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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.

December 14, 2022 - Intellectual Property, Pharma, Regulatory, European Union
Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers
By: Robert Grohmann
In two recent landmark decisions, Novartis v. Abacus (C ‑ 147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union ( CJEU ) strengthened the position of drug manufacturers against repackaging practices of parallel importers. The court held that, based
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December 12, 2022 - Agtech, FDA, Regulatory, United States
FDA Final Food Traceability Rule: Overview and Key Takeaways from FDA’s Food Safety Modernization Act Webinar
Food Traceability Final Rule Overview On November 21, 2022, the U.S. Food and Drug Administration (FDA) officially published its Final Rule: Requirements for Additional Traceability Records for Certain Foods (“Final Rule”) in the Federal Register. The Final Rule establishes additional traceability recordkeeping requirements for
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December 09, 2022 - Agtech, Financing, Startup
Financing Options in the Alternative Protein Industry
By: Simon Arlington and Michelle Si-Ting Luo
This article is Part B of the fifth alert in our series of alerts focussed on the alternative protein industry. While Part A provided an overview of financing options in the industry, this Part B considers a variety of key financing options in more
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December 05, 2022 - Agtech, Regulatory, United States, Intellectual Property
USDA’s PVP System Embraces Transgenic and Gene Edited Plants
By: Liz Freeman Rosenzweig Ph.D., Christopher D Lew, Abby C. Burrus Ph.D. and Michael Ward Ph.D.
This is an excerpt from a longer piece. For more information on the history and landscape of PVPs on transgenic plants, read more. Plant Variety Protection (PVP) is a form of intellectual property protection administered through the United States Department of Agriculture (USDA) for
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December 02, 2022 - Healthcare, FDA, Regulatory, Litigation, United States
The USPTO and the FDA Join Hands to Promote Competition
By: Mehran Arjomand and Jean Nguyen Ph.D.
On November 15, 2022, the Berkeley Center for Law and Technology hosted a webinar to address the recent, unprecedented collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). The webinar, entitled “The USPTO‑FDA Collaboration: A Discussion of
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November 29, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma, United States
CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies
On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) published the final 2023 Medicare Physician Fee Schedule (“2023 Fee Schedule”). Although the 2023 Fee Schedule most notably sets the rates for Medicare services for the coming year, the rulemaking also traditionally includes
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November 22, 2022 - FDA, Agtech, Regulatory
FDA Clears the Path to Lab-Grown Meat
By: Simon Arlington, Brigid DeCoursey Bondoc and Owen Grayson Hosseinzadeh
Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post. On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken. This
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November 17, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma
FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance
By: Brigid DeCoursey Bondoc
On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass
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November 15, 2022 - FDA, Healthcare, Digital Health, Regulatory
Prevent a Clinical Trial from Turning Into a Criminal Trial
By: Kate Driscoll, Brian K. Kidd and Brian R. Michael
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement,” during the
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November 11, 2022 - Agtech, Intellectual Property, Startup, Corporate + Venture Capital
Top Three IP Issues for AgTech Startups
By: Matthew A. Ferry and Edith A. Pierre-Jerome Ph.D.
Innovation, agriculture, and technology took center stage at San Diego’s first AgTech Hackathon. The event took place October 21 – 23 in the city of Escondido, a key farming hub in San Diego County looking to attract agtech startups to the region. The event
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