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HTMLRecent Decision in Lance Armstrong False Claims Act Case Raises New Timeliness Arguments
Peter F. Garvin, Meghan E. Greenfield, J. Andrew Jackson, Grant H. Willis, Alexander M. Yabroff; Jones Day;
Legal Alert/Article
July 24, 2014, previously published on July 2014
For several years now, litigants have wrestled with three questions: (i) does the Wartime Suspension of Limitations Act ("WLSA") apply to civil False Claims Act ("FCA") actions, (ii) do the 2009 Fraud Enforcement and Recovery Act ("FERA") amendments to the FCA apply to...

 

HTMLIn re: Kellogg Brown & Root, Inc., et al.: D.C. Circuit Grants Petition for Mandamus and Protects Attorney-Client Privilege of Internal Investigation in False Claims Act Case
J. Andrew Jackson, Lindsey Lonergan, Rebekah N. Plowman, Stephen G. Sozio; Jones Day;
Legal Alert/Article
July 24, 2014, previously published on July 2014
In March 2014, we issued an Alert summarizing a decision issued by the U.S. District Court for the District of Columbia in United States ex rel. Barko v. Halliburton Co., et al. The District Court granted a relator's motion to compel and ordered defendants to produce documents reflecting the...

 

HTMLNew Tax Treaty Between Mexico and United Arab Emirates Enters into Force
Rodrigo Gómez, Karl L. Kellar, Andrés Lieja, Luis Ignacio Martel, Luis Rodrigo Salinas; Jones Day;
Legal Alert/Article
July 24, 2014, previously published on July 2014
The Mexico-United Arab Emirates tax treaty, signed on May 20, 2012 (the "Treaty"), entered into force on July 9, 2014 after its publication in the Mexican Official Gazette. Pursuant to Article 28, the Treaty will be applicable on January 1, 2015. The Treaty results from Mexico's...

 

HTMLPayers, Pension Plans, Pharmacies Ask FDA Not to Give Unique Names to Biosimilars
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
Earlier this month, a group of 32 companies and organizations, including health insurers, pharmacies, labor unions, and pension plans, urged FDA not to require distinct names for biosimilar products, explaining that such a policy would undermine the potential cost savings generated by such generic...

 

HTMLFDA Contemplates Further Revisions to "Off-Label" Drug Marketing Rules and Guidance
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
According to recent reports, FDA is reevaluating longstanding policies regarding the marketing of pharmaceutical products for "off-label" uses, such as when a manufacturer promotes an otherwise approved product for an indication, age group, or dosage that has not been approved. As...

 

HTMLFDA Continues to Bolster Regulation of Compounding Pharmacies
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
Armed with new authority granted by the Drug Quality and Security Act ("DQSA"), FDA is increasingly using its regulatory powers to enhance oversight of compounding pharmacies. DSQA amended section 503A of the Food, Drug, and Cosmetic Act ("FDCA") to clarify the scope of...

 

Adobe PDFSoftware Inventions—Keeping it Eligible
John V. Biernacki, David B. Cochran, Douglas H. Pearson; Jones Day;
Legal Alert/Article
July 15, 2014, previously published on July 2014
Takeaways and Practical Considerations from the PTO's Preliminary Examination Instructions on Patent-Eligible Subject Matter in view of Alice Corporation Pty. Ltd. v. CLS Bank International, et al.

 

HTMLRecent Decision in Lance Armstrong False Claims Act Case Raises New Timelines Arguments
Peter F. Garvin, Meghan E. Greenfield, J. Andrew Jackson, Grant H. Willis, Alexander M. Yabroff; Jones Day;
Legal Alert/Article
July 14, 2014, previously published on July 2014
For several years now, litigants have wrestled with three questions: (i) does the Wartime Suspension of Limitations Act ("WLSA") apply to civil False Claims Act ("FCA") actions, (ii) do the 2009 Fraud Enforcement and Recovery Act ("FERA") amendments to the FCA apply to...

 

HTMLConditional Pricing Practices in the U.S. Spotlight
Kathryn M. Fenton, J. Bruce McDonald, David P. Wales; Jones Day;
Legal Alert/Article
July 11, 2014, previously published on July 2014
On June 23, 2014, the Federal Trade Commission (“FTC”) and the Antitrust Division of the U.S. Department of Justice (“DOJ”) hosted a one day workshop to explore the economic and legal implications of conditional pricing practices such as loyalty discounts, market share...

 

HTMLUtility Regulatory Group v. EPA: U.S. Supreme Court Stops EPA's Rewrite of the Clean Air Act
Daniella A. Einik, Kevin P. Holewinski, Charles T. Wehland; Jones Day;
Legal Alert/Article
July 11, 2014, previously published on July 2014
In its third encounter with greenhouse gas emissions in the context of the Clean Air Act, the United States Supreme Court, in Utility Air Regulatory Group v. EPA, No. 12-1146, 573 U.S. &under;&under;&under;&under; (June 23, 2014) ("UARG"), reinforced bedrock separation of powers...

 


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