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Duane Morris LLP Boston, MA Document Search Results (7) Sort by:  | Federal Circuit Addresses Infringement of Method-of-Use Patents by Generics in Yasmin® Case
Kristina Caggiano, Vincent L. Capuano, Michele A. Kliem, Matthew C. Mousley; Duane Morris LLP;
Legal Alert/Article April 23, 2012, previously published on April 18, 2012 The U.S. Court of Appeals for the Federal Circuit on April 16, 2012, in Bayer Schering Pharma AG v. Sandoz, Inc., Nos. 2011-1143, -1228 (YASMIN®), affirmed a district court's holding that as a matter of law, generic drug makers could not infringe patent claims reciting a method of use of an...
| | U.S. Supreme Court Restores Generic Pharma's Ability to Challenge Orange Book Use Code Information
Christopher S. Kroon, Laura A. Vogel; Duane Morris LLP;
Legal Alert/Article April 23, 2012, previously published on April 19, 2012 The U.S. Supreme Court's unanimous ruling on April 17, 2012, in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S was a resounding win for both Caraco and the generic pharmaceutical industry as a whole. Specifically, the Court held that a generic manufacturer may employ the counterclaim...
| | FDA Issues Draft Guidance Documents to Implement the Biologics Price Competition and Innovation Act of 2009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on February 13, 2012 On February 9, 2012, the U.S. Food and Drug Administration (FDA) issued eagerly anticipated draft guidance documents on biosimilar product development in three installments, collectively the "Biosimilar Draft Guidances":
| | New 2012 Offshore Voluntary Disclosure Program; Taxpayer Advocate Criticizes IRS "Bait & Switch"; Current Offshore Enforcement Initiatives
Stanley A. Barg, Michael A. Gillen, Jon Grouf, Hope P. Krebs, Anthony D. Martin, Thomas W. Ostrander, Megan R. Worrell; Duane Morris LLP;
Legal Alert/Article January 26, 2012, previously published on January 24, 2012 On January 9, 2012, the Internal Revenue Service (IRS) announced that it had reopened the Offshore Voluntary Disclosure Program (OVDP) following the closure of the 2011 and 2009 programs and the collection of more than $4.4 billion USD from those programs. The third offshore program comes as the...
| | FDA 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...
| | Massachusetts Appeals Court Invalidates Mechanic's Liens Against Condo Common Areas
Michael B. Donahue, Stanley A. Martin, Robert A. Prentice; Duane Morris LLP;
Legal Alert/Article January 12, 2012, previously published on January 11, 2012 A Massachusetts Appeals Court decision last month portends far-ranging implications for the construction industry. The court ruled that a subcontractor's mechanic's lien filed against the common areas of a condominium was barred by M.G.L. c. 186A § 13—a section of the condominium...
| | First Circuit Holds That Warranty Not Exclusive Remedy When Repeated Corrective Efforts Fail
Michael B. Donahue; Duane Morris LLP;
Legal Alert/Article November 21, 2011, previously published on November 16, 2011 According to the U.S. Court of Appeals for the First Circuit in Berkshire Medical Center, Inc. v. U.W. Marx, Inc., an owner is at some point legally entitled to run out of patience, at least where defective work is concerned.
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