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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.

October 25, 2022 - Medical Devices + Diagnostics
Cybersecurity Expectations Intensify for Medical Device Cos.
Josephine Garban, Patent Agent in New York and San Diego, contributed to this article. Stacy Cline Amin, Kristen Mathews, and Rachel Park co-authored an article for Law360 that discusses the FBI’s private industry notification reminding medical device companies that cybersecurity has to be front
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October 21, 2022 - Agtech, Financing, Startup
Financing Options for an Early Stage Company in the Alternative Protein Industry
By: Simon Arlington and Michelle Si-Ting Luo
Having a clear picture of financing options is key for early-stage companies and will be relevant to players in the alternative protein industry generally, given the significant amounts of investment that the industry has seen in recent years (a record US $5bn was invested
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October 18, 2022 - FDA, Digital Health, Healthcare
Telehealth Fraud Enforcement: Trends, Predictions, and Best Practices
By: Kate Driscoll
Morrison Foerster's Kate Driscoll joined the American Bar Association Health Law Section "Voices in Health Law" podcast to discuss the latest telehealth enforcement trends. The rise of telehealth services during the COVID-19 pandemic resulted in new and adapted forms of fraud, and Kate offers
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October 05, 2022 - Intellectual Property, United States
Sawing Through Patent Term—the Federal Circuit’s Recent Decision In Sawstop
By: Mehran Arjomand and Meghan McLean Poon Ph.D.
Patent Term Adjustment (PTA) is additional patent term for U.S. patents to compensate for delay in issuance. The statute (35 U.S.C. § 154(b)) provides three bases for PTA: delayed response by the USPTO (“A delay”), failure to issue a patent within three years (“B delay”),
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October 04, 2022 - FDA, Product Liability + Class Action
Water Is in, White Bread Is Out: “Healthy” Gets a New Look in 2023
By: Claudia M. Vetesi and Lena Gankin
For decades, health-conscious consumers have argued about what it really means for a food to be “healthy.” Is dark chocolate “healthy”? How about breakfast cereal, coffee, or fruit gummies? At the same time, class action litigants have seized on ever-evolving and subjective definitions of “healthy,” pursuing claims
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September 30, 2022 - United States, Healthcare
A Day Late and a Dollar Short: AAG Polite Warns That Corporate Leaders Who Fail to Invest in Compliance “Early and Often” Do So “At Their Own Risk”
By: Nathaniel R. Mendell, Brian R. Michael, Christine Y. Wong, Kate Driscoll and Mitchell E. Feldman
On September 28, 2022, the Assistant Attorney General for the Criminal Division of the United States Department of Justice (DOJ) joined the Inspector General for the United States Department of Health and Human Services (HHS-OIG) to offer some stern advice for corporate leaders and
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September 28, 2022 - FDA, COVID-19, Healthcare, Medical Devices + Diagnostics, Regulatory, United States
FDA Updates COVID-19 Test Policy
Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 Test Policy Guidance to encourage test developers to pursue full marketing authorization as opposed to Emergency
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September 28, 2022 - FDA, Healthcare, Medical Devices + Diagnostics, Regulatory, United States
FDA Releases Foundational Digital Health Guidance
By: Brigid DeCoursey Bondoc
On September 27, 2022, the U.S. Food and Drug Administration (FDA) issued its long-awaited final clinical decision support (CDS) software function guidance. This final guidance presents a significant departure from the previous draft version issued three years prior, including updates to address concerns voiced
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September 23, 2022 - Healthcare, FDA, Regulatory, Medical Devices + Diagnostics, United States
New Opportunities for Test Developers: Monkeypox Diagnostics
By: Brigid DeCoursey Bondoc
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. However, test developers must act fast. The Food and Drug Administration is
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September 13, 2022 - Agtech, United Kingdom, Regulatory
Key Considerations for Early-Stage Companies in the Alternative Protein Industry
By: Simon Arlington and Michelle Si-Ting Luo
Companies in the UK are regulated by many statutes, ranging from those dictating how much tax they need to pay, to those centred on how they treat their employees. At a corporate level, the main statute that companies should be familiar with is the
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