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By Kurt R. Karst – An April 21st letter penned by David Balto, a Senior Fellow at American Progress who focuses on competition policy, intellectual property law and health care,…
…exclusivity with respect to the ‘013 patent has expired.” Nostrum says in its May 27, 2011 Complaint that the June 2009 order “did not qualify as the type of order…
…shall be made effective upon the expiration of the [30-month stay] . . . or such shorter or longer period as the court may order because either party to the…
…After all, how could the agency articulate reasons for non-compliance when it had not yet decided whether to comply (that is, whether to produce all of the requested documents)? Defining…
…the Supremacy Clause to argue that the FDCA preempts the 2013 Act.” But the Court declined to adjudicate Plaintiffs’ Foreign Commerce Clause claims (and dismissed Count II of the Complaint)…
By Karla L. Palmer – A very busy House Energy and Commerce’s Subcommittee on Health (chaired by Joe Pitts (R-PA)) held a hearing earlier this week to review six bi-partisan bills intended to…
…District of Illinois. As we previously reported (here and here), the case stems from a November 2012 Complaint for Declaratory Judgment filed by Apotex, Inc. (“Apotex”) in an effort to…
…retailer QVC, Inc. The Consent Decree stems from a June 14, 2000 Federal Trade Commission (“FTC”) decision and order in which the Commission ordered QVC to cease representing certain products…
…follows: The OIRA review process under Executive Order 12866 seeks to ensure that agencies, to the extent permitted by law, comply with the regulatory principles stated in the Executive Order…
…will soon follow. An Astellas press release issued after the court’s order states that the company is evaluating its options. The district court’s Memorandum Opinion was issued on August 17th…
…their patients.” (FN 5). FDA notes that hospital compounding and distribution varies: Some compound only for use and administration within the hospital and others compound for distribution throughout a broader…
…patent covering a medical device, though such actions on a Patent Term Extension (“PTE”) request do come up from time to time (see our previous posts here and here). The…
…us quickly noticing. That recently happened when Prometheus Laboratories Inc. (“Prometheus”) filed a Complaint and a Motion for Temporary Restraining Order and/or Preliminary Injunction in the U.S. District Court for…
…44 44 Thus, it appears that the increase in early notifications to FDA that began as a result of the 2011 Executive Order (Executive Order 13588) has enabled FDA to…
…earlier and in another agency – the Federal Trade Commission. In September 2008, the FTC announced enforcement actions against 11 sellers of bogus cancer cures. One of these 11 companies…