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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.

July 08, 2024 - Litigation, Intellectual Property
Federal Circuit Wades Into Article III Standing in Patent Cases Once Again
By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.
Article III standing can differ from the statutory requirements of 35 U.S.C. § 281 in patent cases. In certain instances, a secured creditor can obtain rights that become actionable only upon default, which may include the ability to license or enforce a patent. However, these rights
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June 28, 2024 - Healthcare, United States, Pharma, Medical Devices + Diagnostics
USPTO Seeks Input on Experimental Use Exception to Patent Infringement and Possible Legislative Action
By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.
On June 28, 2024, the United States Patent and Trademark Office (USPTO) issued a Notice requesting public comments on the current state of the common law experimental use exception to patent infringement and whether Congress should consider codifying the experimental use exception through legislative
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June 07, 2024 - Pharma, FDA
Federal Court Invalidates Dosing Patent Based on Clinical Trials Disclosure
By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.
As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in their overall patent strategy. Disclosure of a protocol summary of the
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May 12, 2024 - Intellectual Property
USPTO Considers Changing Terminal Disclaimer Practice to Require Agreement Regarding Enforceability
By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.
On May 10, 2024, the USPTO issued a Notice of Proposed Rulemaking that proposes major changes to terminal disclaimer practice that could greatly affect both patent prosecution and patent litigation strategies. Specifically, the USPTO proposes amending the patent rules “to require that a terminal
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April 30, 2024 - Corporate + Venture Capital, Employment, Financing, Global, Intellectual Property, Litigation, Privacy + Data Security, Regulatory, Startup
When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets
By: Kate Driscoll, Nathaniel R. Mendell and Jim Krenn
MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now available. The podcast features interviews with legal experts who share insights and advice you just might
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April 04, 2024 - COVID-19
Non-Lab Diagnostics: FDA Regulatory Considerations
By: Brigid DeCoursey Bondoc, Matthew A. Ferry, Matt Karlyn and Hannah Koo
FDA REGULATORY ISSUES [1] The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional
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March 29, 2024 - COVID-19
At-Home Diagnostics Articles: Non-Lab Diagnostics: Supply, Manufacturing, and Distribution Agreements
By: Brigid DeCoursey Bondoc, Matthew A. Ferry, Matt Karlyn and Hannah Koo
DEVELOPMENT/SUPPLY/MANUFACTURING/DISTRIBUTION ISSUES [1] The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional healthcare
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March 29, 2024 - Litigation, United States
USPTO Issues Reminder to Examiners on Proper “Means-Plus-Function” Analysis
By: Karen G Potter Ph.D. and Jeffrey W. Schmidt Ph.D.
On March 18, 2024, the USPTO issued a memorandum to its Examiners reminding them of the resources and proper analysis for interpreting limitations under 35 U.S.C. § 112(f), which are commonly referred to as “means-plus-function” or “step-plus-function” limitations. These types of claim formats provide
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March 19, 2024 - Agtech, Intellectual Property, United States
UPOV Updates Explanatory Note on Essentially Derived Varieties (EDVs)
By: Michael Ward Ph.D., Liz Freeman Rosenzweig Ph.D., Cory Ellison Ph.D. and Edith A. Pierre-Jerome Ph.D.
In October 2023, the International Union for the Protection of New Varieties of Plants (UPOV) published a long-awaited updated Explanatory Note on Essentially Derived Varieties (EDVs). The UPOV Convention outlines a popular sui generis form of IP protection for plant varieties and was first
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March 19, 2024 - COVID-19
Non-Lab Diagnostics: Consumer and User Agreements
By: Brigid DeCoursey Bondoc, Matthew A. Ferry, Matt Karlyn and Hannah Koo
CONSUMER/USER ISSUES[1] The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional health care
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Welcome to Mofo Life Sciences

Federal Circuit Wades Into Article III Standing in Patent Cases Once Again

By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.

USPTO Seeks Input on Experimental Use Exception to Patent Infringement and Possible Legislative Action

By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.

Federal Court Invalidates Dosing Patent Based on Clinical Trials Disclosure

By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.

USPTO Considers Changing Terminal Disclaimer Practice to Require Agreement Regarding Enforceability

By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.

When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets

By: Kate Driscoll, Nathaniel R. Mendell and Jim Krenn

Non-Lab Diagnostics: FDA Regulatory Considerations

By: Brigid DeCoursey Bondoc, Matthew A. Ferry, Matt Karlyn and Hannah Koo

At-Home Diagnostics Articles: Non-Lab Diagnostics: Supply, Manufacturing, and Distribution Agreements

By: Brigid DeCoursey Bondoc, Matthew A. Ferry, Matt Karlyn and Hannah Koo

USPTO Issues Reminder to Examiners on Proper “Means-Plus-Function” Analysis

By: Karen G Potter Ph.D. and Jeffrey W. Schmidt Ph.D.

UPOV Updates Explanatory Note on Essentially Derived Varieties (EDVs)

By: Michael Ward Ph.D., Liz Freeman Rosenzweig Ph.D., Cory Ellison Ph.D. and Edith A. Pierre-Jerome Ph.D.

Non-Lab Diagnostics: Consumer and User Agreements

By: Brigid DeCoursey Bondoc, Matthew A. Ferry, Matt Karlyn and Hannah Koo