In Vanda Pharmaceuticals, Inc. v. United States, No. 23-629C (Fed. Cl. 2024), 2024 WL 201890, the Court of Federal Claims (COFC) addressed whether government disclosure of a company’s trade secrets and commercial information could create a viable claim for a taking under the Fifth Amendment or for breach of an implied-in-fact contract. The company, Vanda Pharmaceuticals (Vanda), claimed that the government’s disclosure of its confidential trade secrets—including its trademarked drugs’ dissolution rates—to competitors seeking U.S. Food and Drug Administration (FDA) approval of generic drug alternatives was an unlawful regulatory taking that diminished the value of Vanda’s brand name drugs and infringed upon Vanda’s right to exclude generics from the market. The government moved to dismiss Vanda’s claims for lack of subject matter jurisdiction and for failure to state a claim. The COFC denied the government’s motion in part, holding as a matter of first impression that Vanda adequately stated a takings claim based on the government’s disclosures but failed to state a claim for breach of an implied-in-fact contract. The COFC also held that Vanda’s claims involving one generic drug manufacturer were outside the Tucker Act’s six-year statute of limitations and were time barred. Continue Reading Does Government Disclosure of a Company’s Trade Secrets Amount to an Unlawful Taking Under the Fifth Amendment?
In Section 839 of the Fiscal Year 2021 National Defense Authorization Act, Congress directed the Government Accountability Office (“GAO”) to prepare a report evaluating the implementation of Department of Defense (“DoD”) Instruction 5010.44 relating to Intellectual Property Acquisition and Licensing, including but not limited to, DoD’s establishment of a cadre of intellectual property (“IP”) experts…
2013 has been a historic year for cybersecurity, privacy and data breach issues. From the President’s Executive Order, to the revised NIST security & privacy controls, and to the groundbreaking Mandiant report on cyber espionage, the pressure is on for companies to secure their handling of sensitive data.
In order to mitigate the risk of data breach, cyber theft, and the loss of trade secrets and other intellectual property, both the government agencies and private companies need to understand the sector-specific rules and requirements for information security, privacy, and data protection. Only after the rules of the road are fully understood can agencies and contractors implement policies to mitigate the risks posed by cyber threats.
Continue Reading Cybersecurity and Data Privacy in 2013: Contracting in a Time of Increased Scrutiny