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Fresenius Medical Care and NxStage Medical, In the Matter of

The FTC required healthcare companies Fresenius Medical Care AG & KGaA and NxStage Medical, Inc. to divest all rights and assets related to NxStage’s bloodline tubing set business to B. Braun Medical, Inc. as part of a settlement resolving charges that Fresenius’s proposed $2 billion acquisition of NxStage likely would be anticompetitive. The FTC’s complaint alleges that the proposed merger would harm competition in the U.S. market for bloodline tubing sets that are compatible with hemodialysis machines used in clinics that treat chronic renal failure. Bloodline tubing sets are single-use plastic tube sets used during hemodialysis treatments. Fresenius and NxStage are two of only three significant suppliers of bloodline tubing sets used in open architecture hemodialysis machines in the United States. Fresenius and NxStage together control 82 percent of the market for bloodlines.The settlement requires Fresenius and NxStage to divest to B. Braun all assets and rights to research, develop, manufacture, market, and sell NxStage’s bloodline tubing sets.

Type of Action
Administrative
Last Updated
FTC Matter/File Number
171 0227
C-4671

FTC Chairman Releases 2018 Annual Highlights

Date
Federal Trade Commission Chairman Joe Simons released the agency’s 2018 Annual Highlights today, highlighting the FTC’s ongoing efforts to protect the interests of consumers and promote a competitive...

Watson Pharmaceuticals, Inc., et al. (FTC v. Actavis)

On 2/2/2009, the Commission filed a complaint in federal district court challenging and agreement between Solvay Pharmaceuticals and two generic drug manufacturers in which Solvay paid for the delayed release of generic equivalents to its own testosterone-replacement drug, AndroGel, typically used in the treatment of men with low testosterone levels due to advanced age, certain cancers, and HIV/AIDS. According to the Commission’s complaint, in an effort to prevent Watson Pharmaceuticals and Par Pharmaceuticals from acquiring patents for their competing testosterone replacement drugs, Solvay paid the companies to delay entry for a nine year period, ending in 2015. 

This case was transferred from the United States District Court for the Central District of California to the Northern District of Georgia.  The district court dismissed the Commission's complaint, and the Eleventh Circuit affirmed, holding that anticompetitive effects within the scope of patent protection are per se legal under the antitrust laws.

On 10/4/2012, the FTC filed a writ of certiorari to the Supreme Court.  On June 17, 2013, the Supreme Court reversed the 11th Circuit, rejecting the scope of the patent test and permitting antitrust review of reverse payment patent settlement agreements.

There are three related administrative proceedings:

Type of Action
Federal
Last Updated
FTC Matter/File Number
071 0060

Allergan, Watson and Endo

The FTC's complaint alleges that Endo Pharmaceuticals Inc. and several other drug companies violated antitrust laws by using pay-for-delay settlements to block consumers’ access to lower-cost generic versions of Lidoderm.  The agreement not to market an authorized generic – often called a “no-AG commitment” – is the form of reverse payment.  The FTC’s complaint alleges that Endo paid the first generic companies that filed for FDA approval – Watson Laboratories, Inc. – to eliminate the risk of competition for Lidoderm, in violation of the Federal Trade Commission Act.  Lidoderm is a topical patch used to relieve pain associated with post-herpetic neuralgia, a complication of shingles.  Under federal law, the first generic applicant to challenge a branded pharmaceutical’s patent, referred to as the first filer, may be entitled to 180 days of exclusivity as against any other generic applicant upon final FDA approval. But a branded drug manufacturer is permitted to market an authorized generic version of its own brand product at any time, including during the 180 days after the first generic competitor enters the market. According to the FTC, a no-AG commitment can be extremely valuable to the first-filer generic, because it ensures that this company will capture all generic sales and be able to charge higher prices during the exclusivity period.  The FTC is seeking a court judgment declaring that the defendants’ conduct violates the antitrust laws, ordering the companies to disgorge their ill-gotten gains, and permanently barring them from engaging in similar anticompetitive behavior in the future.

Endo agreed to settle the charges in a proposed stipulated order to be entered by the court.

Type of Action
Federal
Last Updated
FTC Matter/File Number
141 0004

Cephalon, Inc.

On 2/13/2008, the Commission filed a complaint in federal district court charging Cephalon, Inc. with preventing competition to its branded drug Provigil. The conduct under challenge includes paying four firms to refrain from selling generic versions of Provigil until 2012. Cephalon’s anticompetitive scheme, according to the Commission, denies patients access to lower-cost, generic versions of Provigil and forces consumers and other purchasers to pay hundreds of millions of dollars a year more for Provigil. According to the complaint, Cephalon entered into agreements with four generic drug manufacturers that each planned to sell a generic version of Provigil. Each of these companies had challenged the only remaining patent covering Provigil, one relating to the size of particles used in the product. The complaint charges that Cephalon was able to induce each of the generic companies to abandon its patent challenge and agree to refrain from selling a generic version of Provigil until 2012 by agreeing to pay the companies a total amount in excess of $200 million. In so doing, Cephalon achieved a result that assertion of its patent rights alone could not. In 2008, this case was transferred from the District Court of District of Columbia to the District Court for the Eastern District of Pennsylvania.

Type of Action
Federal
Last Updated
FTC Matter/File Number
061 0182

Watson Pharmaceuticals / Actavis Inc., In the Matter of

The FTC required Watson Pharmaceuticals, Inc. and Actavis Inc. to sell the rights and assets to 18 drugs to Sandoz International GmbH and Par Pharmaceuticals, Inc, and relinquish the manufacturing and marketing rights to three others, to settle charges that Watson’s proposed $5.9 billion acquisition of Actavis would otherwise be anticompetitive. The settlement protects competition in the markets for 21 current and future generic drugs, used to treat a wide range of conditions ranging from hypertension and diabetes to anxiety and attention deficit hyperactivity disorder (ADHD).

There is a related federal proceeding and two related administrative proceedings:

Type of Action
Administrative
Last Updated
FTC Matter/File Number
1210132
Docket Number
C-4373