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Welcome to Mofo Life Sciences

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.

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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December 09, 2019 - United States, Litigation, Pharma, Intellectual Property
Striking the Balance in Trade Secret and Corporate Espionage Disputes
By: Matthew A. Chivvis
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
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November 22, 2019 - United States, FDA, Litigation, Biotech, Healthcare, Pharma, Regulatory, Intellectual Property
FDA Approves 25th Biosimilar
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 pharmaceutical
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October 30, 2019 - AI + Robotics, Medical Devices + Diagnostics, Data Analytics, Asia
Reflecting on the Challenges and Opportunities of Data at the Hitachi Social Innovation Forum 2019
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
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October 15, 2019 - United States, CFIUS, Regulatory
Foreign Investment 2020: CFIUS Spotlight on “TID” U.S. Businesses
By: Charles L. Capito 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
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October 01, 2019 - Licensing + Commercial, Biotech, Regulatory, Intellectual Property, Asia
China Patent Eligibility Update: Human Embryonic Stem Cells
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 1,
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September 25, 2019 - United States, CFIUS, Regulatory
Foreign Investment 2020: Key Takeaways from the “Modernized” CFIUS Regulations
By: Joseph A. Benkert and Charles L. Capito
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 notably included
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September 19, 2019 - AI + Robotics, United States, FDA, Product Liability + Class Action, Pharma, Regulatory, Data Analytics
Artificial Intelligence and Pharma
Bethany Hills authored an article for PHARMAnetwork , covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Bethany discusses that the pharmaceutical sector has been one of the more robust areas where private partnerships with artificial intelligence-based technology companies have
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September 04, 2019 - United States, Litigation, Biotech, Pharma, Intellectual Property, Cell + Gene Therapy
Analyzing Biologics Under the Doctrine of Equivalents and Prosecution History Estoppel
By: Janet Xiao Ph.D. and Meghan McLean Poon Ph.D.
In a recent decision, Ajinomoto v. ITC , the Federal Circuit addressed the issues of doctrine of equivalents and prosecution history estoppel as applied to patent claims reciting specific amino acid sequence of a biologic. On appeal, the Federal Circuit affirmed the decision by
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August 28, 2019 - AI + Robotics, United States, Regulatory, Data Analytics, Intellectual Property
AI Patent Policy – Calling all Life Sciences Practitioners
By: Anna Yuan and Karen G Potter Ph.D.
In the life sciences, artificial intelligence (AI) may be facilitating a sea change in how diseases are diagnosed, prognosed, and treated, and even how therapies are discovered and produced. Indeed, it is possible for AI to provide insights into disease and treatment that could
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