GREENBELT, Md. (Legal Newsline) – Genus Lifesciences’ attempt to use litigation to corner the market on a cocaine-based anesthetic must fail, the federal government is telling a federal judge.
The U.S. Food and Drug Administration and the Department of Health and Human Services filed a motion to dismiss Jan. 15 in Maryland federal court. They are named defendants in Genus’ lawsuit over the approval of a competitor’s anesthetic.
That lawsuit says an error on Lannett Company’s application – that its Numbrino would be manufactured in Wyoming even though it is being produced in New York – should void the FDA’s approval of the drug.
It is one of multiple lawsuits Genus has filed in its attack on Numbrino. Lannett is intervening in the case.
“Genus lacks constitutional standing, prudential standing, and third-party standing,” the feds argue. “Simply having Lannett as a competitor is not a direct injury that provides standing. Genus alleges harm related to the safety and efficacy of Lannett’s drugs, but any such harm is disconnected from the allegedly untrue statements in Lannett’s NDA.”
The feds want the judge hearing the case to “understand the larger implications” of Genus’ strategy.
“Under Genus’s theory, a company can force an agency to investigate a competitor for any potential violation based on the company’s perception that the agency has exercised its discretion not to act,” the motion says.
“Multiple legal hurdles prevent Genus from bringing such litigation for good reason. If such actions were allowed to proceed, it could cripple FDA’s operations. Drug companies would scour their competitors’ applications and attempt to force FDA to investigate every statement that the companies could spin as ‘untrue.’
“If forced to pursue every such hunch, FDA’s limited resources would be diverted from protecting the public health to investigating the enforcement whims of drug companies.”