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FTC presses for end to drug patent payoffs

Consumers could save $3.5b, lower prescription costs

By Matthew Perrone
Associated Press / June 24, 2009
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WASHINGTON - The chairman of the Federal Trade Commission says eliminating lucrative patent settlements between brand name and generic drug companies would save consumers $3.5 billion annually.

The FTC has waged a yearslong campaign against so-called pay-to-delay settlements, in which a branded drug company rewards a generic competitor for keeping cheaper versions of its drugs off the market.

Drug makers argue the settlements are an efficient way to end costly patent litigation, but an FTC commissioner, Jon Leibowitz, said yesterday that they also deprive consumers of low-cost medicines.

“Clearly, these are win-win deals for both companies,’’ Leibowitz said in a speech in Washington. “But they leave American consumers footing the bill.’’

Leibowitz called on Congress to pass a bill that would ban the settlements. He said the legislation - currently making its way through congressional committees - could save consumers $35 billion over 10 years, about $12 billion of which would go to the government.

The federal government pays about one-third of the nation’s $235 billion in prescription drug costs through programs like Medicare and Medicaid. Because generic drugs can cost up to 80 percent less than the originals, they are seen as an easy way to lower medical expenses. Leibowitz said the pay-to-delay issue could be addressed as part of President Obama’s effort to overhaul the healthcare system.

“I see encouraging signs in the administration, in the courts, and in Congress. As the evidence mounts, there appears to be growing recognition that pay-for-delay deals should be stopped,’’ Leibowitz told an audience at the Center for American Progress, a left-leaning think tank.

Traditionally, generic drug makers challenge the patents on branded drugs in order to bring their own cheaper versions to market. But under pay-to-delay agreements, the generic drug maker settles in exchange for either cash or exclusive rights to market the first generic version later.

While the FTC criticizes such arrangements as anticompetitive, agency lawyers have a mixed track record of challenging them in court. In 2005, two appeals courts upheld agreements reached by Schering-Plough Corp. and AstraZeneca PLC with generic companies. The courts found that such settlements are permissible as long as a generic’s entry isn’t delayed past when the drug’s patent would expire.

Since then, lucrative settlements between generic and branded drug makers have flourished.

The Pharmaceutical Research and Manufacturers Association said a ban on settlements could dissuade generic drug companies from challenging patents in the first place, resulting in a slower rate of generic treatments entering the market.

“Banning reverse payment patent settlements - which often hasten generic availability - will ultimately delay generic entry in many cases,’’ Ken Johnson, the group’s senior vice president, said in a statement.

Representatives for the Generic Pharmaceutical Association had no comment.