MoFo Life Sciences

February 13, 2020 - AI + Robotics, European Union, Intellectual Property
CAN AI BE AN INVENTOR? NOT AT THE EUROPEAN PATENT OFFICE
By: Alistair Maughan and Anna Yuan
The European Patent Office has denied two patent applications on the grounds that an AI system cannot be listed as the inventor. For the first time, the European Patent Office (EPO) has issued a ruling on its approach to patent applications that designate artificial
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January 15, 2020 - Agtech, European Union, Regulatory
Silver lining? Genome-editing regulation following CRISPR ban in Europe’s Agribusiness
By: Wolfgang Schönig
In its landmark decision of July 25 2018, the Court of Justice of the European Union (“CJEU”) essentially banned crops obtained by new genome editing techniques from the EU market. The decision left the European biotech industry in awe, as it came unexpectedly and
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December 11, 2019 - European Union, Privacy + Data Security
EU Adopts Whistleblowing Directive to Protect Whistleblowers
By: Alja Poler De Zwart
The whistleblowing rules in Europe are about to change dramatically. The new Directive on the protection of persons who report breaches of Union law , also referred to as the “Whistleblowing Directive,” will require Member States to create rules that mandate organizations with more
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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 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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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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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 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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Topic Archives: European Union

CAN AI BE AN INVENTOR? NOT AT THE EUROPEAN PATENT OFFICE

By: Alistair Maughan and Anna Yuan

Silver lining? Genome-editing regulation following CRISPR ban in Europe’s Agribusiness

By: Wolfgang Schönig

EU Adopts Whistleblowing Directive to Protect Whistleblowers

By: Alja Poler De Zwart

CJEU on Genuine-Use of Trademarks in Clinical Trials

By: Wolfgang Schönig and Robert Grohmann

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

Manufacturing Waiver Weakens SPC Protection in Europe

By: Wolfgang Schönig

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

By: Miriam H. Wugmeister

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