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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 16, 2024 - Intellectual Property, Healthcare, Pharma
Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers
By: Paige N. Chandler Ph.D., Meghan McLean Poon Ph.D. and Matthew A. Chivvis
The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of reducing drug prices. The APPA would
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August 15, 2024 - Intellectual Property, Litigation, Pharma
Federal Circuit Clarifies Scope of Obviousness-type Double Patenting in Allergan Usa V. Msn Laboratories
By: Jeffrey W. Schmidt Ph.D., Meghan McLean Poon Ph.D. and Karen G Potter Ph.D.
On August 13, 2024, the U.S. Court of Appeals for the Federal Circuit issued a welcomed decision to patentees in Allergan USA, Inc. v. MSN Laboratories Private Ltd. , No. 24-1061 (Fed. Cir. 2024) clarifying the scope of obviousness-type double patenting (ODP) in the
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August 14, 2024 - Intellectual Property, Healthcare
The PTAB Axes Skin Treatment Patent Under Amgen
By: Yuxiang Chen and Mark D. McBriar Ph.D.
The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. ( See Forte Biosciences Inc v. University of Massachusetts , PGR2023-00014.) The PTAB found UMass’s claims
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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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Welcome to Mofo Life Sciences

Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers

By: Paige N. Chandler Ph.D., Meghan McLean Poon Ph.D. and Matthew A. Chivvis

Federal Circuit Clarifies Scope of Obviousness-type Double Patenting in Allergan Usa V. Msn Laboratories

By: Jeffrey W. Schmidt Ph.D., Meghan McLean Poon Ph.D. and Karen G Potter Ph.D.

The PTAB Axes Skin Treatment Patent Under Amgen

By: Yuxiang Chen and Mark D. McBriar Ph.D.

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