Legal Library: Cases and Proceedings

The FTC issued an administrative complaint and authorized staff to seek a preliminary injunction to enjoin the transaction pending the results of the administrative proceeding, charging that Staples, Inc.’s proposed $6.3 billion acquisition of Office Depot, Inc. would  significantly reduce competition nationwide in the market for “consumable” office supplies sold to large business customers for their own use. The complaint alleges that, in competing for contracts, both Staples and Office Depot can provide the low prices, nationwide distribution and combination of services and features that many large business customers require. The complaint further alleges that, by eliminating the competition between Staples and Office Depot, the transaction would lead to higher prices and reduced quality, and that entry or expansion into the market – by other office supplies vendors, manufacturers, wholesalers, or online retailers – would not be timely, likely, or sufficient to counteract the anticompetitive effects of the merger. On May 19, 2016, Staples and Office Depot abandoned their proposed merger after the district court granted the Commission’s request for a preliminary injunction. FTC dismissed the case from administrative trial process.

The FTC issued an administrative complaint and authorized staff to seek a preliminary injunction to enjoin the transaction pending the results of the administrative proceeding, charging that Staples, Inc.’s proposed $6.3 billion acquisition of Office Depot, Inc. would  significantly reduce competition nationwide in the market for “consumable” office supplies sold to large business customers for their own use. The complaint alleges that, in competing for contracts, both Staples and Office Depot can provide the low prices, nationwide distribution and combination of services and features that many large business customers require. The complaint further alleges that, by eliminating the competition between Staples and Office Depot, the transaction would lead to higher prices and reduced quality, and that entry or expansion into the market – by other office supplies vendors, manufacturers, wholesalers, or online retailers – would not be timely, likely, or sufficient to counteract the anticompetitive effects of the merger. On May 19, 2016, Staples and Office Depot abandoned their proposed merger after the district court granted the Commission’s request for a preliminary injunction. FTC dismissed the case from administrative trial process.

Drug manufacturer Hikma Pharmaceuticals PLC agreed to sell the rights and assets for two generic drugs, and relinquish its U.S. marketing rights to a third generic drug, in order to settle FTC charges that its proposed $2 billion acquisition of Roxane would likely be anticompetitive. The merger would have combined two of five firms marketing prednisone tablets and two of four firms marketing lithium carbonate capsules. In the market for flecainide tablets, Roxane is currently one of only two firms with significant market share. Absent the merger, Hikma was expected to market flecainide tablets in the U.S. following FDA approval, which its partner, Unimark, is currently seeking. The order preserves competition by requiring the companies to divest to Pennsylvania-based Renaissance Pharma, Inc., three strengths of anti-inflammatory and immunosuppressant prednisone tablets and all strengths of lithium carbonate capsules, used to treat bipolar disorder. The order also requires Hikma to relinquish to its drug development partner, India-based Unimark Remedies Ltd., its equity interest as well as the rights to market flecainide acetate tablets in the United States, a drug used to prevent and treat abnormally fast heart rhythms.

Generic drug manufacturers Lupin Ltd. and Gavis Pharmaceuticals LLC agreed to sell the rights and assets for two generic drugs, in order to settle FTC charges that Lupin’s proposed $850 million acquisition of Gavis would likely be anticompetitive.The merger would have combined two of only four companies that currently market generic doxycycline monohydrate capsules in two dosage strengths, used to treat bacterial infections, likely resulting in higher prices. The merger also would have eliminated one of only a few companies likely to enter the market for  generic mesalamine extended release capsules, used to treat ulcerative colitis, in the near future, thereby delaying beneficial competition and the prospect of price decreases. Under the terms of the order, Lupin is required to transfer to G&W Laboratories all of Gavis’s rights and assets related to generic doxycycline monohydrate capsules no later than ten days after the acquisition is consummated. The order also requires that Gavis divest its rights and assets related to generic mesalamine capsules to G&W before the acquisition takes place.

Generic drug marketer Hikma Pharmaceuticals PLC agreed to divest its rights and interests in five generic injectable pharmaceuticals to settle charges that its $5 million acquisition of the rights to various drug products and related assets from Ben Venue Laboratories, Inc. would likely be anticompetitive. According to the complaint, without a remedy, Hikma’s purchase of certain generic injectables would likely harm future competition in the U.S. markets for (1) Acyclovir sodium injection: an antiviral drug used to treat chicken pox, herpes, and other related infections, (2) Diltiazem hydrochloride injection: a calcium channel  blocker and antihypertensive used to treat hypertension, angina, and arrhythmias, (3) Famotidine injection: a treatment for ulcers and gastroesophageal reflux disease, (4) Prochlorperazine edisylate injection: an antipsychotic drug used to treat schizophrenia and nausea, and (5) Valproate sodium injection: a treatment for epilepsy, seizures, bipolar disorder, anxiety, and migraine headaches. Hikma is required to divest the five generic injectable drug assets to Amphastar Pharmaceuticals, Inc., a California-based specialty pharmaceutical company that sells generic injectable and inhalation products.

