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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 31, 2022 - Global, FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 1 OF 3)
By: Wolfgang Schönig and Robert Grohmann
Research assistant Nicole Gebert contributed to this article. In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public
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May 26, 2022 - United States, FDA, Healthcare, Pharma, Regulatory, Intellectual Property
Senators Call for Report on State of Psychedelic Research
By: Stacy Cline Amin
Thanks to our Life Sciences Transactions + Licensing Group, including Matthew Karlyn, Mai Zymaris, and Hannah Koo, for contributing to this post. Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and
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May 24, 2022 - United States, Intellectual Property
The USPTO Proposes to Establish Permanent Electronic Filing for Patent Term Extension Applications
By: Lisa N. Silverman and Yuying (Kate) You
On May 6, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice, proposing to amend the Rules of Practice in Patent Cases to allow electronic submissions of patent term extension (PTE) applications, interim PTE applications, and any related submissions to the
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May 20, 2022 - Agtech, Intellectual Property, Asia
China’s New Seed Law: Molecular Varieties and Macro Developments
By: Liz Freeman Rosenzweig
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
The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022
By: Liz Newman and Karen G Potter
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 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, Nicole Victoria Ozeran 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
FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing
By: Brigid DeCoursey Bondoc and Rachel Park
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 and Rachel Park
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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