Jones Day Washington, DC Document Search Results (109)
Show: results per page
|FDA Finalizes Three Guidance Documents on Biosimilars|
Edgar J. Asebey, Maureen Bennett, Christian B. Fulda, Colleen Heisey, Christopher M. Mikson; Jones Day;
May 15, 2015, previously published on May 2015FDA recently finalized three draft guidance documents addressing scientific and regulatory issues associated with the development and licensure of biosimilars.
|U.S. DOJ Brings Renewed Attention to Antitrust Compliance Programs|
Glen C. Cheng, Kathryn M. Fenton, J. Bruce McDonald; Jones Day;
May 14, 2015, previously published on April 2015On March 31, 2015, a federal court issued a summons to AU Optronics Corporation ("AU Optronics") to respond to allegations that it violated its probation for a criminal price-fixing conviction through failure to implement an effective antitrust compliance program. Corporate defendants can...
|The Significance of In re Cuozzo and its Ongoing Spot in the Limelight|
Gregory A. Castanias, David B. Cochran, Matthew W. Johnson, Jennifer L. Swize; Jones Day;
May 14, 2015, previously published on April 2015When the United States Court of Appeals for the Federal Circuit issued its decision in In re Cuozzo Speed Technologies in February 2015┐the first decision in an appeal from an inter partes review ("IPR") conducted by the Patent Trial and Appeal Board (the "PTAB")┐both the Patent...
|Claim Construction, Findings of Fact, and Indefiniteness in the Wake of Teva v. Sandoz|
Gregory A. Castanias, Calvin P. Griffith, Tharan Gregory Lanier, Matthew J. Silveira, Jennifer L. Swize; Jones Day;
May 14, 2015, previously published on April 2015In its January 2015 decision in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the United States Supreme Court held, contrary to the Federal Circuit's longstanding practice, that a district court's claim constructions are to be reviewed on appeal under the two-part test set forth in Federal Rule...
|Insurance Coverage Considerations for Unmanned Aircraft Systems|
Tyrone R. Childress, Jeffrey J. Immel, Rebecca MacPherson; Jones Day;
May 13, 2015, previously published on April 2015On February 23, 2015, the Federal Aviation Administration ("FAA") issued new proposed regulations for the operation and certification of small unmanned aircraft systems ("sUAS"), popularly referred to as "drones." Although the proposed rules do not require that sUAS...
|Digital Health Transactions┐Are You Doing Your Due Diligence?|
Scott A. Edelstein, Stephen E. Gillette, Alexis Slagle Gilroy, Kevin D. Lyles, Soleil E. Teubner; Jones Day;
May 12, 2015, previously published on April 2015With investment in digital health start-ups growing exponentially in recent years, it is important that interested parties proceed with a transactional perspective attuned to the unique regulatory environment of this industry. Investors, strategic partners, and others looking to acquire a stake in...
|Once More Unto the Breach—The New "Fiduciary" Definition|
Alan S. Miller, Sara R. Pikofsky; Jones Day;
May 12, 2015, previously published on April 2015On April 14, 2015, the Department of Labor (the "Department") re-proposed regulations (the "Proposed Regulations") that define when someone becomes a fiduciary by reason of providing "investment advice for a fee or other compensation." The Proposed Regulations are the...
|EU's Accelerated M&A Activity in Telecom and Tech Sectors Prompts Regulatory Questions|
Paloma Bru, Francesco Liberatore, Holger Neumann, Bruce A. Olcott, Alexandre G. Verheyden; Jones Day;
May 12, 2015, previously published on April 2015M&A activity in the telecommunications and technology sectors is running at levels not seen since the dot-com bubble of the late 1990s. Much of the optimism stems from the rise of new communications services, such as, amongst others, Communications as a Service ("CaaS"), Voice over IP...
|NLRB Accuses USPS of Failing to Bargain Data Breach Response|
Terri L. Chase, Doreen S. Davis, Patricia A. Dunn, Jacqueline M. Holmes, Alison B. Marshall; Jones Day;
May 7, 2015, previously published on April 2015The National Labor Relations Board recently issued a complaint against the United States Postal Service alleging that USPS failed to furnish information and bargain over its response to a data breach that compromised sensitive employee information. This case raises the novel question of whether and...
|The Solar Energy Compensation Debate Continues in 2015|
Gerald P. Farano; Jones Day;
April 29, 2015, previously published on Winter 2015The ongoing advance of distributed photovoltaic ("PV") solar power generation in the U.S. continues to stoke debate regarding how residential PV customers should be compensated for feeding power back into the grid.