MoFo Life Sciences

February 15, 2022 - United States, FDA, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
PATENT TERM EXTENSION FOR BIOLOGICS
By: Meghan McLean Poon and Yuying (Kate) You
Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S. Food and Drug Administration (FDA). To be eligible for
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February 09, 2022 - United States, COVID-19, Healthcare
DOJ Releases False Claims Act Statistics for Fiscal Year 2021
By: Brian K. Kidd, Adam L. Braverman and Demme Doufekias
On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it collected more than $5.6 billion in False Claims Act (FCA) settlements and judgments in fiscal year 2021. This is the largest annual total since 2014, and the second largest in FCA history. Though
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January 31, 2022 - United States, Digital Health, Biotech, Healthcare, Pharma
RECORDINGS NOW AVAILABLE: 2022 LIFE SCIENCES MOFORUM – GROWTH, INNOVATION, AND STRATEGY
Last week, Morrison & Foerster’s Life Sciences & Healthcare Group hosted its first program of the year with the firm’s 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy. We welcomed 100+ participants over the three-day virtual program to hear from leaders from across the
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January 25, 2022 - United States, Digital Health, Biotech, Healthcare, Pharma
2022 Life Sciences MOFORUM Starts This Week
By: Matthew Karlyn
Morrison & Foerster kicked off its virtual 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy on January 25, 2022. With three days of programming planned, the series started with a discussion on the “Digital Transformation in Life Sciences,” featuring digital health advisor Melinda
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January 21, 2022 - United States, Medical Devices + Diagnostics, Healthcare, Privacy + Data Security
Latest Genetic Data Privacy Law Goes into Effect
By: Melissa M. Crespo
California is ringing in the New Year with new privacy and security protections for genetic data. On January 1, 2022, California’s new Genetic Information Privacy Act (GIPA) became the latest state genetic data privacy law to go into effect, adding to a growing number
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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
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January 13, 2022 - United States, Digital Health, Healthcare, Data Analytics, Intellectual Property, Bioinformatics
Bioinformatics Patents – Subject Matter Eligibility in 2022
By: Jean Nguyen
The increasing presence of data-driven solutions in the healthcare and life sciences sector is apparent from the rise in numbers of patents and patent applications. The number of published bioinformatics patents and patent applications in the last decade has nearly doubled. Bioinformatics patents face
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November 30, 2021 - United States, FDA, Healthcare
Rescinding the MCIT/R&N Final Rule, CMS Seeks New Approaches for Innovative Technology Coverage
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As we reported in an earlier blog post , CMS first proposed
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November 18, 2021 - AI + Robotics, United States, FDA, Digital Health
Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space
By: Stacy Cline Amin
FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was the panel on “FDA’s Digital Health Center of Excellence: Working with the FDA on Digital Health.” The panel featured Bakul
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November 16, 2021 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Digital Health
Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference
By: Stacy Cline Amin
The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond , November 9-10, 2021. Morrison & Foerster’s Stacy Cline Amin and Bethany Hills led panel discussions during the two-day conference. Stacy Cline Amin, who
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