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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.

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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June 11, 2019 - United States, Biotech, Pharma, Intellectual Property
Patent Term Adjustment: A Post-Supernus Update from the Patent and Trademark Office
By: Karen G Potter Ph.D.
On May 9, the United States Patent and Trademark Office (“PTO”) published a notice in the Federal Register that it is modifying its patent term adjustment (“PTA”) procedures in view of the Federal Circuit’s decision in Supernus Pharmaceuticals v. Iancu .[1] Under the PTO
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June 05, 2019 - United States, Product Liability + Class Action, Litigation, Pharma
Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer
By: Erin M. Bosman and Julie Y. Park
The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third Circuit’s holding that questions of pharmaceutical preemption should be decided by juries. Merck Sharp &
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June 04, 2019 - AI + Robotics, United States, Biotech, Pharma, Data Analytics
Artificial Intelligence and Machine Learning: Real-world applications
With Artificial Intelligence (AI) and Machine Learning (ML) rapidly becoming significant players in multiple areas of science and technology, it came as no surprise to witness a full house for Athena’s program “Taking Artificial Intelligence (AI) and Machine Learning (ML) from Concept to Application,”
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Welcome to Mofo Life Sciences

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

Patent Term Adjustment: A Post-Supernus Update from the Patent and Trademark Office

By: Karen G Potter Ph.D.

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

By: Erin M. Bosman and Julie Y. Park

Artificial Intelligence and Machine Learning: Real-world applications