Search Results (2987)
Documents on pharmaceuticals
Show: results per page
|The Federal Circuit Clarifies the Scope of Protection for Process Patents|
Steven M. Amundson; Frommer Lawrence & Haug LLP;
February 1, 2013In August 2003, the Federal Circuit in Bayer AG v. Housey Pharmaceuticals, Inc. addressed the scope of 35 U.S.C. § 271(g). That provision in the patent statute concerns process patents, and it makes the importation, offer, sale, or use of a product "made" by a patented process an...
|Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants|
Aileen M. McGill; Patterson Belknap Webb & Tyler LLP;
February 1, 2013, previously published on January 2013On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from criminal prosecution in United States v. Caronia, --- F. 3d ---&under;, 2012 WL...
|FDA Releases New Rule Directing the Application of Current Good Manufacturing Practices for Combination Products|
John H. Fuson, Kevin C. Mayer; Crowell & Moring LLP;
February 1, 2013, previously published on January 30, 2013On January 22, 2013, the United States Food and Drug Administration (FDA) released a final rule clarifying which current good manufacturing practices (CGMPs) are applicable to "combination products." 78 Fed. Reg. 4307 (Jan. 22, 2013). The rule establishes 21 C.F.R. Part 4 - Regulation of...
|Another Court Holds Daubert Analysis Required When Critical to Class Certification|
Joseph J. Langkamer, Theresa E. Loscalzo; Schnader Harrison Segal & Lewis LLP;
February 1, 2013, previously published on January 2013With a split among the Circuits, no authoritative decision from the Third Circuit, and certiorari already granted by the U.S. Supreme Court on the issue, another district court has concluded that a thorough Daubert analysis is appropriate and necessary at the class certification stage when the...
|Supreme Court Declines Opportunity to Clarify Scope of Hatch-Waxman Safe Harbor|
Loeb Loeb LLP;
February 1, 2013, previously published on January 2013The U.S. Supreme Court on Jan. 14, 2013, denied GlaxoSmithKline’s petition for certiorari seeking review of the Federal Circuit’s interpretation of the Hatch-Waxman safe-harbor provision at 35 USC 271(e)(1) in Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011)....
|FDA Will Not Appeal Second Circuit Decision in U.S. v. Caronia|
Ellyn L. Sternfield; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
February 1, 2013, previously published on January 29, 2013After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug and Cosmetic Act (FDCA), I predicted in a previous post that the...
|USPTO Announces New, Higher USPTO Patent Fees|
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
January 31, 2013, previously published on January 22, 2013The USPTO has published the new patent fee structure that it is implementing pursuant to its fee-setting authority under the Leahy-Smith America Invents Act (AIA). While some patent prosecution fees are decreasing, most large entities will see their total patent prosecution fees increase. The...
|"Prevent D": New FDA Proposed Rule Seeks to Implement Preventive Food Safety System|
Robert "Rob" E. Browne, Matthew M. Morrissey, William P. Pipal, Diane J. Romza-Kutz; Troutman Sanders LLP;
January 30, 2013, previously published on January 24, 2013On January 16, 2013, the U.S. Food and Drug Administration (the “FDA”) published in the Federal Register a proposed rule designed to put into practice the goals set forth in the Food Safety Modernization Act (the “FSMA”) which was signed into law by President Obama on...
|Drug Manufacturers New to Medicare Part D: Less Than One Week Left to Ensure You Can Contract for 2014|
Mark A. McAndrew; Taft Stettinius & Hollister LLP;
January 30, 2013, previously published on January 25, 2013Under regulations issued by the Centers for Medicare and Medicaid Services (CMS) last spring, drug manufacturers that are new to the Medicare Part D program are required to have a Coverage Gap Discount Program agreement in place with CMS by January 30, 2013, to be eligible for inclusion on Part D...
|HHS Finalizes HIPAA/HITECH Rule: Dramatic Revisions to Marketing Practices and Research Authorizations|
Jeffrey N. Wasserstein; Hyman, Phelps & McNamara, P.C.;
January 29, 2013, previously published on January 22, 2013On January 17, 2013, the Office for Civil Rights of the U.S. Department of Health and Human Services announced the issuance of its much anticipated (and long-awaited) final rule (in prepublication form) relating to the modification to the HIPAA Privacy, Security and Enforcement Rules under the...