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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...

 

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...

 

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...

 

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...

 

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 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...

 

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.

 

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...

 

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...

 

HTMLBrussels Regulation Reform—Effects Felt Beyond Europe
Christopher Braithwaite, Adam R. Brown, Lucas J. Moore; Jones Day;
Legal Alert/Article
July 14, 2014, previously published on July 2014
From 10 January 2015, the reformed Brussels Regulation will be applied by the courts of all Member States of the European Union to regulate matters of jurisdiction and the recognition and enforcement of judgments in connection with civil and commercial claims. The impact of the "key"...

 


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