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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...

 

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 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...

 

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...

 

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...

 

HTMLFifth Third Bancorp v. Dudenhoeffer: Supreme Court Rejects "Presumption of Prudence" for Stock Drop Cases
M. Travis DeHaven, Daniel C. Hagen, Alan S. Miller, Evan Miller, Sara R. Pikofsky; Jones Day;
Legal Alert/Article
July 10, 2014, previously published on June 2014
On June 25, the United States Supreme Court issued its decision in Fifth Third Bancorp v. Dudenhoeffer, a decision that had been highly anticipated by the ERISA bar. The question before the Court was whether the so-called Moench presumption of prudence applied to a motion to dismiss. Rather than...

 

Adobe PDFFERC Acts to Ensure that Utility Cost-Based Rates Include an Adequate Return on Equity
James C. Beh, Kenneth B. Driver, Matthew R. McGuire, Kevin J. McIntyre, William Weaver; Jones Day;
Legal Alert/Article
July 10, 2014, previously published on June 2014
In June, the Federal Energy Regulatory Commission ("FERC" or "Commission") issued Opinion No. 531, which details three significant changes to the way FERC determines the rate of return on equity ("ROE") in public utility rate cases.[1] First, FERC modified its...

 

Adobe PDFAlice Corp. v. CLS Bank: Did the Supreme Court Sign the Warrant for the "Death of Hundreds of Thousands of Patents"?
John V. Biernacki, Gregory A. Castanias, David M. Maiorana; Jones Day;
Legal Alert/Article
July 1, 2014, previously published on June 2014
Many software and internet companies have secured patents to protect their technology investments. For some companies — especially startups — software or business - method patents may be their only valuable assets. In recent years, those kinds of patents have been attacked for being too...

 


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