Pennsylvania Court Rejects Bid to Reargue Mensing Denial

Last month, we reported on the attempt by several generic manufacturers of metoclopramide to seek reargument before the Pennsylvania Superior Court on the issue of whether the claims against them are preempted under the jurisprudence of the United States Supreme Court’s opinion in PLIVA, Inc. v. Mensing and its progeny. The generic manufacturers’ bid for reargument was rejected by the Pennsylvania Superior Court last week, meaning that the Superior Court’s prior divided decision that upheld the trial court’s refusal to dismiss the claims as preempted…
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Dietary Supplement Company Slammed By FDA For Failure To Comply With CGMP

Brower Enterprises was recently hit with a warning letter from the U.S. Food and Drug Administration (FDA) that excoriates them for violating Current Good Manufacturing Practices (CGMPs). The violation of CGMPs caused a number of Brower’s products to be adulterated within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). Examples of violations of CGMPs included keeping written procedures for quality control operations, holding and distributing operations, returned dietary supplements, and product complaints. Additionally, Brower failed to comply with CGMPs because it…
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Cephalon’s Billion Dollar Patent Struck Down

On April 8, 2013, the Federal Court upheld the trial court’s judgment of invalidity and unenforceability for Cephalon’s RE’516 patent.  Cephalon’s RE’516 patent used to protect their mainstay drug – Provigil®.  Provigil® is the brand name for modafinil which is used to treat sleep disorders.  In 2007, Cephalon, now owned by Teva Pharmaceuticals, had over $800 million in sales from Provigil®. Apotex, a generic drug manufacturer, challenged the validity and enforceability of Cephalon’s RE’516 patent, in Apotex, Inc. v. Cephalon Inc.  The trial court found…
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