MoFo Life Sciences

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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January 26, 2019 - United States, Biotech, Pharma, Regulatory, Intellectual Property
Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment
The Federal Circuit ruled on January 23, 2019, that the United States Patent and Trademark Office (“PTO”) erred in reducing the term of a patent owned by Supernus Pharmaceuticals by 546 days, during which time the company could not have furthered prosecution of the
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January 25, 2019 - European Union, Pharma, Regulatory, Intellectual Property
A Structured Guide to Recent Case Law of the Court of Justice of the European Union on Supplementary Protection Certificates in Europe
By: Wolfgang Schönig
In principle, patents confer protection for a maximum of 20 years. In Europe, however, the patent terms for pharmaceutical products that meet the conditions necessary for supplementary protection certificates (“SPC”) can be extended for up to five years. Once a patent has been filed,
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January 11, 2019 - Litigation, European Union, Pharma, Regulatory, Intellectual Property
The EU General Court’s Ruling on Pay for Delay
By: Wolfgang Schönig, Andreas Grünwald, Jens Hackl, Theresa Oehm and Robert Grohmann
The EU General Court (“Court”) reduced the fines imposed on Servier SAS and its subsidiaries (“Servier”) from a total of €428 million to €315 million (see press release no. 194/18), thereby partially annulling a European Commission (“Commission”) decision. The Court confirmed the Commission’s finding that
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December 05, 2018 - European Union, Regulatory, Intellectual Property
IP Protection Post-Brexit: A Right-by-Right Analysis
By: Alistair Maughan, Wolfgang Schönig, Sana Ashcroft and Robert Grohmann
The United Kingdom is set to leave the European Union on 29 March 2019 (“Exit Date”). With Brexit fast approaching, on 25 November 2018 the EU and the UK announced their consensus on a withdrawal agreement that sets out the terms of the UK's
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December 02, 2018 - Global, Agtech, Regulatory, Intellectual Property
Planting the Seeds of Change
By: Michael Ward Ph.D., Liz Freeman Rosenzweig Ph.D. and Liz Newman Ph.D.
Morrison & Foerster partner Michael R. Ward explained the specialized versions of IP law that have been developed for new plants in his article for Intellectual Property Magazine , “Planting the seeds of change.” “…plants are unlike other inventions in that they can often
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November 09, 2018 - AI + Robotics, United States, Regulatory, Data Analytics, Intellectual Property
Patenting Artificial Intelligence in the U.S. – Considerations for AI Companies
By: Jonathan Bockman and Anna Yuan
Artificial intelligence (AI) encompasses technologies that have become increasingly relevant — and strategically important — to companies of all sizes across a wide range of fields. For example, AI technologies such as computer vision are critical to the operation of autonomous vehicles and pick-and-place
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October 30, 2018 - United States, Biotech, CFIUS, Pharma, Regulatory
New CFIUS Pilot Program: What Life Sciences Companies and Investors Need to Know
By: Robert S. Litt and Joseph A. Benkert
As many life sciences companies and investors are aware, the U.S. Department of the Treasury (“Treasury”) recently announced a new “pilot program” for the Committee on Foreign Investment in the United States (“CFIUS”) effective November 10, 2018. The pilot program implements certain provisions of
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Topic Archives: Regulatory

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

Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment

A Structured Guide to Recent Case Law of the Court of Justice of the European Union on Supplementary Protection Certificates in Europe

By: Wolfgang Schönig

The EU General Court’s Ruling on Pay for Delay

By: Wolfgang Schönig, Andreas Grünwald, Jens Hackl, Theresa Oehm and Robert Grohmann

IP Protection Post-Brexit: A Right-by-Right Analysis

By: Alistair Maughan, Wolfgang Schönig, Sana Ashcroft and Robert Grohmann

Planting the Seeds of Change

By: Michael Ward Ph.D., Liz Freeman Rosenzweig Ph.D. and Liz Newman Ph.D.

Patenting Artificial Intelligence in the U.S. – Considerations for AI Companies

By: Jonathan Bockman and Anna Yuan

New CFIUS Pilot Program: What Life Sciences Companies and Investors Need to Know

By: Robert S. Litt and Joseph A. Benkert