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In a recent policy reversal, the Department of Justice has, for the first time, pursued antitrust liability for “reverse payment” settlements. These settlements occur in the pharmaceutical industry when brand-name and generic drug companies settle patent-infringement litigation. In a reverse-payment settlement, the generic drug company agrees not to enter the market for some period of time and the patent holder agrees to give it something of value—often quarterly cash payments. The DOJ claims that such settlements should be analyzed under the rule of reason but in fact seeks an unwarranted presumption that reverse payments are unreasonably anticompetitive. At first glance, reverse-payment settlements do seem bad— they resemble anticompetitive market-division arra...
A divisive practice is roiling the generic pharmaceutical industry, with some companies saying consumers are losing out. The practice involves "authorized generics," which are basically brand drugs with a generic label. A brand pharmaceutical company supplies its drug to a generic firm and allows that firm to market the product as a generic in return for royalties. Brand companies also have used their own generic divisions to launch authorized generics.
SCOTUS Decision in Pliva v. Mensing Affects 70 Percent of All Drug Prescriptions WASHINGTON, June 23, 2011 /PRNewswire-USNewswire/ -- Today's U.S. Supreme Court decision in Pliva v. Mensing is a disastrous outcome for patient safety, giving generic drug companies legal immunity when they ignore harmful side-effects of the drugs they manufacture and profit from. This decision eliminates any incentive for generic manufacturers to ensure their drug is safe and adequately warn consumers of their drugs' potential dangers.
Schumer called the Merck-UnitedHealth deal "highly disturbing and and-competitive." He charged that such agreements will discourage expensive patent challenges by generic drug companies, leaving consumers with fewer and costlier drug choices in the long-run. "This could close the door on future generics," said Schumer. "It's a desperate move to keep prices high and generics out of the market.
Lilly has filed lawsuits against seven generic drug companies in federal court in Indianapolis, asking a judge to declare its Cymbalta patent valid and to tell the generic companies to back off. Charles Anthony Butler, a pharmaceutical analyst at Barclays Capital, agrees that generic drugmakers have been more aggressive in the last decade, particularly since Barr Laboratories' 2000 victory over Lilly that broke the patent on the iconic antidepressant Prozac.
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