed amendments to China’s Guideline on Patent Examination (the “Guideline”), which is the counterpart of the Manual of Patent Examining Procedure in the U.S. The proposed amendments will become effective November …›

September 25, 2019 - CFIUS, Regulatory, United States

Foreign Investment 2020: Key Takeaways from the “Modernized” CFIUS Regulations

By: John P. Carlin, Nicholas J. Spiliotes, Joseph A. Benkert, Panagiotis C. Bayz, Charles L. Capito III, and Amy S. Josselyn

After more than a year of anticipation, the U.S. Department of the Treasury (“Treasury”) has released proposed regulations to implement the Foreign Investment Risk Review Modernization Act (FIRRMA). These proposed regulations follow an initial round of FIRRMA-implementing regulations issued in October 2018, which most …›

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