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Supreme Court Rules on Scope of Federal Contractors' Rights in Federally Funded Inventions

Client Alert | 1 min read | 06.07.11

On June 6, 2011, the United States Supreme Court, by a 7-2 margin, held in Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., No. 09-1159, that the term "subject invention" in the Bayh-Dole Act (35 U.S.C. § 200, et seq.), the statute that allocates certain rights in federally funded "subject invention[s]," includes only inventions for which the contractor has obtained a valid assignment from the employee inventor(s), and, therefore, that a contractor (and presumably the government) cannot obtain rights to an invention under the Bayh-Dole Act absent such an assignment. In so holding, the Court stated that the Bayh-Dole Act "simply assures contractors that they may keep title to whatever it is they already have" – which serves as a reminder to federal contractors desiring title to their employees' inventions to obtain valid assignments.

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Client Alert | 2 min read | 05.09.25

FDA Seeks Stakeholder Consultation on Prescription Drug User Fee Reauthorization

On May 8, the U.S. Food and Drug Administration (FDA) took steps to begin the process for reauthorizing the Prescription Drug User Fee Amendments (PDUFA) by announcing a public meeting to be held on July 14, 2025. The agency invited public stakeholders, including patient and consumer advocate groups, health care professionals, and scientific and academic experts to participate in the meeting and subsequent public meetings to consult on the PDUFA reauthorization....