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Duane Morris LLP San Diego, PA Document Search Results (4)

 

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HTMLFDA Issues Draft Guidance Documents to Implement the Biologics Price Competition and Innovation Act of 2009
W. Blake Coblentz, Lee Crews, L. Norwood "Woody" Jameson, Vicki G. Norton, Siegfried J.W. Ruppert; Duane Morris LLP;
Legal Alert/Article
February 15, 2012, previously published on February 13, 2012
On February 9, 2012, the U.S. Food and Drug Administration (FDA) issued eagerly anticipated draft guidance documents on biosimilar product development in three installments, collectively the "Biosimilar Draft Guidances":

 

HTMLFDA Sends Prescription Drug User Fee Act V to Congress for Reauthorization
Lee Crews, L. Norwood "Woody" Jameson, Vicki G. Norton, Siegfried J.W. Ruppert; Duane Morris LLP;
Legal Alert/Article
January 24, 2012, previously published on January 23, 2012
The Prescription Drug User Fee Act (PDUFA) allows the U.S. Food and Drug Administration (FDA) to collect fees from drug manufacturers to facilitate reviewing their new drug applications. In a statement released January 13, 2012, the FDA said it had completed and transmitted to Congress for...

 

HTMLFederal Circuit Reverses N.Y. District Court: Claims to "Isolated" DNA Are Eligible for Patent Protection
Lewis F. Gould, Vicki G. Norton, Gretchen L. Temeles; Duane Morris LLP;
Legal Alert/Article
August 4, 2011, previously published on August 2, 2011
On July 29, 2011, the U.S. Court of Appeals for the Federal Circuit reversed in part the U.S. District Court for the Southern District of New York's ruling in Association for Molecular Pathology v. USPTO, Myriad Genetics, et al. ("Myriad") and held that claims to "isolated" DNA...

 

HTMLSupreme Court Rules That Federally Funded Inventions Are Not Automatically Owned by Universities
Lewis F. Gould, Vicki G. Norton, Gretchen L. Temeles, Nicholas A. Zachariades; Duane Morris LLP;
Legal Alert/Article
June 10, 2011, previously published on June 8, 2011
On June 6, 2011, in a case that has been closely followed by U.S. universities, the U.S. Supreme Court—in Board of Trustees of the Leland Stanford Jr. University v. Roche Molecular Systems —confirmed that rights to an invention belong to the individual inventor and held that inventions...

 


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