Pharmaceutical companies Endo International plc and Par Pharmaceuticals, Inc. agreed to divest all of Endo’s rights and assets to generic glycopyrrolate tablets and generic methimazole tablets in order to settle FTC charges that Endo’s proposed $8 billion acquisition of Par would likely be anticompetitive. New Jersey-based generic drug marketer Rising Pharmaceuticals will acquire the divested assets. Under the settlement, Endo must supply Rising with the divested products for two years, while it transfers the manufacturing technology to Rising’s chosen third-party manufacturer. Endo also must provide technical assistance, training, and other transitional services to help Rising establish manufacturing capabilities. Without the divestitures required by the proposed order, the FTC alleges that the acquisition would combine the two most significant suppliers in the market for generic glycopyrrolate tablets, which are used with other drugs to treat certain types of ulcers, and two of only four active suppliers in the market for generic methimazole tablets, which are used to treat the body’s production of excess thyroid hormone.

Pfizer Inc. agreed to sell the rights and assets related to four pharmaceutical products in order to settle FTC charges that its proposed $16 billion acquisition of Hospira, Inc. would likely be anticompetitive. Pfizer is one of the world’s largest drug companies and principally competes with Hospira in markets for certain sterile injectable pharmaceutical products. The order requires Pfizer to supply Alvogen with the clindamycin phosphate injection product for three years while Pfizer transfers the manufacturing technology to Alvogen or its designee. Pfizer also is required to provide transitional services to Alvogen to assist with establishing manufacturing capabilities and securing FDA approvals to market all of the divested products.

Medical device company Zimmer Holdings, Inc. agreed to divest U.S. rights and assets related to unicondylar knee implants, total elbow implants, and bone cement in order to settle FTC charges that its proposed $13.35 billion acquisition of Biomet Inc. is anticompetitive. According to the complaint, Zimmer and Biomet are two of the only three substantial competitors in the U.S. markets for unicondylar knee implants and total elbow implants, and two of only four significant competitors in the U.S. market for bone cement. The order requires Zimmer to divest to Smith & Nephew the U.S. intellectual property, manufacturing technology, and existing inventory relating to its unicondylar knee implant, and to provide transitional services to help them establish manufacturing capabilities and secure necessary FDA approvals. The order also requires Biomet to divest to DJO the U.S. intellectual property, manufacturing technology, and existing inventory relating to its total elbow implant and bone cement products, and it facilitates DJO’s hiring of the Biomet sales representatives and other staff who work with these products.

Tobacco companies Reynolds American Inc. and Lorillard Inc. agreed to divest four cigarette brands to Imperial Tobacco Group to settle FTC charges that their proposed $27.4 billion merger would likely be anticompetitive. The order requires Reynolds to divest to Imperial four established cigarette brands: Winston, Kool, Salem, and Maverick. Imperial is an international tobacco manufacturer with a competitive presence in about 70 countries, but a comparatively small presence in the United States. With the acquisition of the divested assets, Imperial would become a more substantial competitor in the United States. The Commission’s order requires not only that the brands be divested, but also that Reynolds divest to Imperial the Lorillard manufacturing facilities in Greensboro, North Carolina, and provide Imperial with the opportunity to hire most of the existing Lorillard management, staff, and salesforce. It also requires the newly merged Reynolds and Lorillard to provide Imperial with retail shelf space for a short period, and to provide other operational support during the transition.

The Commission challenged major consumer electronics manufacturers Panasonic Corporation's proposed $9 billion acquisition of Sanyo Electric Co., Ltd., requiring that Sanyo sell its portable nickel metal hydride (NiMH) battery business related assets, including a premier manufacturing plant in Japan. NiMH batteries power two-way radios, among other products, which are used by police and fire departments nationwide.

Pharmaceutical companies Impax Laboratories Inc. and CorePharma, LLC agreed to divest all of CorePharma’s rights and assets to generic pilocarpine tablets and generic ursodiol tablets, in order to settle FTC charges that Impax’s proposed $700 million acquisition of CorePharma would likely be anticompetitive. Without the divestitures required by the proposed order, the FTC alleges that the acquisition would reduce the number of future suppliers in the markets for generic pilocarpine tablets, which are used to treat dry mouth, and generic ursodiol tablets, which are used to treat biliary cirrhosis, a chronic disease of the liver, as well as gall bladder diseases. CorePharma’s entry as an independent competitor would likely have resulted in significantly lower prices for each of these drugs. According to the FTC’s complaint, there are currently only two suppliers in the market for generic pilocarpine tablets, and Impax and CorePharma are the only likely new entrants into this market in the near future. In the market for generic ursodiol tablets, there are currently four suppliers, including Impax. This market
has recently experienced supply shortages, which can diminish competition among suppliers. CorePharma is one of a limited number of firms likely to enter the generic ursodiol market in the near future.

