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Justices hint at suits for drugmakers' pay-for-delay

U.S. Supreme Court justices suggested they will open drugmakers to suits over so-called pay-for-delay agreements, hinting at a ruling that would rewrite the rules governing the release of generic medicines.

FILE - In this Aug. 12, 2011 file photo, Jeremy Lazarus, president-elect of the American Medical Association (AMA) speaks in Portland, Oregon. The Supreme Court will struggle this week with whether it's legal for patent-holding pharmaceutical companies to pay rivals, who make generic drugs, to temporarily keep those cheaper versions of their brand-name drugs off the market. Now AMA President, Lazarus said in a statement,"The AMA believes that pay-for-delay agreements undermine the balance between spurring innovation through the patent system and fostering competition through the development of generic drugs. Pay for delay must stop to ensure the most cost-effective treatment options are available to patients." (AP Photo/Rick Bowmer, File)
FILE - In this Aug. 12, 2011 file photo, Jeremy Lazarus, president-elect of the American Medical Association (AMA) speaks in Portland, Oregon. The Supreme Court will struggle this week with whether it's legal for patent-holding pharmaceutical companies to pay rivals, who make generic drugs, to temporarily keep those cheaper versions of their brand-name drugs off the market. Now AMA President, Lazarus said in a statement,"The AMA believes that pay-for-delay agreements undermine the balance between spurring innovation through the patent system and fostering competition through the development of generic drugs. Pay for delay must stop to ensure the most cost-effective treatment options are available to patients." (AP Photo/Rick Bowmer, File)Read moreAP
    by By Greg Stohr, Bloomberg News, Inquirer
    Published 

U.S. Supreme Court justices suggested they will open drugmakers to suits over so-called pay-for-delay agreements, hinting at a ruling that would rewrite the rules governing the release of generic medicines.

Hearing arguments Monday in Washington, the justices voiced skepticism about the accords, which the Federal Trade Commission says cost buyers as much as $3.5 billion a year. The antitrust agency says brand-name drug companies are paying generic rivals to forestall low-priced versions of popular treatments.

The accords benefit the companies "to the detriment of consumers," Justice Elena Kagan said.

The FTC says 40 more pay-for-delay accords were struck in fiscal 2012 alone. Bayer AG, Merck & Co., and Bristol-Myers Squibb Co. units already have faced lawsuits. Companies say the accords are legitimate patent settlements.

Several justices suggested they were not comfortable with the FTC's proposed test to determine whether the accords are anticompetitive. The antitrust agency says courts should start with the presumption that a payment from a brand-name drugmaker to a generic rival is illegal. Justice Stephen Breyer called that test "rigid."

Justice Anthony Kennedy, often the court's swing vote, suggested that brand-name drugmakers at least shouldn't be allowed to pay generic companies more than the generic companies could expect to get by winning patent litigation.

The disputed settlements are a product of the economics of the pharmaceutical industry, where companies can reap billions of dollars from blockbuster drugs - and then see those sales plummet the moment a generic alternative appears. The FTC says generic drugs sell for an average of 15 percent of the original price, with the brand-name company losing 90 percent of its market share by unit sales. Generics have saved purchasers $1.1 trillion in the last decade, the industry says.

Pharmaceutical patent settlements typically arise when a generic-drug maker has either secured, or is poised to receive, Food and Drug Administration approval.