The legal battle between VANDA Pharmaceuticals, Inc. and the United States government provides guidance on the minimum requirements that the government must meet to protect trade secrets provided during the regulatory approval process for pharmaceuticals. The case, which involves alleged unlawful disclosure of trade secrets by government officials to generic drug competitors, presents several issues
In a case pitting Wasco County, Oregon residents and a newspaper against the City of Dalles, Oregon, a court will decide whether a public interest exception in a state law will mandate the disclosure of potential trade secrets. After a reporter from The Oregonian inquired into Google’s water use, the City of Dalles (“Dalles”) filed a Complaint against both the reporter and the newspaper (the “Defendants”) seeking declaratory relief, requesting that the court declare Google’s water use a trade secret under Oregon’s Public Records Law, ORS 192.311 et seq, and the Oregon Uniform Trade Secrets Act, ORS 646.461 et seq. As described below, the issue is whether Google’s water use is a trade secret, and if so, if the public interest exception, which may permit public disclosure of trade secrets, applies.
Continue Reading City Claims Google’s Water Use Is A Trade Secret and Exempt from Oregon’s Public Records Laws
The U.S. Food and Drug Administration (“FDA”) is strongly encouraging cannabis producers to share information regarding their clinical studies with the FDA, so it, in turn, can better understand the effects of chronic use of cannabis. This will then help the FDA develop sound science-based policies and regulations relating to cannabis and cannabis derived products. But cannabis producers also understandably want to protect their trade secret information in this rapidly growing industry. The FDA’s DMF process may be the solution where everybody can win.
Continue Reading High-ly Sensitive Information: Use of FDA’s DMF Process to Protect Cannabis Trade Secrets
On October 7, 2019, the U.S. Department of Justice (“DOJ”) issued a Step-by-Step Guide for Determining if Commercial or Financial Information Obtained from a Person is Confidential Under Exemption 4 of the FOIA. The Step-by-Step Guide is used by agencies, in conjunction with guidance from the Office of Information Policy (“OIP”) to determine whether commercial or financial information provided by a person is “confidential” under FOIA Exemption 4. FOIA Exemption 4 protects trade secrets and commercial information that is privileged or confidential. The DOJ Guidance is another tool that can be used by practitioners to determine when information must be disclosed under a FOIA Request.
The DOJ Guidance followed on the heels of the Supreme Court’s decision in in Food Marketing Institute v. Argus Leader Media (described in a previous blog post) where the Supreme Court addressed the question of “when does information provided to a federal agency qualify as confidential.” The Supreme Court held that information is confidential and protected if: (1) the information is “customarily kept private, or at least closely held” and (2) where the receiving party provides “some assurance” that the information will be kept secret.
The DOJ Guidance outlines three questions to help determine if information is confidential under FOIA Exemption 4.
Continue Reading DOJ Step-by-Step Guidance to Determine if Trade Secrets are Confidential Under the Freedom of Information Act (FOIA)
Pennsylvania’s medical marijuana bill went into effect in 2016. In order to obtain a permit under that bill, potential medical marijuana grower/processors or dispensaries are required to provide detailed business information with their applications. However, under the state’s Right-to-Know Law (“RTKL”), applicants who can show that information about their security, storage and transportation are trade…
In a recent decision, the Supreme Court of Vermont affirmed its commitment to protecting commercial secrets of private companies, even if they may have been disclosed to a public agency. Long v. City of Burlington, 199 A.3d 542 (Vt. 2018). The Burlington City Council was working with its consultant, ECONorthwest, and private property owners…