Global pharmaceutical company Novartis AG agreed to divest Habitrol, its nicotine replacement therapy patch, to settle FTC charges that its consumer health care products joint venture with GlaxoSmithKline (GSK) would likely be anticompetitive. Under the terms of the proposed joint venture agreement, GSK will control the joint venture and contribute, among other products, its nicotine patch business. Novartis will have a 36.5 percent interest in the joint venture, and without the divestitures required by the proposed order, would continue to own the Habitrol business. According to the complaint, without the divestiture contained in the proposed settlement, Novartis’s ownership of both Habitrol and a substantial interest in the joint venture that sells GSK’s nicotine patches would substantially reduce competition and lead to higher prices for Habitrol and Novartis’s private-label patches.  (C-4498)

Separately, Novartis AG also agreed to divest all assets related to its BRAF and MEK inhibitor drugs, products in development, to Boulder, Colorado-based Array BioPharma to settle FTC charges that Novartis’s $16 billion acquisition of GlaxoSmithKline’s portfolio of cancer-treatment drugs would likely be anticompetitive. According to the complaint, the Switzerland-based Novartis and the London-based GSK are two of a small number of companies with either a BRAF or MEK inhibitor currently on the market or in development, and two of only three companies marketing or developing a BRAF/MEK combination product to treat melanoma. If the acquisition goes forward as proposed, Novartis would likely delay or terminate development of both its BRAF and MEK inhibitors, as well as the combination product. Under the terms of the consent agreement, Novartis is required to provide transitional services to Array BioPharma to ensure that development of the BRAF and MEK inhibitors continues uninterrupted and that competition in BRAF and MEK inhibitor markets is not reduced. (C-4510)

Pharmaceutical companies Sun Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. agreed to divest Ranbaxy’s interests in generic minocycline tablets in order to settle FTC charges that Sun’s $4 billion proposed acquisition of Ranbaxy would likely be anticompetitive. Torrent Pharmaceuticals Ltd., a global drug company based in India that markets generic drugs in the United States, will acquire the divested assets. Under the settlement, Sun and Ranbaxy must also sell Ranbaxy’s generic minocycline capsule assets to Torrent, to enable Torrent to achieve regulatory approval for a change in ingredient suppliers for its minocycline tablets as quickly as Ranbaxy would have been able to do in the absence of the deal. In addition, Sun and Ranbaxy must supply generic minocycline tablets and capsules to Torrent until the company establishes its own manufacturing infrastructure.

Eli Lilly and Company agreed to divest its Sentinel product line of medications for treating heartworm disease in dogs in order to settle FTC charges that its proposed $5.4 billion acquisition of Novartis Animal Health would likely be anticompetitive. Under the settlement, Eli Lilly will divest its Sentinel product line and associated assets to the French pharmaceutical company, Virbac S.A. The FTC’s complaint challenging the transaction alleges that the proposed acquisition would be anticompetitive and lead to higher prices. According to the complaint, Eli Lilly’s Trifexis and Novartis Animal Health’s Sentinel products are particularly close substitutes because they are the only two products that are given orally once a month, contain the same active ingredient, and also treat fleas and other internal parasites in dogs.

The FTC required Surgery Center Holdings, Inc., known as Surgery Partners, and Symbion Holdings Corporation, to divest Symbion’s ownership interest in an ambulatory surgery center in Orange City, Florida to Dr. Mark W. Hollmann, as part of a settlement resolving charges that Surgery Partners’ $792 million purchase of Symbion would be anticompetitive. Both companies operate a large number of ambulatory surgery centers located throughout the country that sell and provide outpatient surgical services to commercial health plans and commercially insured patients. The proposed merger would have combined the only two multi-specialty ambulatory surgical centers in the Orange City/Deltona area of Florida, and would have left commercial health plans and commercially insured patients there with only one meaningful alternative to Surgery Partners’ outpatient surgical services.

Global medical technology company Medtronic, Inc. agreed to divest the drug-coated balloon catheter business of Ireland-based medical products company Covidien plc, in order to settle FTC charges that its $42.9 billion acquisition of Covidien would likely be anticompetitive. Under the FTC’s proposed settlement, Medtronic will sell the drug-coated balloon catheter business to a Colorado-based medical device company, The Spectranetics Corporation. According to the FTC’s complaint, both Medtronic and Covidien are developing drug-coated balloon catheters to compete with C.R. Bard, Inc., which currently is the only company that supplies these products, used to treat peripheral artery disease, in the U.S. market. Medtronic and Covidien are the only companies with products in clinical trials in the Food and Drug Administration’s approval process, which makes it unlikely that other competitors could enter the market in time to counteract the effects of the merger.

Pharmaceutical company Prestige Brands Holdings, Inc., the maker of Dramamine, agreed to divest assets and marketing rights for the over-the-counter motion sickness drug Bonine to settle FTC charges that Prestige’s proposed acquisition of Insight Pharmaceuticals Corporation would likely be anticompetitive. Prestige proposed to acquire Insight for $750 million. According to the FTC’s complaint, Prestige’s Dramamine, which is the best-selling branded product in the market for over-the-counter motion-sickness drugs, and Insight’s Bonine, are the only two branded products with significant sales. Absent a remedy, the acquisition would eliminate the close competition between Dramamine and Bonine, likely leading to higher prices for consumers.