Published April 29, 2011 in Drug Industry Daily
A federal judge harshly questioned Mylan’s standing to sue the FDA in efforts to wedge itself into the 180-day exclusivity period for a generic version of the blockbuster drug Lipitor.
Judge James Boasberg of the U.S. District Court in Washington D.C., questioned Mylan’s standing during a hearing Thursday, noting the generic-drug maker has neither first-filer status nor a tentative ANDA approval for generic Lipitor (atorvastatin).
Mylan filed a lawsuit against the FDA in the court last month to force the agency to rule on Ranbaxy’s ANDA for generic Lipitor. The generic-drug maker believes Ranbaxy’s right to generic exclusivity is nullified by the company providing false data to the FDA in past ANDAs (DID, March 22).
Mylan claims first-filer status, which otherwise belongs to Ranbaxy, would then be granted to the next in line, which the company believes it is. The FDA has asked the case be thrown out (DID, April 8).
However, Boasberg noted that in previous cases, plaintiffs could state injury from the FDA’s inaction on ANDAs because they had either tentative approval or sought FDA action on their ANDA.
“In this case, it’s not your ANDA you’re seeking action on, and you’re not the first filer,” Boasberg said. “Why are you coming to federal court to force the FDA to take action on their ANDA?”
Doug Farquhar, an attorney with Hyman, Phelps & McNamara representing Mylan, admitted he could find no other cases where a drugmaker successfully sued when it lacked such a position.
“I don’t think I know of such a case, but I also must say, your Honor, I don’t think there has ever been such a case like this,” Farquhar said. “There are multiple cases where courts have told FDA where companies can challenge another company’s exclusivity.”
Pfizer’s Lipitor — the best-selling drug in the world — took in $7.2 billion in sales last year. The drug loses exclusivity in November.
Farquhar called the launch of generic Lipitor possibly the largest generic launch in history both for volume and sales.
Mylan hinges its case on the enormity of Lipitor sales, and the lengthy period — nine years — the FDA has delayed a decision on Ranbaxy’s ANDA, well beyond the granted 180 days the agency has to act.
“This has to stop,” Farquhar told the court. “It’s more than 18 times past the statutory deadline for the FDA to make a decision.”
“There is absolutely no precedent to do what Mylan is asking to do,” Justice Department attorney Andrew Clark countered. “The fact that they don’t have tentative approval deems no harm.”
Not every ANDA filed is granted approval. “The FDA expects to be able to make a decision on exclusivity at the proper time,” Clark said.
Boasberg said he would issue an opinion in the case by Monday. After the companies tell him what they hope to remain private in the opinion, the ruling would become public later next week.
Judges in the D.C. federal court have recently taken a hard stance on when drug companies can sue the FDA.
Less than two weeks ago, a judge dismissed a case against the FDA brought by ViroPharma which claimed the agency wrongly changed its bioequivalence testing standards for a generic version of a ViroPharma product. The judge ruled the drugmaker lacked serious financial impact because of the FDA’s actions (DID, April 21). — David Pittman