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Preload of Generic Software Precludes Finding of Substantial Transformation in U.S. When Replaced with Proprietary Software That Enhanced Functionality

Client Alert | less than 1 min read | 05.31.16

Customs and Border Protection has released its final determination concerning different versions of certain network transceivers and high speed cabling devices that require software to be functional. CBP concluded that “blank” network transceivers imported into the U.S. where proprietary software was first downloaded were substantially transformed in the U.S., whereas network transceivers already programmed with generic software when imported were not substantially transformed by subsequent replacement of the generic software with proprietary software that enhanced and broadened functionality allowing interoperability with different OEM systems.

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Client Alert | 6 min read | 11.25.25

Brussels Court Clarifies the EU’s SPC Manufacturing Waiver Regulation Rules

On November 13, 2025, the president of the French-speaking Brussels Enterprise Court ruled in the long-running battle between Sandoz and Regeneron about the correct interpretation of the EU’s Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation regarding exports to a non-EU market. The Brussels Court dismissed Regeneron’s claim that Sandoz had provided a defective notification and agreed with Sandoz’s interpretation of the Regulation....