Tag: Prescription Drugs

Bristol-Myers Squibb Company (BMS) settled charges that it engaged in illegal business practices to delay the entry of three low price generic pharmaceuticals that would be in direct competition with three of its branded drugs. The complaint alleged that BMS purposely made wrongful listings in the Orange Book of the U.S. Food & Drug Administration and that it also paid a potential competitor over $70 million to delay the entry of its generic drug. The three drugs involved in the complaint are: Taxol (containing the active ingredient paclitaxel) – used to treat ovarian, breast, and lung cancers; Platinol (containing the active ingredient cisplatin) – used for the treatment of various forms of cancer; and BuSpar (containing the active ingredient buspirone) – used to manage anxiety disorders. To prevent recurrence of Bristol's pattern of alleged improper listings, the consent order eliminates Bristol's ability to obtain a 30-month stay on later-listed patents. By denying Bristol the benefit of the 30-month stay on later-listed patents, the order would reduce Bristol's incentive to engage in improper behavior before the PTO and the FDA to obtain and list a patent for the purpose of obtaining an unwarranted automatic 30-month stay.

In the complaint dated March 30, 2001 the Commission alleged that Schering - Plough, the manufacturer of K-Dur 20 - a prescribed potassium chloride, used to treat patients with low blood potassium levels - entered into anticompetitive agreements with Upsher-Smith Laboratories and American Home Products Corporation to delay their generic versions of the K-Dur 20 drug from entering the market. According to the charges, Schering-Plough paid Upsher- Smith $60 million and paid American Home Products $15 million to keep the low-cost generic version of the drug off the market. The charges against American Home Products were settled by a consent agreement. An initial decision filed July 2, 2002 dismissed all charges against Schering - Plough and Upsher-Smith Laboratories. On December 8, 2003 the Commission reversed the administrative law judge’s initial decision and found that Schering-Plough Corporation entered into agreements with Upsher-Smith Laboratories, Inc. and American Home Products to delay the entry of generic versions of Schering’s branded K-Dur 20. According to the opinion, the parties settled patent litigation with terms that included unconditional payments by Schering in return for agreements to defer introduction of the generic products. The Commission entered an order that would bar similar conduct in the future. The United States Court of Appeals for the Eleventh Circuit set aside and vacated the Commission decision finding that the agreements were immune from antitrust review if their anticompetitive effects were within the scope of the exclusionary potential of the patent. The Commission filed a petition for writ of certiorari with the U.S. Supreme Court in August 2005, which the Court denied.

Consent order requires divestiture of Baxter's Autoplex product line of Factor VIII inhibitors used in the treatment for hemophilia and the licensing of Immuno International AG's fibrin sealant, a biologic product in development to be used to control bleeding in surgical procedures. According to the complaint issued with the final order, the acquisition of Immuno International would tend to create a monopoly and increase Baxter's ability to unilaterally raise prices in the market for the research, manufacture and sale of biologic products derived from human blood plasma.

A final consent order permits Pfizer Inc.'s acquisition of Phamacia Corporation while requiring the divestiture of various products including extended release drugs used in the treatment of an overactive bladder; hormone replacement therapies; erectile dysfunction; canine arthritis; and motion sickness. Novartis AG, Neurocrine Biosciences, Inc., Schering-Plough Corporation, Johnson & Johnson, Insight Pharmaceuticals Corporation, and Cadbury Schweppes are named in the order as potential buyers of the various pharmaceuticals and products.

Baxter settled Commission concerns stemming from its $316 million proposed acquisition of Wyeth Corporation's generic injectable drug business and agreed to divest several pharmaceutical products. The Commission charged that the acquisition would reduce competition in the manufacture and sale of propofol (a general anesthetic); new injectable iron replacement therapies; metocloprarnide (used to treat nausea); and vecuronium and pancuronium (neuromuscular blocking agents used to temporarily freeze muscles during surgery). The consent order requires divestitures in each of the pharmaceutical markets.

Amgen settled antitrust charges that its proposed $16 billion acquisition of Immunex Corporation would reduce competition and tend to create a monopoly in the biopharmaceutical markets for neutrophil (white blood cell) regeneration factors; tumor necrosis factor (TNF) inhibitors; and interleukin-1 (IL-1) inhibitors. The consent order requires the firms to sell all of Immunex's assets related to Leukine -a neutrophil regeneration factor -to Schering AG; license certain intellectual property rights to TNF inhibitors to Serono S.A.; and license certain intellectual property rights related to IL-1 inhibitors to Regeneron Pharmaceuticals Inc.

The Commission charged Biovail Corporation with illegally acquiring an exclusive patent license for Tiazac, a pharmaceutical used to treat high blood pressure and chronic chest pain. The complaint further alleged that Biovail, in an effort to maintain its monopoly, wrongfully listed the acquired license in the U.S. Food and Drug Administration’s “Orange Book” for the purpose of blocking generic competition to its branded Tiazac. The consent order requires Biovail to divest part of its exclusive rights to DOV; prohibits the firm from taking any action that would trigger additional statutory stays on final FDA approval of a generic form of Tiazac; and also prohibits Biovail from wrongfully listing any patents in the Orange Book for a product for which the company already has an New Drug Application from the FDA.

