MoFo Life Sciences

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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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 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 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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May 30, 2019 - United States, Medical Devices + Diagnostics, Regulatory, Intellectual Property
The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims
By: Karen G Potter Ph.D.
While many life sciences companies are built on platforms involving the development of diagnostic products and methods that underlie personalized medicine allowing treatment that is customized to a patient’s unique biology, the U.S. Supreme Court dealt a blow to the industry with its decision
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May 24, 2019 - United States, Biotech, Pharma, Regulatory, Intellectual Property
Congress releases bipartisan draft bill to repair the law on patent eligibility
By: Karen G Potter Ph.D. and Jeffrey W. Schmidt Ph.D.
On May 22, 2019, members of Congress made available for public comment a one-page draft of a bill that aims to rewrite the patent eligibility provisions of the Patent Act to address the muddled jurisprudence spawned by the Supreme Court cases of Mayo Collaborative
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May 22, 2019 - Biotech, European Union, Pharma, Regulatory, Intellectual Property
Manufacturing Waiver Weakens SPC Protection in Europe
By: Wolfgang Schönig
On May 14, 2019, the Council of the European Union adopted the amending Regulation (EC) No. 469/2009 , effectively exempting certain manufacturing activities in the EU from the scope of Supplementary Protection Certificates that have not yet been granted (“New SPC Regulation”). The New SPC Regulation will enter
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Topic Archives: Regulatory

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

By: Joseph A. Benkert and Charles L. Capito

Artificial Intelligence and Pharma

AI Patent Policy – Calling all Life Sciences Practitioners

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

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

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

By: Erin M. Bosman and Julie Y. Park

The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims

By: Karen G Potter Ph.D.

Congress releases bipartisan draft bill to repair the law on patent eligibility

By: Karen G Potter Ph.D. and Jeffrey W. Schmidt Ph.D.

Manufacturing Waiver Weakens SPC Protection in Europe

By: Wolfgang Schönig