MoFo Life Sciences

January 09, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 2)
Yesterday , we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our series, we look at the specifics of FDA’s 2019 consent decrees. FDA Consent Decrees FDA published
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January 08, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 1)
The year 2019 was one of uncertainty for FDA, as former Commissioner Scott Gottlieb announced his departure in March, ultimately stepping down in April. For the bulk of the year, FDA was led by Acting Commissioner, Ned Sharpless, until Brett Giroir took over in
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December 09, 2019 - United States, Litigation, Pharma, Intellectual Property
Striking the Balance in Trade Secret and Corporate Espionage Disputes
By: Matthew A. Chivvis
In 2017, the Commission on the Theft of American Intellectual Property issued a report to Congress estimating that the theft of trade secrets could cost the United States economy as much as $600 billion annually. In the years following, news reports indicate that alleged
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November 22, 2019 - United States, FDA, Litigation, Biotech, Healthcare, Pharma, Regulatory, Intellectual Property
FDA Approves 25th Biosimilar
On November 15, Pfizer’s adalimumab product became the 25th biosimilar approved by FDA under the Biologics Price Competition and Innovation Act (BPCIA). The road to the 25th approval has been long and has involved some of the biggest companies and medications in the pharmaceutical
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October 15, 2019 - United States, CFIUS, Regulatory
Foreign Investment 2020: CFIUS Spotlight on “TID” U.S. Businesses
By: Charles L. Capito and Joseph A. Benkert
FIRRMA directed the U.S. Department of the Treasury (“Treasury”), as the chair of CFIUS, to issue regulations that, among other things, address national security concerns arising from foreign investment in U.S. businesses with critical technologies, critical infrastructure, and personal data (referred to in the
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September 25, 2019 - United States, CFIUS, Regulatory
Foreign Investment 2020: Key Takeaways from the “Modernized” CFIUS Regulations
By: Joseph A. Benkert and Charles L. Capito
After more than a year of anticipation, the U.S. Department of the Treasury (“Treasury”) has released proposed regulations to implement the Foreign Investment Risk Review Modernization Act (FIRRMA). These proposed regulations follow an initial round of FIRRMA-implementing regulations issued in October 2018, which most notably included
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September 19, 2019 - AI + Robotics, United States, FDA, Product Liability + Class Action, Pharma, Regulatory, Data Analytics
Artificial Intelligence and Pharma
Bethany Hills authored an article for PHARMAnetwork , covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Bethany discusses that the pharmaceutical sector has been one of the more robust areas where private partnerships with artificial intelligence-based technology companies have
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September 04, 2019 - United States, Litigation, Biotech, Pharma, Intellectual Property, Cell + Gene Therapy
Analyzing Biologics Under the Doctrine of Equivalents and Prosecution History Estoppel
By: Janet Xiao Ph.D. and Meghan McLean Poon Ph.D.
In a recent decision, Ajinomoto v. ITC , the Federal Circuit addressed the issues of doctrine of equivalents and prosecution history estoppel as applied to patent claims reciting specific amino acid sequence of a biologic. On appeal, the Federal Circuit affirmed the decision by
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August 28, 2019 - AI + Robotics, United States, Regulatory, Data Analytics, Intellectual Property
AI Patent Policy – Calling all Life Sciences Practitioners
By: Anna Yuan and Karen G Potter Ph.D.
In the life sciences, artificial intelligence (AI) may be facilitating a sea change in how diseases are diagnosed, prognosed, and treated, and even how therapies are discovered and produced. Indeed, it is possible for AI to provide insights into disease and treatment that could
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July 09, 2019 - United States, Litigation, Pharma, Intellectual Property
Federal Circuit Diagnoses the Patent Eligibility Problem – But Denies a Remedy
By: Karen G Potter Ph.D.
On July 3, 2019, in a 7-5 en banc decision, the Federal Circuit declined to reconsider its decision in Athena Diagnostics v. Mayo Collaborative Services ,[1] finding that claims to a diagnostic method were patent ineligible for being directed to a law of nature.
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Topic Archives: United States

2019 FDA Enforcement and Related Litigation Trends (Part 2)

2019 FDA Enforcement and Related Litigation Trends (Part 1)

Striking the Balance in Trade Secret and Corporate Espionage Disputes

By: Matthew A. Chivvis

FDA Approves 25th Biosimilar

Foreign Investment 2020: CFIUS Spotlight on “TID” U.S. Businesses

By: Charles L. Capito and Joseph A. Benkert

Foreign Investment 2020: Key Takeaways from the “Modernized” CFIUS Regulations

By: Joseph A. Benkert and Charles L. Capito

Artificial Intelligence and Pharma

Analyzing Biologics Under the Doctrine of Equivalents and Prosecution History Estoppel

By: Janet Xiao Ph.D. and Meghan McLean Poon Ph.D.

AI Patent Policy – Calling all Life Sciences Practitioners

By: Anna Yuan and Karen G Potter Ph.D.

Federal Circuit Diagnoses the Patent Eligibility Problem – But Denies a Remedy

By: Karen G Potter Ph.D.