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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 | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....