WASHINGTON — The Supreme Court said on Friday that it would decide whether a pharmaceutical company should be allowed to pay a competitor millions of dollars to keep a generic copy of a best-selling drug off the market.
Stephen Crowley/The New York Times
Ralph Neas, head of the Generic Pharmaceutical Association, said the case would alter the marketing of new generics.
The case could settle a decade-long battle between federal regulators, who say the deals violate antitrust law, and the pharmaceutical industry, which contends that they are really just settlements of disputes over patents that protect the billions of dollars they pour into research and development.
Three separate federal circuit courts of appeal have ruled over the last decade that the deals were allowable. But in July a federal appeals court in Philadelphia — which covers the territory where many big drug makers are based — said the arrangements were anticompetitive.
Both sides in the case supported the petition for the Supreme Court to decide the case, each arguing that the conflicting appeals court decisions would inject uncertainty into their operations.
By keeping lower-priced generic drugs off the market, drug companies are able to charge higher prices than they otherwise could. Last year, the Congressional Budget Office estimated that a Senate bill to outlaw those payments would lower drug costs in the United States by $11 billion and would save the federal government $4.8 billion over 10 years.
Senator Charles E. Grassley, an Iowa Republican who co-sponsored the Senate bill, which never came to the floor for a vote, praised the decision.
The Federal Trade Commission first filed the suit in question in 2009. Jon Leibowitz, chairman of the F.T.C., said, “These pay-for-delay deals are win-win for the drug companies, but big losers for U.S. consumers and taxpayers.”
Generic drug makers say that the payments preserve a system that has saved American consumers hundreds of billions of dollars.
“This case could determine how an entire industry does business because it would dramatically affect the economics of each decision to introduce a new generic drug,” Ralph G. Neas, president of the Generic Pharmaceutical Association, said in a statement. “The current industry paradigm of challenging patents on branded drugs in order to bring new generics to market as soon as possible has produced $1.06 trillion in savings over the past 10 years.”
The case will review a decision by the United States Court of Appeals for the 11th Circuit, based in Atlanta, which in the spring ruled in favor of the drug makers, Watson Pharmaceuticals and Solvay Pharmaceuticals. Watson had applied for federal approval to sell a generic version of AndroGel, a testosterone replacement drug made by Solvay.
While courts have long held that paying a competitor to stay off the market creates unfair competition, the pharmaceuticals case is different because it involves patents, whose essential purpose is to prevent competition.
When a generic manufacturer seeks approval to market a copy of a brand-name drug, it also often files a lawsuit challenging a patent that the drug’s originator says prevents competition.
Last year, for the third time since 2003, the 11th Circuit upheld the agreements as long as the allegedly anticompetitive behavior that results — in this case, keeping the generic drug off the market — is the same thing that would take place if the brand-name company’s patent were upheld.
Two other federal circuit courts, the Second Circuit and the Federal Circuit, have ruled similarly. But in July, the Third Circuit Court of Appeals said that those arrangements were anticompetitive on their face and violated antitrust law.
The agreements are also affected by a peculiar condition in the law that legalized generic competition for prescription drugs. That law, known as the Hatch-Waxman Act, gives a 180-day period of exclusivity to the first generic drug maker to file for approval of a generic copy and to file a lawsuit challenging the brand-name drug’s patent.
Brand-name drug companies have taken advantage of that law, finding that they can settle the patent suit by getting the generic company to agree to stay out of the market for a period of time. Because that generic company also has exclusivity rights, no other generic companies can enter the market.
Michael A. Carrier, a professor at Rutgers School of Law-Camden, said that while there were provisions in the law under which a generic company could forfeit that exclusivity, “they really are toothless in practice.”
One wild card could still prevent the Supreme Court from definitively settling the question. In granting the petition to hear the case, the Supreme Court said that Justice Samuel A. Alito Jr. recused himself, taking no part in the consideration or decision.
That opens the possibility that a 4-4 decision could result, upholding the lower court case that went against the F.T.C. and in favor of the drug makers. But it would leave the broader question for another day.
The case is Federal Trade Commission v. Watson Pharmaceuticals et al, No. 12-416.
Justices to Take Up Generic Drug Case
This article
Justices to Take Up Generic Drug Case
can be opened in url
http://successfullynews.blogspot.com/2012/12/justices-to-take-up-generic-drug-case.html
Justices to Take Up Generic Drug Case