Roche agreed to divest, certain assets in the U.S. and Canada to settle antitrust concerns stemming from its proposed acquisition of Corange Limited. The consent order permits the acquisition but requires the divestiture of Cardiac thrombolytic agents (drugs used to treat heart attack victims) and ongoing business assets relating to chemicals used to test for the presence of illegal or abused drugs.

The Commission negotiated an agreement with The Hearst Corporation (Hearst) to settle a permanent injunction action filed by the FTC alleging that Hearst failed to provide documents required by premerger notification law and then consummated a merger that monopolized the integrated drug information database market. Under the terms of the order, Hearst divested the Medi-Span business to Lippincott Williams & Wilkins, Inc. , a subsidiary of Wolters Kluwer, n.v., disgorged $19 million in profits, and to complied with certain other obligations.

A consent order settled allegations in an administrative complaint that charged that Hoechst agreed to pay Andrx Corporation millions of dollars not to market and distribute a generic version of Hoechst’s branded Cardizem CD, a once-a-day diltiazem drug product used in the treatment of hypertension and angina. The consent order prohibits the companies from entering into agreements designed to restrict the entry of generic competitors in an attempt to monopolize relevant markets .

Under terms of a final consent order settling charges stemming from the merger of SmithKline and Glaxo Wellcome plc, the parties agreed to divest pharmaceutical products in six markets: antiemetics; the antibiotic, ceftazidime; oral and intravenous antiviral drugs for the treatment of herpes; topical antiviral drugs for the treatment of genital herpes; and over-the-counter H-2 blocker acid relief products.

Complaint filed in the U.S. District Court for the District of Columbia charged Mylan with restraint of trade, monopolization and conspiracy to monopolize the market for two generic drugs used to treat anxiety, lorazepam and clorazepate, through exclusive dealing arrangements.  The Commission alleged that Mylan, Gyma Laboratories of America, Inc., Cambrex Corporation and Profarmaco S.R.L. conspired to deny Mylan’s competitors ingredients necessary to manufacture lorazepam and 40 clorazepate. The complaint sought consumer redress of at least $120 million and to enjoin the alleged illegal exclusive licensing agreements. The district court upheld the Commission’s authority to seek restitution in antitrust injunction actions under Section 13(b).  The Commission approved a $100 million settlement. The opinion settled Commission concerns that Mylan, Gyma Laboratories of America, Inc., Cambrex Corporation and Profarmaco S.R.L. conspired to deny Mylan’s competitors ingredients necessary to manufacture lorazepam and 40 clorazepate. On Feburary 1, 2002, the court granted approval to a plan of distribution to injured consumers who paid the increased prices and state agencies, including Medicaid programs, that purchased the drugs while the illegal agreements were in effect. The funds were distributed by the states.

Final consent order permits Pfizer’s merger with Warner-Lambert Company and requires divestitures in several pharmaceutical markets including: Pfizer’s RID brand of head lice treatment; Pfizer’s antidepressant drug, Celexa; Warner’s Cognex, a drug used in the treatment of Alzheimer’s disease; and assets relating to the Epidermal Growth Factor receptor tryosine kinase inhibitor - drugs under development to treat solid cancerous tumors such as head and neck, non-small cell lung, breast, ovarian, pancreas and colorectal cancers.

Abbott and Geneva Pharmaceuticals settled charges that the two firms entered into an illegal agreement to stop the marketing and development of a competing generic drug. According to the complaint, Abbott, manufacturer of Hytrin – the brand name for terazosin HCL, a prescription drug used to treat hypertension and benign prostatic hyperplasia, entered into an agreement with Geneva Pharmaceuticals whereby Abbott would pay Geneva millions of dollars not to market a generic version of Hytrin. The orders bars Abbott and Geneva, among other things, from entering into agreements in which a generic company agrees with a manufacturer of a branded drug to delay or stop the production of a competing drug.

Consent order, resolving antitrust concerns relating to Zeneca's merger with Astra AB requires the divestiture of all assets relating to levobupivacaine, a long-acting local anesthetic. The assets were sold to Chiroscience Group plc, the developer of levobupivacaine.

The complaint, issued with the consent order, alleged that as a result of Merck's 1993 acquisition of Medco, the nation's largest benefits manager, Merck's drugs received favorable treatment through Medco's drug-list formulary made available to medical professionals who prescribe and dispense prescriptions to health plan beneficiaries. The consent order requires Medco, among other things, to maintain an "open formulary" to include drugs approved by an independent Pharmacy and Therapeutics Committee, staffed by physicians and pharmacologists who have no financial interest in Merck.