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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.

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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July 29, 2019 - Biotech, European Union, Pharma, Intellectual Property
CJEU on Genuine-Use of Trademarks in Clinical Trials
By: Wolfgang Schönig and Robert Grohmann
The pharmaceutical market presents unique challenges to pharmaceutical companies seeking to launch new products. One such challenge involves the lengthy process of executing clinical trials as a prerequisite for obtaining market authorization. In this context, the fact that trademark laws in most jurisdictions provide
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July 23, 2019 - Biotech, Pharma, Regulatory, Intellectual Property, Asia
China’s new administrative regulations on human genetic resources as applied to foreign persons
The Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, went into effect on July 1, 2019, superseding prior regulations on China’s human genetic resources (“China HGR”), particularly the 1998 Interim Methods of Human
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July 19, 2019 - Biotech, European Union, Pharma, Regulatory, Intellectual Property
Confidentiality of Documents: Only if Related to Court Proceedings or Commercial Interests
By: Wolfgang Schönig
In particular for commercial reasons, pharmaceutical companies have an interest in the confidentiality of documents submitted in connection with the marketing authorization for medicinal products vis-á-vis its competitors as well as vis-á-vis the public. The Court of Justice of the European Union (“CJEU”) ruled
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July 16, 2019 - European Union, Regulatory, Privacy + Data Security
European Commission Q&A on the interplay between the Clinical Trials Regulation and GDPR
By: Alex van der Wolk
In response to the opinion of European Data Protection Board (EDPB), the European Commission has issued its Question and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR) (Q&A). The non-binding Q&A offers some additional clarifications
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July 09, 2019 - United States, Litigation, Pharma, Intellectual Property
Federal Circuit Diagnoses the Patent Eligibility Problem – But Denies a Remedy
By: Karen G Potter Ph.D.
On July 3, 2019, in a 7-5 en banc decision, the Federal Circuit declined to reconsider its decision in Athena Diagnostics v. Mayo Collaborative Services ,[1] finding that claims to a diagnostic method were patent ineligible for being directed to a law of nature.
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July 02, 2019 - Medical Devices + Diagnostics, Product Liability + Class Action, Regulatory
Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR
By: Erin M. Bosman and Julie Y. Park
On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.”[1] This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. In
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Welcome to Mofo Life Sciences

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

By: Joseph A. Benkert and Charles L. Capito

Artificial Intelligence and Pharma

Analyzing Biologics Under the Doctrine of Equivalents and Prosecution History Estoppel

By: Janet Xiao Ph.D. and Meghan McLean Poon Ph.D.

AI Patent Policy – Calling all Life Sciences Practitioners

By: Anna Yuan and Karen G Potter Ph.D.

CJEU on Genuine-Use of Trademarks in Clinical Trials

By: Wolfgang Schönig and Robert Grohmann

China’s new administrative regulations on human genetic resources as applied to foreign persons

Confidentiality of Documents: Only if Related to Court Proceedings or Commercial Interests

By: Wolfgang Schönig

European Commission Q&A on the interplay between the Clinical Trials Regulation and GDPR

By: Alex van der Wolk

Federal Circuit Diagnoses the Patent Eligibility Problem – But Denies a Remedy

By: Karen G Potter Ph.D.

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

By: Erin M. Bosman and Julie Y. Park