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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...

 

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...

 

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...

 

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...

 

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...

 

HTMLRussia Adopts Restrictive Changes to its Data Privacy Law Data Location Requirement Will Adversely Affect Data Flows
Veronica Fridman, Anita Leung, Mauricio F. Paez, Sergei Volfson, Undine von Diemar; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
During the first week of July 2014, the State Duma (lower chamber of the Russian Parliament) adopted a set of amendments to the Federal Law "On Information, Information Technologies, and Information Protection" ("Information Law") and to the Federal Law "On Personal...

 

Adobe PDFStay or Go! Tracking District Court Stays Pending Parallel USPTO Post-Grant Review Proceedings
David B. Cochran, John A. Marlott, Scott B. Poteet, Peter G. Thurlow; Jones Day;
Legal Alert/Article
July 16, 2014
Recent data from the U.S. Patent and Trademark Office's ("USPTO") Patent Trial and Appeal Board ("PTAB") indicates that 80 percent of inter partes review ("IPR") and 90 percent of covered business method ("CBM") review proceedings are directed to patents...

 

Adobe PDFFrench Regulator Clarifies Position with Respect to Marketing of Alternative Investment Funds in France
Philippe Goutay, Anselme Mialon; Jones Day;
Legal Alert/Article
July 15, 2014, previously published on July 2014
On June 30, the French Securities Regulator (the "AMF") issued guidance in the form of Instruction DOC-2014-03[1] on the procedures for marketing shares and units of alternative investment funds ("AIFs"). In doing so, the AMF brings welcome clarity to the French position with...

 

Adobe PDFThe Italian Government Introduces Measures to Boost the Italian Lending Market
Alessandro E. Corno, Luca Ferrari, Marco Lombardi, Francesco Squerzoni; Jones Day;
Legal Alert/Article
July 15, 2014, previously published on July 2014
In the last few years, Italy has embarked on a program of economic and financial reforms to ensure the country's future sustainability and growth. As part of this program, the Italian Council of Ministers enacted Law Decree No. 91 of June 24, 2014 (the "Law Decree"), which introduces new...

 


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