MoFo Life Sciences

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) (see our alert ), 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
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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 25, 2019 - United States, FDA, Regulatory, Privacy + Data Security
Nationally Recognized FDA Partner Bethany J. Hills Joins Morrison & Foerster in New York
Ms. Hills brings a full-service FDA practice to the firm rounding out its market-leading Life Sciences Group Morrison & Foerster, a leading global law firm, is pleased to announce that Bethany J. Hills has joined the firm in the New York office as a
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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
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 and Jeffrey W. Schmidt
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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March 12, 2019 - United States, Product Liability + Class Action, Agtech, Regulatory
Cannabidiol: Is CBD Legal in the United States in 2019?
By: William F. Tarantino
Cannabis-derived extracts are one of the hottest trends in the consumer products industry. Sales of consumer products containing cannabidiol (CBD) are reported to exceed $510 million in 2018. Experts predict that the market for CBD products could grow to $22 billion by 2022. Hemp oil can now be found
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February 26, 2019 - European Union, Pharma, Regulatory, Privacy + Data Security
The Trials That Lie Ahead: EDPB Opines on Interplay Between EU Clinical Trials Regulation and GDPR
By: Miriam H. Wugmeister
There has been a lot of confusion in the past months on applying the General Data Protection Regulation (GDPR) to clinical trials. For example, the GDPR requires honoring specific individual rights such as notice, access and deletion. However, that seems to be at odds
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Topic Archives: Regulatory

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

Nationally Recognized FDA Partner Bethany J. Hills Joins Morrison & Foerster in New York

The Diagnostics Dilemma: Securing and Protecting Diagnostic-Based Claims

By: Karen G Potter

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

By: Karen G Potter and Jeffrey W. Schmidt

Manufacturing Waiver Weakens SPC Protection in Europe

By: Wolfgang Schönig

Cannabidiol: Is CBD Legal in the United States in 2019?

By: William F. Tarantino

The Trials That Lie Ahead: EDPB Opines on Interplay Between EU Clinical Trials Regulation and GDPR

By: Miriam H. Wugmeister