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FTC Study Finds that in FY 2011, Pharmaceutical Industry Continued to Make Numerous Business Deals that Delay Consumers' Access to Lower-Cost Generic Drugs
Date:10/25/2011

tudy has found that patent settlements that include a payment or other compensation delay generic entry on average by 17 months longer than those that do not include a payment.  According to the Congressional Budget Office, proposed legislation would reduce the federal deficit by $2.67 billion over 10 years.

The FTC has challenged a number of these patent settlement agreements in court, contending that they are anticompetitive and violate U.S. antitrust laws.  The agency also has supported legislation in Congress that would prohibit pay-for-delay settlements that increase the cost of prescription drugs.

According to the new staff report, companies reached a total of 156 final patent settlements in FY 2011.  Twenty-eight settlements contained a payment to a generic manufacturer and also restricted the generic's ability to market its product.  Of those 28 settlements, 18 involved generics that were so-called "first filers," meaning that they were the first to seek FDA approval to market a generic version of the branded drug, and, at the time of the settlement, were eligible to exclusively market the generic product for a period of time.  Because of the regulatory framework, when first filers delay entering the market, other generic manufacturers can also be blocked from entering the market, which makes such patent settlement deals particularly harmful to consumers.

The report summarizes data on patent settlements filed with the FTC and the Department of Justice during FY 2011 under the Medicare Modernization Act of 2003.

The FTC's Bureau of Competition works with the Bureau of Economics to investigate alleged anticompetitive business practices and, when appropriate, recommends that the Commission take law enforcement action.  To inform the Bureau about particular business practices, call 202-326-3300, send an e-mail to antitrust{at}ftc{dot}gov, or write to the Office of Policy and Coordination, Bureau of
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SOURCE Federal Trade Commission
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