Legal Library: Cases and Proceedings

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.

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.

10 Companies and 10 individuals settled Federal Trade Commission allegations that their deceptive and unfair tactics violated the FTC Act and the Fair Debt Collection Practice Act. The action is part of the FTC's continuing crackdown on all players involved in phantom debt schemes, including those who sell fake debt portfolios and those who harass consumers to collect the phony debt. 

The Federal Trade Commission is sending payments totaling more than $1 million to 1,966 consumers who were harmed by a debt collection scheme that conned consumers into paying debts they did not owe. The defendants used several names including GAFS Group, Global Mediation Group, and Mediation Services.

Following a public comment period, the FTC has approved two final orders settling allegations that Creaxion Corporation, Inside Publications, LLC, and their respective principals misrepresented that paid endorsements were independent consumer opinions and that commercial advertising was independent journalistic content.

Following a public comment period, the FTC has approved two final orders settling allegations that Creaxion Corporation, Inside Publications, LLC, and their respective principals misrepresented that paid endorsements were independent consumer opinions and that commercial advertising was independent journalistic content.

The FTC is mailing 227,995 checks totaling more than $6 million to consumers who purchased health products from three individuals and the 19 companies they controlled—collectively known as Tarr, Inc. Affected consumers will receive their refund checks, which average $26.57, soon.

Office supply distributors Staples Inc. and Essendant Inc. have agreed to a settlement as part of the companies’ proposed $482.7 million merger in order to resolve Federal Trade Commission allegations that the deal may have harmed competition in the market for office supply products sold to small- and mid-sized businesses.

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:

• Watson Pharmaceuticals, Inc., a corporation, and Robin Hood Holdings Limited, a limited liability company
• Watson Pharmaceuticals, Inc. and Andrx Corporation