A years-long patent battle brought by Momenta and Sandoz has ended in Amphastar’s favor. On Friday, a Massachusetts federal jury invalidated a Momenta patent, freeing Amphastar from the threat of almost $1 billion in damages, at least for now.
Momenta and Sandoz, which once had an exclusive hold on the market for generic enoxaparin, sued Amphastar way back in 2011. According to Amphastar’s lawyers at Wilson Sonsini Goodrich & Rosati, the plaintiffs argued during a recent trial that Amphastar’s testing method infringed a Momenta patent.
The jury verdict is the latest development in a saga that began in 2003, when Amphastar first filed for FDA approval, beating Momenta and Sandoz to the punch. The agency first sent the med back for additional studies and later clapped an import alert on Amphastar's chosen supplier, all while Amphastar wrangled in court. Since the drug's 2012 launch, the enoxaparin knockoff has suffered repeated sales declines on pricing pressures and other setbacks.
After hearing the evidence in the 2011 case, the jury disagreed with Momenta's contentions and ruled that the patent was invalid for lack of enablement and lack of an adequate written description, according to WSGR. Momenta and Sandoz wanted $938 million in damages, but won’t see any under the jury’s verdict.
It’s a big win for Amphastar, as enoxaparin remains the California drugmaker’s largest product by sales, according to a recent SEC filing. A generic of Sanofi’s clot fighter Lovenox, the med brought in $59.3 million last year, $84.5 million in 2015 and $107.5 million in 2014.
The plaintiffs aren't giving up, however. After the jury handed down its verdict, Momenta CEO Craig Wheeler said it is “considering all available legal options to overturn the verdict, including post-trial motions and appeals."
"We are disappointed in the jury's verdict and believe the facts and the law do not support these findings,” Wheeler said in a statement.
Still, according to Wells Fargo analyst David Maris, the decision puts Amphastar in “good position for further wins” if Momenta decides to appeal, “or settlement talks if the parties decide that further spending on this lawsuit is less important than the business of getting drugs approved." Maris wrote a note on the decision Friday.
Amphastar started selling its version of enoxaparin in January 2012 after legal battles with Sanofi and the two copycat makers, an FDA requirement for immunogenicity studies and a supplier’s problems with the U.S. agency, resulting in an import alert.
After filing for approval way back in March 2003, Amphastar didn’t win a U.S. green light with the injectable generic until 2011. Even after passing FDA gatekeepers, the company came under fire from Momenta and Sandoz. In 2011, those partners won an injunction against Amphastar's launch, but that decision was reversed in appeals.
In a statement, Amphastar CEO Jack Zhang said his company has “always believed that the facts and the law do not support the plaintiffs’ baseless allegations and we are very pleased that justice has prevailed.”