MoFo Life Sciences

March 15, 2022 - United States, Litigation, Biotech, Healthcare, Pharma, Intellectual Property
Possession of an "Effective" Dose
By: Kelsey J. Roberts Kingman and Bu Yin
Update: On March 16, 2022, the U.S. Court of Appeals for the Federal Circuit denied Biogen International’s petition for panel rehearing and rehearing en banc , following a November split decision discussed below. Judges Lourie, Moore, and Newman dissented on the denial of en
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January 05, 2022 - Litigation, Biotech, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
Life Sciences Patent Trends in 2022 – Doctrine of Equivalents
By: Meghan McLean Poon
The Federal Circuit continues to tighten the standards for written description of functional claims, particularly in the biologics realm, which is putting patent applicants in the position of having to pursue narrow claims directed to specific sequences. At the same time, reliance on the
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December 23, 2021 - FDA, Medical Devices + Diagnostics, Litigation, Healthcare
3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session
FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021. The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022. The session included presentations from Ann Oxenham (CFSAN),
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October 08, 2021 - United States, FDA, Litigation, Pharma, Intellectual Property
Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices
By: Fitz B. Collings
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a “Comprehensive Plan for Addressing High Drug Prices.” The HHS Report—issued
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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 Ward Ph.D.
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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