MoFo Life Sciences

May 26, 2021 - Litigation, European Union
The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16
By: Wolfgang Schönig
Summary The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis technologies such as CRISPR-Cas9, left the community in awe. A study recently published by the European Commission (“Commission”)
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May 04, 2021 - FDA, Litigation
Ninth Circuit Weighs in on Fraud-on-the-FDA Theory, Marketing Devices for Off-Label Use, and Kickbacks
The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.: (1) Engaged in “fraud-on-the-FDA” when obtaining clearance for several devices used in spinal fusion surgeries;
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April 19, 2021 - Litigation, European Union, Pharma, Intellectual Property, Antitrust
Pay-for-Delay has a tough (antitrust) time at EU Top Court
By: Jens Hackl and Andreas Grünwald
In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts.[1] In two recent rulings – “Lundbeck”[2] and “Paroxetine”[3] – the European Court of Justice (ECJ) dealt with settlement agreements
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February 26, 2021 - COVID-19, Litigation, Healthcare
Do You Have the COVID-19 Blues? Don’t Forget About Sunshine!
While the Centers for Medicare and Medicaid Services (CMS) acknowledges the impact COVID-19 has had on the healthcare industry, CMS does not have the authority to postpone the deadline for Sunshine Act reporting. Accordingly, March 31, 2021, remains the deadline for reporting for 2020.
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February 04, 2021 - United States, Litigation, Regulatory
EHR Vendor Settles Kickback Allegations to the Tune of $18.25 Million
On January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million settlement with athenahealth Inc. (“Athena”) to resolve allegations that Athena violated the False Claims Act by paying impermissible kickbacks related to its electronic health records (EHR) product. At the
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January 05, 2021 - United States, Litigation, Intellectual Property
Considerations for ANDA and BPCIA Litigation
By: Matthew A. Chivvis and Michael R. Ward
Matthew Chivvis , life sciences IP litigation partner in Morrison & Foerster’s San Francisco office led session 5 of our course on Legal Topics for Scientists, Entrepreneurs, and Start Ups. Matthew discussed the Hatch-Waxman and Biologics Price Competition and Innovation Act for generics and
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November 09, 2020 - Licensing + Commercial, United States, Corporate + Venture Capital, FDA, United Kingdom, Litigation, Startup, Regulatory, Intellectual Property, Announcements
Legal Topics for Scientists, Entrepreneurs, and Start Ups
By: Michael R. Ward, Anita Choi, Andrew Boyd, Alfredo B. D. Silva, Matthew Karlyn, Jim Krenn and Matthew A. Chivvis
The GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups features a combination of lectures and interactive workshops and is designed for students, post-docs, entrepreneurs, and investors with life sciences and tech backgrounds to learn
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October 07, 2020 - United States, FDA, Litigation, Intellectual Property
Navigating The CRISPR Patent Landscape and Understanding The FDA and its Process
By: Michael R. Ward
“What can be a better day to talk about the complex CRISPR/Cas9 patent landscape than the big day that the Nobel Prize was awarded to pioneers of this revolutionary technology? The story of the continuing dispute on the fundamental CRISPR/Cas9 patents offers a lot
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August 18, 2020 - United States, Litigation, Intellectual Property
Personalized Medicine Claims Get a Boost under New MPEP Revision
By: Meghan McLean Poon
The United States Patent and Trademark Office (USPTO) published the latest revision to its Manual of Patent Examining Procedure (MPEP) on June 30, 2020. According to the Executive Summary, in this revision, nearly all of the 27 chapters have been updated to incorporate new
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August 12, 2020 - United States, Litigation, Pharma, Intellectual Property
Casting a New Light on Diagnostic Patents: “Methods of Preparation” Patent-Eligible
By: Karen G Potter
The ability of life sciences companies to rely on patent protection for diagnostic methods has been eroded over the last ten years, although recent court decisions evidence a rebuilding framework. While courts have consistently invalidated diagnostic methods as lacking patent eligibility, claims re-framed as
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Topic Archives: Litigation

The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16

By: Wolfgang Schönig

Ninth Circuit Weighs in on Fraud-on-the-FDA Theory, Marketing Devices for Off-Label Use, and Kickbacks

Pay-for-Delay has a tough (antitrust) time at EU Top Court

By: Jens Hackl and Andreas Grünwald

Do You Have the COVID-19 Blues? Don’t Forget About Sunshine!

EHR Vendor Settles Kickback Allegations to the Tune of $18.25 Million

Considerations for ANDA and BPCIA Litigation

By: Matthew A. Chivvis and Michael R. Ward

Legal Topics for Scientists, Entrepreneurs, and Start Ups

By: Michael R. Ward, Anita Choi, Andrew Boyd, Alfredo B. D. Silva, Matthew Karlyn, Jim Krenn and Matthew A. Chivvis

Navigating The CRISPR Patent Landscape and Understanding The FDA and its Process

By: Michael R. Ward

Personalized Medicine Claims Get a Boost under New MPEP Revision

By: Meghan McLean Poon

Casting a New Light on Diagnostic Patents: “Methods of Preparation” Patent-Eligible

By: Karen G Potter