MoFo Life Sciences

October 28, 2022 - United States, Healthcare, Regulatory, Digital Health, Biotech
U.S. Government Launches Billion-Dollar Biomedical Agency
By: Tina D. Reynolds
As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). Authorized by Congress in March 2022, the new
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May 12, 2022 - United States, Biotech, Healthcare, Intellectual Property, Cell + Gene Therapy
The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022
By: Liz Newman Ph.D. and Karen G Potter Ph.D.
Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in the form of a sequence listing. The inclusion of sequences in patent applications are compulsory to satisfy patent office
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March 15, 2022 - United States, Litigation, Biotech, Healthcare, Pharma, Intellectual Property
Possession of an "Effective" Dose
By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin Ph.D.
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 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 27, 2022 - FDA, Biotech, Healthcare, Pharma
FDA OKs Mail-Order Mifepristone: State Laws May Inhibit its Use
By: Brigid DeCoursey Bondoc
In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and through telemedicine in order to reduce the burden on patient access.
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January 25, 2022 - United States, Digital Health, Biotech, Healthcare, Pharma
2022 Life Sciences MOFORUM Starts This Week
By: Matt 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 20, 2022 - FDA, Biotech, Healthcare, Pharma, Regulatory, Cell + Gene Therapy
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
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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 Ph.D.
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 05, 2022 - Litigation, Biotech, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
Life Sciences Patent Trends in 2022 – Doctrine of Equivalents
By: Meghan McLean Poon Ph.D.
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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June 07, 2021 - Agtech, Biotech
Alternative Protein Industry Series
By: Andrew Boyd, Michael Ward Ph.D. and Simon Arlington
With an expanding global population and finite resources, our food systems are under significant pressure. Alternative proteins are increasingly presented as the solution to relieving the pressure that our food systems are under and to improving global food security. They can provide excellent nutritional
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Topic Archives: Biotech

U.S. Government Launches Billion-Dollar Biomedical Agency

By: Tina D. Reynolds

The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022

By: Liz Newman Ph.D. and Karen G Potter Ph.D.

Possession of an "Effective" Dose

By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin Ph.D.

RECORDINGS NOW AVAILABLE: 2022 LIFE SCIENCES MOFORUM – GROWTH, INNOVATION, AND STRATEGY

FDA OKs Mail-Order Mifepristone: State Laws May Inhibit its Use

By: Brigid DeCoursey Bondoc

2022 Life Sciences MOFORUM Starts This Week

By: Matt Karlyn

FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products

USPTO Launches Program to Defer Subject Matter Eligibility Responses

By: Meghan McLean Poon Ph.D.

Life Sciences Patent Trends in 2022 – Doctrine of Equivalents

By: Meghan McLean Poon Ph.D.

Alternative Protein Industry Series

By: Andrew Boyd, Michael Ward Ph.D. and Simon Arlington