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Welcome to Mofo Life Sciences

MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

May 20, 2022 - Agtech, Intellectual Property, Asia
China’s New Seed Law: Molecular Varieties and Macro Developments
By: Liz Freeman Rosenzweig Ph.D.
Liz Freeman Rosenzweig co-authored an article for China IPR examining China's new and much anticipated Seed Law, which went into effect on March 1, 2022. "The new Seed Law reflects a significant expansion in the scope of plant breeders' rights (PRB) protection in China,"
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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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April 15, 2022 - United States, Agtech, Litigation, Intellectual Property
Stepping Stones to Success: Supporting Claims in the Life Sciences
By: Meghan McLean Poon Ph.D. and Owen Grayson Hosseinzadeh
Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post. The standard for written description in the life sciences seems to have tightened lately, leading patent applicants to wonder what level of written support and working example data is
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April 13, 2022 - FDA, Product Liability + Class Action, Litigation, Regulatory
RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS
By: Claudia M. Vetesi and Lena Gankin
Originally published by Law360 , Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein content statements violate U.S. Food and Drug Administration (FDA) regulations, and mislead consumers by overstating the amount
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April 08, 2022 - Litigation, European Union, Intellectual Property
A Long Courtship for Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About a Unitary Supplementary Protection Certificate Gain Momentum
By: Wolfgang Schönig
After a myriad of challenges , delays , and hurdles, the setting up of the pan-European patent court, the Unified Patent Court (UPC), is finally gaining traction. On January 19, 2022, the UPC came into existence as an international organization. This date marks the
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April 07, 2022 - United States, FDA, Healthcare, Regulatory, Cell + Gene Therapy
FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing
By: Brigid DeCoursey Bondoc
On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “ Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell product development. These draft guidance documents were issued on
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April 01, 2022 - FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
QMSR: Welcomed by the Industry, but Lacking in Practicality
By: Brigid DeCoursey Bondoc
On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments." If finalized, the proposed rule will rename the current 21 CFR Part 820 as the
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March 22, 2022 - FDA, Agtech, Regulatory
FDA Clears CRISPR-Edited Cattle for Market Through Abbreviated Procedure: A First for Food-Use Animals
By: Brigid DeCoursey Bondoc, Liz Freeman Rosenzweig Ph.D. and Owen Grayson Hosseinzadeh
Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post. On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) determined that Acceligen Inc. ’s genome-edited, heat-tolerant cattle, pose a “low
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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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March 14, 2022 - United States, Healthcare, Pharma, Regulatory
New Jersey Court Affirms Prohibition of Physician Practice from Opening and Operating In-Office Pharmacy
At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the application from a New Jersey oncology practice (the “Petitioner”) to register, open, and operate a pharmacy within
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Welcome to Mofo Life Sciences

China’s New Seed Law: Molecular Varieties and Macro Developments

By: Liz Freeman Rosenzweig Ph.D.

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

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

Stepping Stones to Success: Supporting Claims in the Life Sciences

By: Meghan McLean Poon Ph.D. and Owen Grayson Hosseinzadeh

RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS

By: Claudia M. Vetesi and Lena Gankin

A Long Courtship for Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About a Unitary Supplementary Protection Certificate Gain Momentum

By: Wolfgang Schönig

FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing

By: Brigid DeCoursey Bondoc

QMSR: Welcomed by the Industry, but Lacking in Practicality

By: Brigid DeCoursey Bondoc

FDA Clears CRISPR-Edited Cattle for Market Through Abbreviated Procedure: A First for Food-Use Animals

By: Brigid DeCoursey Bondoc, Liz Freeman Rosenzweig Ph.D. and Owen Grayson Hosseinzadeh

Possession of an "Effective" Dose

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

New Jersey Court Affirms Prohibition of Physician Practice from Opening and Operating In-Office Pharmacy