Legal Library: Cases and Proceedings

Mylan N.V. agreed to sell the rights and assets related to seven generic drugs in order to settle FTC charges that its proposed acquisition of Perrigo Company plc would be substantially reduce competition in the markets for those drugs if the merger proceeded as originally proposed. 

Drug Testing Compliance Group, LLC, agreed to settle charges that it illegally invited one of its competitors to enter into a customer allocation agreement in violation of Section 5 of the FTC Act.  The proposed settlement prohibits DTC Group from communicating with competitors about rates or prices (although it does not bar public posting of rates). The settlement also prohibits the company from soliciting, entering into, or maintaining an agreement with any competitor to divide markets, allocate customers, or fix prices; and from urging any competitor to raise, fix, or maintain prices, or to limit or reduce service.

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.

Wright Medical Group, Inc. and Tornier N.V. agreed to sell Tornier’s U.S. rights and assets related to its total ankle replacements and total silastic toe joint replacements to resolve FTC charges that the proposed $3.3 billion merger would illegally reduce competition for these devices. According to the complaint, the merger would likely substantially lessening competition in the U.S. markets for total ankle replacements and total silastic toe joint replacements. Under the settlement, Wright and Tornier will divest the rights and assets to these devices to Integra Lifesciences Corporation and provide Integra with intellectual property, manufacturing technology, and existing inventory, as well as other assets and assistance to ensure that Integra can effectively compete in the markets. The order also requires Wright and Tornier to supply Integra with total ankle replacements for up to three years and total silastic toe joint replacements for up to a year, while Integra transitions to become an independent competitor in these markets.

The FTC issued an administrative complaint charging that Steris Corporation’s proposed $1.9 billion acquisition of Synergy Health plc would violate the antitrust laws by significantly reducing future competition in regional markets for sterilization of products using radiation, particularly gamma or x-ray radiation. The Commission also authorized agency staff to seek a temporary restraining order and preliminary injunction in federal court to maintain the status quo pending an administrative trial on the merits. According to the FTC, it is unlikely that new competitors in the market for contract radiation sterilization services would replicate the competition that would be eliminated by the merger. The Commission alleged that the challenged acquisition would eliminate likely future competition between Steris’s gamma sterilization facilities and Synergy’s planned x-ray sterilization facilities in the United States, thus depriving customers of an alternative sterilization service and additional competition. On September 25, 2015 the district court denied the FTC motion for a PI. On October 30, the Commission dismissed the administrative complaint.

As part of a settlement, The Coca-Cola Company agreed to restrict its access to confidential competitive business information of rival Dr Pepper Snapple Group as a condition for completing Coca-Cola’s proposed $12.3 billion acquisition of its largest North American bottler, which also distributes Dr Pepper Snapple carbonated soft drinks. In a complaint filed with the settlement, the FTC charged that access to cmmercially sensitive information likely would have harmed competition in the U.S. markets for carbonated soft drinks.Under the settlement with the FTC, Coca-Cola will set up a “firewall” to ensure that its ownership of the bottling company does not give certain Coca-Cola employees access to commercially sensitive confidential Dr Pepper Snapple marketing information and brand plans.

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.

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 companies Actavis plc and Forest Laboratories, Inc. agreed to sell or relinquish their rights to four generic pharmaceuticals that treat hypertension, angina, cirrhosis, and prevent seizures to settle FTC charges that Actavis’s acquisition of Forest likely would be anticompetitive. According to the FTC’s complaint, Actavis’s acquisition of Forest, as originally proposed, would violate federal antitrust laws by reducing competition in the markets for three current generic products. In addition, the FTC’s complaint also alleges that the proposed transaction would delay the introduction of another generic drug. Under the proposed FTC settlement order, the companies have agreed to relinquish their rights to market generic diltiazem hydrochloride (AB4) to Valeant Pharmaceuticals International, Inc.; sell generic ursodiol and generic lamotrigine ODT to Impax Laboratories, Inc.; and sell generic propranolol hydrochloride to Catalent Pharma Solutions, Inc. Under the terms of the proposed settlement, Actavis and Forest must ensure the viability, marketability, and competitiveness of the drugs that are
being divested until they are sold.