MoFo Life Sciences

January 20, 2022 - FDA, Biotech, Healthcare, Pharma, Regulatory
FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products
Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data and real-world evidence into clinical research, product
... ›
January 14, 2022 - United States, Digital Health, Biotech, Pharma, Intellectual Property, Bioinformatics
USPTO Launches Program to Defer Subject Matter Eligibility Responses
By: Meghan McLean Poon
Starting February 1, 2022, the U.S. Patent and Trademark Office (USPTO) will begin inviting selected applicants to participate in a pilot program to defer subject matter eligibility examination until final disposition of the application or all other rejections have been addressed. The theory behind
... ›
January 05, 2022 - Litigation, Biotech, Healthcare, Pharma, Intellectual Property
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
... ›
December 23, 2021 - FDA, COVID-19, Healthcare, Pharma
Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address
By: Rachel Park
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the Consumer Protection Branch in 2021, and highlighted areas of
... ›
October 25, 2021 - United States, FDA, Rare Disease, Pharma, Regulatory
FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products
By: Rachel Park and Brigid DeCoursey Bondoc
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “ Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations .” The guidance finalizes the January 2020 draft guidance and provides FDA’s current perspective on certain criteria
... ›
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
... ›
September 15, 2021 - United States, COVID-19, Healthcare, Pharma
Is the Future of Telehealth in OIG’s Hands?
Telehealth services may be at a crossroads. While the COVID-19 pandemic brought about widespread adoption of telehealth services, the Department of Justice and the U.S. Department of Health and Human Services Office of Inspector General (OIG) appear primed to audit telehealth services and ramp
... ›
June 29, 2021 - United States, FDA, COVID-19, Healthcare, Pharma
EUAs and the FDA’s Fight Against COVID-19: An Evolving Landscape
Christine Lentz , a Morrison & Foerster summer associate in our San Diego office , contributed to the writing of this article. The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in
... ›
May 11, 2021 - United States, FDA, COVID-19, Healthcare, Pharma
COVID-19 Vaccines: And Then There Were Three (Again)
On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others (produced by Moderna and Johnson & Johnson) have also been
... ›
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
... ›