AbbVie subsidiary Forest Laboratories has been battling in the courts for seven years over its efforts to extend patents for its Alzheimer's drug Namenda. But with a new ruling, the fight is set to drag on longer as the sides prepare for a jury trial next year.
In a suit brought by pension fund the Sergeants Benevolent Association (SBA) Health & Welfare Fund, AbbVie's Forest Labs faces claims that it made unlawful pay-for-delay deals to keep generic versions of its Alzheimer’s disease drug Namenda off the market.
The fund had sought summary judgement against Forest for its “unlawful maintenance of monopoly power," court filings show. On Friday, U.S. District Judge Colleen McMahon rejected the motion as well as a bid by Forest and fellow defendant Merz Pharmaceuticals to throw the suit out.
There are “myriad factual disputes” which make a quick resolution impossible, Judge McMahon wrote in her order. Those disputes surround a settlement Forest made with generic drugmaker Mylan to manufacture a generic version of its antidepressant Lexapro.
“Fundamentally, the parties dispute whether the reverse-payment settlements were anticompetitive and—if they were anticompetitive—whether they caused a delay in generic competition,” McMahon wrote. “But since they are disputes of fact including, but not necessarily limited to, the issues of the ‘fair value’ of the Lexapro Amendment and causation, these cross-motions for summary judgement are denied—just as they were in the direct-purchaser case.”
The court will apply for a trial date in the first quarter of 2022, McMahon said.
In a small win for Forest, one aspect of the suit that will not go forward is SBA’s claim that the company illegally executed a “hard switch,” moving patients from Namenda to a timed-release version of the drug, Namenda XR, to retain monopoly power.
Forest first came under fire for its management of Namenda in 2014 when it was accused of the “hard switch,” also known as “product hopping,” when it pulled the drug off shelves before its patent expired, compelling users to shift to the more expensive and patent-protected version, Namenda XR.
When purchasers sued Forest, saying the scheme was illegal under antitrust law, the company threatened to take the case all the way to the Supreme Court.
In 2015, Forest agreed to stop the switch and pay litigation fees in exchange for dropping its legal defense.
By then, generic drugmakers Dr. Reddy’s and Mylan had brought their cheaper versions of Namenda to the market. But purchasers came at Forest again, claiming they had paid too much for the drug because of the company’s actions to delay the generic rollout.
In October of 2019, Forest avoided an oncoming trial with a $750 million settlement.
Namenda’s sales plummeted during the litigation, dropping from $899 million in 2014 to $71 million in 2018. Sales of its follow-on, Namzaric, have been weak, declining each year from $116 million in 2018.
AbbVie acquired Forest through its massive purchase of Allergan.