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Federal Circuit Reaffirms Deferential OCI Standard

Client Alert | 1 min read | 05.06.09

The Federal Circuit in Axiom Resource Mgmt., Inc. v. U.S. (May 4, 2009) reversed the CFC decision granting a protest on the basis of an organization conflict of interest ("OCI"), and, in doing so, reaffirmed that, when the CFC reviews an OCI determination by a CO, including, in this case, the adequacy of a mitigation plan, it must apply the deferential "arbitrary and capricious" standard of the Administrative Procedure Act. In addition, the appellate court criticized the CFC for accepting litigation affidavits and relying on them when there was no need to supplement the administrative record, along the way casting doubt on the vitality of the Esch factors commonly used by the CFC in deciding whether to supplement an agency record in a bid protest case.

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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....