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DoD Releases IP Guidebook

Client Alert | 1 min read | 05.05.25

On May 1, 2025, the Department of Defense announced the release of the long-anticipated 81-page Intellectual Property Guidebook for DoD Acquisition, which is aimed primarily at assisting acquisition professionals to develop, execute, and manage IP strategies that support functional area requirements and objectives across program life cycles. The Guidebook also provides guidance on the implementation of IP laws and regulations, describes operational challenges related to IP, and promotes industry partnerships. Crowell will provide more details regarding the Guidebook and its potential impacts in the coming days.

Insights

Client Alert | 3 min read | 06.26.25

FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”

In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and “immediate review” of new clinical trials where American patients’ cells are sent to China or other “hostile countries” for genetic engineering with the expectation that the cells will be infused back into U.S. patients.[1] A subsequent podcast published by the agency also said that therapies that involved cells that were sent to China for genetic engineering and intended for subsequent infusion into U.S. patients would not be approved going forward. The announcement said that there is “mounting evidence” that some clinical researchers failed to obtain informed consent from trial participants about the international transfer and manipulation of biological material....