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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.

August 08, 2024 - Regulatory
Updates in Uruguay – Accession to the PCT and Announcement of a New GMO Regulatory Framework
By: Liz Freeman Rosenzweig Ph.D. and Michael Ward Ph.D.
Earlier in 2024, Uruguay announced two major updates in the patent and regulatory spheres that are likely to encourage outside investment in Uruguayan industry, particularly for agbiotech: Uruguay is acceding to the Patent Cooperation Treaty (PCT) and is also rolling out a new Gene
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August 02, 2024 - Regulatory, Biotech
Microbes, Biotech Investigations, and Impacts: Midsummer Regulatory Updates from USDA-APHIS
By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.
After overhauling its biotechnology regulations for plants developed using genetic engineering , the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its regulatory procedures, both by opening the door to major regulatory changes for microbes developed through
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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 and Matt Karlyn
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 and Matt Karlyn
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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Welcome to Mofo Life Sciences

Updates in Uruguay – Accession to the PCT and Announcement of a New GMO Regulatory Framework

By: Liz Freeman Rosenzweig Ph.D. and Michael Ward Ph.D.

Microbes, Biotech Investigations, and Impacts: Midsummer Regulatory Updates from USDA-APHIS

By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.

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 and Matt Karlyn

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

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

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

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